Aging, PrematureSNAPNCT05678660

Study of Neurological Aging Among People Living With HIV

An observational study of Aging, Premature, run by University of Rochester at 3 sites in Zambia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

A prospective, exposure-control cohort study of older adults living with HIV comparing the neurological status of those who have had HIV infection for a longer period of time (long HIV group) to age, gender, and community-matched comparison group who have had HIV infection for a shorter period of time (short HIV… Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Aging, Premature
How many people: 298 participants
Where: 3 sitesZambia
Study dates: 6 Jul 2022to 30 Apr 2027
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Potential participants will be identified through the antiretroviral clinics associated with Chikankata Hospital and Monze Mission Hospital in Zambia's Southern Province. Individuals will first be identified in the long group and will then be matched to a PLWH in the short group matching based upon gender, age and community of residents

Who may be able to join

For the short group, stable on ART for 1 year, but no more than 2 years.
For long group, on ART for 7 or more years

Who cannot join

Acute medical illness.
Decisional impairment precluding informed consent as noted by clinicians providing care to the patient or by the research staff team members.
Communication impairments-unable to hear or unable to speak.
Being unable to communicate in English or in the dominant language at the study site (Tonga).

Trial locations and contacts

3 sites in 1 country.

Zambia3 sites

Chilenje Level 1 Hospital
Lusaka
Chikankata Hospital
Mazabuka, Southern Province
Monze Mission Hospital
Monze, Southern Province

Other trials in Zambia

About this study

Official title: Study of Neurological Aging Among People Living With HIV (SNAP)

Read the detailed description

There is a substantial body of evidence that individuals with long-standing HIV infection experience accelerated neurological aging and prospective lifespan studies that incorporate neuropsychological and imaging outcomes are needed. Elevated risks of cerebrovascular disease are evident throughout the life course of persons living with HIV. Stroke risks are clearly increased in the first few months after antiretroviral initiation. Autopsy studies of adults with HIV 24-48 years of age showed all have vascular changes, specifically lymphocytic perivascular infiltration, thickening of arterial and arteriolar walls, widened perivascular space, hypertrophy of the vascular muscle layers and perivascular amyloid deposition. Even when excluding individuals with a history of stroke, cerebrovascular disease risk factors are associated with decreased cognitive capacity in persons with HIV. Basal ganglia enhancement on MRI indicative of decreased regional cerebral blood flow and blood brain barrier breakdown is associated with HIV dementia.

HIV-associated neurocognitive disorder is another manifestation of accelerated aging. Using diffusion tensor imaging and data from healthy controls to calculate an "brain age gaps" in individuals with HIV infection, the "brain age gap", is associated with plasma viral load and cognitive function. In an autopsy study comparing HIV+ persons age 36-60 years with age-matched controls, HIV showed increased amyloid beta immunostaining. The accumulation of these proteins may be one possible mechanisms of accelerated aging in HIV. Some have proposed that BBB breakdown secondary to vascular dysfunction may contribute to this deposition. Distal sensory polyneuropathy (DSPN), a common neurological comorbidity in HIV that also increases in frequency with age in HIV negative individuals. Despite extensive diagnostic evaluations, ~40% of people with a DSPN will have no clear underlying cause identified. DSPN is more common and complex in African population with additional underlying etiologies being medication toxicities and nutritional deficiencies.In the RAAZ study, investigators identified a high prevalence of DSPN among HIV infected individuals prior to ART initiation which is associated with low body mass index and food insecurity. More recent neuropathy studies have shown that folate deficiency may play a role in DSPN in Zambia with HIV+ individuals being especially susceptible. Epilepsy incidence shows a bimodal age distribution with the increased incidence of seizures and epilepsy in the elderly attributed to the increase of age-related and aging-related epileptogenic conditions. While the overall prevalence of epilepsy can be expected to increase with advanced age in HIV, identifying risk factors for this among persons for epilepsy among those with controlled systemic disease may offer important insights into the pathophysiology.

HIV-associated accelerated aging of the nervous system is thought to be related to ongoing low grade inflammation in the setting of treated HIV. Poor CNS penetration of some antiretroviral therapies (ARVs) has also been proposed as one problem contributing to neurological morbidity in systemically controlled HIV. ARV neurotoxicity is also important. Multiple studies have highlighted both the short and long term neurotoxicity of efavirenz. Darunavir and ritonavir may increase the risk of aging-related cerebral degeneration. Heneka 2020 proposed that COVID survivors may be at increased risk of neurological disorders due to direct negative effects of SARS-CoV-2, acceleration of pre-existing problems or de novo induction of neurodegenerative process. Poor complex motor performance in persons with HIV is associated with higher inflammatory burden. A recent report from Ghana found stroke admissions and mortality rates have increased since SARS-CoV-2's arrival.

In the SNAP Study, the investigators will utilize the existing consortia of neuro-HIV rural study sites to enroll 150 HIV+ adults >45 years of age stable on ARVs for at least 7 years and an age, gender, and community-matched comparison group of HIV+ adults stable on ARVs for 1-2 years. These individuals will undergo annual assessments for 6 years to evaluate their general and neurological health and the aging process that evolves during the 6 years of assessments.

Understanding whether or not PLWH experience accelerated aging of the nervous system will provide critical insights for health services planning as antiretroviral therapies allow PLWH to live into middle and late years. Identifying risk factors for specific neurologic aging issues will guide clinical care and screening and may inform regarding the pathophysiological mechanisms involved including the possibility that some therapies contribute to the long-term neurotoxicity of the condition.

Conditions: Aging, Premature
Keywords: frailty, cognitive impairment, neuropathy, mental health, antiretroviral toxicity
Medical subject headings: Aging, Premature, Frailty, Cognitive Dysfunction, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05678660
Study group	Role	What they receive
Long Group		Older adults individuals with longstanding HIV, stable and on antiretroviral therapy for at least 7 years
Short Group		Older adults living with HIV, on stable antiretroviral treatment for at least 1 but not more than 2 years,

What is being measured

The primary outcome is the main question the study is designed to answer.

Cognition - Zambian Mini-Mental Status Examination (zMMSE) - During enrollment
The zMMSE is an adaptation of the well-known MMSE which provides single summary score with a maximum of 30 points
Measured: baseline/during enrollment
Cognition - Zambian Mini-Mental Status Examination (zMMSE) - on Year 1 of evaluation
The zMMSE is an adaptation of the well-known MMSE which provides single summary score with a maximum of 30 points
Measured: Year 1 evaluation
Cognition - Zambian Mini-Mental Status Examination (zMMSE) - on Year 2 of evaluation
The zMMSE is an adaptation of the well-known MMSE which provides single summary score with a maximum of 30 points
Measured: Year 2 evaluation
Cognition - International HIV Dementia Scale (I-HDS) - on Year 3 of evaluation
The IHDS assesses registration, recall, motor speed and psychomotor speed and provides a single summary score of a maximum of 12 points
Measured: Year 3 evaluation
Cognition - International HIV Dementia Scale (I-HDS)- on Year 4 of evaluation
The IHDS assesses registration, recall, motor speed and psychomotor speed and provides a single summary score of a maximum of 12 points
Measured: Year 4 evaluations
Cognition - International HIV Dementia Scale (I-HDS) - on Year 5 of evaluation
The IHDS assesses registration, recall, motor speed and psychomotor speed and provides a single summary score of a maximum of 12 points
Measured: Year 5 evaluation
Cognition - International HIV Dementia Scale (I-HDS)- on Year 6 of evaluation
The IHDS assesses registration, recall, motor speed and psychomotor speed and provides a single summary score of a maximum of 12 points
Measured: Year 6 evaluation
Mental Health - The Alcohol Use Disorders Identification Test (AUDIT) -Baseline/during enrollment
The Alcohol Use Disorders Identification Test (AUDIT) is an alcohol screening instrument for patient self reporting. This 10-item alcohol screen helps identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). A score of 1 to 7 =low-risk consumption; 8 to 14 suggest harmful alcohol consumption, and ≥15 moderate-severe alcohol use disorder with a total score of 40.
Measured: Baseline/during enrollment
Mental Health - The Alcohol Use Disorders Identification Test (AUDIT) - on Year 1 of enrollment
The Alcohol Use Disorders Identification Test (AUDIT) is an alcohol screening instrument for patient self reporting. This 10-item alcohol screen helps identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). A score of 1 to 7 =low-risk consumption; 8 to 14 suggest harmful alcohol consumption, and ≥15 moderate-severe alcohol use disorder with a total score of 40.
Measured: Year 1 evaluation
Mental Health - The Alcohol Use Disorders Identification Test (AUDIT)- on year 2 of evaluation
The Alcohol Use Disorders Identification Test (AUDIT) is an alcohol screening instrument for patient self reporting. This 10-item alcohol screen helps identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). A score of 1 to 7 =low-risk consumption; 8 to 14 suggest harmful alcohol consumption, and ≥15 moderate-severe alcohol use disorder with a total score of 40.
Measured: Year 2 evaluation
Mental Health - The Alcohol Use Disorders Identification Test (AUDIT) - on year 3 of evaluation
The Alcohol Use Disorders Identification Test (AUDIT) is an alcohol screening instrument for patient self reporting. This 10-item alcohol screen helps identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). A score of 1 to 7 =low-risk consumption; 8 to 14 suggest harmful alcohol consumption, and ≥15 moderate-severe alcohol use disorder with a total score of 40.
Measured: Year 3 evaluation
Mental Health - Center for Epidemiologic Studies Depression Scale (CES-D)- on year 4 of evaluation
is a 7-item screen with a total score for the seven items ranging from 0 to 21. In most populations, 0-4: minimal anxiety / 5-9: mild anxiety / 10-14: moderate anxiety/ 15-21: severe anxiety.
Measured: Year 4 evaluation
Mental Health - Center for Epidemiologic Studies Depression Scale (CES-D)- on year 5 of evaluation
is a 7-item screen with a total score for the seven items ranging from 0 to 21. In most populations, 0-4: minimal anxiety / 5-9: mild anxiety / 10-14: moderate anxiety/ 15-21: severe anxiety.
Measured: Year 5 evaluation
Mental Health - Center for Epidemiologic Studies Depression Scale (CES-D)- on year 6 of evaluation
is a 7-item screen with a total score for the seven items ranging from 0 to 21. In most populations, 0-4: minimal anxiety / 5-9: mild anxiety / 10-14: moderate anxiety/ 15-21: severe anxiety.
Measured: Year 6 evaluation
Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- baseline/during enrollment
General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.
Measured: Baseline
Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- baseline/during enrollment
General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.
Measured: Baseline/during enrollment
Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 1 of evaluation
General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.
Measured: Year 1 evaluation
Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 2 of evaluation
General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.
Measured: Year 2 evaluation
Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 3 of evaluation
General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.
Measured: Year 3 evaluation
Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 4 of evaluation
General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.
Measured: Year 4 evaluation
Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 5 of evaluation
General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.
Measured: Year 5 evaluation
Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 6 of evaluation
General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.
Measured: Year 6 evaluation
Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)-baseline/during enrolment
Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.
Measured: Baseline/during enrollment
Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 1 of enrolment
Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.
Measured: Year 1 evaluation
Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 1 of evaluation
Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.
Measured: Year 2 evaluation
Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 3 of evaluation
Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.
Measured: Year 3 evaluation
Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 4 of evaluation
Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.
Measured: Year 4 evaluation
Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 5 of evaluation
Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.
Measured: Year 5 evaluation
Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ) - on year 6 of evaluation
Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.
Measured: Year 6 evaluation
Frailty assessment - Body weight - baseline/during enrollment
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurement: Body weight in kilograms (kg).
Measured: Baseline/during enrollment
Frailty assessment - Body weight - on year 1 of evaluation.
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight in kilograms (kg)
Measured: Year 1 evaluation
Frailty assessment - Body weight- on year 2 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight in kilograms (kg)
Measured: Year 2 evaluation
Frailty assessment - Body weight - on year 3 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight, Body Fat, Body Muscle, and the Body Mass Index (BMI).
Measured: Year 3 evaluation
Frailty assessment - Body weight on year 4 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight in kilograms(kg)
Measured: Year 4 evaluation
Frailty assessment - Body weight - on year 5
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight, Body Fat, Body Muscle, and the Body Mass Index (BMI).
Measured: Year 5 evaluation
Frailty assessment - Body weight - on year 6 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight in kilograms(kg).
Measured: Year 6 evaluation
Frailty assessment - Body height- baseline/during enrollment
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).
Measured: Baseline/during enrollment
Frailty assessment - Body height- on year 1 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).
Measured: Year 1 of evaluation
Frailty assessment - Body height- on year 2 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).
Measured: Year 2 of evaluation
Frailty assessment - Body height- on year 3 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).
Measured: Year 3 of evaluation
Frailty assessment - Body height- on year 4 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).
Measured: Year 4 of evaluation
Frailty assessment - Body height- on year 5 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).
Measured: Year 5 of evaluation
Frailty assessment - Body height- on year 6 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).
Measured: Year 6 of evaluation
Frailty assessment - Body mass index-baseline/during enrollment
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.
Measured: Baseline/during enrollment
Frailty assessment - Body mass index- on year 1 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.
Measured: Year 1 of evaluation
Frailty assessment - on year 2 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.
Measured: Year 2 of evaluation
Frailty assessment - Body mass index- on year 3 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.
Measured: Year 3 of evaluation
Frailty assessment - Body mass index- on year 4 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.
Measured: Year 4 of evaluation
Frailty assessment - Body mass index- on year 5 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.
Measured: Year 5 of evaluation
Frailty assessment - Body mass index- on year 6 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.
Measured: Year 6 of evaluation
Frailty assessments - Grip strength- baseline/during enrollment
Grip strength will be assessed by dynamometry against international norms for age and SNAP_Protocol_V2.3_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.
Measured: Baseline
Frailty assessments - Grip strength - on year 1 of evaluation
Grip strength will be assessed by dynamometry against international norms for age and SNAP_Protocol_V2.3_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.
Measured: Year 1 evaluation
Frailty assessments - Grip strength- on year 2 of evaluation
Grip strength will be assessed by dynamometry against international norms for age and SNAP_Protocol_V2.3_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.
Measured: Year 2 evaluation
Frailty assessments - Grip strength- on year 3 of evaluation
Grip strength will be assessed by dynamometry against international norms for age and SNAP_Protocol_V2.3_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.
Measured: Year 3 evaluation
Frailty assessments - Grip strength- on year 4 of evaluation
Grip strength will be assessed by dynamometry against international norms for age and SNAP_Protocol_V2.3_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.
Measured: Year 4 evaluation
Frailty assessments - Grip strength-on year 5 of evaluation
Grip strength will be assessed by dynamometry against international norms for age and SNAP_Protocol_V2.3_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.
Measured: Year 5 evaluation
Frailty assessments - Grip strength- on year 6 of evaluation
Grip strength will be assessed by dynamometry against international norms for age and SNAP_Protocol_V2.3_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.
Measured: Year 6 evaluation
Frail assessment - Physical Activity- baseline/during enrollment
Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.
Measured: Baseline
Frail assessment - Physical Activity- on year 1 of evaluation
Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.
Measured: Year 1 evaluation
Frail assessment - Physical Activity- on year 2 of evaluation
Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.
Measured: Year 2 evaluation
Frail assessment - Physical Activity- on year 3 of evaluation
Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.
Measured: Year 3 evaluation
Frail assessment - Physical Activity- on year 4 of evaluation
Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.
Measured: Year 4 evaluation
Frail assessment - Physical Activity- on year 5 of evaluation
Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.
Measured: Year 5 evaluation
Frail assessment - Physical Activity- on year 6 of evaluation
Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.
Measured: Year 6 evaluation
Frail assessment - Time Gait- baseline/during enrollment
Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.
Measured: baseline
Frail assessment - Time Gait- on year 1 of evaluation
Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.
Measured: Year 1 evaluation
Frail assessment - Time Gait- on year 2 of evaluation
Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.
Measured: Year 2 evaluation
Frail assessment - Time Gaiton year 3 of evaluation
Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.
Measured: Year 3 evaluation
Frail assessment - Time Gait- on year 4 of evaluation
Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.
Measured: Year 4 evaluation
Frail assessment - Time Gait- on year 5 of evaluation
Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.
Measured: Year 5 evaluation
Frail assessment - Time Gait- on year 6 of evaluation
Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.
Measured: Year 6 evaluation
Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- baseline/during enrollment
The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).
Measured: baseline/ during enrollment
Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 1 of evaluation
The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).
Measured: Year 1 of evaluation
Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 2 of evaluation
The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).
Measured: Year 2 evaluation
Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 3 of evaluation
The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).
Measured: Year 3 evaluation
Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 4 of evaluation
The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).
Measured: Year 4 evaluation
Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 5 of evaluation
The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).
Measured: Year 5 evaluation
Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 6 of evaluation
The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).
Measured: Year 6 evaluation
Peripheral nerve health - Heart Rate Variability(HRV)- baseline/during enrollment
Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.
Measured: Baseline/during enrollment
Peripheral nerve health - Heart Rate Variability(HRV)- on year 1 of evaluation
Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.
Measured: Year 1 evaluation
Peripheral nerve health - Heart Rate Variability(HRV) - on year 2 of evaluation
Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.
Measured: Year 2 evaluation
Peripheral nerve health - Heart Rate Variability(HRV)- on year 3 of evaluation
Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.
Measured: Year 3 evaluation
Peripheral nerve health - Heart Rate Variability(HRV)- on year 4 of enrollment
Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.
Measured: Year 4 evaluation
Peripheral nerve health - Heart Rate Variability(HRV)- on year 5 of evaluation
Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.
Measured: Year 5 evaluation
Peripheral nerve health - Heart Rate Variability(HRV)- on year 6 of evaluation
Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.
Measured: Year 6 evaluation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 202230 Apr 2027

First posted10 Jan 2023
Study start6 Jul 2022
Primary completion30 Apr 2027 (estimated)
Study completion30 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (49)Papers the sponsor has linked to this study.
Other trials for Aging, PrematureStudies of the same condition, open and under way.
More trials run by University of RochesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 298 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05678660
Sponsor's protocol ID: STUDY00007234
Other IDs: R35NS122265
Acronym: SNAP
Status last verified: May 2026
First submitted: 11 Aug 2022
Last updated: 29 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Access to databases and associated software tools generated under the project will be available for educations, research and non-profit purposes. Such access will be provided using web-based applications, as appropriate.

Publications

Mbewe EG, Kabundula PP, Mwanza-Kabaghe S, Buda A, Adams HR, Schneider C, Potchen MJ, Mweemba M, Mathews M, Menon JA, Wang B, Baseler T, Paciorkowski A, Birbeck GL, Bearden DR. Socioeconomic Status and Cognitive Function in Children With HIV: Evidence From the HIV-Associated Neurocognitive Disorders in Zambia (HANDZ) Study. J Acquir Immune Defic Syndr. 2022 Jan 1;89(1):56-63. doi: 10.1097/QAI.0000000000002825.
PubMed 34878435
Bearden DR, Omech B, Rulaganyang I, Sesay SO, Kolson DL, Kasner SE, Mullen MT. Stroke and HIV in Botswana: A prospective study of risk factors and outcomes. J Neurol Sci. 2020 Jun 15;413:116806. doi: 10.1016/j.jns.2020.116806. Epub 2020 Mar 26.
PubMed 32244092
Dean O, Buda A, Adams HR, Mwanza-Kabaghe S, Potchen MJ, Mbewe EG, Kabundula PP, Moghaddam SM, Birbeck GL, Bearden DR. Brain Magnetic Resonance Imaging Findings Associated With Cognitive Impairment in Children and Adolescents With Human Immunodeficiency Virus in Zambia. Pediatr Neurol. 2020 Jan;102:28-35. doi: 10.1016/j.pediatrneurol.2019.08.014. Epub 2019 Sep 9.
PubMed 31604645
Heneka MT, Golenbock D, Latz E, Morgan D, Brown R. Immediate and long-term consequences of COVID-19 infections for the development of neurological disease. Alzheimers Res Ther. 2020 Jun 4;12(1):69. doi: 10.1186/s13195-020-00640-3.
PubMed 32498691
Kvalsund M, Kayamba V, Kelly P, Birbeck GL, Mwansa-Thurman C, Sommer IN, Lamers Y, Gardiner J, Herrmann DN. Is folate deficiency a common cause of distal symmetric polyneuropathy in Zambian clinics? J Neurol Sci. 2020 Feb 15;409:116583. doi: 10.1016/j.jns.2019.116583. Epub 2019 Nov 20.
PubMed 31864072
Monreal E, Gullon P, Perez-Torre P, Escobar-Villalba A, Acebron F, Quereda Rodriguez-Navarro C, Sanchez-Ruano L, Fernandez-Felix BM, Muriel A, Perez-Elias MJ, Masjuan J, Corral I. Increased HIV infection in patients with stroke in Spain. A 16-year population-based study. Enferm Infecc Microbiol Clin (Engl Ed). 2020 May;38(5):219-225. doi: 10.1016/j.eimc.2019.10.006. Epub 2019 Dec 16. English, Spanish.
PubMed 31859019
Sarfo FS, Mensah NO, Opoku FA, Adusei-Mensah N, Ampofo M, Ovbiagele B. COVID-19 and stroke: Experience in a Ghanaian healthcare system. J Neurol Sci. 2020 Sep 15;416:117044. doi: 10.1016/j.jns.2020.117044. Epub 2020 Jul 16.
PubMed 32702560
Barrell K, Smith AG. Peripheral Neuropathy. Med Clin North Am. 2019 Mar;103(2):383-397. doi: 10.1016/j.mcna.2018.10.006. Epub 2018 Dec 17.
PubMed 30704689
Feinstein MJ, Hsue PY, Benjamin LA, Bloomfield GS, Currier JS, Freiberg MS, Grinspoon SK, Levin J, Longenecker CT, Post WS. Characteristics, Prevention, and Management of Cardiovascular Disease in People Living With HIV: A Scientific Statement From the American Heart Association. Circulation. 2019 Jul 9;140(2):e98-e124. doi: 10.1161/CIR.0000000000000695. Epub 2019 Jun 3.
PubMed 31154814
Hammond CK, Eley B, Ing N, Wilmshurst JM. Neuropsychiatric and Neurocognitive Manifestations in HIV-Infected Children Treated With Efavirenz in South Africa-A Retrospective Case Series. Front Neurol. 2019 Jul 9;10:742. doi: 10.3389/fneur.2019.00742. eCollection 2019.
PubMed 31338063
Kuhn T, Jin Y, Huang C, Kim Y, Nir TM, Gullett JM, Jones JD, Sayegh P, Chung C, Dang BH, Singer EJ, Shattuck DW, Jahanshad N, Bookheimer SY, Hinkin CH, Zhu H, Thompson PM, Thames AD. The joint effect of aging and HIV infection on microstructure of white matter bundles. Hum Brain Mapp. 2019 Oct 15;40(15):4370-4380. doi: 10.1002/hbm.24708. Epub 2019 Jul 4.
PubMed 31271489
Lin HL, Muo CH, Lin CY, Chen HJ, Chen PC. Incidence of stroke in patients with HIV infection: A population-based study in Taiwan. PLoS One. 2019 May 22;14(5):e0217147. doi: 10.1371/journal.pone.0217147. eCollection 2019.
PubMed 31116762
Mapoure Njankouo Y, Mondomobe Atchom C, Halle MP, Mbatchou Ngahane BH, Luma NH. Prevalence of HIV infection among stroke patients in Douala. Med Sante Trop. 2019 May 1;29(2):184-189. doi: 10.1684/mst.2019.0895.
PubMed 31379346
Montoya JL, Campbell LM, Paolillo EW, Ellis RJ, Letendre SL, Jeste DV, Moore DJ. Inflammation Relates to Poorer Complex Motor Performance Among Adults Living With HIV on Suppressive Antiretroviral Therapy. J Acquir Immune Defic Syndr. 2019 Jan 1;80(1):15-23. doi: 10.1097/QAI.0000000000001881.
PubMed 30365450
Pluta A, Wolak T, Sobanska M, Gawron N, Egbert AR, Szymanska B, Horban A, Firlag-Burkacka E, Bienkowski P, Sienkiewicz-Jarosz H, Scinska-Bienkowska A, Desowska A, Rusiniak M, Biswal BB, Rao S, Bornstein R, Skarzynski H, Lojek E. HIV and age underlie specific patterns of brain abnormalities and cognitive changes in high functioning patients. Neuropsychology. 2019 Mar;33(3):358-369. doi: 10.1037/neu0000504. Epub 2019 Jan 28.
PubMed 30688492

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Neurological Aging Among People Living With HIV (SNAP)
ClinicalTrials.gov ID: NCT05678660
Acronym / sponsor ID: SNAP / STUDY00007234
Conditions: Aging, Premature
Keywords: frailty, cognitive impairment, neuropathy, mental health, antiretroviral toxicity
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 298 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), Centre for Infectious Disease Research in Zambia
Study start: 6 Jul 2022 (actual)
Primary completion: 30 Apr 2027 (estimated)
Study completion: 30 Apr 2027 (estimated)
First posted: 10 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Long Group	–	–Older adults individuals with longstanding HIV, stable and on antiretroviral therapy for at least 7 years
Short Group	–	–Older adults living with HIV, on stable antiretroviral treatment for at least 1 but not more than 2 years,

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Potential participants will be identified through the antiretroviral clinics associated with Chikankata Hospital and Monze Mission Hospital in Zambia's Southern Province. Individuals will first be identified in the long group and will then be matched to a PLWH in the short group matching based upon gender, age and community of residents

Key inclusion criteria (2 listed)

For the short group, stable on ART for 1 year, but no more than 2 years.
For long group, on ART for 7 or more years

Key exclusion criteria (4 listed)

Acute medical illness.
Decisional impairment precluding informed consent as noted by clinicians providing care to the patient or by the research staff team members.
Communication impairments-unable to hear or unable to speak.
Being unable to communicate in English or in the dominant language at the study site (Tonga).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Cognition - Zambian Mini-Mental Status Examination (zMMSE) - During enrollment
Time frame: baseline/during enrollment
The zMMSE is an adaptation of the well-known MMSE which provides single summary score with a maximum of 30 points
Cognition - Zambian Mini-Mental Status Examination (zMMSE) - on Year 1 of evaluation
Time frame: Year 1 evaluation
The zMMSE is an adaptation of the well-known MMSE which provides single summary score with a maximum of 30 points
Cognition - Zambian Mini-Mental Status Examination (zMMSE) - on Year 2 of evaluation
Time frame: Year 2 evaluation
The zMMSE is an adaptation of the well-known MMSE which provides single summary score with a maximum of 30 points
Cognition - International HIV Dementia Scale (I-HDS) - on Year 3 of evaluation
Time frame: Year 3 evaluation
The IHDS assesses registration, recall, motor speed and psychomotor speed and provides a single summary score of a maximum of 12 points
Cognition - International HIV Dementia Scale (I-HDS)- on Year 4 of evaluation
Time frame: Year 4 evaluations
The IHDS assesses registration, recall, motor speed and psychomotor speed and provides a single summary score of a maximum of 12 points
Cognition - International HIV Dementia Scale (I-HDS) - on Year 5 of evaluation
Time frame: Year 5 evaluation
The IHDS assesses registration, recall, motor speed and psychomotor speed and provides a single summary score of a maximum of 12 points
Cognition - International HIV Dementia Scale (I-HDS)- on Year 6 of evaluation
Time frame: Year 6 evaluation
The IHDS assesses registration, recall, motor speed and psychomotor speed and provides a single summary score of a maximum of 12 points
Mental Health - The Alcohol Use Disorders Identification Test (AUDIT) -Baseline/during enrollment
Time frame: Baseline/during enrollment
The Alcohol Use Disorders Identification Test (AUDIT) is an alcohol screening instrument for patient self reporting. This 10-item alcohol screen helps identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). A score of 1 to 7 =low-risk consumption; 8 to 14 suggest harmful alcohol consumption, and ≥15 moderate-severe alcohol use disorder with a total score of 40.
Mental Health - The Alcohol Use Disorders Identification Test (AUDIT) - on Year 1 of enrollment
Time frame: Year 1 evaluation
The Alcohol Use Disorders Identification Test (AUDIT) is an alcohol screening instrument for patient self reporting. This 10-item alcohol screen helps identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). A score of 1 to 7 =low-risk consumption; 8 to 14 suggest harmful alcohol consumption, and ≥15 moderate-severe alcohol use disorder with a total score of 40.
Mental Health - The Alcohol Use Disorders Identification Test (AUDIT)- on year 2 of evaluation
Time frame: Year 2 evaluation
The Alcohol Use Disorders Identification Test (AUDIT) is an alcohol screening instrument for patient self reporting. This 10-item alcohol screen helps identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). A score of 1 to 7 =low-risk consumption; 8 to 14 suggest harmful alcohol consumption, and ≥15 moderate-severe alcohol use disorder with a total score of 40.
Mental Health - The Alcohol Use Disorders Identification Test (AUDIT) - on year 3 of evaluation
Time frame: Year 3 evaluation
The Alcohol Use Disorders Identification Test (AUDIT) is an alcohol screening instrument for patient self reporting. This 10-item alcohol screen helps identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). A score of 1 to 7 =low-risk consumption; 8 to 14 suggest harmful alcohol consumption, and ≥15 moderate-severe alcohol use disorder with a total score of 40.
Mental Health - Center for Epidemiologic Studies Depression Scale (CES-D)- on year 4 of evaluation
Time frame: Year 4 evaluation
is a 7-item screen with a total score for the seven items ranging from 0 to 21. In most populations, 0-4: minimal anxiety / 5-9: mild anxiety / 10-14: moderate anxiety/ 15-21: severe anxiety.
Mental Health - Center for Epidemiologic Studies Depression Scale (CES-D)- on year 5 of evaluation
Time frame: Year 5 evaluation
is a 7-item screen with a total score for the seven items ranging from 0 to 21. In most populations, 0-4: minimal anxiety / 5-9: mild anxiety / 10-14: moderate anxiety/ 15-21: severe anxiety.
Mental Health - Center for Epidemiologic Studies Depression Scale (CES-D)- on year 6 of evaluation
Time frame: Year 6 evaluation
is a 7-item screen with a total score for the seven items ranging from 0 to 21. In most populations, 0-4: minimal anxiety / 5-9: mild anxiety / 10-14: moderate anxiety/ 15-21: severe anxiety.
Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- baseline/during enrollment
Time frame: Baseline
General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.
Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- baseline/during enrollment
Time frame: Baseline/during enrollment
General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.
Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 1 of evaluation
Time frame: Year 1 evaluation
General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.
Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 2 of evaluation
Time frame: Year 2 evaluation
General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.
Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 3 of evaluation
Time frame: Year 3 evaluation
General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.
Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 4 of evaluation
Time frame: Year 4 evaluation
General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.
Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 5 of evaluation
Time frame: Year 5 evaluation
General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.
Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 6 of evaluation
Time frame: Year 6 evaluation
General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.
Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)-baseline/during enrolment
Time frame: Baseline/during enrollment
Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.
Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 1 of enrolment
Time frame: Year 1 evaluation
Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.
Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 1 of evaluation
Time frame: Year 2 evaluation
Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.
Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 3 of evaluation
Time frame: Year 3 evaluation
Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.
Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 4 of evaluation
Time frame: Year 4 evaluation
Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.
Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 5 of evaluation
Time frame: Year 5 evaluation
Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.
Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ) - on year 6 of evaluation
Time frame: Year 6 evaluation
Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.
Frailty assessment - Body weight - baseline/during enrollment
Time frame: Baseline/during enrollment
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurement: Body weight in kilograms (kg).
Frailty assessment - Body weight - on year 1 of evaluation.
Time frame: Year 1 evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight in kilograms (kg)
Frailty assessment - Body weight- on year 2 of evaluation
Time frame: Year 2 evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight in kilograms (kg)
Frailty assessment - Body weight - on year 3 of evaluation
Time frame: Year 3 evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight, Body Fat, Body Muscle, and the Body Mass Index (BMI).
Frailty assessment - Body weight on year 4 of evaluation
Time frame: Year 4 evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight in kilograms(kg)
Frailty assessment - Body weight - on year 5
Time frame: Year 5 evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight, Body Fat, Body Muscle, and the Body Mass Index (BMI).
Frailty assessment - Body weight - on year 6 of evaluation
Time frame: Year 6 evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight in kilograms(kg).
Frailty assessment - Body height- baseline/during enrollment
Time frame: Baseline/during enrollment
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).
Frailty assessment - Body height- on year 1 of evaluation
Time frame: Year 1 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).
Frailty assessment - Body height- on year 2 of evaluation
Time frame: Year 2 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).
Frailty assessment - Body height- on year 3 of evaluation
Time frame: Year 3 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).
Frailty assessment - Body height- on year 4 of evaluation
Time frame: Year 4 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).
Frailty assessment - Body height- on year 5 of evaluation
Time frame: Year 5 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).
Frailty assessment - Body height- on year 6 of evaluation
Time frame: Year 6 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The height scale will be used to capture height in meters (m).
Frailty assessment - Body mass index-baseline/during enrollment
Time frame: Baseline/during enrollment
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.
Frailty assessment - Body mass index- on year 1 of evaluation
Time frame: Year 1 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.
Frailty assessment - on year 2 of evaluation
Time frame: Year 2 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.
Frailty assessment - Body mass index- on year 3 of evaluation
Time frame: Year 3 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.
Frailty assessment - Body mass index- on year 4 of evaluation
Time frame: Year 4 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.
Frailty assessment - Body mass index- on year 5 of evaluation
Time frame: Year 5 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.
Frailty assessment - Body mass index- on year 6 of evaluation
Time frame: Year 6 of evaluation
Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.
Frailty assessments - Grip strength- baseline/during enrollment
Time frame: Baseline
Grip strength will be assessed by dynamometry against international norms for age and SNAP_Protocol_V2.3_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.
Frailty assessments - Grip strength - on year 1 of evaluation
Time frame: Year 1 evaluation
Grip strength will be assessed by dynamometry against international norms for age and SNAP_Protocol_V2.3_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.
Frailty assessments - Grip strength- on year 2 of evaluation
Time frame: Year 2 evaluation
Grip strength will be assessed by dynamometry against international norms for age and SNAP_Protocol_V2.3_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.
Frailty assessments - Grip strength- on year 3 of evaluation
Time frame: Year 3 evaluation
Grip strength will be assessed by dynamometry against international norms for age and SNAP_Protocol_V2.3_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.
Frailty assessments - Grip strength- on year 4 of evaluation
Time frame: Year 4 evaluation
Grip strength will be assessed by dynamometry against international norms for age and SNAP_Protocol_V2.3_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.
Frailty assessments - Grip strength-on year 5 of evaluation
Time frame: Year 5 evaluation
Grip strength will be assessed by dynamometry against international norms for age and SNAP_Protocol_V2.3_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.
Frailty assessments - Grip strength- on year 6 of evaluation
Time frame: Year 6 evaluation
Grip strength will be assessed by dynamometry against international norms for age and SNAP_Protocol_V2.3_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.
Frail assessment - Physical Activity- baseline/during enrollment
Time frame: Baseline
Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.
Frail assessment - Physical Activity- on year 1 of evaluation
Time frame: Year 1 evaluation
Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.
Frail assessment - Physical Activity- on year 2 of evaluation
Time frame: Year 2 evaluation
Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.
Frail assessment - Physical Activity- on year 3 of evaluation
Time frame: Year 3 evaluation
Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.
Frail assessment - Physical Activity- on year 4 of evaluation
Time frame: Year 4 evaluation
Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.
Frail assessment - Physical Activity- on year 5 of evaluation
Time frame: Year 5 evaluation
Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.
Frail assessment - Physical Activity- on year 6 of evaluation
Time frame: Year 6 evaluation
Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.
Frail assessment - Time Gait- baseline/during enrollment
Time frame: baseline
Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.
Frail assessment - Time Gait- on year 1 of evaluation
Time frame: Year 1 evaluation
Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.
Frail assessment - Time Gait- on year 2 of evaluation
Time frame: Year 2 evaluation
Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.
Frail assessment - Time Gaiton year 3 of evaluation
Time frame: Year 3 evaluation
Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.
Frail assessment - Time Gait- on year 4 of evaluation
Time frame: Year 4 evaluation
Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.
Frail assessment - Time Gait- on year 5 of evaluation
Time frame: Year 5 evaluation
Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.
Frail assessment - Time Gait- on year 6 of evaluation
Time frame: Year 6 evaluation
Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.
Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- baseline/during enrollment
Time frame: baseline/ during enrollment
The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).
Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 1 of evaluation
Time frame: Year 1 of evaluation
The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).
Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 2 of evaluation
Time frame: Year 2 evaluation
The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).
Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 3 of evaluation
Time frame: Year 3 evaluation
The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).
Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 4 of evaluation
Time frame: Year 4 evaluation
The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).
Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 5 of evaluation
Time frame: Year 5 evaluation
The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).
Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- on year 6 of evaluation
Time frame: Year 6 evaluation
The brief peripheral neuropathy screen yields a dichotomous outcome (neuropathy present vs absent).
Peripheral nerve health - Heart Rate Variability(HRV)- baseline/during enrollment
Time frame: Baseline/during enrollment
Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.
Peripheral nerve health - Heart Rate Variability(HRV)- on year 1 of evaluation
Time frame: Year 1 evaluation
Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.
Peripheral nerve health - Heart Rate Variability(HRV) - on year 2 of evaluation
Time frame: Year 2 evaluation
Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.
Peripheral nerve health - Heart Rate Variability(HRV)- on year 3 of evaluation
Time frame: Year 3 evaluation
Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.
Peripheral nerve health - Heart Rate Variability(HRV)- on year 4 of enrollment
Time frame: Year 4 evaluation
Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.
Peripheral nerve health - Heart Rate Variability(HRV)- on year 5 of evaluation
Time frame: Year 5 evaluation
Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.
Peripheral nerve health - Heart Rate Variability(HRV)- on year 6 of evaluation
Time frame: Year 6 evaluation
Heart rate variability will measure autonomic function. Baseline heart rate will be assessed and a heart rate variability score produced with higher scores generally representing better autonomic function. Comparisons between the two groups and the individual participants HRV trajectory over time will be evaluated.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
Background: PubMed 34878435Mbewe EG, Kabundula PP, Mwanza-Kabaghe S, Buda A, Adams HR, Schneider C, Potchen MJ, Mweemba M, Mathews M, Menon JA, Wang B, Baseler T, Paciorkowski A, Birbeck GL, Bearden DR. Socioeconomic Status and Cognitive Function in Children With HIV: Evidence From the HIV-Associated Neurocognitive Disorders in Zambia (HANDZ) Study. J Acquir Immune Defic Syndr. 2022 Jan 1;89(1):56-63. doi: 10.1097/QAI.0000000000002825.
Background: PubMed 32244092Bearden DR, Omech B, Rulaganyang I, Sesay SO, Kolson DL, Kasner SE, Mullen MT. Stroke and HIV in Botswana: A prospective study of risk factors and outcomes. J Neurol Sci. 2020 Jun 15;413:116806. doi: 10.1016/j.jns.2020.116806. Epub 2020 Mar 26.
Background: PubMed 31604645Dean O, Buda A, Adams HR, Mwanza-Kabaghe S, Potchen MJ, Mbewe EG, Kabundula PP, Moghaddam SM, Birbeck GL, Bearden DR. Brain Magnetic Resonance Imaging Findings Associated With Cognitive Impairment in Children and Adolescents With Human Immunodeficiency Virus in Zambia. Pediatr Neurol. 2020 Jan;102:28-35. doi: 10.1016/j.pediatrneurol.2019.08.014. Epub 2019 Sep 9.
Background: PubMed 32498691Heneka MT, Golenbock D, Latz E, Morgan D, Brown R. Immediate and long-term consequences of COVID-19 infections for the development of neurological disease. Alzheimers Res Ther. 2020 Jun 4;12(1):69. doi: 10.1186/s13195-020-00640-3.
Background: PubMed 31864072Kvalsund M, Kayamba V, Kelly P, Birbeck GL, Mwansa-Thurman C, Sommer IN, Lamers Y, Gardiner J, Herrmann DN. Is folate deficiency a common cause of distal symmetric polyneuropathy in Zambian clinics? J Neurol Sci. 2020 Feb 15;409:116583. doi: 10.1016/j.jns.2019.116583. Epub 2019 Nov 20.
Background: PubMed 31859019Monreal E, Gullon P, Perez-Torre P, Escobar-Villalba A, Acebron F, Quereda Rodriguez-Navarro C, Sanchez-Ruano L, Fernandez-Felix BM, Muriel A, Perez-Elias MJ, Masjuan J, Corral I. Increased HIV infection in patients with stroke in Spain. A 16-year population-based study. Enferm Infecc Microbiol Clin (Engl Ed). 2020 May;38(5):219-225. doi: 10.1016/j.eimc.2019.10.006. Epub 2019 Dec 16. English, Spanish.
Background: PubMed 32702560Sarfo FS, Mensah NO, Opoku FA, Adusei-Mensah N, Ampofo M, Ovbiagele B. COVID-19 and stroke: Experience in a Ghanaian healthcare system. J Neurol Sci. 2020 Sep 15;416:117044. doi: 10.1016/j.jns.2020.117044. Epub 2020 Jul 16.
Background: PubMed 30704689Barrell K, Smith AG. Peripheral Neuropathy. Med Clin North Am. 2019 Mar;103(2):383-397. doi: 10.1016/j.mcna.2018.10.006. Epub 2018 Dec 17.
Background: PubMed 31154814Feinstein MJ, Hsue PY, Benjamin LA, Bloomfield GS, Currier JS, Freiberg MS, Grinspoon SK, Levin J, Longenecker CT, Post WS. Characteristics, Prevention, and Management of Cardiovascular Disease in People Living With HIV: A Scientific Statement From the American Heart Association. Circulation. 2019 Jul 9;140(2):e98-e124. doi: 10.1161/CIR.0000000000000695. Epub 2019 Jun 3.
Background: PubMed 31338063Hammond CK, Eley B, Ing N, Wilmshurst JM. Neuropsychiatric and Neurocognitive Manifestations in HIV-Infected Children Treated With Efavirenz in South Africa-A Retrospective Case Series. Front Neurol. 2019 Jul 9;10:742. doi: 10.3389/fneur.2019.00742. eCollection 2019.
Background: PubMed 31271489Kuhn T, Jin Y, Huang C, Kim Y, Nir TM, Gullett JM, Jones JD, Sayegh P, Chung C, Dang BH, Singer EJ, Shattuck DW, Jahanshad N, Bookheimer SY, Hinkin CH, Zhu H, Thompson PM, Thames AD. The joint effect of aging and HIV infection on microstructure of white matter bundles. Hum Brain Mapp. 2019 Oct 15;40(15):4370-4380. doi: 10.1002/hbm.24708. Epub 2019 Jul 4.
Background: PubMed 31116762Lin HL, Muo CH, Lin CY, Chen HJ, Chen PC. Incidence of stroke in patients with HIV infection: A population-based study in Taiwan. PLoS One. 2019 May 22;14(5):e0217147. doi: 10.1371/journal.pone.0217147. eCollection 2019.
Individual participant dataSharing planned: Yes. Access to databases and associated software tools generated under the project will be available for educations, research and non-profit purposes. Such access will be provided using web-based applications, as appropriate.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gretchen L. Birbeck, MD principal investigator

University of Rochester

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Aging, Premature, run by University of Rochester at 3 sites in Zambia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognition - Zambian Mini-Mental Status Examination (zMMSE) - During enrollment (time frame: baseline/during enrollment). The study lists 85 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05678660, which also lists 49 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.