HIVNCT02126696
Comorbidities and Virologic Outcome Among Patients on Anti-retroviral Therapy in Rural Lesotho
An observational study of HIV and Metabolic Syndrome, run by Swiss Tropical & Public Health Institute at 2 sites in Lesotho.
Trial summary
This study is conducted in a cohort of HIV-positive patients on first-line anti-retroviral therapy (ART) in rural health facilities in Lesotho, Southern Africa. It examines virologic treatment failure as well as chronic communicable and non-communicable comorbidities among patients on ART. The study has two phases. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- HIV, Metabolic Syndrome, Depression
- How many people
- 1,754 participants
- Where
- 2 sitesLesotho
- Study dates
- May 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients on anti-retroviral therapy ≥ 6 months followed at one of the facilities involved in the study.
Who may be able to join
- on anti-retroviral therapy ≥ 6 months
- informed consent given
Who cannot join
- on anti-retroviral therapy for < 6 months or documented treatment interruption of ≥ 7 days during the last 3 months
- children < 16 years without the caretaker who can provide informed consent for study participation
- patients on second-line anti-retroviral therapy
Trial locations and contacts
2 sites in 1 country.
Lesotho2 sites
Seboche Hospital
Butha-Buthe, Butha-Buthe, 400
Paray Hospital
Thaba-Tseka, Thaba-Tseka
About this study
Official title: Study on Non-communicable and Selected Communicable Chronic Comorbidities Among HIV-positive Patients on Anti-retroviral Therapy in Rural Lesotho and Their Association to Virologic Outcome
This study is conducted in a cohort of HIV-positive patients on first-line anti-retroviral therapy (ART) in rural health facilities in Lesotho, Southern Africa. It examines virologic treatment failure as well as chronic communicable and non-communicable comorbidities among patients on ART. The study has two phases. Phase 1 consists of a cross-sectional survey to determine prevalence of treatment failure as well as the prevalence of the following comorbidities: diabetes mellitus, arterial hypertension, dyslipidemia, depression, alcohol use disorder, hepatitis B and hepatitis C. Phase 2 is a cohort study, where patients with treatment failure or a comorbidity or both are followed-up for 12 months.
Read the detailed description
Background
Owing to successful scale-up and decentralization of anti-retroviral therapy (ART) in rural Lesotho, the number of persons infected with HIV who stay alive increased dramatically. The new situation of HIV having turned from a deadly disease into a chronic but manageable condition creates a new challenge to health care providers in rural facilities of the country. Patients on long-time ART may suffer from comorbidities endangering the success of ART and their health and/or from ART-failure due to development of resistance of the virus. The magnitude of the burden of comorbidities as well as ART- failure has not been examined extensively in Lesotho yet.
Objectives of the Study
The study has six major objectives:
- To assess the prevalence of virologic failure and genotype-resistance of HIV among patients on ART in rural Lesotho.
- To assess the prevalence of hepatitis C and hepatitis B among patients on ART in rural facilities in Lesotho
- To assess the prevalence of diabetes mellitus, arterial hypertension and dyslipidaemia among patients on ART in rural facilities in Lesotho
- To assess the prevalence of depression and alcohol use disorder among patients on ART in rural facilities in Lesotho
- To examine associations between chronic comorbidities and virologic outcome among patients on ART in rural Lesotho
- To follow-up patients with virologic failure and/or comorbidity(ies) among patients on ART in rural Lesotho
Design/Methods
The study is planned to take place in two districts of Lesotho: Botha-Bothe and Thaba-Tseka. Prevalence of the selected comorbidities is measured in a cross-sectional, facility-based survey in eight health centers and two hospitals from the two districts. Patients with a detectable viral load will receive enhanced adherence counselling and a second viral load measurement after 2-3 months. In case of confirmed virologic failure, a genotype resistance testing will be done before patients are switched to second-line. Patients with specific comorbidities or patients with virologic failure who had been switched to second-line ART will be followed-up in a cohort study 12-18 months after the survey.
Expected Results and Impact
Prevalence of the selected comorbidities will inform the Ministry of Health as well as its implementing partners on which chronic conditions might be most urgent to be addressed among patients on ART in Lesotho and the national HIV-programme may be used to leverage on for other chronic conditions. Data on virologic failure will inform on the prevalence of virologic failure among a previously not virologically monitored cohort. Moreover it will provide data on the resistance patterns among patients who fail on first-line ART and on the one-year outcome after switch to a second-line regimen.
- Conditions
- HIV, Metabolic Syndrome, Depression, Alcoholism, Hepatitis
- Keywords
- Anti-retroviral Therapy, Lesotho, Southern Africa, Comorbidity, Virologic failure
- Medical subject headings
- Metabolic Syndrome, Depression, Alcoholism, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients on anti-retroviral therapy | The cohort consists of patients on first-line anti-retroviral therapy since at least 6 months, followed at one of the facilities involved in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of comorbidities among patients on anti-retroviral therapy in rural Lesotho
The prevalence of the following comorbidities/conditions will be assessed:
- Diabetes Mellitus
- Arterial Hypertension
- Dyslipidemia
- Depression
- Alcohol use disorder
- Hepatitis B
- Hepatitis C
Measured: at enrollment
Prevalence of virologic failure and genotype resistance patterns among patients on anti-retroviral therapy who were not monitored virologically
All patients on first-line ART ≥ 6 months will receive viral load testing. Those with a detectable viral load will receive enhanced adherence counselling and again a viral load measurement 3 months after the initial viral load (as recommended by the consolidated WHO-guidelines). In case of persistent virologic failure (2 times detectable viral load) a genotype resitance testing will be done and patients will be switched to second-line ART. This will allow to validate the WHO algorithm for virologic failure in a remote, resource-limited setting.
Measured: At enrollment
Secondary outcomes (4)
1-year follow-up outcomes of patients with virologic failure and subsequent switch to second-line ART
Patients with virologic failure at enrollment will be followed-up after 12-18 months to assess the following outcomes:
- clinical outcome: alive and on ART / lost to follow-up / dead
- virological outcome: viral load suppressed / viral load detectable
Measured: 12-18 months after enrollment
1-year outcomes of patients with comorbidities diagnosed at enrollment
Patients diagnosed with a specific comorbidity at enrollment (see first primary outcome) will be followed-up to assess their outcome after one year:
- clinical outcome: alive and on ART / lost to follow-up / dead
- virologic outcome: viral load suppressed / viral load detectable
Measured: 12-18 months after enrollment
Predictors of sustained virologic failure 3 months after a detectable viral load at initial measurement
Potential clinical/laboratory predictors to predict sustained virologic failure among patients with a detectable viral load at initial measurement will be collected at enrollment.
Measured: enrollment + 3 months
Association of comorbidities and virologic outcomes among patients on anti-retroviral therapy in rural Lesotho
Virologic outcome of anti-retroviral therapy will be compared between patient-groups with and without one or more of the comorbidities listed under the first primary outcome.
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 1,754 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Foundation for Excellence and Talent in Biomedical Research, SolidarMed - Swiss Organization for Health in Africa, University of Basel, Central Laboratories, University Hospitals Basel-Land (Liestal)
- Responsible party
- Sponsor
- Investigators
- Niklaus D Labhardt, MD, MIH, Principal investigator, Swiss Tropical & Public Health InstituteChristoph Hatz, Prof, Study director, Swiss Tropical & Public Health InstituteThomas Klimkait, Prof, Study chair, Department of Biomedicine, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126696
- Sponsor's protocol ID
- CART-1
- Status last verified
- Apr 2016
- First submitted
- 28 Apr 2014
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Labhardt ND, Muller UF, Ringera I, Ehmer J, Motlatsi MM, Pfeiffer K, Hobbins MA, Muhairwe JA, Muser J, Hatz C. Metabolic syndrome in patients on first-line antiretroviral therapy containing zidovudine or tenofovir in rural Lesotho, Southern Africa. Trop Med Int Health. 2017 Jun;22(6):725-733. doi: 10.1111/tmi.12872. Epub 2017 May 4.
PubMed 28342180Cerutti B, Broers B, Masetsibi M, Faturiyele O, Toti-Mokoteli L, Motlatsi M, Bader J, Klimkait T, Labhardt ND. Alcohol use and depression: link with adherence and viral suppression in adult patients on antiretroviral therapy in rural Lesotho, Southern Africa: a cross-sectional study. BMC Public Health. 2016 Sep 8;16(1):947. doi: 10.1186/s12889-016-3209-4.
PubMed 27608764
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Non-communicable and Selected Communicable Chronic Comorbidities Among HIV-positive Patients on Anti-retroviral Therapy in Rural Lesotho and Their Association to Virologic Outcome
- ClinicalTrials.gov ID
- NCT02126696
- Acronym / sponsor ID
- CART-1
- Conditions
- HIV, Metabolic Syndrome, Depression, Alcoholism, Hepatitis
- Keywords
- Anti-retroviral Therapy, Lesotho, Southern Africa, Comorbidity, Virologic failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,754 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Swiss Foundation for Excellence and Talent in Biomedical Research, SolidarMed - Swiss Organization for Health in Africa, University of Basel, Central Laboratories, University Hospitals Basel-Land (Liestal)
- Study start
- May 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Apr 2014 (estimated)
- 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.
This study is conducted in a cohort of HIV-positive patients on first-line anti-retroviral therapy (ART) in rural health facilities in Lesotho, Southern Africa. It examines virologic treatment failure as well as chronic communicable and non-communicable comorbidities among patients on ART. The study has two phases. Phase 1 consists of a cross-sectional survey to determine prevalence of treatment failure as well as the prevalence of the following comorbidities: diabetes mellitus, arterial hypertension, dyslipidemia, depression, alcohol use disorder, hepatitis B and hepatitis C. Phase 2 is a cohort study, where patients with treatment failure or a comorbidity or both are followed-up for 12 months.
Detailed description
Background
Owing to successful scale-up and decentralization of anti-retroviral therapy (ART) in rural Lesotho, the number of persons infected with HIV who stay alive increased dramatically. The new situation of HIV having turned from a deadly disease into a chronic but manageable condition creates a new challenge to health care providers in rural facilities of the country. Patients on long-time ART may suffer from comorbidities endangering the success of ART and their health and/or from ART-failure due to development of resistance of the virus. The magnitude of the burden of comorbidities as well as ART- failure has not been examined extensively in Lesotho yet.
Objectives of the Study
The study has six major objectives:
- To assess the prevalence of virologic failure and genotype-resistance of HIV among patients on ART in rural Lesotho.
- To assess the prevalence of hepatitis C and hepatitis B among patients on ART in rural facilities in Lesotho
- To assess the prevalence of diabetes mellitus, arterial hypertension and dyslipidaemia among patients on ART in rural facilities in Lesotho
- To assess the prevalence of depression and alcohol use disorder among patients on ART in rural facilities in Lesotho
- To examine associations between chronic comorbidities and virologic outcome among patients on ART in rural Lesotho
- To follow-up patients with virologic failure and/or comorbidity(ies) among patients on ART in rural Lesotho
Design/Methods
The study is planned to take place in two districts of Lesotho: Botha-Bothe and Thaba-Tseka. Prevalence of the selected comorbidities is measured in a cross-sectional, facility-based survey in eight health centers and two hospitals from the two districts. Patients with a detectable viral load will receive enhanced adherence counselling and a second viral load measurement after 2-3 months. In case of confirmed virologic failure, a genotype resistance testing will be done before patients are switched to second-line. Patients with specific comorbidities or patients with virologic failure who had been switched to second-line ART will be followed-up in a cohort study 12-18 months after the survey.
Expected Results and Impact
Prevalence of the selected comorbidities will inform the Ministry of Health as well as its implementing partners on which chronic conditions might be most urgent to be addressed among patients on ART in Lesotho and the national HIV-programme may be used to leverage on for other chronic conditions. Data on virologic failure will inform on the prevalence of virologic failure among a previously not virologically monitored cohort. Moreover it will provide data on the resistance patterns among patients who fail on first-line ART and on the one-year outcome after switch to a second-line regimen.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients on anti-retroviral therapy | – | –The cohort consists of patients on first-line anti-retroviral therapy since at least 6 months, followed at one of the facilities involved in the study. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients on anti-retroviral therapy ≥ 6 months followed at one of the facilities involved in the study.
Key inclusion criteria (2 listed)
- on anti-retroviral therapy ≥ 6 months
- informed consent given
Key exclusion criteria (3 listed)
- on anti-retroviral therapy for < 6 months or documented treatment interruption of ≥ 7 days during the last 3 months
- children < 16 years without the caretaker who can provide informed consent for study participation
- patients on second-line anti-retroviral therapy
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
Prevalence of comorbidities among patients on anti-retroviral therapy in rural Lesotho
Time frame: at enrollment
The prevalence of the following comorbidities/conditions will be assessed: * Diabetes Mellitus * Arterial Hypertension * Dyslipidemia * Depression * Alcohol use disorder * Hepatitis B * Hepatitis C
Prevalence of virologic failure and genotype resistance patterns among patients on anti-retroviral therapy who were not monitored virologically
Time frame: At enrollment
All patients on first-line ART ≥ 6 months will receive viral load testing. Those with a detectable viral load will receive enhanced adherence counselling and again a viral load measurement 3 months after the initial viral load (as recommended by the consolidated WHO-guidelines). In case of persistent virologic failure (2 times detectable viral load) a genotype resitance testing will be done and patients will be switched to second-line ART. This will allow to validate the WHO algorithm for virologic failure in a remote, resource-limited setting.
4 secondary outcomes
1-year follow-up outcomes of patients with virologic failure and subsequent switch to second-line ART
Time frame: 12-18 months after enrollment
1-year outcomes of patients with comorbidities diagnosed at enrollment
Time frame: 12-18 months after enrollment
Predictors of sustained virologic failure 3 months after a detectable viral load at initial measurement
Time frame: enrollment + 3 months
Association of comorbidities and virologic outcomes among patients on anti-retroviral therapy in rural Lesotho
Time frame: at enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Derived from this study: PubMed 28342180Labhardt ND, Muller UF, Ringera I, Ehmer J, Motlatsi MM, Pfeiffer K, Hobbins MA, Muhairwe JA, Muser J, Hatz C. Metabolic syndrome in patients on first-line antiretroviral therapy containing zidovudine or tenofovir in rural Lesotho, Southern Africa. Trop Med Int Health. 2017 Jun;22(6):725-733. doi: 10.1111/tmi.12872. Epub 2017 May 4.
- Derived from this study: PubMed 27608764Cerutti B, Broers B, Masetsibi M, Faturiyele O, Toti-Mokoteli L, Motlatsi M, Bader J, Klimkait T, Labhardt ND. Alcohol use and depression: link with adherence and viral suppression in adult patients on antiretroviral therapy in rural Lesotho, Southern Africa: a cross-sectional study. BMC Public Health. 2016 Sep 8;16(1):947. doi: 10.1186/s12889-016-3209-4.
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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.
Niklaus D Labhardt, MD, MIH principal investigator
Swiss Tropical & Public Health Institute
Christoph Hatz, Prof study director
Swiss Tropical & Public Health Institute
Thomas Klimkait, Prof study chair
Department of Biomedicine, University of Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Metabolic Syndrome, run by Swiss Tropical & Public Health Institute at 2 sites in Lesotho.
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 3 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: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lesotho. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of comorbidities among patients on anti-retroviral therapy in rural Lesotho (time frame: at enrollment). The study lists 2 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 NCT02126696, which also lists 2 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 21 Apr 2016.