HIV/AIDSNCT07091253
Physical Activity and People Living With HIV in New York City
An observational study of HIV/AIDS, run by Queens College, The City University of New York at 1 site in United States.
Trial summary
The study evaluates the physical activity and sedentary behaviors, as well as the relationship between physical activity an overall health in people living with HIV (PLWH). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- HIV+
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2019to 31 Dec 2020
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: People living with HIV
Who may be able to join
- Having an HIV diagnosis
- Able to engage in daily physical activities
- Willing to carry an accelerometer for seven days at the waist
- Living within the 5 boroughs of New York City, and
- Willing to be contacted daily by phone or text during the study.
Who cannot join
- Having an unmanaged chronic disease or musculoskeletal disease that would limit physical activity
- Having suicidal ideations
- Currently being pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Physiology Laboratory
Flushing, New York, 11375
About this study
Official title: Objective Physical Activity and Sedentary Behaviors of People Living With HIV in New York City
The study evaluates the physical activity and sedentary behaviors, as well as the relationship between physical activity an overall health in people living with HIV (PLWH).
Read the detailed description
PLWH now live longer due to the effectiveness and availability of anti-retroviral therapy (ART). However, serious physical and mental health issues are often reported in this population. Research suggests that physical activity (PA) can improve physical and mental health in PLWH. However, while studies on self-reported PA among PLWH abound, very few studies have reported on the objectively measured PA (i.e., the standard for PA assessment) and sedentary behaviors of PLWH and the relationship between PA and physical and mental health in this population. The purpose of this study are to evaluate the objectively measured PA and sedentary behaviors of PLWH in New York City, as well as the relationship between PA and overall health in this population. A better understanding of the PA and sedentary behaviors is critical to establishing PA programs that can lead to enhancement of overall health.
The study is cross-sectional in design and will last a total of one week. Participants who agree to participate will be asked to complete a series of questionnaires evaluating physical health, mental health, physical activity and nutrient intake, and will be asked to wear an accelerometer at the hip for seven consecutive days.
- Conditions
- HIV/AIDS
- Being tested
- HIV+
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV+Other
Participants living with HIV will use a triaxial accelerometer for a week in order to measure the physical activity and sedentary behaviors
| Study group | Role | What they receive |
|---|---|---|
| HIV+ | Not described Receives: Other: HIV+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity and sedentary time
Time engaged in moderate to vigorous physical activity, as well as sedentary time, during the measurement week as assessed through accelerometry.
Measured: one week
Secondary outcomes (5)
Health Status
Overall health status will be assessed through 4 short questions from the Behavioral Risk Factor Surveillance System. The questions ask about the participant's perception of their current general health in a Likert scale, the number of days during the past 30 days their physical health was not good, the number of days during the past 30 days their mental health was not good and number of days in the last 30 days their physical or mental health kept them from doing their usual activities.
Measured: last 30 days
Exercise Vital Sign questionnaire
Self reported physical activity will be evaluated using the Exercise Vital Sign questionnaire. The questionnaire provides information on the days per week the participant engages in moderate to strenuous physical activity, and the number of minutes per day the participant engages in such behaviors. The range of days is 0 to 7, and the range of minutes per day is 0 to 1440. The number of days and the number of minutes per day that the participant engages in moderate to strenuous physical activity will be multiplied to get the total number of minutes per week that the participant engages in such activity. Less than 150 minutes per week of physical activity will be considered "not meeting physical activity guidelines for Americans", and equal or more than 150 minutes per week will be considered "meeting physical activity guidelines for Americans". The questionnaire will be administered at the beginning and at the end of the study.
Measured: From enrollment to the end of the protocol at 7 days
Nutrient Intake Assessment
Nutrient intake will be evaluated using the Rapid Eating Assessment for Participants (REAPS) questionnaire. The questionnaire includes 16 questions. The first 13 questions are used to calculate the diet quality score. They include 3 possible answers: "usually/always"= 1 point, "sometimes"= 2 points, "rarely/never" = 3 points. The scores are added to determine diet quality on a scale of 13 (worst outcome) to 39 (best outcome). Higher scores indicating a healthier diet.
The last 2 questions are not included in the total score calculation. One question includes "Yes" or "No" answers, and 1 question is rated on a 5-point scale ranging from 1 (best outcome) to 5 (Worst outcome).
Measured: From enrollment to the end of the protocol at 7 days
Diagnosed Diseases
Participants will also be asked questions from the Behavioral Risk Factor Surveillance System about diagnosed diseases including: coronary heart disease, myocardial infarction, stroke, chronic obstructive pulmonary disease, depressive disorder and diabetes. Possible answers include: "Yes", "No", "Don't know/Not sure" or "Refused". This is done for descriptive purposes and and there is no scale or score associated with this measure.
Measured: At enrollment, on the first day of the protocol.
Depressive symptoms using the Beck Depression Inventory II (BDI-II)
Depressive symptoms will be evaluated using the Beck Depression Inventory II (BDI-II). The BDI-II is a self-report questionnaire designed to assess the severity of depressive symptoms in adults and adolescents aged 13 and older during the past 2 weeks. Items are rated on a 4-point scale ranging from 0 (minimum score) to 3 (maximum score) based on severity of each item. The minimum total score is 0 and the maximum total score is 63. The higher the score the worse the severity of depressive symptoms.
Measured: From enrollment to the end of the protocol at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start5 Aug 2019
- Primary completion1 Jul 2020
- Study completion31 Dec 2020
Why it stopped: The PI moved to another institution. The award and program are no longer at Queens College.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queens College, The City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norberto Quiles, Ed.D., Principal investigator, Queens College CUNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091253
- Sponsor's protocol ID
- 62057-0050
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2019
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Quiles NN, Balachandran A, Ortiz A. Comparison of the Exercise Vital Sign Questionnaire With Accelerometry and Physical Activity Behaviors in People Living With HIV in New York City: A Cross-Sectional Study. J Assoc Nurses AIDS Care. 2025 Dec 29. doi: 10.1097/JNC.0000000000000617. Online ahead of print.
PubMed 41459937
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Physical Activity and Sedentary Behaviors of People Living With HIV in New York City
- ClinicalTrials.gov ID
- NCT07091253
- Acronym / sponsor ID
- 62057-0050
- Conditions
- HIV/AIDS
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The PI moved to another institution. The award and program are no longer at Queens College.
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Queens College, The City University of New YorkUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Jul 2025 (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.
The study evaluates the physical activity and sedentary behaviors, as well as the relationship between physical activity an overall health in people living with HIV (PLWH).
Detailed description
PLWH now live longer due to the effectiveness and availability of anti-retroviral therapy (ART). However, serious physical and mental health issues are often reported in this population. Research suggests that physical activity (PA) can improve physical and mental health in PLWH. However, while studies on self-reported PA among PLWH abound, very few studies have reported on the objectively measured PA (i.e., the standard for PA assessment) and sedentary behaviors of PLWH and the relationship between PA and physical and mental health in this population. The purpose of this study are to evaluate the objectively measured PA and sedentary behaviors of PLWH in New York City, as well as the relationship between PA and overall health in this population. A better understanding of the PA and sedentary behaviors is critical to establishing PA programs that can lead to enhancement of overall health.
The study is cross-sectional in design and will last a total of one week. Participants who agree to participate will be asked to complete a series of questionnaires evaluating physical health, mental health, physical activity and nutrient intake, and will be asked to wear an accelerometer at the hip for seven consecutive days.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV+ | – | Other: HIV+ |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People living with HIV
Key inclusion criteria (5 listed)
- Having an HIV diagnosis
- Able to engage in daily physical activities
- Willing to carry an accelerometer for seven days at the waist
- Living within the 5 boroughs of New York City, and
- Willing to be contacted daily by phone or text during the study.
Key exclusion criteria (3 listed)
- Having an unmanaged chronic disease or musculoskeletal disease that would limit physical activity
- Having suicidal ideations
- Currently being pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV+Participants living with HIV will use a triaxial accelerometer for a week in order to measure the physical activity and sedentary behaviors | Other | HIV+ |
Primary outcome
Physical activity and sedentary time
Time frame: one week
Time engaged in moderate to vigorous physical activity, as well as sedentary time, during the measurement week as assessed through accelerometry.
5 secondary outcomes
Health Status
Time frame: last 30 days
Exercise Vital Sign questionnaire
Time frame: From enrollment to the end of the protocol at 7 days
Nutrient Intake Assessment
Time frame: From enrollment to the end of the protocol at 7 days
Diagnosed Diseases
Time frame: At enrollment, on the first day of the protocol.
Depressive symptoms using the Beck Depression Inventory II (BDI-II)
Time frame: From enrollment to the end of the protocol at 7 days
Results and safety
The study was stopped early (reason given: The PI moved to another institution. The award and program are no longer at Queens College.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 41459937Quiles NN, Balachandran A, Ortiz A. Comparison of the Exercise Vital Sign Questionnaire With Accelerometry and Physical Activity Behaviors in People Living With HIV in New York City: A Cross-Sectional Study. J Assoc Nurses AIDS Care. 2025 Dec 29. doi: 10.1097/JNC.0000000000000617. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Norberto Quiles, Ed.D. principal investigator
Queens College CUNY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS, run by Queens College, The City University of New York at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: The PI moved to another institution. The award and program are no longer at Queens College.). Results are not available in the source record.
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?
Physical activity and sedentary time (time frame: one week). 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 NCT07091253, which also lists 1 linked publication.
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 1 Oct 2025.