Alcohol ConsumptionRISHTANCT03746457
Alcohol and ART Adherence in India
A study testing Behavioral intervention in people with Alcohol Consumption and HIV Infection Primary, run by UConn Health at 1 site in United States.
Trial summary
The focus of this project was to reduce alcohol consumption among male "persons living with HIV" (PLHIV) on antiretroviral treatment (ART) at government hospitals in urban Maharashtra, India and factors associated with both these outcomes including depression, stigma, social support networks, quality of life and… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Alcohol Consumption, HIV Infection Primary
- What is being tested?
- Behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 940 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2015to 15 Oct 2018
- Phase
- Interventional
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male
- age 18-60
- six months or more on ART
- consumed alcohol at least once in the last 30 days
Who cannot join
- Female
- outside the age range
- less than 6 months on ART
- did not consume alcohol in the last 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health
Farmington, Connecticut, 06030
About this study
Official title: Alcohol and ART Adherence: Assessment, Intervention and Modeling in India
The focus of this project was to reduce alcohol consumption among male "persons living with HIV" (PLHIV) on antiretroviral treatment (ART) at government hospitals in urban Maharashtra, India and factors associated with both these outcomes including depression, stigma, social support networks, quality of life and health status. The project consisted of three phases; formative research, implementation of multilevel interventions and analysis of process and outcome data. The project utilized a crossover design to compare outcomes of individual interventions and the sequences of intervention.
Read the detailed description
The focus of this project was to reduce alcohol consumption among male "persons living with HIV" (PLHIV) on antiretroviral treatment (ART) at government hospitals in urban Maharashtra, India and factors associated with both these outcomes including depression, stigma, social support networks, quality of life and health status.
The project consisted of three phases; formative research, intervention implementation and analysis and dissemination. Formative research included key informant interviews and observation at the ART Centers, screening of close to 10,000 patients to identify male PLHIV who met the eligibility criteria, a baseline survey instrument (T1) that assessed a wide range of variables associated with the outcome variables and modeling alternative intervention programs for impact and cost effectiveness. Of 13 ART Centers in the Mumbai, Navi Mumbai, and Thane areas of Maharashtra, five ART Centers were selected for the project with a sample of 940 male PLHIV, 188 from each of the five ART Centers.
The second phase of the project was the development and implementation of three interventions assigned randomly to each of the experimental ART Centers with two of the Centers selected randomly as controls. The interventions were individual counseling (IC), group intervention (GI) and collective advocacy (CA). In Cycle 1 of the intervention phase, the interventions were implemented in each of three experimental ART Centers. In Cycle 2, each of the experimental centers received a second intervention (e.g. GI in Cycle 1+ IC in Cycle 2) and in Cycle 3 each of the experimental Centers received the third intervention (GI in Cycle 1 + IC in Cycle 2 + CA in Cycle 3). In addition, in Cycle 3, one of the two controls received an integrated package of IC, GI and CA. This crossover design test the sequencing and packaging of multi-level interventions for behavior change by examining the efficacy of any one intervention versus control, any two combinations of interventions versus controle, all interventions versus control and the integrated package versus control.
The IC intervention involved one-on-one interaction with a project counselor involving a pre-intervention session in which the PLHIV participant selected the priority issues to be discussed and four additional sessions to address tensions and anxieties, stigma and disclosure, relationships and alcohol and adherence. The sessions were facilitated by in the use of a tablet both to structure the interaction and to collect process data. GI involved four sessions in which 6-10 PLHIV were gathered for intervention on healthy living with HIV, tension, relationships and alcohol and adherence. CA involved groups of 10-15 PLHIV in five sessions in which the focus was on increasing the capacity of participants to advocate both for themselves and a collective group for issues that affected PLHIV human rights, entitlements and services.
The third and current phase of the project is analysis of qualitative data including key informant and in-depth interviews with PLHIV and assessments of fidelity and acceptability of the interventions and quantitative data that includes the screening instrument and baseline (T1) and follow-up outcome data (T2, T3, T4 follow-up surveys after each intervention for both experimental and control centers. This phase will also involve dissemination of results to the National AIDS Control Organizations and its subsidiaries at the State and District levels, the participating ART Centers and to Positive Peoples' Networks at the state and national levels and to national and international meetings and publications.
- Conditions
- Alcohol Consumption, HIV Infection Primary
- Being tested
- Behavioral intervention
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral interventionBehavioural
Individual counseling, group intervention, collective advocacy
| Study group | Role | What they receive |
|---|---|---|
| Control ART Center | No intervention | Control arm with no intervention throughout the course of the study |
| Control and Cycle 3 integrated package | Active comparator | Control arm in Cycles 1 and 2 and in Cycle three converts to experimental Receives: Behavioral: Behavioral intervention |
| GI + CA + IC | Experimental | Receives one alternative sequence of three interventions Receives: Behavioral: Behavioral intervention |
| IC + GI + CA | Experimental | Receives a second alternative sequence of three interventions Receives: Behavioral: Behavioral intervention |
| CA + IC + GI | Experimental | Receives a third alternative sequence of three interventions Receives: Behavioral: Behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use Disorders Identification Test (AUDIT)
Alcohol problem drinking measured by 10-item Alcohol Use Disorders Identification Test (AUDIT) developed by WHO and validated in India. The responses for each item were scored from 0 to 4. The total score range from 1 to 32 with higher scores indicating a high level of alcohol use. The total scores categorized as low risk (0-7), moderate risk (8-15), high risk (≥ 16).
Measured: Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.
The AIDS Clinical Trials Group (ACTG) Adherence Questionnaire
The AIDS Clinical Trials Group (ACTG) Adherence Questionnaire, 4-day recall, involves a self-report of the number of times an HIV+ individuals have taken their ART medication in relation to the number of times prescribed, for the previous four (4) day period. if the prescription is twice per day, then a single missed dose results in a score of 1/8 or 12.5%.
Measured: Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.
CD-4 count
The CD4 count measures the functioning of the immune system the number of white blood (T) cells that fight infection. As HIV infection progresses, the number of these cells declines.
Measured: Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.
Viral Load
The HIV viral load test is used to determine the level of HIV infection in a person diagnosed with the disease. HIV viral load testing measures the amount of HIV genetic material (RNA) in the blood and reports how many copies per ml of the virus are present
Measured: Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.
Secondary outcomes (2)
Center for Epidemiologic Studies-Depression scale (CES-D)
Depressive symptoms are measured using the 10-item Center for Epidemiologic Studies-Depression (CES-D) scale which covers depressed mood, feelings of guilt, worthlessness, and helplessness, loss of appetite, and sleep disturbance, and has been validated in India. The total score ranges from 0 to 30. The resulting scale was skewed, so it was transformed to a categorized variable by using the standardized cut of of 10 to distinguish none/mild (0-9) from moderate (10-14) and severe (15 or higher) depressive symptoms.
Measured: Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.
HIV Internalized Stigma
HIV-related self stigma 16-item scale measuring rejection by family, friends, workplace and services, derived from Berger's HIV stigma scale validated in India that covers three domains: fears related to disclosure (6 items); negative self-image (5 items); and concerns with public attitudes about people with HIV (5 items). Participants responded to each question using a four-item Likert scale (strongly disagree = 1, disagree = 2, agree = 3 and strongly agree = 4). The total score ranged from 16-64 with higher scores indicating greater perception of HIV related self-stigma.
Measured: Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start10 May 2015
- Primary completion15 Oct 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Participants in the three experimental ART Centers received three cycles of intervention, while two ART Centers served as the controls. In the first cycle, participants in the three experimental Centers each received individual counseling, group intervention (GI) and collective advocacy (CA). In Cycle 2, participants in each experimental center received a second intervention (e.g. GI + CA) and in the third cycle, participants in each experimental Center received a third intervention (GI + CA + IC). In addition, in Cycle 3, the participants in one of the Control Centers received an integrated package of IC-GI-CI.
- Masking
- None (open label)
- Enrolment
- 940 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Community Research, International Center for Research on Women, Population Council
- Responsible party
- Principal investigator, Stephen Schensul, UConn Health
- Investigators
- Stephen L Schensul, PhD, Principal investigator, UConn HealthJean J Schensul, PhD, Principal investigator, Institute for Community ResearchNiranjan Saggurti, PhD, Principal investigator, Population Council, India Country officeAvina Sarna, MD, Principal investigator, Population Council, India Country office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746457
- Sponsor's protocol ID
- U01AA021990
- Acronym
- RISHTA
- Status last verified
- Dec 2018
- First submitted
- 11 Nov 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be available in a de-identified status, three years after termination of the project
Publications
Schensul SL, Ha T, Schensul JJ, Vaz M, Singh R, Burleson JA, Bryant K. The Role of Alcohol on Antiretroviral Therapy Adherence Among Persons Living With HIV in Urban India. J Stud Alcohol Drugs. 2017 Sep;78(5):716-724. doi: 10.15288/jsad.2017.78.716.
PubMed 28930059Schensul JJ, Ha T, Schensul S, Sarna A, Bryant K. Identifying the Intersection of Alcohol, Adherence and Sex in HIV Positive Men on ART Treatment in India Using an Adapted Timeline Followback Procedure. AIDS Behav. 2017 Nov;21(Suppl 2):228-242. doi: 10.1007/s10461-017-1916-1.
PubMed 28993911Ruggles KV, Patel AR, Schensul S, Schensul J, Nucifora K, Zhou Q, Bryant K, Braithwaite RS. Betting on the fastest horse: Using computer simulation to design a combination HIV intervention for future projects in Maharashtra, India. PLoS One. 2017 Sep 5;12(9):e0184179. doi: 10.1371/journal.pone.0184179. eCollection 2017.
PubMed 28873452Patel AR, Ruggles KV, Nucifora K, Zhou Q, Schensul S, Schensul J, Bryant K, Braithwaite RS. Evaluating Alternative Designs of a Multilevel HIV Intervention in Maharashtra, India: The Impact of Stakeholder Constraints. MDM Policy Pract. 2018 Oct 16;3(2):2381468318803940. doi: 10.1177/2381468318803940. eCollection 2018 Jul-Dec.
PubMed 30349875Pham TQ, Wu Q, Pan C, Ha L, Bui TC, Sujan MSH, Schensul SL, Shrestha R, Le NT, Ha T. Enhancing quality of life through tailored interventions for men living with HIV. Qual Life Res. 2026 Jan 9;35(2):27. doi: 10.1007/s11136-025-04146-z.
PubMed 41511671Ha T, Pham TQ, Misra S, Su TW, Ha L, Cunningham SD, Carandang RR, Schensul SL. Impact of multilevel interventions on reducing reasons for drinking among men living with HIV. AIDS Care. 2025 Oct;37(10):1696-1705. doi: 10.1080/09540121.2025.2547030. Epub 2025 Aug 22.
PubMed 40844326Ha T, Shi H, Pham BN, Dsouza A, Shrestha R, Kuchipudi SV, Luu HN, Le NT, Schensul SL. Assessing the Effectiveness of Multilevel Intervention Sequences on "Tension" Among Men Living with HIV: A Randomized-Control Trial. Int J Behav Med. 2025 Oct;32(5):647-657. doi: 10.1007/s12529-024-10310-5. Epub 2024 Jul 29.
PubMed 39073518Ha T, Shi H, Shrestha R, Gaikwad SS, Joshi K, Padiyar R, Schensul SL. The Mediating Effect of Changes in Depression Symptoms on the Relationship between Health-Related Quality of Life and Alcohol Consumption: Findings from a Longitudinal Study among Men Living with HIV in India. Int J Environ Res Public Health. 2023 Apr 18;20(8):5567. doi: 10.3390/ijerph20085567.
PubMed 37107849Schensul SL, Ha T, Schensul JJ, Grady J, Burleson JA, Gaikwad S, Joshi K, Malye R, Sarna A. Multilevel and Multifactorial Interventions to Reduce Alcohol Consumption and Improve ART Adherence and Related Factors Among HIV Positive Men in Mumbai, India. AIDS Behav. 2021 Dec;25(Suppl 3):290-301. doi: 10.1007/s10461-021-03303-y. Epub 2021 May 20.
PubMed 34014429
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol and ART Adherence: Assessment, Intervention and Modeling in India
- ClinicalTrials.gov ID
- NCT03746457
- Acronym / sponsor ID
- RISHTA / U01AA021990
- Conditions
- Alcohol Consumption, HIV Infection Primary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 940 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Institute for Community Research, International Center for Research on Women, Population Council
- Study start
- 10 May 2015 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 19 Nov 2018 (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 focus of this project was to reduce alcohol consumption among male "persons living with HIV" (PLHIV) on antiretroviral treatment (ART) at government hospitals in urban Maharashtra, India and factors associated with both these outcomes including depression, stigma, social support networks, quality of life and health status. The project consisted of three phases; formative research, implementation of multilevel interventions and analysis of process and outcome data. The project utilized a crossover design to compare outcomes of individual interventions and the sequences of intervention.
Detailed description
The focus of this project was to reduce alcohol consumption among male "persons living with HIV" (PLHIV) on antiretroviral treatment (ART) at government hospitals in urban Maharashtra, India and factors associated with both these outcomes including depression, stigma, social support networks, quality of life and health status.
The project consisted of three phases; formative research, intervention implementation and analysis and dissemination. Formative research included key informant interviews and observation at the ART Centers, screening of close to 10,000 patients to identify male PLHIV who met the eligibility criteria, a baseline survey instrument (T1) that assessed a wide range of variables associated with the outcome variables and modeling alternative intervention programs for impact and cost effectiveness. Of 13 ART Centers in the Mumbai, Navi Mumbai, and Thane areas of Maharashtra, five ART Centers were selected for the project with a sample of 940 male PLHIV, 188 from each of the five ART Centers.
The second phase of the project was the development and implementation of three interventions assigned randomly to each of the experimental ART Centers with two of the Centers selected randomly as controls. The interventions were individual counseling (IC), group intervention (GI) and collective advocacy (CA). In Cycle 1 of the intervention phase, the interventions were implemented in each of three experimental ART Centers. In Cycle 2, each of the experimental centers received a second intervention (e.g. GI in Cycle 1+ IC in Cycle 2) and in Cycle 3 each of the experimental Centers received the third intervention (GI in Cycle 1 + IC in Cycle 2 + CA in Cycle 3). In addition, in Cycle 3, one of the two controls received an integrated package of IC, GI and CA. This crossover design test the sequencing and packaging of multi-level interventions for behavior change by examining the efficacy of any one intervention versus control, any two combinations of interventions versus controle, all interventions versus control and the integrated package versus control.
The IC intervention involved one-on-one interaction with a project counselor involving a pre-intervention session in which the PLHIV participant selected the priority issues to be discussed and four additional sessions to address tensions and anxieties, stigma and disclosure, relationships and alcohol and adherence. The sessions were facilitated by in the use of a tablet both to structure the interaction and to collect process data. GI involved four sessions in which 6-10 PLHIV were gathered for intervention on healthy living with HIV, tension, relationships and alcohol and adherence. CA involved groups of 10-15 PLHIV in five sessions in which the focus was on increasing the capacity of participants to advocate both for themselves and a collective group for issues that affected PLHIV human rights, entitlements and services.
The third and current phase of the project is analysis of qualitative data including key informant and in-depth interviews with PLHIV and assessments of fidelity and acceptability of the interventions and quantitative data that includes the screening instrument and baseline (T1) and follow-up outcome data (T2, T3, T4 follow-up surveys after each intervention for both experimental and control centers. This phase will also involve dissemination of results to the National AIDS Control Organizations and its subsidiaries at the State and District levels, the participating ART Centers and to Positive Peoples' Networks at the state and national levels and to national and international meetings and publications.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Participants in the three experimental ART Centers received three cycles of intervention, while two ART Centers served as the controls. In the first cycle, participants in the three experimental Centers each received individual counseling, group intervention (GI) and collective advocacy (CA). In Cycle 2, participants in each experimental center received a second intervention (e.g. GI + CA) and in the third cycle, participants in each experimental Center received a third intervention (GI + CA + IC). In addition, in Cycle 3, the participants in one of the Control Centers received an integrated package of IC-GI-CI.
| Arm | Type | Receives |
|---|---|---|
| Control ART Center | No intervention | –Control arm with no intervention throughout the course of the study |
| Control and Cycle 3 integrated package | Active comparator | Behavioral: Behavioral interventionControl arm in Cycles 1 and 2 and in Cycle three converts to experimental |
| GI + CA + IC | Experimental | Behavioral: Behavioral interventionReceives one alternative sequence of three interventions |
| IC + GI + CA | Experimental | Behavioral: Behavioral interventionReceives a second alternative sequence of three interventions |
| CA + IC + GI | Experimental | Behavioral: Behavioral interventionReceives a third alternative sequence of three interventions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- age 18-60
- six months or more on ART
- consumed alcohol at least once in the last 30 days
Key exclusion criteria (4 listed)
- Female
- outside the age range
- less than 6 months on ART
- did not consume alcohol in the last 30 days
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 |
|---|---|---|
| Behavioral interventionIndividual counseling, group intervention, collective advocacy | Behavioural | CA + IC + GI, Control and Cycle 3 integrated package, GI + CA + IC, IC + GI + CA |
Primary outcome
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.
Alcohol problem drinking measured by 10-item Alcohol Use Disorders Identification Test (AUDIT) developed by WHO and validated in India. The responses for each item were scored from 0 to 4. The total score range from 1 to 32 with higher scores indicating a high level of alcohol use. The total scores categorized as low risk (0-7), moderate risk (8-15), high risk (≥ 16).
The AIDS Clinical Trials Group (ACTG) Adherence Questionnaire
Time frame: Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.
The AIDS Clinical Trials Group (ACTG) Adherence Questionnaire, 4-day recall, involves a self-report of the number of times an HIV+ individuals have taken their ART medication in relation to the number of times prescribed, for the previous four (4) day period. if the prescription is twice per day, then a single missed dose results in a score of 1/8 or 12.5%.
CD-4 count
Time frame: Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.
The CD4 count measures the functioning of the immune system the number of white blood (T) cells that fight infection. As HIV infection progresses, the number of these cells declines.
Viral Load
Time frame: Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.
The HIV viral load test is used to determine the level of HIV infection in a person diagnosed with the disease. HIV viral load testing measures the amount of HIV genetic material (RNA) in the blood and reports how many copies per ml of the virus are present
2 secondary outcomes
Center for Epidemiologic Studies-Depression scale (CES-D)
Time frame: Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.
HIV Internalized Stigma
Time frame: Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.
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 11 Dec 2018.
- Results publication: PubMed 28930059Schensul SL, Ha T, Schensul JJ, Vaz M, Singh R, Burleson JA, Bryant K. The Role of Alcohol on Antiretroviral Therapy Adherence Among Persons Living With HIV in Urban India. J Stud Alcohol Drugs. 2017 Sep;78(5):716-724. doi: 10.15288/jsad.2017.78.716.
- Results publication: PubMed 28993911Schensul JJ, Ha T, Schensul S, Sarna A, Bryant K. Identifying the Intersection of Alcohol, Adherence and Sex in HIV Positive Men on ART Treatment in India Using an Adapted Timeline Followback Procedure. AIDS Behav. 2017 Nov;21(Suppl 2):228-242. doi: 10.1007/s10461-017-1916-1.
- Results publication: PubMed 28873452Ruggles KV, Patel AR, Schensul S, Schensul J, Nucifora K, Zhou Q, Bryant K, Braithwaite RS. Betting on the fastest horse: Using computer simulation to design a combination HIV intervention for future projects in Maharashtra, India. PLoS One. 2017 Sep 5;12(9):e0184179. doi: 10.1371/journal.pone.0184179. eCollection 2017.
- Results publication: PubMed 30349875Patel AR, Ruggles KV, Nucifora K, Zhou Q, Schensul S, Schensul J, Bryant K, Braithwaite RS. Evaluating Alternative Designs of a Multilevel HIV Intervention in Maharashtra, India: The Impact of Stakeholder Constraints. MDM Policy Pract. 2018 Oct 16;3(2):2381468318803940. doi: 10.1177/2381468318803940. eCollection 2018 Jul-Dec.
- Derived from this study: PubMed 41511671Pham TQ, Wu Q, Pan C, Ha L, Bui TC, Sujan MSH, Schensul SL, Shrestha R, Le NT, Ha T. Enhancing quality of life through tailored interventions for men living with HIV. Qual Life Res. 2026 Jan 9;35(2):27. doi: 10.1007/s11136-025-04146-z.
- Derived from this study: PubMed 40844326Ha T, Pham TQ, Misra S, Su TW, Ha L, Cunningham SD, Carandang RR, Schensul SL. Impact of multilevel interventions on reducing reasons for drinking among men living with HIV. AIDS Care. 2025 Oct;37(10):1696-1705. doi: 10.1080/09540121.2025.2547030. Epub 2025 Aug 22.
- Derived from this study: PubMed 39073518Ha T, Shi H, Pham BN, Dsouza A, Shrestha R, Kuchipudi SV, Luu HN, Le NT, Schensul SL. Assessing the Effectiveness of Multilevel Intervention Sequences on "Tension" Among Men Living with HIV: A Randomized-Control Trial. Int J Behav Med. 2025 Oct;32(5):647-657. doi: 10.1007/s12529-024-10310-5. Epub 2024 Jul 29.
- Derived from this study: PubMed 37107849Ha T, Shi H, Shrestha R, Gaikwad SS, Joshi K, Padiyar R, Schensul SL. The Mediating Effect of Changes in Depression Symptoms on the Relationship between Health-Related Quality of Life and Alcohol Consumption: Findings from a Longitudinal Study among Men Living with HIV in India. Int J Environ Res Public Health. 2023 Apr 18;20(8):5567. doi: 10.3390/ijerph20085567.
- Derived from this study: PubMed 34014429Schensul SL, Ha T, Schensul JJ, Grady J, Burleson JA, Gaikwad S, Joshi K, Malye R, Sarna A. Multilevel and Multifactorial Interventions to Reduce Alcohol Consumption and Improve ART Adherence and Related Factors Among HIV Positive Men in Mumbai, India. AIDS Behav. 2021 Dec;25(Suppl 3):290-301. doi: 10.1007/s10461-021-03303-y. Epub 2021 May 20.
- Individual participant dataSharing planned: Yes. Will be available in a de-identified status, three years after termination of the project
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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.
Stephen L Schensul, PhD principal investigator
UConn Health
Jean J Schensul, PhD principal investigator
Institute for Community Research
Niranjan Saggurti, PhD principal investigator
Population Council, India Country office
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral intervention in people with Alcohol Consumption and HIV Infection Primary, run by UConn Health 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 4 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: finished, as of the sponsor's last update on 11 Dec 2018. 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 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?
Alcohol Use Disorders Identification Test (AUDIT) (time frame: Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.). The study lists 4 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 NCT03746457, which also lists 9 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 11 Dec 2018.