Alcohol and ART Adherence in India

NCT03746457 | Completed DMC

• 1 other identifier: U01AA021990
• Study Type: interventional
• Target: 940
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Alcohol Consumption; HIV Infection Primary

Outcome Measures

Primary Outcomes (4)

• 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).

  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%.

  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.

  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

  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)

  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

  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.

Study Arms (5)

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

Behavioral: Behavioral intervention

GI + CA + IC

EXPERIMENTAL

Receives one alternative sequence of three interventions

Behavioral: Behavioral intervention

IC + GI + CA

EXPERIMENTAL

Receives a second alternative sequence of three interventions

Behavioral: Behavioral intervention

CA + IC + GI

EXPERIMENTAL

Receives a third alternative sequence of three interventions

Behavioral: Behavioral intervention

Interventions

Behavioral intervention BEHAVIORAL

Individual counseling, group intervention, collective advocacy

CA + IC + GI; Control and Cycle 3 integrated package; GI + CA + IC; IC + GI + CA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Based on self-representation
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• age 18-60
• six months or more on ART
• consumed alcohol at least once in the last 30 days

You may not qualify if:

• Female
• outside the age range
• less than 6 months on ART
• did not consume alcohol in the last 30 days

Sponsors & Collaborators

• UConn Health: lead
• Institute for Community Research: collaborator
• International Center for Research on Women: collaborator
• Population Council: collaborator

Study Sites (1)

University of Connecticut Health

Farmington, Connecticut, 06030, United States

Location

Related Publications (8)

• 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.

  PMID: 28930059 RESULT

• Schensul 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.

  PMID: 28993911 RESULT

• Ruggles 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.

  PMID: 28873452 RESULT

• Patel 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.

  PMID: 30349875 RESULT

• Ha 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.

  PMID: 40844326 DERIVED

• Ha 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.

  PMID: 39073518 DERIVED

• Ha 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.

  PMID: 37107849 DERIVED

• Schensul 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.

  PMID: 34014429 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Stephen L Schensul, PhD

  UConn Health

  PRINCIPAL INVESTIGATOR

• Jean J Schensul, PhD

  Institute for Community Research

  PRINCIPAL INVESTIGATOR

• Niranjan Saggurti, PhD

  Population Council, India Country office

  PRINCIPAL INVESTIGATOR

• Avina Sarna, MD

  Population Council, India Country office

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 11, 2018
• First Posted: November 19, 2018
• Study Start: May 10, 2015
• Primary Completion: October 15, 2018
• Study Completion: October 15, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: February 1, 2023
• Access Criteria: All researchers in research organizations

Locations

US (1)