Alcohol and ART Adherence in India (RISHTA)

December 8, 2018 updated by: Stephen Schensul, UConn Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

940

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control ART Center
Control arm with no intervention throughout the course of the study
Active Comparator: Control and Cycle 3 integrated package
Control arm in Cycles 1 and 2 and in Cycle three converts to experimental
Behavioral: Behavioral intervention
Individual counseling, group intervention, collective advocacy
Experimental: GI + CA + IC
Receives one alternative sequence of three interventions
Behavioral: Behavioral intervention
Individual counseling, group intervention, collective advocacy
Experimental: IC + GI + CA
Receives a second alternative sequence of three interventions
Behavioral: Behavioral intervention
Individual counseling, group intervention, collective advocacy
Experimental: CA + IC + GI
Receives a third alternative sequence of three interventions
Behavioral: Behavioral intervention
Individual counseling, group intervention, collective advocacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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%.
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
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.
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
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Collaborators

Population Council
International Center for Research on Women
Institute for Community Research

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2015

Primary Completion (Actual)

October 15, 2018

Study Completion (Actual)

October 15, 2018

Study Registration Dates

First Submitted

November 11, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (Actual)

November 19, 2018

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 8, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01AA021990 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will be available in a de-identified status, three years after termination of the project

IPD Sharing Time Frame

February 1, 2023

IPD Sharing Access Criteria

All researchers in research organizations

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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