Alcohol and ART Adherence in India
Condition: Alcohol Consumption; HIV Infection Primary
MeSH terms: Alcohol Drinking
Study type: Interventional

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.
    

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.
    

Intervention name(s): Behavioral intervention
Intervention type(s): Behavioral
Intervention description(s): Individual counseling, group intervention, collective advocacy
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention 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)
Primary purpose: Other