Alcohol and ART Adherence in India
Status: | Completed |
---|---|
Conditions: | HIV / AIDS, Psychiatric |
Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 12/13/2018 |
Start Date: | May 10, 2015 |
End Date: | October 15, 2018 |
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials