Clinical trial NCT03746457: Alcohol and ART Adherence in India
Official title: Alcohol and ART Adherence: Assessment, Intervention and Modeling in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
HIV Infection Primary
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Institute for Community Research
name: International Center for Research on Women
name: Population Council
First posted: 2018-11-19
Enrollment: 940
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: 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.
measure: The AIDS Clinical Trials Group (ACTG) Adherence Questionnaire
timeFrame: 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.
measure: CD-4 count
timeFrame: 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.
measure: Viral Load
timeFrame: 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:
measure: Center for Epidemiologic Studies-Depression scale (CES-D)
timeFrame: 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.
measure: HIV Internalized Stigma
timeFrame: 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.
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health
state: Connecticut
Study officials:
affiliation: UConn Health
name: Stephen L Schensul, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Community Research
name: Jean J Schensul, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Council, India Country office
name: Niranjan Saggurti, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Council, India Country office
name: Avina Sarna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.