Expired Study
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Farmington, Connecticut 06030


Purpose:

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 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, 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.


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


Study is Available At:


Original ID:

U01AA021990


NCT ID:

NCT03746457


Secondary ID:


Study Acronym:

RISHTA


Brief Title:

Alcohol and ART Adherence in India


Official Title:

Alcohol and ART Adherence: Assessment, Intervention and Modeling in India


Overall Status:

Completed


Study Phase:

N/A


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

UConn Health


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

5


Number of Groups:

0


Total Enrollment:

940


Enrollment Type:

Actual


Overall Contact Information

Official Name:Stephen L Schensul, PhD
Principal Investigator
UConn Health

Study Dates

Start Date:May 10, 2015
Completion Date:October 15, 2018
Completion Type:Actual
Primary Completion Date:October 15, 2018
Primary Completion Type:Actual
Verification Date:December 2018
Last Changed Date:December 8, 2018
First Received Date:November 11, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Alcohol Use Disorders Identification Test (AUDIT)
Time Frame:Measurements to assess change made at four (4) time points; baseline and 80-120 days post interventi
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure: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 interventi
Safety Issues:False
Description: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 per
Outcome Type:Primary Outcome
Measure:CD-4 count
Time Frame:Measurements to assess change made at four (4) time points; baseline and 80-120 days post interventi
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Viral Load
Time Frame:Measurements to assess change made at four (4) time points; baseline and 80-120 days post interventi
Safety Issues:False
Description: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 prese
Outcome Type:Secondary Outcome
Measure: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 interventi
Safety Issues:False
Description: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 i
Outcome Type:Secondary Outcome
Measure:HIV Internalized Stigma
Time Frame:Measurements to assess change made at four (4) time points; baseline and 80-120 days post interventi
Safety Issues:False
Description: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)

Study Interventions

Intervention Type:Behavioral
Name:Behavioral intervention
Description:Individual counseling, group intervention, collective advocacy
Arm Name:Control and Cycle 3 integrated package

Study Arms

Study Arm Type:No Intervention
Arm Name:Control ART Center
Description:Control arm with no intervention throughout the course of the study
Study Arm Type:Active Comparator
Arm Name:Control and Cycle 3 integrated package
Description:Control arm in Cycles 1 and 2 and in Cycle three converts to experimental
Study Arm Type:Experimental
Arm Name:GI + CA + IC
Description:Receives one alternative sequence of three interventions
Study Arm Type:Experimental
Arm Name:IC + GI + CA
Description:Receives a second alternative sequence of three interventions
Study Arm Type:Experimental
Arm Name:CA + IC + GI
Description:Receives a third alternative sequence of three interventions

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:UConn Health
Agency Class:Other
Agency Type:Collaborator
Agency Name:Institute for Community Research

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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.
PMID:28930059
Reference Type:Results Reference
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.
PMID:28993911
Reference Type:Results Reference
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.
PMID:28873452
Reference Type:Results Reference
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.
PMID:30349875

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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