Improving HIV Adherence Care for Key Populations in India

NCT05869461 | Active Not Recruiting DMC

• 2 other identifiers: R01MH1281621R01MH128162-01A1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to adapt and pilot test a comprehensive wellness program to address the barriers to engagement in the HIV care continuum among men who have sex with men (MSM) and transgender women (TGW) in India. The content involves an adaptation of the earlier Chetana wellness adherence intervention which was found to successfully improve adherence and viral suppression among mainstream Indian persons living with HIV (PLWH). Based on the initial formative work, the adaptation includes added wellness group content and will be offered in a flexible format. It also uses peer navigators (PN), rather than Master-level counselors, to deliver tailored support at mutually convenient times and places. This PN model has been used successfully by Indian collaborators and in previous research in South Africa to link and retain PLWH in care. The intervention is intended to break the link between stigma and care seeking, which is especially important for key populations (KPs), who must deal with historically hostile legal environments and substantial isolation that further reduces engagement in HIV preventive practices and services . Investigators are conducting this research to address the following aims: 1\) To engage community stakeholders in the adaptation and pilot testing of the Chetana-PN wellness adherence intervention for use with Indian MSM and TGW who are living with HIV and who are newly or insufficiently engaged in care. 2a) To assess in a small randomized control trial (RCT) the acceptability and feasibility of the theoretically-guided, adapted intervention and to obtain preliminary effect size estimations for the impact of the intervention on engagement in care, among MSM and TGW. 2b) To characterize participant and navigator experiences in the Chetana-PN intervention and describe the practices that were most successful at overcoming barriers to care with 25 participants who received the Chetana-PN intervention and the peer navigators. These findings will subsequently be used to inform a future RCT designed to establish the efficacy of this adapted Chetana-PN intervention for sexual minorities in India.

Conditions

Treatment Adherence

Outcome Measures

Primary Outcomes (3)

• Change in Appointment Keeping Frequency

  Data on kept ART clinic appointments will be obtained from the ART clinic booklet (aka "the green book") carried by participants. This procedure has been used successfully in our previous studies with similar populations.

  Baseline to 12 months

• Change in Medication Adherence

  Self-report using validated self-reported measures used previously by our team with similar populations in India to assess percent of pills taken in past month and number/ days of treatment interruptions

  Baseline to 12 months

• Change in Viral Load

  Viral load will be tested using a validated real-time PCR assay by Metropolis laboratories, authorized and used by MDACS. The study will arrange and pay for baseline VL tests. Subsequent tests, conducted at each 6-month visit will be conducted by the ART center as part of their "Fast Track City" protocol. All analyses will be conducted by the same laboratory.

  Baseline to 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

This group will receive access to the wellness sessions that have specific content geared towards our key populations and they will also receive peer navigation for 6 months.

Behavioral: KP Specific Wellness Sessions; Behavioral: Peer Navigation

Control

NO INTERVENTION

Control arm participants will receive standard HIV care through the Mumbai Districts AIDS Control Society (MDACS)-run ART clinics. In addition, participants will have access to an abbreviated version of the wellness groups to help them remain engaged with the study team and to control for attention.

Interventions

KP Specific Wellness Sessions BEHAVIORAL

The sessions will include content on yoga, nutrition, legal issues, medical information, and community resources from the original Chetana intervention (further described below). They will also include expanded content informed by our previous studies and focus group discussions with MSM and TGW that addresses the needs for sessions on mental health, financial literacy, substance use, legal rights for key populations and coping skills for interacting with the legal system, and community resources for MSM and TGW. Sessions will include specifically tailored content related to the needs of MSM or TGW.

Intervention

Peer Navigation BEHAVIORAL

Participants will be assigned to a peer navigator (PN) who will be their principal point of contact for the intervention. Within a week, the navigator will set up an initial introductory meeting, either in person or via video chat. This will serve as the first monthly check-in to monitor a participant's progress. During these in-person digital meetings, the navigator will work with a participant to identify their unique barriers that currently affect engagement in care and train participants to identify and break down solutions into manageable steps. Special attention will be paid to barriers associated with intersectional stigma and PNs will draw on their own experiences as members of stigmatized groups in identifying and brainstorming successful coping strategies. While this is not a structural intervention, PNs will work with their clients to develop ways of coping with structural barriers, including transportation and referrals to social services.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: MSM or TGW
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Speak Hindi, Marathi, or English
• Self-identify as MSM or TGW
• Be HIV-positive
• Be either newly linked to ART clinic or be insufficiently engaged in care (defined as having missed or been more than 10 days late for one clinic appointment in the past year, missed more than 10% of their pills in the past month, or have detectable viral loads after more than 6 months on ART)- Be willing and able to give informed consent.

You may not qualify if:

• Impaired cognitive functioning indicating potentially diminished capacity to participate in the study
• Participation in the pilot (AIM 1)

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator
• The Humsafar Trust: collaborator

Study Sites (1)

The Humsafar Trust

Mumbai, 400055, India

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Maria Ekstrand, Ph.D

  University of California

  PRINCIPAL INVESTIGATOR

• Wayne Steward, Ph.D

  University of California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The intervention and assessment study staff do not overlap and all reasonable care is taken to keep assessment staff blinded to intervention allocation for the whole duration of the study. Investigators know intervention arm on a need to know basis but do not have contact with participants directly.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: November 30, 2023
• Primary Completion: May 31, 2026
• Study Completion: May 31, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)