Improving HIV Adherence Care for Key Populations in India

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

Interventions

BEHAVIORAL

KP Specific Wellness Sessions

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.

BEHAVIORAL

Peer Navigation

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• The Humsafar Trust

  collaborator UNKNOWN

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Maria Ekstrand, Ph.D · University of California

• Wayne Steward, Ph.D · University of California

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-30

Primary Completion

2026-05-31

Completion

2026-05-31

Countries

• India

Study Locations