Adapting an Effective Intervention for Enhancing Engagement in HIV Care to Meet the Needs of Key Populations in India

The "Chetana-PN" study aims to improve engagement in care among two key populations living with HIV -MSM and TGW in the Indian state of Maharashtra, which has both India's highest HIV prevalence and LGBT population.

Aim 1: To engage community stakeholders in the adaptation of the Chetana-PN wellness adherence intervention for use with Indian MSM and TGW who are living with HIV. Building on the original Chetana intervention and using the steps described in the adaptation framework12, investigators will add population-specific content and a peer navigator component to provide tailored support. To ensure the content fully meets MSM and TGW needs, investigators will then conduct a stakeholder workshop and incorporate their recommendations. Workshop input will be used to finalize a project manual of operations, which will be presented to stakeholders for review. Subsequently, study procedures and adapted content will be piloted with 10 participants and gather feedback to determine if additional modifications are needed to finalize.

Aim 2A: To assess in a RCT the acceptability and feasibility of the theoretically-guided, adapted intervention and obtain preliminary effect size estimations for the impact of the intervention on (1) appointment keeping, (2) ART adherence, and (3) viral suppression among MSM and TGW who are newly or insufficiently engaged in HIV care. 110 MSM and TGW living with HIV and sub-optimally engaged in care will be randomized to an acceptability and feasibility trial of the adapted Chetana-PN intervention versus a wellness attention control arm. Both groups will receive standard ART center medical treatment and counseling. Data will be collected over 12 months using interviewer-administered questionnaires, ART center booklets and viral load. Data will be analyzed to preliminarily examine whether the intervention impacts model drivers of care-seeking behaviors. These include depression, stigma, disclosure, and barriers to care.

Aim 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. 25 intervention participants and three navigators will be interviewed at the end of their involvement in the intervention to identify practices and other intervention components that were more and less successful at keeping the participants engaged in care and adherent to their ART regimens. The data will also shed additional light on the acceptability and feasibility of the intervention. Data will contextualize the findings from the pilot trial and inform a future RCT designed to establish the efficacy of Chetana-PN intervention for sexual minorities in India.

The proposed intervention adaptation builds upon the original Chetana intervention, tailoring content, enhancing flexibility, and adding a peer navigation component based on work conducted by the study team in India and other settings. The intervention involves wellness sessions with KP specific content and flexibility and peer navigation. The Control arm will receive general wellness sessions without any content focusing on engagement in care. Given the challenges of MSM and TGW to attend groups with fixed schedules, the Chetana-PN groups will be offered on a drop-in basis and scheduled at multiple times.