NCT05869461Completed
Improving HIV Adherence Care for Key Populations in India
Adapting an Effective Intervention for Enhancing Engagement in HIV Care to Meet the Needs of Key Populations in India
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 106 (actual)
- First submitted
- 11 May 2023
- Start date
- 30 Nov 2023
- Primary completion date
- 31 May 2026
- Lead sponsor
- University of California, San Francisco
- Diseases
- HIV
- NCT number
- NCT05869461
What you commit to
- Study type: Interventional
- Participants enrolled: 106
- From 30 Nov 2023 to the primary completion date, 31 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Impaired cognitive functioning indicating potentially diminished capacity to participate in the study
- Participation in the pilot (AIM 1)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Humsafar Trust Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.