INCLUDE digital tool to identify and reduce overlapping stigma and improve HIV care in ART centers in Nepal
Developing and Testing a Digital Health Tool for INterseCtional Stigma Assessment and Reduction at Multiple Levels and mUltiple DimEnsions (INCLUDE) to Improve HIV Care in ART Centers in Nepal
This project tests a digital tool designed to find and reduce overlapping HIV-related and mental health stigma for adults with HIV who are missing care or struggling with mental health at ART centers in Nepal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Possible Academic / other |
| Locations | 1 site (Kathmandu, Bagmati) |
| Trial ID | NCT07370298 on ClinicalTrials.gov |
What this trial studies
This interventional project will deploy the INCLUDE digital health tool, co-designed with people living with HIV and healthcare workers, to screen for multi-dimensional intersectional stigma and deliver tailored stigma-reduction activities. The tool comprises three components intended to be integrated into routine workflows at ART centers to support both patients and clinic staff. Researchers will enroll adults with HIV who have poor HIV outcomes and screen positive for anxiety or depression, along with healthcare workers at participating ART centers, then follow participants to measure changes in care engagement, stigma scores, ART adherence, and viral suppression. The work aims to test implementation across clinic settings and whether the tool improves recognition of layered stigma and patient retention in care.
Who should consider this trial
Good fit: Adults (≥18) living with HIV in the catchment area of participating ART centers who have poor HIV outcomes (detectable viral load, missed visits, or late medication pick-up), screen positive for anxiety or depression, and plan to remain in the area are ideal candidates.
Not a fit: People with significant cognitive impairment that prevents participation, those not living in the participating ART center catchment areas or planning to leave during the study, and patients who are already stable on ART with sustained viral suppression may not receive benefit from this intervention.
Why it matters
Potential benefit: If successful, the tool could help clinics identify and address layered stigma earlier, provide personalized support, and improve retention in care and viral suppression for people living with HIV in Nepal.
How similar studies have performed: Some digital and mHealth interventions for stigma reduction and ART adherence have shown promise, but multi-dimensional, intersectional stigma tools implemented at multiple levels like INCLUDE remain largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
There are two groups of study participants: people living with HIV (PLWH) and healthcare workers (HCWs) in ART centers (clinics for HIV treatment) in Nepal. 1. Inclusion Criteria for PLWH: * PLWH with poor HIV outcomes (a. been in care for more than 6 months but with detectable VL; b. missed clinic visit by more than a month; and/or c. did not pick up medications for more than 2 weeks from the expected refill date); * age ≥18; * screening positive for having mental health conditions (with the Generalized Anxiety-7 and Patient Health Questionnaire-9 screening tools); and * living in the ART (Anti-Retroviral Therapy) center's catchment area with no plans to leave during the study period. * Sexual and Gender Minorities and/or Ethnic Minorities. Participants will be drawn randomly from this list, stratified by having additional stigma dimension(s) vs. not. 2. Exclusion Criteria for PLWH: * presence of significant cognitive problems/disability precluding participation 3. Inclusion Criteria for HCWs: * All HCWs of ART centers: HIV counselors, ART center leads, and other HCWs.
Where this trial is running
Kathmandu, Bagmati
- Possible — Kathmandu, Bagmati, Nepal (Recruiting)
Study contacts
- Principal investigator: Bibhav Acharya, MD — University of California, San Francisco
- Study coordinator: Bibhav Acharya, MD
- Email: bibhav.acharya@ucsf.edu
- Phone: +1 917 653 9385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.