NCT07370298 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
| NCT ID | NCT07370298 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Possible |
| Condition | HIV Care Loss to Followup |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2026-02-12 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 88 participants in total. It began in 2026-02-12 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
People living with HIV (PLWH) have poor clinical outcomes when they are excluded from care due to intersectional stigma related to HIV, mental health (MH), and other dimensions. Recent studies and reviews have highlighted three major challenges in identifying and addressing intersectional stigma: a lack of stigma assessment strategies that are multi-dimensional and can be incorporated into routine clinical care, a lack of tailored stigma-reduction activities, and a lack of implementation of multi-level interventions. These gaps make it difficult to recognize and address intersectional stigma, leading to poor HIV care outcomes globally. Digital health tools, co-designed with PLWH and healthcare workers (HCWs), have the potential to assist ART centers in addressing these challenges. Guided by the principles of human-centered design, our team has developed a digital tool with three components that can address the challenges in assessing, prioritizing, and addressing intersectional stigma in ART centers. The components include: 1) a dynamic assessment strategy that can be used during a clinic visit to collect both quantitative (i.e., ratings) and qualitative data (i.e., free text of client's perspectives) on stigma reported by PLWH; 2) a dashboard that incorporates this stigma assessment data alongside routine clinical data (i.e., existing registry of clients in the ART center) so that ART centers can directly link stigma with care engagement, and also identify relevant stigma-reduction activities; and 3) a repository of evidence-based, culturally appropriate activities that can reduce stigma at the intrapersonal-, interpersonal-, and clinic-levels. The three components of the digital intervention are theoretically grounded and are based on prior studies and consultations with local partners. The study aims to assess the acceptability and feasibility of INCLUDE among clients, HCWs, and ART center leads in four ART centers. For this aim, we will conduct a pilot trial at four ART centers to assess the acceptability and feasibility of INCLUDE. If successful, this study will provide an intervention that can be incorporated into routine clinical practice to systematically identify and address intersectional stigma to improve HIV care, and can be tested in a cluster randomized trial with ART centers in Nepal and other regions that face similar challenges.
Eligibility 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.
Contact & Investigator
Bibhav Acharya, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07370298 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV Care Loss to Followup. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07370298 currently recruiting?
Yes, NCT07370298 is actively recruiting participants. Contact the research team at bibhav.acharya@ucsf.edu for enrollment information.
Where is the NCT07370298 trial being conducted?
This trial is being conducted at Kathmandu, Nepal.
Who is sponsoring the NCT07370298 clinical trial?
NCT07370298 is sponsored by Possible. The principal investigator is Bibhav Acharya, MD at University of California, San Francisco. The trial plans to enroll 88 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.