Status:
RECRUITING
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
Lead Sponsor:
Possible
Collaborating Sponsors:
Fogarty International Center of the National Institute of Health
National Institutes of Health (NIH)
Conditions:
HIV Care Loss to Followup
HIV Antiretroviral Therapy (ART) Adherence
Eligibility:
All Genders
18+ years
Phase:
NA
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 rev...
Detailed Description
Intersectional stigma is a pervasive barrier to care that disproportionately affects people living with HIV (PLWH) and leads to poor clinical outcomes. While the understanding of intersectional stigma...
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.
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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.
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Exclusion Criteria for PLWH:
- presence of significant cognitive problems/disability precluding participation
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Inclusion Criteria for HCWs:
- All HCWs of ART centers: HIV counselors, ART center leads, and other HCWs.
Key Trial Info
Start Date :
February 12 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT07370298
Start Date
February 12 2026
End Date
May 1 2027
Last Update
April 17 2026
Active Locations (1)
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1
Possible
Kathmandu, Bagmati, Nepal