FindMyKOL
Clinical trialNCT07370298Active, not recruitingInterventional

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

SponsorPossibleEnrollment88Ethnic MinoritiesGender Minority IndividualsHIV Antiretroviral Therapy (ART) AdherenceHIV Care Loss to FollowupHIV StigmaIntersectional Stigma+2 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Nepal
  • Possible

    Kathmandu, Bagmati, Nepal

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
25 Jan 2026
Primary completion
1 May 2027
Completion
1 May 2027
Last update posted
18 Jun 2026
Registered enrollment
88
Registry id
NCT07370298

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.