Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
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

Led by Possible · Updated on 2026-04-17

88

Participants Needed

1

Research Sites

63 weeks

Total Duration

On this page

Sponsors

P

Possible

Lead Sponsor

F

Fogarty International Center of the National Institute of Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • People living with HIV (PLWH) who have poor HIV outcomes, including being in care for over 6 months with detectable viral load, missing clinic visits by more than a month, or missing medication refills by more than 2 weeks
  • Age 18 years or older
  • Screening positive for mental health conditions using Generalized Anxiety-7 and Patient Health Questionnaire-9
  • Living in the ART center's catchment area with no plans to leave during the study period
  • Sexual and Gender Minorities and/or Ethnic Minorities, with participants drawn randomly and stratified by additional stigma dimensions
  • All healthcare workers (HCWs) at ART centers, including HIV counselors and ART center leads
Not Eligible

You will not qualify if you...

  • Significant cognitive problems or disabilities that prevent participation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Possible

Kathmandu, Bagmati, Nepal

Actively Recruiting

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Research Team

B

Bibhav Acharya, MD

CONTACT

S

Sabitri Sapkota, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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