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

NCT07370298 | Recruiting DMC

• 2 other identifiers: INCLUDEPossible1R01TW012682
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Antiretroviral Therapy (ART) Adherence; HIV Care Loss to Followup; HIV Stigma; Mental Health Conditions; Stigma; Intersectional Stigma; Gender Minority Individuals; Ethnic Minorities

Keywords

Stigma; Intersectional Stigma; HIV; HIV Care; Mental health conditions; Sexual and gender minorities; Ethnic minorities; digital health intervention

Outcome Measures

Primary Outcomes (13)

• Acceptability ratings

  Acceptability of the INCLUDE tool among healthcare workers will be assessed via a quarterly survey. Ratings will be provided on a 5-point Likert scale ranging from 1 to 5, where higher scores indicate greater acceptability. The outcome will be reported as the proportion of healthcare workers with specific rating categories.

  9 months

• Acceptability of the INCLUDE tool

  Acceptability among PLWHs will be measured by serial in-depth interviews (IDIs) to understand their perspectives and overall experience with the INCLUDE tool.

  4 and 9 months from baseline

• Rate of assessment app launch

  We will use paradata collected passively from the INCLUDE tool to measure the rate of assessment app launch per client per quarter.

  9 months

• Assessment Duration

  The mean duration, in minutes, required for clients to complete the INCLUDE assessment form. Duration is calculated using passively collected system paradata, tracking the time from assessment initiation to submission.

  9 months

• Frequency of assessment completion

  The number of completed assessment forms submitted by clients in the INCLUDE tool.

  9 months

• Frequency of user-led early termination/non-completion

  The number of times the platform launch was terminated early or not completed by users.

  9 months

• Frequency of application errors/crashes

  Frequency of the INCLUDE tool displaying error messages or crashing while in use (proportion of all user encounters where an error message/application crash occurs)

  9 months

• Rate of client data completion in the INCLUDE tool's dashboard

  The completion rate of client data in the INCLUDE tool's dashboard relative to the total number of clients registered.

  9 months

• Feasibility of the INCLUDE intervention

  We will conduct serial in-depth interviews (IDIs) with people living with HIV to ask about them about the feasibility of using the INCLUDE tool.

  4 and 9 months from baseline

• Rate of INCLUDE conference meetings

  The rate of INCLUDE conference meetings will be defined as the percentage of scheduled monthly conference meetings conducted. This data will be derived from the research staff logs.

  9 months

• Conference meeting time

  We will measure the average length of time spent in each conference meeting from research staff logs.

  9 months

• Rate of stigma-reduction activity being recommended

  We will measure the rate of at least one stigma-reduction activity being recommended in response to assessment data from each client, as recorded in the counselor form of the INCLUDE tool.

  9 months

• Implementation rate of recommended activities

  We will track the implementation rate of recommended stigma reduction activities from past conference meetings.

  9 months

Study Arms (1)

INCLUDE

EXPERIMENTAL

INterseCtional stigma assessment and reduction at multiple Levels and mUltiple DimEnsions (INCLUDE) is a new digital health tool with three components that can address the challenges in assessing, prioritizing, and addressing intersectional stigma in ART centers. The components include: 1) an 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 intersectional stigma reported by people living with HIV (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.

Behavioral: INCLUDE

Interventions

INCLUDE BEHAVIORAL

INterseCtional stigma assessment and reduction at multiple Levels and mUltiple DimEnsions (INCLUDE) is a new digital health tool with three components that can address the challenges in assessing, prioritizing, and addressing intersectional stigma in ART centers. The components include: 1) an 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 intersectional stigma reported by people living with HIV (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.

INCLUDE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• presence of significant cognitive problems/disability precluding participation
• All HCWs of ART centers: HIV counselors, ART center leads, and other HCWs.

Sponsors & Collaborators

• Possible: lead
• Fogarty International Center of the National Institute of Health: collaborator
• National Institutes of Health (NIH): collaborator
• National Center for AIDS and STD Control, Government of Nepal: collaborator

Study Sites (1)

Possible

Kathmandu, Bagmati, Nepal

RECRUITING

MeSH Terms

Conditions

Social Stigma; Coitus

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Sexual Behavior

Study Officials

• Bibhav Acharya, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Sabitri Sapkota, PhD

  Possible

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bibhav Acharya, MD

CONTACT

+1 917 653 9385; bibhav.acharya@ucsf.edu

Sabitri Sapkota, PhD

CONTACT

+977 9851031363; sabitri.sapkota@possiblehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a 9-month single-arm acceptability and feasibility pilot trial to test INCLUDE in diverse ART centers to prepare for a future cluster-randomized trial. We will conduct this study in four ART centers. The staff at these ART centers will be trained on the INCLUDE digital health tool and then incorporate it for the 9-month trial period into the ART center's daily operations. We will recruit 40 PLWHs, 10 from each ART center, who will use the tool as part of their care at the participating ART center.

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 27, 2026
• Study Start: February 12, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available approximately 12 months following the end of the trial. IPD will be available to the research community in perpetuity.
• Access Criteria: All shared data will be publicly accessible in the National Institute of Mental Health (NIMH) Data Archive (NDA).

Locations

NE (1)