Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05807867

RCT of an Intersectional Stigma Intervention to Sustain Viral Suppression Among Women Living With Serious Mental Illness and HIV in Botswana

Led by New York University · Updated on 2026-04-23

360

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

Sponsors

N

New York University

Lead Sponsor

U

University of Pennsylvania

Collaborating Sponsor

AI-Summary

What this Trial Is About

The study goal is to promote viral load suppression among women with serious mental illness (SMI) and HIV in Botswana, given that these women are especially vulnerable to psychiatric medication nonadherence and symptom exacerbation, which are made worse by stigma and threaten antiretroviral therapy (ART) adherence. The investigators propose to test an intervention to reduce stigma due to the statuses of SMI and HIV, against an attention control condition, in the high-risk transition period after discharge from an initial psychiatric hospitalization. Specifically, the investigators are conducting a two-arm randomized controlled trial (RCT) with a 4-month follow-up to compare the effectiveness of 1) What Matters Most (WMM)-based intersectional stigma intervention delivered as clients transition from psychiatric hospitalization to outpatient care; and 2) an attention placebo control condition that follows a similar format to isolate the effects of the intervention. The investigators will also assess policymaker workshops where peer women with SMI and HIV co-lead the reporting of RCT findings via lived experience to policymakers to initiate structural change. Enabling women with SMI and HIV to resist stigma has the potential to improve their HIV outcomes and empower these women to elicit broader, structural-level change.

CONDITIONS

Official Title

RCT of an Intersectional Stigma Intervention to Sustain Viral Suppression Among Women Living With Serious Mental Illness and HIV in Botswana

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 55 years with serious mental illness and confirmed HIV positive status
  • Meet DSM-5 criteria for current psychotic, mood, or other functionally impairing disorders excluding substance use and developmental disorders
  • Have capacity and provide written informed consent
  • Speak English or Setswana
  • Be a citizen of Botswana
  • Family members aged 18 to 65 years identified as most involved in care, speaking English or Setswana, and Botswana citizens
  • Policymakers aged 18 to 55 years in senior public sector or related positions involved in mental health and HIV services or related organizations
Not Eligible

You will not qualify if you...

  • Individuals younger than 18 or older than 55 years for women participants
  • Diagnoses limited to substance use disorders or developmental disorders only
  • Inability to provide informed consent
  • Non-English or non-Setswana speakers
  • Non-citizens of Botswana
  • Family members not identified as most involved in care
  • Policymakers outside designated senior roles or age range

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Princess Marina Hospital IDCC

Gaborone, Botswana

Actively Recruiting

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Research Team

A

Ari Ho-Foster, MPH

CONTACT

L

Lawrence Yang, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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