NCT05807867Recruiting
RCT of an Intersectional Stigma Intervention to Sustain Viral Suppression Among Women Living With Serious Mental Illness and HIV in Botswana
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 23 Nov 2022
- Start date
- 1 Aug 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- New York University
- Diseases
- HIV
- NCT number
- NCT05807867
What you commit to
- Study type: Interventional
- Planned participants: 360
- From 1 Aug 2024 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- (A) WOMEN WITH SMI AND HIV
- At Sbrana Psychiatric Hospital, the investigators will recruit women with SMI and HIV who are receiving treatment at that facility. Women with SMI and HIV will be receiving psychiatric care and ART and must:
- Meet DSM-5 criteria for current psychotic disorder or mood disorders or other disorders causing functional impairment except substance use disorders and developmental disorders, per clinician interview based on the MINI
- Have confirmed HIV positive status
- Be 18-55 years of age
- Be female
- Have capacity to provide consent and written informed consent
- Speak English or Setswana
- Be a Botswana citizen
- The investigators will also recruit 6 to 8 women with SMI and HIV as peer co-leaders to facilitate the intervention. For women who are peer co-leaders, inclusion criteria include #1 to #7 above in addition to:
- Remaining adherent to psychiatric medications
- Being symptomatically stable for \>2 years
- Maintaining consistent ART adherence.
- (B) FAMILY MEMBERS OF WOMEN WITH SMI AND HIV.
- In Botswana, families are usually contacted and engaged in psychiatric treatment planning during inpatient stay or on admission. The involvement of family continues during outpatient follow-ups since most patients are accompanied by some relative or caregiver on such visits. Eligible participants include:
- Identified by participant and/or clinician as the relative 'most involved in the client's care'.
- Be 18-65 years of age
- English or Setswana speaking
- Botswana citizen.
- (C) POLICY MAKERS AND OTHER STAKEHOLDERS.
- Policy makers will be
- Be 18-55 years of age
- Include: (a) bureaucratic officials of Botswana, public sector ministries (government) at the national level holding appointment to senior offices that develop, interpret and/or implement national mental health and HIV programs (prevention and treatment) or related clinical services; (b) senior bureaucratic officials of the National AIDS and Health Promotion Agency (NAHPA); and (c) senior members of civil society organizations (CSOs), nongovernment organizations (NGOs) or other entities that support the national Botswana government to implement services to People Living With HIV (PLWH) and mental health patients.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Marina Hospital IDCC Coordinator of this site? Confirm its status | Gaborone | Botswana | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.