Reducing stigma to help women with serious mental illness and HIV in Botswana stay virally suppressed
RCT of an Intersectional Stigma Intervention to Sustain Viral Suppression Among Women Living With Serious Mental Illness and HIV in Botswana
We will test a stigma-reduction program for women in Botswana who have serious mental illness and HIV to help them stay on HIV treatment and keep their viral load low after leaving psychiatric hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | New York University Academic / other |
| Locations | 1 site (Gaborone) |
| Trial ID | NCT05807867 on ClinicalTrials.gov |
What this trial studies
This two-arm randomized controlled trial compares a culturally tailored 'What Matters Most' (WMM) intersectional stigma intervention to an attention-matched control delivered as women transition from psychiatric hospitalization to outpatient care. Participants are women aged 18–55 with confirmed HIV and a current serious mental illness diagnosis recruited from inpatient psychiatric care in Botswana and followed for four months after discharge. The primary outcome is viral load suppression at four months, with secondary outcomes including ART and psychiatric medication adherence, mental health symptoms, family-level stigma, and social integration. The project also includes a family-level stigma component and a pilot policymaker workshop to explore mechanisms and potential structural changes.
Who should consider this trial
Good fit: Women aged 18–55 who are Botswana citizens, have confirmed HIV and a current DSM-5 serious mental illness diagnosis, are receiving psychiatric care and ART, can consent, and speak English or Setswana are ideal candidates.
Not a fit: People who are male, outside the 18–55 age range, not Botswana citizens, do not have both HIV and a qualifying serious mental illness, have primary substance use or developmental disorders, or cannot attend local follow-up visits are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could help more women with serious mental illness and HIV maintain viral suppression, improve medication adherence, and strengthen family and social support.
How similar studies have performed: Intersectional stigma interventions using the WMM framework are relatively novel and prior stigma-reduction studies have shown mixed results, especially for people with co-occurring serious mental illness and HIV, so evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
(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: 1. 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 2. Have confirmed HIV positive status 3. Be 18-55 years of age 4. Be female 5. Have capacity to provide consent and written informed consent 6. Speak English or Setswana 7. 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: 8. Remaining adherent to psychiatric medications 9. Being symptomatically stable for \>2 years 10. 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: 1. Identified by participant and/or clinician as the relative 'most involved in the client's care'. 2. Be 18-65 years of age 3. English or Setswana speaking 4. Botswana citizen. (C) POLICY MAKERS AND OTHER STAKEHOLDERS. Policy makers will be 1. Be 18-55 years of age 2. 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.
Where this trial is running
Gaborone
- Princess Marina Hospital IDCC — Gaborone, Botswana (Recruiting)
Study contacts
- Principal investigator: Lawrence Yang, PhD — New York University
- Study coordinator: Ari Ho-Foster, MPH
- Email: hofostera@ub.ac.bw
- Phone: 267 355 4855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.