Reducing stigma to help women with serious mental illness and HIV in Botswana stay virally suppressed

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

(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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.