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Recruiting NCT05807867

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

Trial Parameters

Condition Hiv
Sponsor New York University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 360
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2024-08-01
Completion 2026-12
Interventions
WMM-based intersectional stigma interventionAttention placebo control

Brief Summary

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.

Eligibility 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.

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