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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary and study completion dates: Dec 2026 to Dec 2027v8
  2. Notable Trial status: Not Yet Recruiting to Recruitingv7 Show 4 more changesShow less
    • Primary completion date: May 31, 2025 to Dec 2026
    • Study completion date: Jun 30, 2025 to Dec 2026
    • Eligibility criteria expanded, about 10 words
    • Site details revised
  3. Notable Start date: Jun 1, 2024 to Aug 1, 2024
    • Primary completion date: Dec 31, 2024 to May 31, 2025
    • Study completion date: Jul 1, 2025 to Jun 30, 2025
    • Eligibility criteria expanded, about 6 words
    v6
  4. Notable Start date: Dec 1, 2023 to Jun 1, 2024v5
  5. Notable Start date: Sep 1, 2023 to Dec 1, 2023v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Start date: Jul 1, 2023 to Sep 1, 2023v3
  2. Notable Start date: Apr 1, 2023 to Jul 1, 2023v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05807867
Lead Sponsor New York University
Collaborators: University of Pennsylvania, University of Botswana
Conditions
(from sponsor)
Hiv, Serious Mental Illness
Related terms Acquired Immunodeficiency Syndrome, Social Stigma
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov