About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
WMM-based intersectional stigma intervention
BehavioralIntervention components consist of: 1. psychoeducation: facilitating the achievement of "good womanhood" by adhering to psychiatric medications and ART post-discharge 2. cognitive restructuring to challenge stereotypes: involves reframing psychiatric and ART adherence postdischarge as enacting 'good womanhood' by countering stereotypes of being unable to care for the family or be a suitable marriage partner 3. Coping skills for discrimination: promoting safe disclosure of SMI and/or HIV status to facilitate psychiatric and ART adherence post-discharge. Note: "enhancing skills for discrimination" sessions for women and family members are provided when female participants transition to outpatient care, thus enabling practice of skills in community-based situations. Intervention closes with a ceremony intended to convey WMM by bestowal of ceremonial shawls. The family member version will follow the same format, but each component will be covered in one session (3 sessions total).
Attention placebo control
BehavioralTo isolate intervention effects, our attention control is designed to mimic all salient features of the WMM-based intervention (i.e., group format, co-leaders, duration, inpatient followed by community location) except for the WMM stigma content.
Treatment groups
Trial outcomes
Primary outcomes
Viral load (VL)
1\) Blood draw: VL defined dichotomously (0=\<25 copies/mL, 1= \>25 copies/mL) and continuously (log transformed)
Viral load
2\) Medical records: Routine \& month VL monitoring at IDCC
Secondary outcomes
Mental Health (MH) and Social outcomes
(Self-report) PRIME screen: psychosis,12 items
Mental Health (MH) and Social outcomes
(Self-report) CES-D: depressive symptoms, 20 items
Mental Health (MH) and Social outcomes
(Self-report) GAD-7: Anxiety symptoms, 7 items
Mental Health (MH) and Social outcomes
(Self-report) PCL-5: trauma symptoms, 20 items
Other outcomes
Women's stigma
(Self-report) Kalichman HIV Stigma Scale: Internalized stigma e.g. HIV disclosure; 6 items
Women's stigma
(Self-report) Berger HIV Stigma Scale: perceived community stigma, anticipated stigma, enacted stigma; 27 items
Women's stigma
(Self-report) Internalized stigma of mental illness scale: 3 subscales (a) discrimination experience 5 items, (b) alienation 6 items, (c) social withdrawal 6 items
Women's stigma
(Self-report) Gender-Equitable Scale: attitudes towards gender norms e.g. sexuality; 4 subscales, 24 items
Sponsors and contacts
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New York University
Lead sponsor
University of Pennsylvania
Collaborator
University of Botswana
Collaborator