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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNew York University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • WMM-based intersectional stigma intervention

    Behavioral

    Intervention 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

    Behavioral

    To 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

360 Participants
are divided into 2 treatment groups
Group A: WMM-based intersectional stigma interventionExperimental treatment 1 intervention
Group B: Attention placebo controlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Viral load (VL)

1\) Blood draw: VL defined dichotomously (0=\<25 copies/mL, 1= \>25 copies/mL) and continuously (log transformed)

Time frame
Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
2

Viral load

2\) Medical records: Routine \& month VL monitoring at IDCC

Time frame
Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)

Secondary outcomes

1

Mental Health (MH) and Social outcomes

(Self-report) PRIME screen: psychosis,12 items

Time frame
Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
2

Mental Health (MH) and Social outcomes

(Self-report) CES-D: depressive symptoms, 20 items

Time frame
Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
3

Mental Health (MH) and Social outcomes

(Self-report) GAD-7: Anxiety symptoms, 7 items

Time frame
Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
4

Mental Health (MH) and Social outcomes

(Self-report) PCL-5: trauma symptoms, 20 items

Time frame
Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion

Other outcomes

1

Women's stigma

(Self-report) Kalichman HIV Stigma Scale: Internalized stigma e.g. HIV disclosure; 6 items

Time frame
Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
2

Women's stigma

(Self-report) Berger HIV Stigma Scale: perceived community stigma, anticipated stigma, enacted stigma; 27 items

Time frame
Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
3

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

Time frame
Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
4

Women's stigma

(Self-report) Gender-Equitable Scale: attitudes towards gender norms e.g. sexuality; 4 subscales, 24 items

Time frame
Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)

Sponsors and contacts

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New York University

Lead sponsor

University of Pennsylvania

Collaborator

University of Botswana

Collaborator