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

NCT05807867 | Recruiting DMC

• 1 other identifier: R01TW012402
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv; Serious Mental Illness

Keywords

HIV; Stigma

Outcome Measures

Primary Outcomes (2)

• Viral load (VL)

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

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

• Viral load

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

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

Secondary Outcomes (12)

• Mental Health (MH) and Social outcomes

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

• Mental Health (MH) and Social outcomes

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

• Mental Health (MH) and Social outcomes

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

• Mental Health (MH) and Social outcomes

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

• Mental Health (MH) and Social outcomes

  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 (23)

• Women's stigma

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

• Women's stigma

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

• Women's stigma

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

Study Arms (2)

WMM-based intersectional stigma intervention

EXPERIMENTAL

N=90 Women with SMI and HIV in arm 1 will receive WMM stigma intervention as clients transition from psychiatric hospitalization to outpatient care. The curriculum, co-led by a trained clinician and a peer woman with SMI and HIV, will comprise of 8 group sessions at \~60 minutes each. Following psychiatric stabilization, but while still an inpatient, women participants will receive 5 (delivered 2x weekly) of 8 session anti-stigma intervention. To facilitate community integration, the final 3 WMM-based intervention sessions will be delivered once every two weeks at a community-based setting in Gabarone. Parallel Group Stigma intervention: N=90 Family members will receive an adapted 3-session WMM-based group intervention that uses the same intervention components. The first 2 sessions will be held weekly in a private room at Sbrana Hospital, while the final session will be held 2 weeks following client discharge in the same community-based setting as above.

Behavioral: WMM-based intersectional stigma intervention

Attention placebo control

ACTIVE COMPARATOR

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. Control co-leaders will receive a 1-day training on the control manual and facilitation techniques. Sessions will focus on general health education (i.e., diet, exercise, avoiding alcohol, and healthy sleep habits) for women with SMI and HIV adapted from Ministry of Health materials. The investigators will offer in-person sessions including facilitated discussions to encourage interaction (per the WMM intervention). The investigators expect participation in the attention control arm (\~84% retention) to approximate that of women (and family members) attending the intervention arm. While intended to be salient to women participants and their family members, this program should not decrease stigma nor has it been shown to impact MH outcomes.

Behavioral: Attention placebo control

Interventions

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).

WMM-based intersectional stigma intervention

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.

Attention placebo control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Remaining adherent to psychiatric medications
• Being symptomatically stable for \>2 years
• 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:
• Identified by participant and/or clinician as the relative 'most involved in the client's care'.
• Be 18-65 years of age
• English or Setswana speaking
• Botswana citizen.
• (C) POLICY MAKERS AND OTHER STAKEHOLDERS.
• Policy makers will be
• Be 18-55 years of age
• 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.

Sponsors & Collaborators

• New York University: lead
• University of Pennsylvania: collaborator
• University of Botswana: collaborator

Study Sites (1)

Princess Marina Hospital IDCC

Gaborone, Botswana

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Social Stigma

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Social Behavior; Behavior

Study Officials

• Lawrence Yang, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ari Ho-Foster, MPH

CONTACT

267 355 4855; hofostera@ub.ac.bw

Lawrence Yang, PHD

CONTACT

9176860183; lawrence.yang@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Staff assessing all outcomes will be blinded to treatment assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Recruit 180 women to allow for 8% attrition post-intervention, with an added 8% during 4-month follow-up (below), to yield a final sample of N=151 expected to complete WMM or control (n=75 in each of 2 arms). 2. The investigators expect to recruit \~180 family members to allow for 16% attrition overall, to yield a final sample of N=151 expected to complete the stigma intervention or control (n=75 in each of the 2 arms, under assumption that attrition on average occurs at the same rate in each arm).

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: April 11, 2023
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)