An interventional study of WMM-based intersectional stigma intervention and Attention placebo control in Hiv and Serious Mental Illness, sponsored by New York University. Recruiting at 1 site in Botswana. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by New York University · Not applicable, Interventional, and Other
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.
The proposed project, "RCT of an intersectional stigma intervention to sustain viral suppression among women living with serious mental illness and HIV in Botswana," will test a culturally tailored stigma intervention among women with co-occurring serious mental illness (SMI) and HIV receiving inpatient treatment at Sbrana Psychiatric Hospital in Lobatse, Botswana, who are then discharged into outpatient care. The culturally tailored stigma intervention is based on our novel 'what matters most' (WMM) approach to target intersectional stigma. The investigators will also be conducting a family-level stigma intervention to test its efficacy at reducing family-level SMI and HIV stigma, and to test family-level stigma as a mechanism for change in VL among women. Lastly, the investigators will pilot a policymaker workshop intended to facilitate structural-level change.
Populations included in the study:
RESEARCH AIM 2.
The investigators propose a two-arm randomized controlled trial (RCT) with a 4-month follow-up to compare the effectiveness of our WMM-based stigma intervention to reduce viral load (VL) at 4-month follow-up (primary outcome) and improve the secondary outcomes of antiretroviral treatment (ART) and psychiatric treatment adherence, MH outcomes (e.g., depression), and social outcomes (e.g., social integration).
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. Because family acceptance can bolster achieving the capabilities of 'good womanhood' (i.e., by being a family caregiver), family members will receive a parallel, group stigma intervention, which could further facilitate treatment adherence of the recently discharged family member. Therefore, the investigators will conduct a parallel two-arm intervention among women's family members to test its effectiveness in reducing family-level stigma and to assess family-level stigma as a mechanism of change for primary and secondary outcomes among women with SMI and HIV (e.g., VL, ART and psychiatric treatment adherence, MH outcomes and Social outcomes).
Participants in Research Aim 2 will be 75% female identified (100% of inpatient participants will be female-identified, and the investigators are accounting for a 50-50 gender split among recruited family members). Estimated distribution is 270 women, 90 men.
RESEARCH AIM 3.
The investigators further propose to pilot and evaluate policymaker workshops whereby peer women with SMI and HIV share RCT findings via lived experience to policymakers to initiate structural-level change.
The investigators anticipate that the multisectoral stakeholder committee members (n=15) and policymakers (n=50) in Research Aim 3 will have \~50-50 gender split - 32 women, 33 men.
OVERVIEW.
UBotswana will recruit participants and conduct the intervention, assessments, and data management. Overseen by PI Yang, NYU will provide study oversight, expertise in WMM and stigma, and conduct data analyses; UPenn will provide expertise in integration of the intervention for SMI and HIV; Botswana-UPenn Partnership will provide expertise in integration of peers into stigma interventions and implementation of community based interventions in Botswana; UCSF and UC Riverside will offer expertise and supervision in stigma interventions.
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(A) WOMEN WITH SMI AND
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:
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:
(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:
(C) POLICY MAKERS AND OTHER STAKEHOLDERS.
Policy makers will be
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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).
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.
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)
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)
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
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
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
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
Mental Health (MH) and Social outcomes
(Self-report) ISEL: social support, 4x 10 item subscales eg. belonging
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
Mental Health (MH) and Social outcomes
(Self-report) Social integration scale: community integration, 10 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
Mental Health (MH) and Social outcomes
(Self-report) EQ5D: health related quality of life, 5 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
Psychiatric adherence
1\) Self report: Medication Adherence Rating Scale (MARS): attitudes and behaviors reflecting members' psychiatric medication adherence, 10 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
Psychiatric adherence
2\) Chart review: adherence to psychiatric outpatient appointments
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
ART adherence
(Medical records) : Refill monitoring via pharmacy records
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
ART adherence
(Self-report) AACTG Adherence Instrument: AACTG Adherence instrument, 3 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
ART adherence
(EHR) : facility-records of HIV visits
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
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)
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)
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)
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)
Women's stigma
(Self-report) WMM Womanhood + HIV: Culture Shapes, Culture Protects subscales; 20 items
Time frame: Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
Women's stigma
(Self-report) WMM Womanhood + SMI: Scale items to be developed in Aim 1
Time frame: Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
Family members' stigma
(Self-report) Devaluation of families scale: family members' experience of SMI stigma, 7 items
Time frame: Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
Family members' stigma
(Self-report) Courtesy Stigma Scale: family members' experience of HIV stigma; 9 items
Time frame: Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
Family members' 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)
Other Covariates for women with SMI and HIV: HIV Treatment adherence
(Self-report) distance to clinic; when ART initiated; side effect profile; 3 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 Covariates for women with SMI and HIV: Psychiatric Treatment Adherence
(Self-report) distance to clinic; visits to spiritual/traditional healers (Y/N and # of visits)
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 Covariates for women with SMI and HIV: Psychiatric Treatment Adherence
(Self-report) Beck Cognitive Insight Scale: illness insight; 15 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 Covariates for women with SMI and HIV: Psychiatric Treatment Adherence
(Self-report) psychiatric medication side effects
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 Covariates for women with SMI and HIV: Gender-based behaviors & experiences
(Self-report) HIV Risk-Taking Behavior Scale: sexual risk behaviors; 11 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 Covariates for women with SMI and HIV: Gender-based behaviors & experiences
(Self-report) Woman Abuse Screening: IPV; 8 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 Covariates for women with SMI and HIV: Social desirability
(Self-report) Marlowe-Crowne Social Desirability Scale: 13 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 Covariates for family members: Subjective family burden inventory scale
(Self-report) Zarit Burden Interview: family burden: subjective; 22 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 Covariates for family members: Causal model subscales
(Self-report) Causal Model Questionnaire for Schizophrenia: 6 subscales assessing explanatory model for SMI
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
Sociodemographics for women with SMI and HIV
(Self-report) : age; education; employment; income; marital status; urban/rural residence; living with family; maternal status; # of children; religiosity/religious affiliation
Time frame: Baseline
Clinical characteristics for women with SMI and HIV
(Self-report) : onset age of psychiatric symptoms; duration of psychiatric illness; first psychiatric tx contact; diagnosis (psychotic/bipolar/severe depression); first diagnosis of HIV; first HIV treatment
Time frame: Baseline
Clinical characteristics for women with SMI and HIV- Alcohol use
(Self-report) AUDIT: alcohol use, 10 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
Clinical characteristics for women with SMI and HIV- Substance use
(Self-report) DUDIT: substance use, used with AUDIT, 11 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
Sociodemographics and clinical characteristics for family members
(Self-report) : Age; gender; education; income/employment; relationship to patient; religiosity/religious affiliation; HIV status; previous psych diagnosis
Time frame: Baseline
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