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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05807867
• Other study ID #: R01TW012402
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: April 2024
• Source: New York University
• Contact: Ari Ho-Foster, MPH
• Phone: +267 355 4855
• Email: hofostera[@]ub.ac.bw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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:

1. Women with SMI and HIV,

2. Family members, and

3. Policymakers and other stakeholders

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.

• 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).

• 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).

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.

• The investigators plan to convene a Multisectoral Stakeholder Committee facilitate development of the policymaker workshops. Our MSC will include policymakers across multiple sectors: Ministry of Health (MoH), District Health Management Team (DHMT), Policy, Academic leaders

• The investigators additionally plan to recruit 50 policy makers to participate in the policymaker workshops in conjunction with 2-3 peer co-leader women with SMI and HIV to reduce stigma among policymakers and lay a foundation for sustaining interventions to improve HIV and other health outcomes in this vulnerable group.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: July 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

(A) WOMEN WITH SMI AND HIV

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:

1. Meet DSM-5 criteria for current psychotic disorder or mood disorders with psychotic features, per clinician interview based on the SCID-5

2. Have confirmed HIV positive status

3. Be 18-55 years of age

4. Be female

5. Have capacity to provide consent and written informed consent

6. Speak English or Setswana

7. 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:

8. Remaining adherent to psychiatric medications

9. Being symptomatically stable for >2 years

10. 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:

1. Identified by participant and/or clinician as the relative 'most involved in the client's care'.

2. Ages 18+

3. English or Setswana speaking

4. Botswana citizen.

(C) POLICY MAKERS AND OTHER STAKEHOLDERS.

Policy makers will be

1. Ages 18+

2. 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.

Related Conditions & MeSH terms

• Hiv
• Mental Disorders
• Serious Mental Illness

Intervention

Behavioral:
• WMM-based intersectional stigma intervention
Intervention components consist of: psychoeducation: facilitating the achievement of "good womanhood" by adhering to psychiatric medications and ART post-discharge 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 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
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.

Locations

Country	Name	City	State
Botswana	Princess Marina Hospital IDCC	Gaborone

Sponsors (3)

Lead Sponsor	Collaborator
New York University	University of Botswana, University of Pennsylvania

Country where clinical trial is conducted

Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Women's stigma	(Self-report) Kalichman HIV Stigma Scale: Internalized stigma e.g. HIV disclosure; 6 items	Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
Other	Women's stigma	(Self-report) Berger HIV Stigma Scale: perceived community stigma, anticipated stigma, enacted stigma; 27 items	Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
Other	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	Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
Other	Women's stigma	(Self-report) Gender-Equitable Scale: attitudes towards gender norms e.g. sexuality; 4 subscales, 24 items	Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
Other	Women's stigma	(Self-report) WMM Womanhood + HIV: Culture Shapes, Culture Protects subscales; 20 items	Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
Other	Women's stigma	(Self-report) WMM Womanhood + SMI: Scale items to be developed in Aim 1	Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
Other	Family members' stigma	(Self-report) Devaluation of families scale: family members' experience of SMI stigma, 7 items	Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
Other	Family members' stigma	(Self-report) Courtesy Stigma Scale: family members' experience of HIV stigma; 9 items	Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
Other	Family members' stigma	(Self-report) Gender-Equitable Scale: attitudes towards gender norms e.g. sexuality; 4 subscales, 24 items	Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
Other	Other Covariates for women with SMI and HIV: HIV Treatment adherence	(Self-report) distance to clinic; when ART initiated; side effect profile; 3 items	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Other	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)	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Other	Other Covariates for women with SMI and HIV: Psychiatric Treatment Adherence	(Self-report) Beck Cognitive Insight Scale: illness insight; 15 items	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Other	Other Covariates for women with SMI and HIV: Psychiatric Treatment Adherence	(Self-report) psychiatric medication side effects	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Other	Other Covariates for women with SMI and HIV: Gender-based behaviors & experiences	(Self-report) HIV Risk-Taking Behavior Scale: sexual risk behaviors; 11 items	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Other	Other Covariates for women with SMI and HIV: Gender-based behaviors & experiences	(Self-report) Woman Abuse Screening: IPV; 8 items	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Other	Other Covariates for women with SMI and HIV: Social desirability	(Self-report) Marlowe-Crowne Social Desirability Scale: 13 items	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Other	Other Covariates for family members: Subjective family burden inventory scale	(Self-report) Zarit Burden Interview: family burden: subjective; 22 items	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Other	Other Covariates for family members: Causal model subscales	(Self-report) Causal Model Questionnaire for Schizophrenia: 6 subscales assessing explanatory model for SMI	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Other	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	Baseline
Other	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	Baseline
Other	Clinical characteristics for women with SMI and HIV- Alcohol use	(Self-report) AUDIT: alcohol use, 10 items	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Other	Clinical characteristics for women with SMI and HIV- Substance use	(Self-report) DUDIT: substance use, used with AUDIT, 11 items	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Other	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	Baseline
Primary	Viral load (VL)	1) Blood draw: VL de?ned 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)
Primary	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	Mental Health (MH) and Social outcomes	(Self-report) PRIME screen: psychosis,12 items	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Secondary	Mental Health (MH) and Social outcomes	(Self-report) CES-D: depressive symptoms, 20 items	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Secondary	Mental Health (MH) and Social outcomes	(Self-report) GAD-7: Anxiety symptoms, 7 items	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Secondary	Mental Health (MH) and Social outcomes	(Self-report) PCL-5: trauma symptoms, 20 items	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Secondary	Mental Health (MH) and Social outcomes	(Self-report) ISEL: social support, 4x 10 item subscales eg. belonging	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Secondary	Mental Health (MH) and Social outcomes	(Self-report) Social integration scale: community integration, 10 items	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Secondary	Mental Health (MH) and Social outcomes	(Self-report) EQ5D: health related quality of life, 5 items	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Secondary	Psychiatric adherence	1) Self report: Medication Adherence Rating Scale (MARS): attitudes and behaviors reflecting members' psychiatric medication adherence, 10 items	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Secondary	Psychiatric adherence	2) Chart review: adherence to psychiatric outpatient appointments	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Secondary	ART adherence	(Medical records) : Refill monitoring via pharmacy records	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Secondary	ART adherence	(Self-report) AACTG Adherence Instrument: AACTG Adherence instrument, 3 items	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
Secondary	ART adherence	(EHR) : facility-records of HIV visits	Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion