Clinical trial NCT05807867: RCT of an Intersectional Stigma Intervention to Sustain Viral Suppression Among Women Living With Serious Mental Illness and HIV in Botswana
Official title: RCT of an Intersectional Stigma Intervention to Sustain Viral Suppression Among Women Living With Serious Mental Illness and HIV in Botswana
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hiv
Serious Mental Illness
Keywords: HIV
Stigma
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: University of Botswana
First posted: 2023-04-11
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: (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. Be 18-65 years of age
3. English or Setswana speaking
4. Botswana citizen.

(C) POLICY MAKERS AND OTHER STAKEHOLDERS.

Policy makers will be

1. Be 18-55 years of age
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.

Primary outcomes:
measure: Viral load (VL)
timeFrame: Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
measure: Viral load
timeFrame: Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
Secondary outcomes:
measure: Mental Health (MH) and Social outcomes
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Mental Health (MH) and Social outcomes
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Mental Health (MH) and Social outcomes
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Mental Health (MH) and Social outcomes
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Mental Health (MH) and Social outcomes
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Mental Health (MH) and Social outcomes
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Mental Health (MH) and Social outcomes
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Psychiatric adherence
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Psychiatric adherence
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: ART adherence
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: ART adherence
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: ART adherence
timeFrame: 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:
measure: Women's stigma
timeFrame: Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
measure: Women's stigma
timeFrame: Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
measure: Women's stigma
timeFrame: Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
measure: Women's stigma
timeFrame: Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
measure: Women's stigma
timeFrame: Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
measure: Women's stigma
timeFrame: Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
measure: Family members' stigma
timeFrame: Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
measure: Family members' stigma
timeFrame: Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
measure: Family members' stigma
timeFrame: Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
measure: Other Covariates for women with SMI and HIV: HIV Treatment adherence
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Other Covariates for women with SMI and HIV: Psychiatric Treatment Adherence
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Other Covariates for women with SMI and HIV: Psychiatric Treatment Adherence
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Other Covariates for women with SMI and HIV: Psychiatric Treatment Adherence
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Other Covariates for women with SMI and HIV: Gender-based behaviors & experiences
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Other Covariates for women with SMI and HIV: Gender-based behaviors & experiences
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Other Covariates for women with SMI and HIV: Social desirability
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Other Covariates for family members: Subjective family burden inventory scale
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Other Covariates for family members: Causal model subscales
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Sociodemographics for women with SMI and HIV
timeFrame: Baseline
measure: Clinical characteristics for women with SMI and HIV
timeFrame: Baseline
measure: Clinical characteristics for women with SMI and HIV- Alcohol use
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Clinical characteristics for women with SMI and HIV- Substance use
timeFrame: Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion
measure: Sociodemographics and clinical characteristics for family members
timeFrame: Baseline
Locations:
city: Gaborone
country: Botswana
facility: Princess Marina Hospital IDCC
Study officials:
affiliation: New York University
name: Lawrence Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: