RCT of an Intersectional Stigma Intervention to Sustain Viral Suppression Among Women Living With Serious Mental Illness and HIV in Botswana
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Viral load (VL)
研究概览
简要总结
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.
详细描述
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:
- Women with SMI and HIV,
- Family members, and
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Staff assessing all outcomes will be blinded to treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •include #1 to #7 above in addition to:
- •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.
排除标准
- 未提供
研究组 & 干预措施
WMM-based intersectional stigma intervention
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.
干预措施: WMM-based intersectional stigma intervention (Behavioral)
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. 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.
干预措施: Attention placebo control (Behavioral)
结局指标
主要结局
Viral load (VL)
时间窗: Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
1\) Blood draw: VL defined dichotomously (0=\<25 copies/mL, 1= \>25 copies/mL) and continuously (log transformed)
Viral load
时间窗: Changes from baseline at 4 months after intervention completion (approximately 16 months from baseline)
2\) Medical records: Routine \& month VL monitoring at IDCC
次要结局
- 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)
- Psychiatric adherence(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(Changes from baseline to intervention completion (an average of 12 months), and to 4 months (or 16 months from baseline) after intervention completion)