[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501331":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":63,"collaborators":65,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":25,"eligibilityCriteria":75,"healthyVolunteers":72,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":25,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"New York University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.\n\nParallel 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.",[13],"Behavioral: WMM-based intersectional stigma intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Behavioral: Attention placebo control",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Intervention components consist of:\n\n1. psychoeducation: facilitating the achievement of \"good womanhood\" by adhering to psychiatric medications and ART post-discharge\n2. 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\n3. Coping skills for discrimination: promoting safe disclosure of SMI and\u002For HIV status to facilitate psychiatric and ART adherence post-discharge.\n\nNote: \"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).",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"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.",[15],[30],{"name":31,"affiliation":5,"role":32},"Lawrence Yang, PhD","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Ari Ho-Foster, MPH","CONTACT","267 355 4855","hofostera@ub.ac.bw",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Lawrence Yang, PHD","9176860183","lawrence.yang@nyu.edu",[44],{"facility":45,"status":46,"city":47,"state":25,"zip":25,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Princess Marina Hospital IDCC","RECRUITING","Gaborone","Botswana","BW",{"type":51,"coordinates":52},"Point",[53,54],25.90859,-24.65451,{"lat":54,"lon":53},[57,60],{"name":58,"role":36,"phone":25,"phoneExt":25,"email":59},"Ari Ho Foster, MPH","ahofoster@fastmail.fm",{"name":61,"role":62,"phone":25,"phoneExt":25,"email":25},"Ari Foster, MPH","SUB_INVESTIGATOR",{"type":64,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[66,68],{"name":67,"class":6},"University of Pennsylvania",{"name":69,"class":6},"University of Botswana","100501331","rct-of-an-intersectional-stigma-intervention-to-sustain-viral-suppression-among-women-living-with-serious-mental-illness-and-hiv-in-botswana-100501331",false,"NCT05807867","RCT of an Intersectional Stigma Intervention to Sustain Viral Suppression Among Women Living With Serious Mental Illness and HIV in Botswana","(A) WOMEN WITH SMI AND HIV\n\nAt 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:\n\n1. Meet DSM-5 criteria for current psychotic disorder or mood disorders or other disorders causing functional impairment except substance use disorders and developmental disorders, per clinician interview based on the MINI\n2. Have confirmed HIV positive status\n3. Be 18-55 years of age\n4. Be female\n5. Have capacity to provide consent and written informed consent\n6. Speak English or Setswana\n7. Be a Botswana citizen\n\n   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:\n8. Remaining adherent to psychiatric medications\n9. Being symptomatically stable for \\>2 years\n10. Maintaining consistent ART adherence.\n\n(B) FAMILY MEMBERS OF WOMEN WITH SMI AND HIV.\n\nIn 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:\n\n1. Identified by participant and\u002For clinician as the relative 'most involved in the client's care'.\n2. Be 18-65 years of age\n3. English or Setswana speaking\n4. Botswana citizen.\n\n(C) POLICY MAKERS AND OTHER STAKEHOLDERS.\n\nPolicy makers will be\n\n1. Be 18-55 years of age\n2. Include: (a) bureaucratic officials of Botswana, public sector ministries (government) at the national level holding appointment to senior offices that develop, interpret and\u002For 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.","ALL","18 Years","65 Years",{"count":80,"type":81},360,"ESTIMATED","INTERVENTIONAL",[84],"NA","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.\n\nThe 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.\n\nThe 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.\n\nEnabling 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.",[87,88],"Hiv","Serious Mental Illness",[90,91],"HIV","Stigma","2026-04-20",{"date":94,"type":95},"2026-04-23","ACTUAL",{"date":97,"type":95},"2024-08-01",{"date":99,"type":81},"2027-12",{"name":5,"class":6},1]