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NCT05807867Toboroz

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. ápr. 23.

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Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
360 (tervezett)
Első benyújtás
2022. nov. 23.
Kezdés
2024. aug. 1.
Elsődleges befejezés
2027. dec.
Fő szponzor
New York University
Betegségek
HIV-fertőzés
NCT-szám
NCT05807867

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 360
  • 2024. aug. 1. és az elsődleges befejezés (2027. dec.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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A regiszterben nem jelölt feltételek

  • (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:
  • 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
  • Have confirmed HIV positive status
  • Be 18-55 years of age
  • Be female
  • Have capacity to provide consent and written informed consent
  • Speak English or Setswana
  • 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:
  • 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.

Életkor a regiszterben: 18 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
Princess Marina Hospital IDCCGaboroneBotswanaToboroz

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