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Search / Trial NCT05807867

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

Launched by NEW YORK UNIVERSITY · Apr 10, 2023

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Hiv Stigma

ClinConnect Summary

This clinical trial is studying a program aimed at helping women in Botswana who are living with both serious mental illness (SMI) and HIV. The goal is to improve their health by reducing the stigma they face, which can make it harder for them to stick to their HIV treatment. The study will compare two groups of women: one group will receive a special support intervention designed to help them deal with stigma as they transition from psychiatric hospitalization to outpatient care, while the other group will participate in a similar but less intensive program for attention. Researchers hope that by empowering these women, they can improve their health outcomes and encourage changes in healthcare policies.

To participate in this study, women must be between the ages of 18 and 55, have a diagnosis of SMI and HIV, and be receiving treatment at Sbrana Psychiatric Hospital. They should be able to speak English or Setswana and must be a citizen of Botswana. Family members who are closely involved in their care and policymakers who work in mental health and HIV programs may also be included in the study. This trial is not yet recruiting participants, but it aims to make a positive impact on both individual lives and the broader mental health and HIV care systems in Botswana.

Gender

ALL

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 or other disorders causing functional impairment except substance use disorders and developmental disorders, per clinician interview based on the MINI
  • 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.

About New York University

New York University (NYU) is a prestigious research institution renowned for its commitment to advancing medical knowledge and improving patient care through innovative clinical trials. With a robust infrastructure and a diverse team of leading experts, NYU conducts cutting-edge research across various therapeutic areas, focusing on translating scientific discoveries into effective treatments. The university fosters collaboration among multidisciplinary teams and engages with a broad patient population, ensuring that its trials adhere to the highest ethical standards and regulatory requirements. NYU's dedication to excellence in research and education positions it as a key contributor to the advancement of healthcare and clinical practice.

Locations

Gaborone, , Botswana

Patients applied

0 patients applied

Trial Officials

Lawrence Yang, PhD

Principal Investigator

New York University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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