Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT05807867
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05807867
Study Brief:
Protocol Section:
NCT05807867