Status:
RECRUITING
Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
University of Zimbabwe
Boston University
Conditions:
HIV Infections
Pregnancy Related
Eligibility:
All Genders
15-55 years
Phase:
NA
Brief Summary
The purpose of this study is to develop a multi-level PrEP adherence and persistence intervention as an adaptation of the TENDAI ('grateful' in Shona) program, a problem-solving approach to reduce dep...
Detailed Description
Zimbabwe's HIV prevalence rate is among the highest globally, and cisgender women of reproductive age are disproportionately affected. Considering the increased risk of HIV acquisition and transmissio...
Eligibility Criteria
Inclusion Criteria:
Across all aims participants must be
-
Pregnant
-
Presenting at the Chitungwiza Central Hospital ANC
-
Aged 15+
-
Willing to provide informed consent or assent
-
Have HIV negative status
-
At risk for HIV acquisition (defined as having a male partner of unknown HIV status, suspicions of partner infidelity, reporting multiple partners, or history of STI and/or recent condomless sexual activity)
-
Score >5 on the Shona Symptom Questionnaire
For the RCT, eligible participants must also be willing to
-
Initiate PrEP prior to randomization
-
Bring their pregnancy partner (if they are safe doing so).
Exclusion Criteria:
- Inability to provide informed consent/assent and/or complete procedures in Shona or English
- Current interfering untreated or unstable mental health condition that precludes functional involvement in the study (e.g., active psychosis, untreated bipolar disorder)
Key Trial Info
Start Date :
October 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06226155
Start Date
October 21 2024
End Date
March 31 2027
Last Update
March 31 2026
Active Locations (1)
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1
University of Zimbabwe
Harare, Zimbabwe