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RECRUITING Not applicable ClinicalTrials.gov

Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe

Sponsor: Massachusetts General Hospital • ClinicalTrials.gov ID: NCT06226155

Registry updated: 2026-09-10
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Description

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 depression and increase HIV treatment adherence among people living with HIV in Zimbabwe. The new intervention, TENDAI4PrEP, will be designed to improve PrEP uptake and persistence among pregnant persons in Zimbabwe. If feasibility, acceptability, and preliminary efficacy are demonstrated, the intervention will be ready for large-scale effectiveness/implementation testing. This program will has the potential to address a critical public health challenge impacting pregnant and postpartum persons in Zimbabwe: the prevention of HIV acquisition and transmission.

Interventions

  • TENDAI4PrEP (Behavioral)
    An adapted problem-solving PrEP use intervention for HIV negative pregnant persons living with psychological distress, their partners, and antenatal care providers.
  • Enhanced treatment as usual (Other)
    Includes monthly visits to the ANC plus a pamphlet of information that describes PrEP efficacy. safety during pregnancy/postpartum, and PrEP availability at the ANC.

Eligibility criteria

Inclusion Criteria: Across all aims participants must be 1. Pregnant 2. Presenting at the Chitungwiza Central Hospital ANC 3. Aged 15+ 4. Willing to provide informed consent or assent 5. Have HIV negative status 6. 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) 7. Score \>5 on the Shona Symptom Questionnaire For the RCT, eligible participants must also be willing to 8. Initiate PrEP prior to randomization 9. Bring their pregnancy partner (if they are safe doing so). Exclusion Criteria: 1. Inability to provide informed consent/assent and/or complete procedures in Shona or English 2. Current interfering untreated or unstable mental health condition that precludes functional involvement in the study (e.g., active psychosis, untreated bipolar disorder)

Conditions

HIV Infections Pregnancy Related Depression, Anxiety

Locations

  • University of Zimbabwe — Harare, Zimbabwe
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record