Recruiting

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

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ClinicalTrials.gov IDNCT06226155

PhaseNA

Enrollment165

SponsorMassachusetts General Hospital

Age15 Years – 55 Years

SexALL

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Conditions studied

HIV Infections, Pregnancy Related, Depression, Anxiety

About this study

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

Behavioral: TENDAI4PrEP — An adapted problem-solving PrEP use intervention for HIV negative pregnant persons living with psychological distress, their partners, and antenatal care providers.
Other: Enhanced treatment as usual — 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.

Primary outcomes

Feasibility (patient level) (T3 (within 5 months post-baseline))
Acceptability (patient level) (T3 (within 5 months post-baseline))
Feasibility (provider level) (T3 (within 5 months post-baseline))
Acceptability (provider level) (T3 (within 5 months post-baseline))

Eligibility information

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)

Study locations

University of Zimbabwe, Harare, Zimbabwe

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-04.