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

  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)

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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Page 1 of 1 (1 locations)

1

University of Zimbabwe

Harare, Zimbabwe

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