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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-55
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Pregnant

Presenting at the Chitungwiza Central Hospital ANC

Aged 15+

Willing to provide informed consent or assent

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • TENDAI4PrEP
  • Enhanced treatment as usual

Treatment groups

132 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

University of Zimbabwe

Collaborator

Boston University

Collaborator