TENDAI4PrEP: Adaptation of a Problem-solving Intervention to Address Individual and Provider Level Barriers to PrEP Uptake and Adherence Among Pregnant Women in Zimbabwe

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 55
Healthy Volunteers: f
View:

⁃ 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).

Locations
Other Locations
Zimbabwe
University of Zimbabwe
RECRUITING
Harare
Contact Information
Primary
Conall O'Cleirigh
cocleirigh@mgh.harvard.edu
617-643-0385
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 132
Treatments
Experimental: TENDAI4PrEP
TENDAI4PrEP problem-solving intervention will likely entail 4-5 sessions, inclusive of the dyadic session with a partner, with an optional postpartum booster session. The intervention will involve PrEP education and psychoeducation, Nzira Itsva (a culturally adapted Life Steps intervention), and problem-solving therapy.
Active_comparator: Enhanced Treatment as Usual (ETAU)
Participants randomized to ETAU will receive care as usual, which is monthly visits to the ANC, plus a pamphlet of information that describes PrEP efficacy, safety during pregnancy/postpartum, and PrEP availability at the ANC. Antenatal treatment as usual will also be enhanced at the clinic level through the provider-level training, which will be offered to all clinic staff in a nonrandomized design. ETAU participants will also be referred for psychological services at the hospital.
Related Therapeutic Areas
Sponsors
Collaborators: University of Zimbabwe, Boston University
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov