RecruitingNot Applicable

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

Zimbabwe132 participantsStarted 2024-10-21

Plain-language 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.

Who can participate

Age range15 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. Initiate PrEP prior to randomization

Exclusion criteria

✕. 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)

What they're measuring

Feasibility (patient level)

Timeframe: T3 (5 months post-baseline)

Acceptability (patient level)

Timeframe: T3 (5 months post-baseline)

Feasibility (provider level)

Timeframe: T3 (5 months post-baseline)

Acceptability (provider level)

Timeframe: T3 (5 months post-baseline)

Trial details

NCT IDNCT06226155

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-01

Contact for this trial

Conall O'Cleirigh

617-643-0385 cocleirigh@mgh.harvard.edu

View on ClinicalTrials.gov More HIV Infections trials

Plain-language summary

Who can participate

Age range15 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. Initiate PrEP prior to randomization

Exclusion criteria

✕. 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)