Adapting a Support Program to Help Pregnant Women in Zimbabwe Use HIV Prevention
Tests an adapted problem-solving program to help pregnant women in Zimbabwe use HIV prevention pills.
Plain-language title generated from the registry record
Registry title: Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe
Key facts
- Where
- Harare, ZimbabweSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for pregnant people at the Chitungwiza Central Hospital antenatal clinic who are HIV negative, at risk of HIV and have signs of depression or anxiety.
- Age
- Aged 15+ (the record lists a maximum of 55 Years).
- Sex
- All sexes.
- Disease stage
- Pregnant, HIV negative, at risk of HIV acquisition, with a score above 5 on the Shona Symptom Questionnaire.
- Earlier treatment
- For the randomized part, people must be willing to start PrEP before randomization.
- Biomarker or test result
- HIV negative status.
Main reasons for not taking part
- Cannot give informed consent or assent
- Cannot complete the study procedures in Shona or English
- Has an untreated or unstable mental health condition that prevents taking part (for example active psychosis or untreated bipolar disorder)
This trial only enrols pregnant participants. The registry sentence this rests on: Pregnant
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 15 and 55 years old?
Source: NCT06226155, who can take part
Where in Zimbabwe
- University of ZimbabweHarare, ZimbabweContact: Walter Mangezi, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Massachusetts General Hospital
- Trial code
- NCT06226155
- Record updated
- 10 September 2026
- Original description
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.Read full original descriptionShow less
TENDAI4PrEP: Adaptation of a Problem-solving Intervention to Address Individual and Provider Level Barriers to PrEP Uptake and Adherence Among Pregnant Women in Zimbabwe
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.
Inclusion: 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).
Exclusion: Current interfering untreated or unstable mental health condition that precludes functional involvement in the study (e.g., active psychosis, untreated bipolar disorder); Inability to provide informed consent/assent and/or complete procedures in Shona or English.