Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe
NCT ID: NCT06226155
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
132 participants
INTERVENTIONAL
2024-10-21
2027-03-31
Brief Summary
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Detailed Description
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A multi-level, problem-solving intervention that addresses barriers to PrEP adherence and persistence during pregnancy and through the postpartum transition among patients, their partners, and antenatal care providers could improve the health of pregnant persons, ultimately decreasing HIV incidence in Zimbabwe.
The aims of this study are as follows:
Aim 1: Explore the impact of intersecting, multi-level barriers on PrEP uptake, adherence, and persistence during pregnancy (n=30), and explore barriers to PrEP provision among antenatal care providers (8-10). In individual interviews with HIV-negative pregnant women with psychological distress (15 PrEP naïve, 15 PrEP experienced), the investigators will probe individual, interpersonal/community, and structural barriers/facilitators. It is anticipated that barriers to uptake, adherence, and persistence may include distress linked to common mental health challenges (e.g., depressed mood, posttraumatic stress) at the individual level; lack of support from partners and providers, stigma, and low PrEP awareness at the interpersonal/community level; and limited access to PrEP care and food insecurity/poverty at the structural level. Among providers, interviews will explore PrEP knowledge, perspectives on HIV prevention during pregnancy, and barriers to prescribing PrEP.
Aim 2: Specify the manual and conduct a small proof-of-concept trial with patients (n=5), their partners (n=5), and providers (n=2). The new manual will teach skills to navigate resources and problem solve the multi-level barriers to PrEP use identified in Aim 1 and will include a group-based training for all providers (education on PrEP during pregnancy, negative PrEP attitudes/stigma, and other barriers to prescribing). Content of the manual will be interactively refined on five participants, their partners, and two providers.
Aim 3a: Evaluate the feasibility and acceptability of the patient-level intervention in a pilot RCT (n=70). PrEP eligible pregnant persons with motivation to initiate PrEP who are experiencing psychological distress will be randomized to either the intervention or to enhanced treatment as usual (mental health referral). Primary outcomes will be feasibility and acceptability; it is hypothesized that the intervention (\~4-5 sessions, including one dyadic session with a partner, plus a postpartum booster) will be both feasible and acceptable. Aim 3b: Evaluate the feasibility and acceptability of the provider training (\~2 sessions), which will be offered to all providers (n\~10) in a nonrandomized design; it is hypothesized that the training will be feasible and acceptable. Aim 3c: Explore perceptions of key implementation outcomes among providers and other administrators (n=15) through individual qualitative exit interviews.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
TENDAI4PrEP
An adapted problem-solving PrEP use intervention for HIV negative pregnant persons living with psychological distress, their partners, and antenatal care providers.
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.
Enhanced treatment as usual
Includes monthly visits to the ANC plus a pamphlet of information that describes PrEP efficacy.
safety during pregnancy/postpartum, and PrEP availability at the ANC.
Interventions
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TENDAI4PrEP
An adapted problem-solving PrEP use intervention for HIV negative pregnant persons living with psychological distress, their partners, and antenatal care providers.
Enhanced treatment as usual
Includes monthly visits to the ANC plus a pamphlet of information that describes PrEP efficacy.
safety during pregnancy/postpartum, and PrEP availability at the ANC.
Eligibility Criteria
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Inclusion Criteria
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
2. Current interfering untreated or unstable mental health condition that precludes functional involvement in the study (e.g., active psychosis, untreated bipolar disorder)
15 Years
55 Years
ALL
No
Sponsors
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University of Zimbabwe
OTHER
Boston University
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Conall O'Cleirigh
Director of Behavioral Medicine / Associate Professor
Principal Investigators
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Amelia M Stanton, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston University
Walter Mangezi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Zimbabwe
Locations
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University of Zimbabwe
Harare, , Zimbabwe
Countries
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Other Identifiers
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2023P003607
Identifier Type: -
Identifier Source: org_study_id
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