Clinical trial NCT06226155: Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe
Official title: TENDAI4PrEP: Adaptation of a Problem-solving Intervention to Address Individual and Provider Level Barriers to PrEP Uptake and Adherence Among Pregnant Women in Zimbabwe
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Pregnancy Related
Depression, Anxiety
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Zimbabwe
name: Boston University
First posted: 2024-01-26
Enrollment: 132
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Zimbabwe's HIV prevalence rate is among the highest globally, and cisgender women of reproductive age are disproportionately affected. Considering the increased risk of HIV acquisition and transmission during pregnancy, there is an urgent public health need to develop interventions that increase the use of efficacious HIV prevention strategies like PrEP in the antenatal context. Oral pre-exposure prophylaxis (PrEP) is safe during pregnancy, effective in preventing HIV, and available in Zimbabwean antenatal care (ANC) clinics. However, PrEP use remains low among cisgender women of reproductive age. Individual-, interpersonal/community-, and provider-level barriers (e.g., psychological distress, stigma, low partner support, limited PrEP knowledge in providers) compromise use.

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.

Eligibility criteria: Inclusion Criteria:

Across all aims participants must be

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:

1. Inability to provide informed consent/assent and/or complete procedures in Shona or English
2. Current interfering untreated or unstable mental health condition that precludes functional involvement in the study (e.g., active psychosis, untreated bipolar disorder)

Primary outcomes:
measure: Feasibility (patient level)
timeFrame: T3 (5 months post-baseline)
measure: Acceptability (patient level)
timeFrame: T3 (5 months post-baseline)
measure: Feasibility (provider level)
timeFrame: T3 (5 months post-baseline)
measure: Acceptability (provider level)
timeFrame: T3 (5 months post-baseline)
Secondary outcomes:
measure: Self-reported PrEP adherence (patient level)
timeFrame: T2 (2 months post-baseline)
measure: Psychological distress (patient level)
timeFrame: T2 (2 months post-baseline)
measure: PrEP persistence (patient level)
timeFrame: T3 (5 months post-baseline)
measure: Change in PrEP knowledge (provider level)
timeFrame: Baseline, T3 (5 months post-baseline)
measure: Change in PrEP stigma (provider level)
timeFrame: Baseline, T3 (5 months post-baseline)
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: University of Zimbabwe
Study officials:
affiliation: Boston University
name: Amelia M Stanton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zimbabwe
name: Walter Mangezi, MD
role: PRINCIPAL_INVESTIGATOR
References: