Adaptation of a problem-solving intervention to address individual and provider level barriers to PrEP uptake and adherence in pregnancy in Zimbabwe

Overview: This proposal directly addresses a critical public health challenge impacting pregnant and postpartum women in Zimbabwe: the prevention of HIV acquisition and transmission. Background/Significance: The risk of HIV acquisition increases three- to four-fold in late pregnancy and early postpartum. Oral pre-exposure prophylaxis (PrEP) is safe during pregnancy, effective in preventing HIV, and available in Zimbabwean antenatal care clinics. However, PrEP use remains low among women of reproductive age. Individual-, interpersonal/community-, and provider-level barriers (e.g., psychological distress, negative attitudes and behaviors, low partner support, limited PrEP knowledge in providers) compromise use. Preliminary studies: In this R34 application, we propose to develop a multi-level PrEP adherence and persistence intervention as an adaptation and extension of our problem-solving program to reduce depression and increase HIV treatment adherence among people living with HIV in Zimbabwe. To develop the previous problem-solving intervention, we culturally adapted evidence-based adherence strategies and combined them with problem-solving therapy for depression, targeting depressed mood as a pathway to reduced antiretroviral therapy adherence. In participants randomized to the intervention, the previous intervention was associated with increased antiretroviral therapy adherence and decreased depression. Therefore, our Zimbabwe-, United States-, and United Kingdom-based team has the expertise required to extend an existing problem-solving intervention into a multi-level, problem-solving PrEP use intervention for pregnant women with psychological distress, their partners, and antenatal care providers. Approach: The present intervention will support PrEP adherence and persistence during pregnancy among individuals with psychological distress who have agreed to initiate PrEP use. In Aim 1, we will explore the impact of intersecting, multi-level barriers to PrEP uptake, adherence, and persistence among pregnant women as well as barriers to the provision of PrEP among antenatal care providers. In Aim 2, we will use the formative data to specify the intervention, likely involving a patient component (with a dyadic session with a partner) and a provider component, and conduct a small proof-of-concept trial. In Aim 3, we will evaluate the feasibility and acceptability (primary outcomes) of (a) the patient-level intervention in a pilot randomized controlled trial and (b) the provider-level component in a pre-post design. Secondary outcomes of the randomized controlled trial will be (1) self-reported PrEP adherence and (2) psychological distress, both at the end of treatment, and (3) PrEP persistence (measured via dried blood spots) at 3-month follow-up. Secondary outcomes of the provider component will be PrEP knowledge and PrEP attitudes and behaviors. We will also explore key implementation outcomes among antenatal clinic providers and administrators. Outcomes/next steps: These aims will lay the groundwork for a full-scale, hybrid effectiveness/implementation trial which could dramatically improve rates of PrEP adherence and persistence during pregnancy and the postpartum period, ultimately decreasing HIV prevalence in Zimbabwe.