Project Summary
Black cisgender women (hereafter, Black women) carry a disproportionate HIV burden than women in other
racial and ethnic groups. Despite its promise, there is an unmet need for pre-exposure prophylaxis (PrEP) among
Black women. Intimate partner violence (IPV) and gendered racism may exacerbate racial disparities in PrEP
access and also curb potential real-world effectiveness. IPV reduces PrEP uptake among women. Black women
also experience unfair treatment due to deeply ingrained stereotypes by healthcare systems. As such, Black
women may feel uncomfortable discussing PrEP with a provider or provider biases may prevent PrEP access.
Integrating trauma-informed care into community health centers that serve Black women may enhance PrEP
adoption. Trauma-informed care can help providers understand IPV, medical mistrust and gendered racism
within the context of Black women’s experiences. System policies can also be modified to be trauma-informed
for both staff and Black women clients. In addition to changing health systems, peer navigation could be a
successful model of care to improve PrEP engagement. Peer navigation can build self-efficacy in patient-provider
communication and decrease medical mistrust offsetting the impact of socio-structural barriers. The proposed
research aims to address this gap via the implementation and evaluation of a trauma-informed multilevel
intervention designed to increase PrEP initiation among Black women. This intervention includes a trauma-
informed PrEP Implementation Toolkit for staff in community healthcare clinics in addition to a trauma-informed
peer navigation model. We propose a hybrid type 2 effectiveness-implementation study with clinical staff, peer
navigators, and clients. Aim 1 includes adapting an existing trauma-informed peer navigation for PrEP-eligible
Black women. Qualitative data from semi-structured interviews with 20 Black women clients will be used to adapt
the peer navigation. Aim 2 includes assessing the effectiveness of the trauma-informed multilevel intervention.
The toolkit will be employed in clinics using a stepped wedge design with monthly aggregated clinic data collected
8 months before and after toolkit implementation in each clinic. Toolkit effectiveness will be assessed using
within- and between-clinic changes in PrEP initiation. Staff will complete baseline, immediate post, and 3-month
post surveys to assess mechanisms of change. In a parallel two-arm trial, 300 Black women clients will be
randomized to receive either peer navigation (intervention arm) or support group only (control arm) and will
complete baseline, 1-, 3-, and 6- month post-randomization surveys. The primary client outcomes will be 1-, 3-,
and 6-month PrEP initiation. Aim 3 includes assessing the implementation of the multilevel intervention.
Adoption, acceptability, appropriateness, and sustainability will be assessed with 3-month post-toolkit staff
surveys; and at 1-, 3-, and 6- month client post-randomization surveys. Intervention costs will be computed using
an ingredients-based approach. Fidelity will be assessed with the fidelity-monitoring approach for multilevel trials.
