An implementation science approach to integration of PrEP in postpartum care

Modified Project Summary/Abstract Section HIV pre-exposure prophylaxis (PrEP) is underutilized among women. Identification and evaluation of implementation strategies to support PrEP uptake are crucial to overcoming barriers to PrEP use among women. The proposed study aims to develop and evaluate implementation strategies to increase PrEP uptake among women who could benefit in a high-incidence jurisdiction through integration of PrEP into postpartum care and support the career development of Dr. Caroline Mullis. Despite the many competing priorities of postpartum women (i.e., breastfeeding, sleep deprivation, postpartum depression, etc.), utilization of postpartum care to provide PrEP education and services has the potential to reach many women who: 1) are known to be HIV negative and engaging in condomless sex; 2) may not otherwise be receiving routine healthcare; and 3) are in an age group where most new HIV infections occur. We will develop and evaluate implementation strategies acting at the patient-, provider- and health systems-level to support uptake of PrEP, an evidence-based intervention. We hypothesize that: 1) provider training to support PrEP discussions and prescribing; 2) delivery of routine PrEP education by nurses; and 3) community health worker navigation assistance will target patient-, provider- and systems-level determinants and increase PrEP uptake among women in the Bronx who may benefit. Specifically, in Aim 1, we will evaluate a provider-level implementation strategy to support obstetricians and gynecologists (OBGYNs) prescribing of PrEP in postpartum care, i.e., the GOALS Approach to Sexual Health and History. In Aim 2, using human-centered design methods, we will develop a toolkit for postpartum nurses and community health workers to efficiently deliver information about PrEP. In Aim 3, we will evaluate acceptability, feasibility and preliminary effectiveness of nursing and community health worker delivered PrEP education as a part of routine postpartum care. Training on the GOALS Approach to Sexual Health and History will be delivered to OBGYNs at an institutional Grand Rounds. A survey will assess acceptability and feasibility of the training. Human-centered design methods will be used to engage postpartum nurses, community health workers and postpartum patients in an iterative co-design process to develop a toolkit for use by postpartum nurses and community health workers to deliver education on PrEP. The toolkit will be evaluated in a randomized, controlled pilot trial to evaluate acceptability, feasibility and preliminary effectiveness of nursing delivered PrEP education and a community health worker navigation call at 5 weeks postpartum. Dr. Mullis’ transition to independence as a physician scientist will be directly supported by training and mentorship to acquire additional skills in understanding systems-level determinants to intervention adoption, implementation, human centered design methods, quasi-experimental and other clinical trial designs. Results will inform development of an R01 application designed to assess the scalability and sustainability of these implementation strategies in a multi-site cluster randomized hybrid type 3 trial.