RFA-PS-21-001 Development and Pilot Testing of an Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders

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Ethnic-minority women continue to bear a disproportionate burden of the health and social consequences of HIV. However, research on effective interventions for engaging women with substance use disorders (SUD) in HIV prevention interventions is lacking. Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention tool but is not widely used by ethnic minority women. According to the Centers for Disease Control and Prevention, in 2016 only 2.1% of the women estimated to have PrEP indications filled PrEP prescriptions. This highlights a significant unmet prevention need. For women who do take PrEP, low adherence to the medication regimen decreases the medication’s ability to prevent HIV. The reasons for low uptake and adherence among women are not completely understood. Based on our work and that of others, individual-level barriers include lack of awareness of personal HIV risk, low knowledge of PrEP, and concerns about stigma. System-level barriers include difficulty accessing providers knowledgeable and willing to prescribe PrEP. The overarching goal of this research is to develop and pilot test an addiction-clinic based bio-behavioral intervention for increasing PrEP uptake and adherence among women who engage in high-risk sexual behaviors and substance use. We will conduct Stage 1A research to identify key issues to address in developing the intervention. Interview data obtained from women undergoing standard SUD treatment will be used to finalize the design of the pilot trial (Stage 1B) comparing standard SUD treatment to SUD treatment integrated with PrEP services and adherence support. The new integrated intervention is expected to include motivational counseling guided by the Information- Motivation-Behavioral Skills Model (IMB) which seeks to influence behavior change via PrEP education, increasing motivation for change, and teaching behavioral skills to increase self-efficacy. This novel intervention will be delivered remotely using the emocha Mobile Health smartphone application and will include contingency management to reward desired behaviors. We hypothesize that compared to standard treatment, 1) the integrated intervention will result in a greater proportion of participants who fill their PrEP prescription; 2) (primary hypothesis) the integrated intervention will result in greater adherence to PrEP in those who fill their prescriptions; and 3) the integrated intervention will be feasible and acceptable by women (enrollment rate, study retention, and participant satisfaction scores). We will explore these hypotheses by pursuing three specific aims; 1) Elicit information on knowledge and attitudes about PrEP use and obtain feedback about the potential design of the integrated intervention; 2) Develop an integrated bio-behavioral intervention to promote PrEP uptake and adherence in women undergoing treatment for SUD who are at high risk for HIV; and 3) Assess initial efficacy, feasibility, and acceptability of the integrated intervention. The approach is innovative in that we will address individual level barriers by focusing on information, motivation, and behavioral skills development utilizing an incentive-based approach to increase adherence to daily PrEP, and we address structural level barriers by integrating the intervention into the addiction treatment setting. The proposed research is significant because it is expected to advance and expand the understanding of barriers and facilitators of PrEP uptake in this understudied vulnerable population.