Developing a PrEP Adherence Intervention Targeting At-Risk and Substance Using Women

Developing a PrEP Adherence Intervention Targeting At-Risk and Substance Using Women

The purpose of this study is to develop and assess the feasibility, acceptability, and preliminary efficacy on adherence of a community-informed intervention for tenofovir/emtricitabine (TDF/FTC) pre-exposure prophylaxis (PrEP) engagement among street-based female sex workers (FSW) in Baltimore, Maryland.

This study is a prospective two-group trial comparing the efficacy of a comprehensive PrEP adherence program compared to PrEP standard of care among FSW. Outcomes will be assessed through self-reported PrEP adherence as well as biological adherence indicators.

The intervention includes three main components: 1) group PrEP engagement sessions, which include four educational sessions that situate PrEP in a broader framework of access and barriers to care, provider/patient communication, sexual health, HIV/sexually transmitted infection (STI) education, harm reduction around drug use, stigma, risk compensation and safe sex, and health/science literacy; 2) peer navigation, which aims to help women navigate healthcare engagement with the SPARC nurse practitioner and other providers; and 3) an mHealth component, consisting of a two-way text messaging system through which women will receive automated daily messages and weekly messages requesting adherence reports.

Inclusion Criteria:

• Age 18 or older
• Assigned female at birth and identify as a woman
• Traded sex for money or drugs at least three times in the past three months
• HIV negative
• Willing to initiate PrEP
• Not knowingly pregnant or planning to become pregnant during the following 6 months.

Exclusion Criteria:

• Currently taking PrEP for HIV prevention
• Inability to provide informed consent in English
• Women who are determined as too high or drunk
• Women who are cognitively impaired
• Does not agree to data sharing with the Baltimore City Health Department