Longitudinal pre-exposure prophylaxis (PrEP) acceptability, initiation and adherence among criminal justice-involved adults in the USA: The Southern PrEP Cohort Study (SPECS) protocol

Introduction HIV prevalence among criminal justice (CJ)-involved adults is five times higher than the general population. Following incarceration, CJ-involved individuals experience multilevel barriers to HIV prevention. Pre-exposure prophylaxis (PrEP) is a widely available, daily medication efficacious in preventing HIV. Little is known about PrEP knowledge, acceptability, initiation and sustained use among CJ-involved persons or about how these outcomes vary by multilevel factors. The Southern Pre-Exposure Prophylaxis Study (SPECS) will investigate barriers and facilitators for PrEP initiation and sustained use among CJ-involved adults, building a foundation for PrEP interventions for this underserved population. Methods and analysis SPECS uses a mixed-methods sequential design, including a multisite, prospective cohort study in three southern states - North Carolina, Florida and Kentucky - and subsequent qualitative interviews. HIV-negative adults clinically indicated for PrEP with CJ-involvement in the past year (n=660; 220 per site) - will be recruited for four quantitative interviews separated by 6 months, with 18 months of follow-up. Interviews will measure CJ involvement, substance use, sexual behaviours, PrEP acceptability and use, healthcare access and utilisation, support systems and psychological and emotional well-being. We will estimate probabilities of PrEP acceptability and use in a CJ-involved population using descriptive and multivariable analyses. After the follow-up, a subsample that never initiated PrEP, initiated but did not sustain PrEP or sustained PrEP will be asked to participate in a qualitative interview to contextualise their experiences and decisions around PrEP. An inductive approach will guide qualitative analyses. Ethics and dissemination PrEP initiation and sustained use rates are unknown among CJ-involved adults. This research will identify individual, social and structural factors that predict PrEP initiation and use. Data generated from the study have the potential to guide research and the development and tailoring of PrEP interventions to CJ-involved populations and provide context to HIV-related outcomes for those with CJ experiences.