Abstract
BackgroundWomen experiencing incarceration (WEI) engage in high rates of sex- and drug-related behavior that places them at risk for HIV. Pre-exposure prophylaxis (PrEP) is an efficacious means of reducing HIV acquisition. There is a general lack of knowledge regarding PrEP among women at elevated risk, and only a small percentage of at-risk women are currently engaged in PrEP care. The period of incarceration represents an opportunity to identify at-risk women, initiate PrEP during incarceration, and establish linkage to community-based PrEP care upon release from incarceration. Further, post-release is a time period that is particularly risky, and there are numerous barriers, including substance use, that may impede linkage to community-based care in the absence of intervention. The current protocol describes plans for the development and pilot randomized controlled trial (RCT) of an intervention to promote PrEP uptake during incarceration and facilitate linkage to community-based PrEP care post-release.Methods/designThe motivational interviewing-navigation (MI-NAV) study intervention is being developed, refined, and tested over three phases within the framework of the social ecological model. All phases of the study are being conducted at a women’s correctional facility and community-based PrEP provider located in the Northeastern region of the United States. Phase 1 consists of individual qualitative interviews to be conducted with key stakeholders (n = 6–10) from the community-based PrEP care site and (n = 6–10) from the women’s correctional facility, as well as with (n = 18–30) WEI. Recruitment for Phase 1 was initiated in November 2017. In Phase 2, MI-NAV will be piloted with a small cohort (n = 8–12) of WEI and will be refined based upon participant feedback. During Phase 3, a pilot RCT of MI-NAV and a standard of care condition will be conducted with 80 WEI. RCT participants will complete baseline and follow-up assessments 1, 3, and 6 months post-release. The primary study outcome is linkage to community-based PrEP care, verified via medical records.DiscussionThis study will develop and evaluate a psychosocial intervention (MI-NAV) to promote PrEP uptake and facilitate linkage to community-based PrEP care among women at-risk for HIV. It is expected that, as a result of this project, the feasibility, acceptability, and preliminary efficacy of MI-NAV will be determined. If found to be efficacious, this intervention has the potential to reduce HIV acquisition in a high-need, underserved community.Clinical trial registration NCT03281343
Highlights
Women experiencing incarceration (WEI) engage in high rates of sex- and drug-related behavior that places them at risk for HIV
The criminal-justice involved population in the United States (US) is among the most vulnerable and heavily impacted by HIV; women experiencing incarceration (WEI) have been found to be as much as 15 times more likely to be HIV infected than women in the general population [1]
Qualitative interviews with recently incarcerated individuals revealed that both sex and drug risk behaviors were prevalent during the post-release period, the highest rates of HIV-risk behaviors occurred during the first few days post-release, there was a general lack of knowledge of HIV, and there were significant barriers to accessing health care and medications post-release [6]
Summary
Women experiencing incarceration (WEI) engage in high rates of sex- and drug-related behavior that places them at risk for HIV. The criminal-justice involved population in the United States (US) is among the most vulnerable and heavily impacted by HIV; women experiencing incarceration (WEI) have been found to be as much as 15 times more likely to be HIV infected than women in the general population [1]. They have consistently been found to report high levels of HIV risk behavior. There is a strong need for effective interventions that reduce HIV risk among this population, especially during the high risk period immediately after release from incarceration
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