Linking women experiencing incarceration to community-based HIV pre-exposure prophylaxis care: protocol of a pilot trial

Abstract

Background Women 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/design The 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. Discussion This 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

Pre-exposure Prophylaxis Uptake, Adherence, and Persistence: A Narrative Review of Interventions in the U.S.

“…Improved uptake: 77% of patients filled their prescription within a week Miami Veterans Affairs Health System 29,31 Miami, FL General population A hybrid approach where pharmacists provided adherence counseling and monitoring between visits. 42,43 Providence, RI MSW Intervention participants will receive the peer-led strengths-based case management for PrEP initiation and a counseling intervention to address individual barriers to PrEP use PrEP n'Shine 44 Providence, RI TGW Phase 1: peer-led SBCM for PrEP linkage and initiation Phase 2: daily 2-way text messaging reminders with intensive counseling sessions for those with poor adherence RAMP (NCT03256435) 45 Jackson, MS Black YMSM Intervention arm receives SBCM to navigate the PrEP care system MI-NAV (NCT03281343) 46 Northeast, U.S. Incarcerated women 2-phase study-Phase 1: promote PrEP uptake through motivational interviewing; Phase 2: link at-risk women to PrEP care on release Technology-based interventions DOT Mobile app (NCT04633200) 47 Cambridge, MA YMSM Daily PrEP reminders and supportive messages to support adherence DOT diary mobile app (NCT03771638) 48 Atlanta, GA; San Francisco, CA YMSM Integrates artificial intelligence with the smartphone camera to confirm that the individual prescribed PrEP is taking it PrEP iT!…”

Factors Correlated with Pre-Exposure Prophylaxis (PrEP) Awareness and Use among Black Adults in the United States: Implications for Improving PrEP Uptake

“…Given the emerging literature, innovative strategies and interventions designed to implement PrEP must consider the relevant factors in uencing PrEP awareness. Speci cally, study ndings underscore the signi cance of various approaches that link adults with incarceration history and HIV risk to comprehensive programs facilitating PrEP access (33,41,42). For example, in people with CJI and HIV risk, Peterson et al found low PrEP awareness and HIV risk perception; yet demonstrated that a program for addiction treatment medication offered by a correctional facility served as a useful pathway to increase PrEP information and may also bolster access and retention upon release (42).…”

“…The prevalence of HIV in a concentrated geosocial space has been demonstrated to mediate the in uence of social (e.g., drug use) and structural (e.g., incarceration) factors on individual-level behaviors (e.g., sexual activity, multiple sexual partners, and injection drug use), to the extent that interactions with multilevel factors can create varying pathways of HIV vulnerability for Black adults, especially women (49). Through social interactions with people involved in various criminal justice systems, it is possible that individuals with sexual and drug use behaviors are more vulnerable to HIV, which renders greater individual-level protection and, subsequently PrEP engagement among Black adults at risk (41). While well over half of the sample reported substance use during sex, only a small proportion had ever used PrEP.…”

Introduction to the special issue

“…These studies aim to improve treatment initiation during incarceration and increase treatment continuation after release to the community. Ramsey et al [8] present a protocol of a pilot study to reduce the risk of HIV infection among incarcerated women. The pilot was designed to increase uptake of pre-exposure prophylaxis (PrEP) during incarceration and linkage to community-based PrEP treatment upon release.…”