Dataset Information

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.

SUBMITTER: Ramsey SE

PROVIDER: S-EPMC6398222 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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

Ramsey Susan E SE Ames Evan G EG Brinkley-Rubinstein Lauren L Teitelman Anne M AM Clarke Jennifer J Kaplan Clair C

Addiction science & clinical practice 20190304 1

<h4>Background</h4>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 inc ...[more]

PMID: 30832717

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Project description:Women in Africa face disproportionate risk of human immunodeficiency virus (HIV) acquisition, accounting for more than half of new infections in Africa and similarly face a disproportionate burden of sexually transmitted infections (STIs). Very high STI prevalence is being observed globally, especially among people taking pre-exposure prophylaxis (PrEP) for HIV prevention. Doxycycline post-exposure prophylaxis (dPEP) has been proposed as an STI prevention strategy to reduce chlamydia, syphilis, and possibly gonorrhea, and trials are ongoing among cisgender men who have sex with men (MSM) and transgender women who are taking PrEP in high-income settings. We designed and describe here the first open-label trial to determine the effectiveness of dPEP to reduce STI incidence among cisgender women. We are conducting an open-label 1:1 randomized trial of dPEP versus standard of care (STI screening and treatment and risk-reduction counseling without dPEP) among 446 Kenyan women aged ≥ 18 and ≤ 30 years old women taking PrEP. Women are followed for 12 months, with quarterly STI testing, treatment, and adherence counseling. The primary trial outcome will be the combined incidence of Chlamydia trachomatis, Neisseria gonorrhoeae, and Treponema pallidum, compared between the randomized groups. We will also assess dPEP acceptability, tolerability, safety, impact on sexual behavior, adherence, and occurrence of antimicrobial resistance (AMR) in N. gonorrhoeae and C. trachomatis isolates. Finally, we will estimate cost per incident STI case and complications averted accounting for nonadherence and benefits relative AMR or side effects. The results of this trial may have immediate implications for the global epidemic of STIs and sexual health. If effective, dPEP could put STI prevention into women's hands. While dPEP may be able to prevent STIs, it carries important risks that could counter its benefits; global debate about the balance of these potential risks and benefits requires data to inform policy and implementation and our study aims to fill this gap. ClinicalTrials.gov NCT04050540 .

Project description:IntroductionAfrican American women (AA), particularly those living in the Southeastern USA, experience disproportionately high rates of HIV infection. Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention tool that may circumvent barriers to traditional HIV prevention tools, such as condom use; however, very little is known about how to improve PrEP access and uptake among AA women who may benefit from PrEP use. This project aims to understand how to increase PrEP access among AA women in the rural Southern USA, which may ultimately affect HIV incidence in this population.Methods and analysisThe goal of the current study is to systematically adapt a patient-provider communication tool to increase PrEP uptake among AA women receiving care at a federally qualified health centre in Alabama. We will use an iterative implementation process, by assessing the feasibility, acceptability and preliminary impact of the tool on PrEP uptake, using a pilot preintervention/postintervention design (N=125). We will evaluate women's reasons for declining a referral to a PrEP provider, reasons for incomplete referrals, reasons for not initiating PrEP after a successful referral and ongoing PrEP use at 3 and 12 months after PrEP initiation among our sample. The proposed work will significantly contribute to our understanding of factors impacting PrEP uptake and use among AA women, particularly in underserved areas in the Deep South that are heavily impacted by the HIV epidemic and experience worse HIV-related health outcomes relative to other areas in the USA.Ethics and disseminationThis protocol has been approved by the Institutional Review Board (IRB) at University of Alabama at Birmingham (Birmingham, AL; protocol 300004276). All participants will review a detailed informed consent form approved by the IRB and will provide written or verbal informed consent prior to enrolment. Results will be disseminated through peer-reviewed manuscripts, reports, and local, national and international presentations.Trial registration numberNCT04373551.

Project description:Pre-exposure prophylaxis (PrEP) provides a strong preventative benefit to individuals at risk for HIV. While PrEP adherence is highly correlated with its efficacy, adherence rates are variable both across and within persons.The objective of this study was to develop and pilot-test a smartphone-based intervention, known as mSMART, that targets PrEP adherence. mSMART provides contingency management in the form of monetary incentives for daily PrEP adherence based on a real-time adherence assessment using a camera-based medication event-monitoring tool as well as medication reminders, PrEP education, individualized behavioral strategies to address PrEP adherence barriers, and medication adherence feedback.This was a 4-week open-label, phase I trial in a community sample of young men who have sex with men already on PrEP (N=10).Although adherence composite scores corresponding to PrEP biomarkers indicated that 90% (9/10) of the sample already had an acceptable baseline adherence in the protective range, by the end of the 4-week period, the scores improved for 30% (3/10) of the sample-adherence did not worsen for any participants. Participants reported mean PrEP adherence rates of 91% via daily entries in mSMART. At the end of the 4-week period, participants indicated acceptable ratings of satisfaction, usability, and willingness to recommend mSMART to others. There were no technical difficulties associated with smartphone compatibility, user misunderstandings about mSMART features that interfered with daily use, or study attrition.This study is the first to apply contingency management to PrEP adherence. Findings indicated that mSMART is feasible and acceptable. Such an adherence intervention administered via a user-friendly smartphone app can allow for widespread dissemination. Future efficacy trials are needed.ClinicalTrials.gov NCT02895893; https://clinicaltrials.gov/ct2/show/NCT02895893 (Accessed by Webcite at http://www.webcitation.org/72JskjDJq).

Dataset Information

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

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

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