Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 19, 2020
Date Accepted: Aug 11, 2020
Pre-Exposure Prophylaxis Integration into Family Planning Services at Title X Clinics in the Southeastern United States: A Mixed Methods Hybrid Type I Effectiveness Implementation Study—(Phase 2 ATN 155)
ABSTRACT
Background:
Adolescent and young adult women (AYAW), particularly racial/ethnic minorities, in the Southern United States are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individual-controlled HIV prevention strategy that is grossly underutilized among women of all ages and requires innovative delivery approaches to optimize its benefit. Anchoring PrEP delivery to family planning services that AYAW already trust, access routinely, and deem useful for their sexual health may offer an ideal opportunity to reach women at risk for HIV and to enhance their PrEP uptake and adherence. However, PrEP has not been widely integrated into family planning services, including Title X-funded family planning clinics that provide safety net sources of care for AYAW. To overcome potential implementation challenges for AYAW, Title X clinics in the Southern United States are uniquely positioned to be focal sites for conceptually informed and thoroughly evaluated PrEP implementation science studies.
Objective:
The objective of this study is two-fold: to evaluate multi-level factors associated with level of PrEP adoption and implementation (e.g. PrEP screening, counseling, and prescription) within and across 3 family planning clinics, and to evaluate PrEP uptake, persistence, and adherence among female patients in these clinics over a 6-month follow-up period.
Methods:
Phase 2 of Planning4PrEP (ATN 155) is a mixed-methods hybrid type 1 effectiveness implementation study to be conducted in 3 clinics in metro-Atlanta, Georgia, USA. Guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS) Framework, this study will prepare clinics for PrEP integration via clinic-wide trainings and technical assistance and to develop clinic-specific PrEP implementation plans. We will monitor and evaluate PrEP implementation, as well as female patient PrEP uptake, persistence, and adherence over a 6-month follow-up period.
Results:
Phase 2 of Planning4PrEP research activities began in February 2018 and are ongoing. Qualitative data analysis is scheduled to begin in Fall 2020.
Conclusions:
This study seeks to evaluate factors associated with level of PrEP adoption and implementation (e.g. PrEP screening, counseling, and prescription) within and across 3 family planning clinics following training and implementation planning, and will evaluate PrEP uptake, persistence, and adherence among female patients over a 6-month follow-up period in order to guide future strategies to support PrEP integration in Title X-funded clinics across the Southern United States. Clinical Trial: ClinicalTrials.gov Identifier: NCT04097834; https://clinicaltrials.gov/ct2/show/NCT04097834
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