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Pre-Exposure Prophylaxis Integration Into Family Planning Services at Title X Clinics in the Southeastern United States: Protocol for a Mixed Methods Hybrid Type I Effectiveness Implementation Study (Phase 2 ATN 155)

Overview
Journal JMIR Res Protoc
Publisher JMIR Publications
Specialty General Medicine
Date 2020 Sep 25
PMID 32975528
Citations 5
Authors
Affiliations
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Abstract

Background: Adolescent and young adult women (AYAW), particularly racial and 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 (FP) 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 FP services, including Title X-funded FP 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 multilevel factors associated with the level of PrEP adoption and implementation (eg, PrEP screening, counseling, and prescription) within and across 3 FP 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 (Adolescent Medicine Trials Network for HIV/AIDS Interventions 155) is a mixed methods hybrid type 1 effectiveness implementation study to be conducted in three clinics in Metro Atlanta, Georgia, United States. Guided by the Exploration, Preparation, Implementation, and Sustainment framework, this study will prepare clinics for PrEP integration via clinic-wide trainings and technical assistance and will 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 the level of PrEP adoption and implementation (eg, PrEP screening, counseling, and prescription) within and across 3 FP clinics following training and implementation planning and to evaluate PrEP uptake, persistence, and adherence among female patients over a 6-month follow-up period. This will guide future strategies to support PrEP integration in Title X-funded clinics across the Southern United States.

Trial Registration: ClinicalTrials.gov NCT04097834; https://clinicaltrials.gov/ct2/show/NCT04097834.

International Registered Report Identifier (irrid): DERR1-10.2196/18784.

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Adolescents Living With or at Risk for HIV: A Pooled Descriptive Analysis of Studies From the Adolescent Medicine Trials Network for HIV/AIDS Interventions.

DeMonte J, McCumber M, Slye N, Amico K, Arnold E, Comulada W J Adolesc Health. 2023; 72(5):712-721.

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Applying implementation science frameworks to identify factors that influence the intention of healthcare providers to offer PrEP care and advocate for PrEP in HIV clinics in Colombia: a cross-sectional study.

Martinez-Cajas J, Torres J, Mueses H, Camargo Plazas P, Arrivillaga M, Gomez S Implement Sci Commun. 2022; 3(1):31.

PMID: 35296369 PMC: 8925047. DOI: 10.1186/s43058-022-00278-2.


Toward Greater Pre-exposure Prophylaxis Equity: Increasing Provision and Uptake for Black and Hispanic/Latino Individuals in the U.S.

Bonacci R, Smith D, Ojikutu B Am J Prev Med. 2021; 61(5 Suppl 1):S60-S72.

PMID: 34686293 PMC: 8668046. DOI: 10.1016/j.amepre.2021.05.027.

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