Principle Investigator(s):
Funder: National Institute on Drug Abuse
Project period: 09/15/2022 - 06/30/2027
Grant Type: Research
Further Detail
Abstract Text:
Problem: There is urgent need to reach women involved in criminal justice (WICJ) for lifesaving, evidence-based PrEP and medications for OUD (MOUD), using innovative healthcare delivery models that surmount existing social and structural barriers to engagement. Purpose: We use our newly validated decision aid and eHealth to remotely deliver integrated PrEP and MOUD to community-based WICJ with OUD in New Haven, Connecticut (CT) and Birmingham, Alabama (AL). Methods: We will enroll 250 PrEP-eligible WICJ with OUD to undergo randomization to: a) the “Athena” strategy, which includes the decision aid + eHealth for remote integrated PrEP/MOUD with a provider using outputs from the decision aid; or b) decision aid-only with referral to community-based PrEP/MOUD. Randomization will be stratified by site; past 6-month use of any stimulants; and baseline receipt of MOUD. Follow-up study assessments occur at months 1, 3, and 6. To understand implementation, we will conduct population modeling and engage with relevant stakeholders through focus groups using nominal group technique and in-depth individual interviews. Aims: The Aims of the project are: 1) To compare the Athena strategy to decision aid-only in terms of patient-level engagement in the PrEP and OUD care continua, considering key site differences; and 2) To assess scale-up potential of the Athena strategy in terms of modelled long-term outcomes and how stakeholders interact with eHealth for integrated PrEP/MOUD in WICJ in two diverse epidemiological and implementation contexts (CT and AL), using standardized definitions of implementation outcomes. Significance: The proposed research directly addresses the key objectives of RFA- DA-22-040 and priorities of the NIH Office of AIDS Research by testing innovative interventions to reduce stigma and improve the PrEP and OUD care continua in the key priority population of WICJ with OUD. Importance is high due to the focus on WICJ with OUD who have high HIV risk and in whom PrEP delivery strategies are limited. Innovation is high through use of a stigma- reducing decision aid and eHealth to overcome documented barriers to PrEP uptake, and a design that measures clinical alongside implementation outcomes in two diverse settings. Feasibility is high due to access to large numbers of WICJ with OUD in both contexts and a research team with considerable content expertise, collaborations, and supportive research infrastructure. Public health significance is high because delivering PrEP to key populations is central to EHE and assessing implementation factors to guide scale-up in two diverse contexts will help guide other settings where HIV prevention is needed.
