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Principal Investigator: Jaimie Meyer
Organization: YALE UNIVERSITY
Fiscal Year: 2024
Award: $691,541
Funding agency: National Institute on Drug Abuse
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.
Terms: <AIDS Virus><AIDS prevention><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Address><Alabama><Assess implementation><Behavioral><COVID-19><CV-19><Caring><Clinical><Collaborations><Communities><Connecticut><Continuity of Care><Continuity of Patient Care><Continuum of Care><Coronavirus Infectious Disease 2019><Criminal Justice><Decision Aid><Diagnosis><Diversion Program><Drugs><Effectiveness><Elements><Eligibility><Eligibility Determination><Enrollment><Epidemic><Epidemiology><Focus Groups><Follow-Up Studies><Followup Studies><Geography><HCV Transmission><HCV therapy><HCV treatment><HIV><HIV Infections><HIV Prevention><HIV risk><HIV/AIDS prevention><HTLV-III Infections><HTLV-III-LAV Infections><Healthcare Delivery><Hepatitis C Therapeutics><Hepatitis C Therapy><Hepatitis C Transmission><Hepatitis C Virus Treatment><Hepatitis C treatment><Human Immunodeficiency Viruses><Human T-Lymphotropic Virus Type III Infections><Implementation assessment><Individual><Intervention><Intervention Strategies><Interview><Jail><Justice><LAV-HTLV-III><Life><Lymphadenopathy-Associated Virus><Measures><Medication><Methods><Modeling><NIH Office of AIDS Research><Opiates><Opioid><Outcome><Output><Patients><Pharmaceutical Preparations><Population><PrEP><Prisons><Protocol Screening><Provider><Public Health><Publishing><QALY><Quality-Adjusted Life Expectancy><Quality-Adjusted Life Years><Randomized><Research><Research Infrastructure><Research Resources><Resources><Risk><Sampling><Service delivery model><Service model><Sexually Transmitted Diseases><Sexually Transmitted Disorder><Sexually Transmitted Infection><Site><Standardization><Stigmatization><Stimulant><Structure><Substance Use Disorder><Supervision><Survey Instrument><Surveys><System><Techniques><Testing><Time><Venereal Diseases><Venereal Disorders><Venereal Infections><Virus-HIV><Woman><Work><barriers to implementation><care as usual><care delivery model><co-morbid><co-morbidity><collaboration with communities><community collaboration><community-based collaboration><comorbidity><context for implementation><coronavirus disease 2019><coronavirus disease-19><coronavirus infectious disease-19><court><delivered remotely><design><designing><disparity in health><drug/agent><e-Health><eHealth><electronic health><enroll><epidemiologic><epidemiological><evaluate implementation><evaluation of implementation><evidence base><health and care delivery><health care delivery><health care delivery model><health delivery systems><health disparity><health services delivery><healthcare delivery model><hepatitis C virus transmission><implementation barriers><implementation challenges><implementation context><implementation determinants><implementation evaluation><implementation factors><implementation outcomes><implementation science><improved><innovate><innovation><innovative><intervention arm><interventional strategy><medication for opioid use disorder><member><opiate use disorder><opioid use disorder><parole><pre-exposure prophylaxis><preference><probation><psychostimulant use><randomisation><randomization><randomly assigned><recruit><remote delivery><scale up><secondary outcome><sexually acquired infection><social><social stigma><stigma><stimulant use><substance use and disorder><support tools><telehealth><tool><treatment arm><treatment as usual><unethical><uptake><use of stimulants><usual care>