An Effectiveness Trial of the PrEP for WINGS Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PrEP for WINGS, PrEP Decision Aid.
- Who it may be relevant to
- Registry conditions: HIV Infections, Alcohol Use Disorder, Violence, Gender-Based. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Effectiveness Trial of WINGS+PrEP: a Syndemic mHealth Intervention to Increase PrEP Uptake Among Women Impacted by Heavy Alcohol Use and Partner Violence in the Criminal Legal System
Overview
(Effectiveness Aim 1) To test the comparative effectiveness of PreP for WINGS versus PrEP alone on primary outcomes of increasing PrEP initiation measured by self-report/medical records, recent adherence and longer-term adherence by self-report/medical records over the 6-month follow-up; and secondary outcomes of decreasing IPV, hazardous drinking, recidivism, and HIV risks. (Moderation Aim 2) To test if the effectiveness of WINGS+PrEP on study outcomes is moderated by key participant subgroups based on race/ethnicity, sexual orientation, age, education, incarceration history, IPV severity, substance use disorders (SUDs), digital access and literacy, housing stability, and medical mistrust.
Detailed description
This hybrid type 1 Effectiveness and Implementation Trial will evaluate an m-Health syndemic intervention (PrEP for WINGS) that aims to increase HIV pre-exposure prophylaxis (PrEP) initiation and adherence among women in community supervision programs (CSPs) including probation, parole, and alternative-to-incarceration (ATI) programs) in New York City (NYC) who report hazardous drinking. PrEP is a proven effective biomedical strategy to prevent HIV infection. To date, however, very few PrEP interventions have focused on cis-gender women, and none have targeted women in CSPs, who due to racialized drug laws, are disproportionately Black and Latinx. Women in CSPs have high rates of HIV risk behaviors (e.g., frequent condomless sex, sex with multiple partners) and elevated rates of HIV infection as high as 17%. Large racial health disparities in PrEP uptake exist, a nationally representative study showing that Black women in the USA were four times less likely to have initiated PrEP than non-Hispanic white women. Advancing an effective PrEP intervention for women in CSPs holds promise for reducing HIV disparities by reaching a large number of Black and Latinx women who remain at high risk for HIV.
Compared to the general population, women in CSPs have very high rates of co-occurring hazardous drinking and intimate partner violence (IPV), which are major syndemic drivers of HIV infection and well-established barriers to PrEP uptake. PrEP enables women to engage in a female-controlled HIV prevention strategy, which is vitally important within the context of hazardous drinking and violent partners. To date, however, there are no evidence-based syndemic-focused PrEP interventions for women that address hazardous drinking and IPV exposure. The PrEP for WINGS intervention is a 3-session syndemic-focused intervention that combines an evidence-based mHealth Alcohol Screening, Brief Intervention, and Referral to Treatment (SBIRT) tool, and an evidence-based mHealth IPV SBIRT tool - WINGS (Women Initiating New Goals of Safety) with an evidence-based PrEP intervention that includes a PrEP decision making aid with novel PrEP telemedicine and peer navigation components delivered by Community Health Advocates (CHA). Peer navigation has been shown to increase PrEP initiation and adherence and reduce barriers related to medical mistrust and stigma, which is important for Black and Latinx women. The same single session evidence-based PrEP intervention with peer navigation will serve as the comparison condition (PrEP alone), allowing us to compare the added value of the WINGS syndemic components and offering a cost-efficient alternative evidence-based PrEP intervention. Both interventions will be implemented at various community-based organizations supporting women in CSPs in NYC.
Interventions
- Behavioral PrEP for WINGS
The PrEP for WINGS intervention involves three sessions of a self-paced and self-directed intervention delivered via a mobile health platform. Session 1 will focus on HIV risk reduction and provide the PrEP Decision Aid, where participants will learn information about PrEP to help them decide if it is appropriate for them. Sessions 2-3 will involve integrated Screening, Brief Intervention, Referral to Treatment (SBIRT) modules focused on IPV and alcohol reduction. The PrEP for WINGS intervention - Behavioral PrEP Decision Aid
The PrEP Decision Aid will be delivered to participants in the control condition, and focus on helping study participants decide if they should initiate PrEP. This single session will focus on HIV risk reduction, and then launch the patient-centered PrEP Decision Aid. This individual session will be identical to the first session of the PrEP for WINGS three session intervention, and will also be delivered through an online survey platform. In addition, study participants in the control condition
Primary outcome measures
- Number of completed PrEP provider meetings (PrEP Initiation) [Time frame: From enrollment (baseline) to the end of 12-month follow up]
Secondary outcome measures (2)
- Revised Conflict Tactic Scale Score [Time frame: From enrollment (baseline) to the end of 12-month follow up]
- AUDIT Score [Time frame: From enrollment (baseline) to the end of 12-month follow up]
Eligibility criteria
Inclusion criteria
Identify as a cis-gender woman Aged 18 or older HIV-negative Previous engagement with the criminal legal system or child protective services.
Meet criteria for hazardous alcohol use Previous experience of intimate partner veiolence Report not taking PrEP in the past 90 days Recent experiences of HIV risk due to HIV risk exposure
Exclusion criteria
Ability to speak and understand English is not sufficient to participate in assessments or intervention sessions.
Inability to complete informed consent process due to a psychiatric or cognitive impairment (assessed by the Mini Folstein exam)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The Columbia Community Partnership for Health — New York
Identifiers
NCT: NCT06853314 · AAAU7312 · 1R01AA030462