Clinical trial NCT06853314: An Effectiveness Trial of the PrEP for WINGS Study
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: HIV Infections
Alcohol Use Disorder
Violence, Gender-Based
Keywords: Intimate partner violence
Hazardous alcohol use
HIV infection
PrEP
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2025-02-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: (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 measured by urine assay of Tenofovir (TDF) and longer-term adherence by self-report/medical records over the 12-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.

Eligibility criteria: Inclusion Criteria:

* Identify as a cis-gender woman
* Aged 18 or older
* Test negative for HIV using a rapid OraSure oral test at screening
* Are currently on probation, parole or an ATI programs as verified by CSP records
* Score positive for risk of hazardous drinking or alcohol dependence on AUDIT with a cut off score of 6 or higher; or indicated they drank 4 or more drinks on one occasion in the past 30 days
* Report ever experiencing any intimate partner violence (HARK score of ≤1)
* Report not taking PrEP in the past 90 days
* Report having had condomless vaginal or anal sex in the past 90 days; and report an outside HIV risk in the past year (i.e. sex with more than one partner, shared injected equipment, tested positive for a bacterial STI, had sex with a man with HIV and not virally suppressed).

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)

Primary outcomes:
measure: Number of completed PrEP provider meetings (PrEP Initiation)
timeFrame: From enrollment (baseline) to the end of 12-month follow up
Secondary outcomes:
measure: Revised Conflict Tactic Scale Score
timeFrame: From enrollment (baseline) to the end of 12-month follow up
measure: AUDIT Score
timeFrame: From enrollment (baseline) to the end of 12-month follow up
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Anindita Dasgupta, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Louisa Gilbert, MSW, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Rachel Groth, MSW, MPH
role: STUDY_DIRECTOR
References: