HIV InfectionsPFWNCT06853314
An Effectiveness Trial of the PrEP for WINGS Study
A study testing PrEP for WINGS and PrEP Decision Aid in people with HIV Infections and Alcohol Use Disorder, run by Columbia University at 1 site in United States.
Trial 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 and longer-term adherence by self-report/medical records over the 6-month follow-up; and secondary outcomes of… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Alcohol Use Disorder, Violence, Gender-Based
- What is being tested?
- PrEP for WINGS and PrEP Decision Aid
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Louisa Gilbert, MSW, PhD contact
United States1 site, 1 recruiting
- Recruiting
The Columbia Community Partnership for Health
New York, New York, 10033
Dora Ventura, 646-697-2274, irvinginst_community@cumc.columbia.edu
Anindita Dasgupta, MPH, PhD
About this 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
(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.
Read the 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.
- Conditions
- HIV Infections, Alcohol Use Disorder, Violence, Gender-Based
- Being tested
- PrEP for WINGS, PrEP Decision Aid
- Keywords
- Intimate partner violence, Hazardous alcohol use, HIV infection, PrEP
- Medical subject headings
- HIV Infections, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP for WINGSBehavioural
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 will also involve peer navigation sessions with Community Health Advocates to help intervention participants trouble shoot any barriers to achieving goals they set during the self-paced sessions. The PrEP for WINGS intervention will take place over a 30 day period and Sessions 2-3, and the peer navigation sessions may be delivered using smart phones or using tablets available at study data collection sites.
PrEP Decision AidBehavioural
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 will also have one peer navigation session with a Community Health Advocate at the end of the self-paced session to help facilitate linkage to care.
| Study group | Role | What they receive |
|---|---|---|
| PrEP for WINGS (intervention arm) | Experimental | Participants randomized to the PrEP for WINGS intervention arm will receive three sessions on a self-paced intervention delivered via a mobile health platform. Session 1 will focus on HIV risk reduction and deliver the PrEP Decision Aid. Sessions 2-3 will involve sessions focused on IPV and alcohol SBIRT sessions with peer navigation that will be completed within a 30 day period (3 sessions total). PrEP for WINGS mHealth sessions may be delivered using smart phones or using tablets available at study data collection sites. Intervention participants will also receive three peer navigation sessions from Community Health Advocates who will help participants trouble shoot any barriers to linking to care, and meeting goals set during the intervention sessions. Receives: Behavioral: PrEP for WINGS |
| PrEP alone (control arm) | Active comparator | Participants randomized to the control arm of the study will receive a single session on HIV risk reduction and 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. Receives: Behavioral: PrEP Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of completed PrEP provider meetings (PrEP Initiation)
Meeting with a PrEP provider to start PrEP once will meet the threshold for PrEP initiation.
Measured: From enrollment (baseline) to the end of 12-month follow up
Secondary outcomes (2)
Revised Conflict Tactic Scale Score
This is designed to assess intimate partner violence (IPV) based on self-reporting on quantitative behavioral survey assessments using the Revised Conflict Tactic Scale 2. Questions are asked for 21 behaviors occurring in the three time frames prior to assessment: ever, past year, and past six months. Positive endorsement of any item will be scored with 1; negative endorsements will be scored 0. Scores range from 0 to 21 for each timeframe, with low score indicated fewer episodes of IPV in the given timeframe, where higher scores indicate higher number of episodes of IPV.
Measured: From enrollment (baseline) to the end of 12-month follow up
AUDIT Score
The self-report version of the AUDIT will be used to assess hazardous alcohol use. The AUDIT has 10 questions and the possible responses to each question are scored 0, 1, 2, 3 or 4, with the exception of questions 9 and 10 which have possible responses of 0, 2 and 4. The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).
Measured: From enrollment (baseline) to the end of 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start9 Apr 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 307 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Anindita Dasgupta, Columbia University
- Investigators
- Anindita Dasgupta, MPH, PhD, Principal investigator, Columbia UniversityLouisa Gilbert, MSW, PhD, Principal investigator, Columbia UniversityRachel Groth, MSW, MPH, Study director, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853314
- Sponsor's protocol ID
- AAAU7312
- Other IDs
- 1R01AA030462
- Acronym
- PFW
- Status last verified
- Jun 2026
- First submitted
- 25 Feb 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06853314
- Acronym / sponsor ID
- PFW / AAAU7312
- Conditions
- HIV Infections, Alcohol Use Disorder, Violence, Gender-Based
- Keywords
- Intimate partner violence, Hazardous alcohol use, HIV infection, PrEP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 307 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrEP for WINGS (intervention arm) | Experimental | Behavioral: PrEP for WINGSParticipants randomized to the PrEP for WINGS intervention arm will receive three sessions on a self-paced intervention delivered via a mobile health platform. Session 1 will focus on HIV risk reduction and deliver the PrEP Decision Aid. Sessions 2-3 will involve sessions focused on IPV and alcohol SBIRT sessions with peer navigation that will be completed within a 30 day period (3 sessions total). PrEP for WINGS mHealth sessions may be delivered using smart phones or using tablets available at study data collection sites. Intervention participants will also receive three peer navigation sessions from Community Health Advocates who will help participants trouble shoot any barriers to linking to care, and meeting goals set during the intervention sessions. |
| PrEP alone (control arm) | Active comparator | Behavioral: PrEP Decision AidParticipants randomized to the control arm of the study will receive a single session on HIV risk reduction and 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEP for WINGSThe 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 will also involve peer navigation sessions with Community Health Advocates to help intervention participants trouble shoot any barriers to achieving goals they set during the self-paced sessions. The PrEP for WINGS intervention will take place over a 30 day period and Sessions 2-3, and the peer navigation sessions may be delivered using smart phones or using tablets available at study data collection sites. | Behavioural | PrEP for WINGS (intervention arm) |
| PrEP Decision AidThe 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 will also have one peer navigation session with a Community Health Advocate at the end of the self-paced session to help facilitate linkage to care. | Behavioural | PrEP alone (control arm) |
Primary outcome
Number of completed PrEP provider meetings (PrEP Initiation)
Time frame: From enrollment (baseline) to the end of 12-month follow up
Meeting with a PrEP provider to start PrEP once will meet the threshold for PrEP initiation.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louisa Gilbert, MSW, PhD contact
Anindita Dasgupta, MPH, PhD principal investigator
Columbia University
Louisa Gilbert, MSW, PhD principal investigator
Columbia University
Rachel Groth, MSW, MPH study director
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEP for WINGS and PrEP Decision Aid in people with HIV Infections and Alcohol Use Disorder, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anindita Dasgupta, MPH, PhD (646-808-4861, ad3341@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of completed PrEP provider meetings (PrEP Initiation) (time frame: From enrollment (baseline) to the end of 12-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.