PrEP for HIV Infection

(PFW Trial)

Overseen By Anindita Dasgupta, MPH, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Non-English speakers, Psychiatric impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of combining PrEP (a medication to prevent HIV) with a program called WINGS in reducing HIV risk compared to using PrEP alone. The study also examines whether this combination addresses other issues, such as reducing intimate partner violence and alcohol use. The trial targets cis-gender women who are HIV-negative, have been on probation or parole, and have faced challenges like risky drinking or unsafe sex. Participants will be divided into two groups: one will receive both PrEP and the WINGS program, while the other will receive only PrEP. The research aims to determine which approach more effectively promotes health and safety. As an unphased trial, this study offers participants the opportunity to contribute to important research that could lead to better health strategies for women facing similar challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does require that you have not taken PrEP in the past 90 days.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that PrEP (Pre-Exposure Prophylaxis) is generally safe for preventing HIV. It may cause mild side effects like nausea and diarrhea, but these are usually not serious and often resolve on their own. Many people have successfully used PrEP to help prevent HIV, indicating it is well-tolerated.

The PrEP for WINGS program includes educational sessions and support to help people use PrEP effectively. Although specific safety findings for the WINGS program are not available, PrEP has a strong safety record.

For those considering joining a trial, it is important to know that PrEP has been studied extensively and is considered safe for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PrEP for WINGS because it offers a unique, comprehensive approach to HIV prevention that integrates technology and personalized support. Unlike standard PrEP treatments that focus solely on medication adherence, this intervention combines a mobile health platform with sessions on reducing HIV risk and addressing issues like intimate partner violence and alcohol use. Additionally, participants receive guidance from Community Health Advocates to overcome barriers to care. This holistic approach not only aims to enhance the effectiveness of PrEP but also addresses broader social and behavioral factors that can impact health outcomes.

What evidence suggests that this trial's treatments could be effective for HIV prevention?

Research shows that PrEP (pre-exposure prophylaxis) effectively lowers the risk of HIV when taken as directed. In this trial, participants in the PrEP for WINGS intervention arm will receive PrEP along with support sessions to help them adhere to the regimen and address issues like partner violence and alcohol use. Studies have shown that similar programs can prevent new HIV cases and promote healthier habits. While specific data on PrEP for WINGS is still being gathered, this approach employs proven methods to help individuals remain on PrEP and reduce their HIV risk. Participants in the control arm will receive PrEP alone, accompanied by a single support session. ^{1 4 5 6 7}

Who Is on the Research Team?

Anindita Dasgupta, MPH, PhD

Principal Investigator

Columbia University

Louisa Gilbert, MSW, PhD

Principal Investigator

Columbia University

Rachel Groth, MSW, MPH

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for individuals with HIV infection who also struggle with alcohol abuse. Participants should be interested in starting PrEP, a medication to prevent HIV, and may have experienced gender-based violence. The study excludes those without digital access or literacy, unstable housing, or severe medical mistrust.

Inclusion Criteria

I identify as a cisgender woman.

Are currently on probation, parole or an ATI programs as verified by CSP records

I have not taken PrEP in the last 90 days.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the PrEP for WINGS intervention, which includes three self-paced mHealth sessions focusing on HIV risk reduction, IPV, and alcohol SBIRT, along with peer navigation sessions.

4 weeks

3 sessions (self-paced, virtual)

Control

Participants in the control arm receive a single session on HIV risk reduction and the PrEP Decision Aid, with one peer navigation session.

1 session

1 session (self-paced, virtual)

Follow-up

Participants are monitored for PrEP initiation, adherence, and secondary outcomes such as IPV and hazardous drinking over a 12-month period.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• PrEP for WINGS

Trial Overview The trial tests the effectiveness of 'PrEP for WINGS' (a support program) plus PrEP medication against PrEP alone. It measures how well participants start and stick to PrEP over 12 months and looks at secondary outcomes like intimate partner violence (IPV), drinking habits, recidivism, and HIV risks.

How Is the Trial Designed?

Group I: PrEP for WINGS (intervention arm) Experimental Treatment 1 Intervention

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.

Group II: PrEP alone (control arm) Active Control 1 Intervention

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. 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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Pre-exposure prophylaxis (PrEP), particularly using Truvada® (tenofovir disoproxil fumarate/emtricitabine), has been shown to effectively reduce the incidence of HIV infection among high-risk individuals, especially when combined with other preventive methods.

While PrEP has a good safety profile, with mild to moderate gastrointestinal side effects being the most common, regular monitoring of liver enzymes, renal function, and bone mineral density is essential to manage potential long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. Tetteh, RA., Yankey, BA., Nartey, ET., et al.[2022]

The study demonstrated that pre-exposure prophylaxis (PrEP) using Truvada is a highly effective strategy for preventing HIV infection among men who have sex with men, with strong retention and compliance rates observed during the study period from January 2017 to March 2021.

Safety assessments indicated that PrEP was well-tolerated, with no significant adverse events related to Truvada, and regular monitoring of renal function showed no major issues, supporting the safety of this preventive approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Pre-Exposure Prophylaxis to Control HIV and Sexually Transmitted Infection Among Men Who Have Sex With Men: Protocol for a Single-Arm Interventional Study. Terada-Hirashima, J., Mizushima, D., Takano, M., et al.[2023]

A review of 808 cases of pre-exposure prophylaxis (PrEP) using TDF/FTC revealed that the most common adverse effects (AEs) were gastrointestinal issues, such as nausea, vomiting, and diarrhea, which aligns with known side effects in HIV-infected populations.

Despite identifying 24% of unexpected adverse effects, including serious ones primarily among chemsex users, the overall data supports the safety of PrEP, indicating it is a viable option for high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[HIV preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine: What about safety?] Jacomet, C., Lebeller, C., Schiestel, T., et al.[2022]

Same-day PrEP prescribing has been shown to be feasible and effective in reducing the gap between initial evaluation and receiving a PrEP prescription, which can help increase overall PrEP usage.

Key components for successful same-day PrEP programs include the ability to conduct laboratory tests during the visit and timely communication of results to patients, which enhances safety and efficacy in HIV prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Same-day prescribing of daily oral pre-exposure prophylaxis for HIV prevention. Rowan, SE., Patel, RR., Schneider, JA., et al.[2021]

HIV pre-exposure prophylaxis (PrEP) is a highly effective and safe antiretroviral medication that significantly reduces the risk of HIV infection in individuals at high risk due to sexual practices or intravenous drug use.

Despite its proven efficacy, PrEP remains underutilized in the U.S., and initial testing for HIV, hepatitis B, and renal function is necessary before starting treatment, with ongoing monitoring required for both approved oral medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV in Primary Care and Beyond. Drallmeier, T., Meyr, A.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06853314

An Effectiveness Trial of the PrEP for WINGS Study (Effectiveness Aim 1) To test the comparative effectiveness of PreP for WINGS versus PrEP alone on primary outcomes of increasing PrEP initiation measured ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC134456/

The cost-effectiveness of the WINGS intervention Results. Under base case assumptions, the intervention prevented an estimated 0.2195 new cases of HIV at a cost of $215,690 per case of HIV averted. When ...

3. withpower.com withpower.com/trial/phase-hiv-infections-3-2025-9aa2d

PrEP for HIV Infection · Info for Participants Research shows that PrEP is highly effective in reducing the risk of HIV transmission when taken as prescribed. A review for the US Preventive Services Task ...

4. sig.columbia.edu sig.columbia.edu/research-projects/prep-wings

PrEP for WINGS - Social Intervention Group This study is implementing and evaluating an m-Health syndemic intervention (PrEP for WINGS) that aims to increase HIV pre-exposure prophylaxis (PrEP) ...

5. prepwatch.org prepwatch.org/wp-content/uploads/2023/12/New-Data-New-Opportunities-Slides.pdf

Global PrEP Learning Network Reduced HIV risk in Phase III trials: 35% in The Ring Study, 27% in. ASPIRE, and demonstrated a strong safety profile. • Open-label extension ...

6. reporter.nih.gov reporter.nih.gov/search/WZKAUhjsoECU8_kUBZT2bA/project-details/11161614

RePORT RePORTER - National Institutes of Health (NIH) | PrEP presents a unique opportunity for women to engage in an HIV prevention strategy, which is vitally important within the context of hazardous drinking and ...

7. communities.springernature.com communities.springernature.com/posts/culturally-tailored-hiv-prevention-empowering-black-women-through-education-and-choice

Culturally Tailored HIV Prevention: Empowering Black Women ... This paper reports outcomes on improved awareness of PrEP, willingness to use PrEP, and PrEP uptake over the 12-month follow-up period.