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

Trial Summary

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.

What data supports the effectiveness of the drug PrEP for WINGS in preventing HIV infection?

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 Force found that oral PrEP significantly decreases the risk of HIV infection in adults who are at higher risk of acquiring HIV. ^{1 2 3 4 5}

Is PrEP for HIV infection safe for humans?

PrEP, which includes medications like Truvada, is generally considered safe for preventing HIV, with most side effects being mild, such as nausea and diarrhea. Regular monitoring is recommended to check liver, kidney, and bone health. ^{6 7 8 9 10}

How is the drug PrEP for WINGS different from other HIV treatments?

PrEP for WINGS is unique because it is a preventive approach using the drug Truvada, which combines two antiretroviral medications, tenofovir disoproxil fumarate and emtricitabine, to stop HIV infection before it starts, unlike other treatments that manage the virus after infection. ^{7 9 11 12 13}

What is the purpose of this trial?

(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.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of Improved HIV Care and Treatment on PrEP Effectiveness in the United States, 2016-2020. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Same-day prescribing of daily oral pre-exposure prophylaxis for HIV prevention. [2021]

3. England pubmed.ncbi.nlm.nih.gov

PrEP uptake and HIV viral suppression when PrEP is integrated into Ugandan ART clinics for HIV-negative members of HIV-serodifferent couples: A stepped wedge cluster randomized trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Preexposure Prophylaxis for the Prevention of HIV: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Acute HIV at the Time of Initiation of Pre-exposure or Post-exposure Prophylaxis: Impact on Drug Resistance and Clinical Outcomes. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV in Primary Care and Beyond. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Evolving Models and Ongoing Challenges for HIV Preexposure Prophylaxis Implementation in the United States. [2020]

9. France pubmed.ncbi.nlm.nih.gov

[HIV preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine: What about safety?] [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Pre-exposure prophylaxis uptake concerns in the Democratic Republic of the Congo: Key population and healthcare workers perspectives. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Primary HIV-1 infection in users of pre-exposure prophylaxis. [2021]

12. Canada 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. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Blood safety implications of donors using HIV pre-exposure prophylaxis. [2018]