Test-to-PrEP for HIV

Overseen By Susanne Doblecki-Lewis, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must be taking: PrEP

Disqualifiers: Cognitive impairment, Age 17 or younger

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

Compensation: Varies

Number of Visits: Unknown

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two strategies to determine which better encourages HIV self-testing. The goal is to increase testing among friends and contacts of individuals already taking Pre-Exposure Prophylaxis (PrEP), a medication that prevents HIV. Participants will join either a group receiving direct testing assistance (Test-to-PrEP) or a group using referrals to promote testing (Access by Referral). This trial suits individuals currently on PrEP who can identify friends who might benefit from HIV testing and prevention information. As an unphased trial, it offers a unique opportunity to contribute to innovative strategies for enhancing HIV testing and prevention.

Do I need to stop my current medications to join the trial?

The trial does not specify whether you need to stop taking your current medications. However, since it involves people already on PrEP, it seems likely you can continue your current PrEP medication.

What prior data suggests that these social network strategies are safe for increasing HIV self-testing?

Research has shown that Pre-Exposure Prophylaxis (PrEP) is a safe and well-tolerated method for preventing HIV. Studies have found that oral PrEP is highly effective and has been safely used for nearly ten years. No serious kidney problems have been reported when starting PrEP on the same day, indicating its safety.

The Access by Referral strategy aims to improve connections to PrEP and other HIV services. This approach helps individuals enter and remain in care more quickly, focusing on service delivery rather than direct safety data.

Overall, both Test-to-PrEP and Access by Referral are considered safe, with PrEP itself being a well-established and safe method for HIV prevention. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Test-to-PrEP and Access by Referral methods because they aim to simplify and expand access to HIV prevention. Unlike traditional methods that typically require multiple clinic visits, Test-to-PrEP streamlines the process by integrating rapid HIV testing with immediate access to pre-exposure prophylaxis (PrEP), potentially allowing individuals to start prevention measures sooner. Meanwhile, the Access by Referral approach focuses on connecting individuals to PrEP through community referrals, which could reach populations who might not otherwise seek care. These methods could significantly enhance early intervention and widen the reach of HIV prevention efforts.

What evidence suggests that this trial's treatments could be effective for increasing HIV self-testing completion rates?

Studies have shown that PrEP (Pre-Exposure Prophylaxis) is highly effective in preventing HIV when used correctly. Research suggests that increasing PrEP use can significantly reduce HIV spread with minimal risk of the virus developing resistance to the medication. In this trial, participants in the Test-to-PrEP group will receive an intervention designed to streamline PrEP access, while those in the Access by Referral group will receive a different intervention focused on community-based and peer-led referrals for testing. Both approaches aim to improve HIV testing and prevention, employing different strategies. The goal is to make HIV testing more accessible and support ongoing prevention efforts. ^{6 7 8 9 10}

Who Is on the Research Team?

Susanne Dobleck-Lewis, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for individuals who are contacts of current Pre-Exposure Prophylaxis (PrEP) clients, aiming to increase HIV self-testing rates. Specific eligibility criteria details were not provided.

Inclusion Criteria

Peers (Alters) must provide electronic informed consent prior to completion of the Quick Response (QR)-linked survey instruments

PrEP Clients (Egos) must have stated willingness to provide informed consent

PrEP Clients (Egos) must have stated willingness to comply with all study procedures

Exclusion Criteria

I am 17 or younger and considering or using PrEP.

PrEP Clients (Egos) with inability or refusal to provide informed consent (e.g., cognitive impairment)

PrEP Clients (Egos) unable or unwilling to comply with study procedures per study investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either the Test-to-PrEP intervention or the Access by Referral intervention

Up to 1 year

Follow-up

Participants are monitored for HIV self-testing completion and PrEP initiation

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Access by Referral
• Test-to-PrEP

Trial Overview The study is testing two methods of increasing HIV self-testing: direct distribution where PrEP users give tests to their contacts, and referral-based distribution where they refer contacts to get tested.

How Is the Trial Designed?

Group I: Test-to-PrEP group Experimental Treatment 1 Intervention

Participants in this group will receive the Test-to-PrEP intervention for up to 1 year

Group II: Access by Referral group Experimental Treatment 1 Intervention

Participants in this group will receive the Access by Referral intervention for up to 1 year

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study involving 939 men who have sex with men (MSM) in China, those using daily pre-exposure prophylaxis (PrEP) showed a high rate of HIV self-testing (HIVST) usage (74.5%) and secondary distribution of kits to partners (52.8%), indicating the feasibility of HIVST in real-world settings.

The results suggest that HIVST could potentially replace facility-based HIV testing to some extent, especially for MSM on daily PrEP, highlighting the importance of innovative testing methods in HIV prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Based HIV Self-Testing Among Men Who Have Sex With Men Through Pre-exposure Prophylaxis: 3-Month Prospective Cohort Analysis From China. Zhang, J., Tucker, J., Tang, W., et al.[2021]

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]

A systematic review of 76 peer-reviewed articles and 28 conference abstracts revealed that while awareness of daily oral PrEP among at-risk populations is low, most individuals expressed a willingness to use it once informed about its benefits.

Concerns regarding safety, side effects, cost, and effectiveness were the main barriers to PrEP adoption, indicating a need for better education and resources for both potential users and healthcare providers before widespread implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Values and Preferences on the Use of Oral Pre-exposure Prophylaxis (PrEP) for HIV Prevention Among Multiple Populations: A Systematic Review of the Literature. Koechlin, FM., Fonner, VA., Dalglish, SL., et al.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0735675725003341

Implementing HIV prevention in the emergency department This was a mixed-methods, type 3 hybrid implementation effectiveness study of seven California EDs that integrated HPS for HIV negative patients.

2. targethiv.org targethiv.org/sites/default/files/file-upload/resources/ihip-linkage-to-Care-Active-Referral-Case-Study-and-Intervention.pdf

Active Referral Intervention, Virginia Dept of Health Monitoring selected national HIV prevention and care objectives by using HIV surveillance data—United States and 6 dependent areas, 2014. HIV Surveillance.

3. link.springer.com link.springer.com/article/10.1007/s10461-025-04745-4

A Systematic Review of the Effectiveness of HIV Prevention ... Most studies found that interventions were associated with positive health-related changes, such as reduced HIV incidence, increased condom use ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8284540/

Evidence on the effectiveness of community-based primary ... Most studies showed that community-based interventions improved HIV prevention and treatment outcomes compared to facility-based approaches alone.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5570465/

Effectiveness of peer-led interventions to increase HIV testing ... Among randomized trials, HIV testing rates were significantly higher in the peer-led intervention versus control groups (pooled OR: 2.48, 95% CI 1.99–3.08).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8715511/

A Review of Recent HIV Prevention Interventions and ... Interventions targeting providers and care delivery increase risk screening, HIV testing, timely linkage to care, and PrEP access for eligible individuals.

7. cdc.gov cdc.gov/hiv-data/nhss/national-hiv-prevention-and-care-outcomes.html

National HIV Prevention and Care Objectives | HIV Data In 2022, over 80% of people with diagnosed HIV were linked to care within one month of diagnosis. Only 76% had received some care, 54% were retained in care, ...

8. journals.lww.com journals.lww.com/jaids/fulltext/2024/06010/outcomes_of_an_emergency_department_program_to.7.aspx

JAIDS Journal of Acquired Immune Deficiency Syndromes The HIV PreventED Program utilized an HIV prevention navigator to identify patients who tested HIV negative but are at higher risk of acquiring HIV.

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2799111

Effectiveness of an Intervention to Improve HIV Service ... This cluster trial examines the effectiveness of the Bridge HIV care continuum intervention implemented in needle and syringe programs for ...

10. hptn.org hptn.org/news-and-events/press-releases/hptn-094-study-examines-a-novel-way-to-take-addiction-care-and-hiv

HPTN 094 Study Examines a Novel Way to Take Addiction ... Primary outcomes were being alive at 26 weeks post-randomization, using MOUD, and ART for HIV prevention or care among people who inject drugs ...