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

Trial Summary

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 data supports the effectiveness of the Test-to-PrEP treatment for HIV?

Research shows that using telehealth and pharmacy-based models can improve access to PrEP, making it easier for people to start and continue the treatment. Same-day prescribing of PrEP has also been found to help more people get the medication they need quickly, which can reduce the risk of HIV transmission. ^{1 2 3 4 5}

Is Test-to-PrEP for HIV safe for humans?

The research articles reviewed do not provide specific safety data for Test-to-PrEP for HIV, but they do mention concerns about safety and side effects as common barriers to using PrEP. This suggests that while PrEP is generally considered safe, potential users and healthcare providers are still cautious and seek more information on its safety. ^{1 2 6 7 8}

How is the Test-to-PrEP treatment for HIV different from other treatments?

The Test-to-PrEP treatment is unique because it focuses on linking individuals who test for HIV directly to pre-exposure prophylaxis (PrEP) services, potentially through innovative methods like telehealth or pharmacy-based models, which can improve access and address barriers in traditional healthcare settings. ^{1 3 9 10 11}

What is the purpose of this trial?

To compare the effectiveness of two social network strategies (direct distribution and referral-based distribution) in increasing HIV self-testing (HIVST) completion rates among social network contacts of current Pre-Exposure Prophylaxis (PrEP) clients.

Research Team

Susanne Dobleck-Lewis, MD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Telehealth effectiveness for pre-exposure prophylaxis delivery in Brazilian public services: the Combine! Study. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Barriers to and strategies for early implementation of pharmacy-delivered HIV PrEP services in Kenya: An analysis of routine data. [2023]

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

The Fidelity of a Pharmacy-Based Oral HIV Pre-Exposure Prophylaxis Delivery Model in Kenya. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Getting PrEP to the patients who need it. [2023]

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

Prescribing of Human Immunodeficiency Virus (HIV) Pre-exposure Prophylaxis by HIV Medical Providers in the United States, 2013-2014. [2020]

7. Australia pubmed.ncbi.nlm.nih.gov

High uptake of pre-exposure prophylaxis (PrEP) during early roll-out in Belgium: results from surveillance reports. [2020]

8. United States 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. [2023]

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

HIV PrEP access and affordability: a multidisciplinary specialty pharmacy model. [2022]

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

Correlates of Linkage to HIV Preexposure Prophylaxis Among HIV-Testing Clients. [2021]

11. Canada 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. [2021]