Telehealth for HIV Prevention

(PROTECT Trial)

Overseen By Hilary L Surratt, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hilary L Surratt, PhD

Must not be taking: PrEP

Disqualifiers: HIV-positive, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to simplify access to PrEP, a medication that helps prevent HIV, for people who inject drugs. It compares two methods of providing PrEP: the usual method, where individuals receive information and a referral to a local provider (CDC PrEP with active referral), and a telehealth approach that offers PrEP education and services more directly (TelePrEP). The researchers aim to determine if the telehealth method results in more people starting PrEP. Individuals who have injected drugs in the last month and are not currently on PrEP may be suitable for this study. Participants should be willing to attend multiple sessions and follow-ups. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in HIV prevention.

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, if you are already receiving PrEP care, you cannot participate in this trial.

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

Research has shown that PrEP (pre-exposure prophylaxis) is a safe method to prevent HIV infection. PrEP involves taking medications like Truvada, which the FDA has approved for this purpose, proving their safety and effectiveness in stopping HIV.

The TelePrEP approach, which utilizes telehealth services, has also improved access to PrEP without compromising safety. Participants using TelePrEP had lab results and health outcomes similar to those who visited a clinic, indicating that telehealth is well-received. No major safety issues have been reported with TelePrEP, making it a reliable choice for HIV prevention.

In summary, both PrEP and TelePrEP are safe for preventing HIV. The trial aims to make these options more accessible, especially for individuals in rural areas or those facing challenges in accessing healthcare. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to improve access to HIV prevention through telehealth. Traditional methods often rely on in-person visits for PrEP education and prescriptions, which can be a barrier for many people. The Integrated Telehealth Care approach combines tailored multi-session PrEP education with telehealth access and on-site testing, making it more convenient and accessible. This method has the potential to reach individuals who might otherwise face challenges accessing standard care, ultimately aiming to increase PrEP uptake and reduce HIV infections.

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

Research shows that telehealth programs, such as TelePrEP, one of the treatment options in this trial, can improve access to HIV prevention care. Studies have found that these online health services keep many people engaged in their care, with some programs retaining over half of participants at least three months after starting. Other research on digital PrEP programs indicates they help people take their medication regularly and remain involved in their care. Early results suggest that telehealth makes it easier and more convenient, especially for those in rural areas, to begin and continue using PrEP. These findings highlight telehealth's ability to help people who inject drugs overcome challenges in accessing PrEP services. The trial will also evaluate the standard of care PrEP education with active referral, based on CDC guidelines, to compare its effectiveness with the TelePrEP approach. ^{1 3 6 7 8}

Who Is on the Research Team?

Hilary L Surratt, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

The PROTECT Trial is for adults over 18 who inject drugs and have used needles in the past month. They must be clients of a syringe service program, willing to join multiple sessions, and not currently on PrEP or HIV-positive. It's aimed at those who meet CDC guidelines for needing PrEP but haven't started it.

Inclusion Criteria

Report at least one occasion of injection drug use in the past month

Express willingness to participate in a multi-session intervention and follow-up

Be a documented client of the county SSP at the time of study entry

Exclusion Criteria

I am currently on PrEP medication.

I am HIV-positive.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PrEP education and intervention through telehealth or standard care

6 months

Multiple sessions (telehealth and in-person)

Follow-up

Participants are monitored for PrEP initiation, persistence, and adherence

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CDC PrEP with active referral
• TelePrEP

Trial Overview This trial tests if telehealth can help people who inject drugs start using PrEP (a medication to prevent HIV) by integrating it into syringe services programs. Participants will either receive standard education with active referral or novel integrated telehealth care.

How Is the Trial Designed?

Group I: Integrated Telehealth Care Experimental Treatment 1 Intervention

A multi-session PrEP education and intervention session that provides tailored PrEP education onsite combined with point-of-care PrEP testing and telehealth access to a PrEP provider.

Group II: Standard of Care Active Control 1 Intervention

One session standard of care (SOC) PrEP education (an in-use PrEP intervention based on CDC guidelines) with active referral to a local PrEP provider.

Who Is Running the Clinical Trial?

Hilary L Surratt, PhD

Lead Sponsor

Trials

4

Recruited

680+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The Iowa TelePrEP program successfully provided HIV preexposure prophylaxis (PrEP) to clients in small urban and rural areas, with 91% of those who had video visits starting PrEP, demonstrating its efficacy in increasing access to this preventive treatment.

The program achieved a 61% retention rate at 6 months and effectively identified and treated 37 sexually transmitted infections (STIs), showcasing its ability to integrate comprehensive sexual health services alongside PrEP delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iowa TelePrEP: A Public-Health-Partnered Telehealth Model for Human Immunodeficiency Virus Preexposure Prophylaxis Delivery in a Rural State. Hoth, AB., Shafer, C., Dillon, DB., et al.[2020]

Pre-exposure prophylaxis (PrEP) can reduce the risk of acquiring HIV by up to 97%, and this 6-month telehealth study demonstrated that telemedicine can effectively provide access to PrEP for high-risk individuals, with 80% of the 20 enrolled participants completing the program.

Self-reported adherence to PrEP remained high (60%-70%) throughout the study, and a significant portion of participants (56.3%) preferred telemedicine for obtaining PrEP, indicating that telehealth can enhance access and comfort for patients seeking HIV prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a telemedicine pilot program for the provision of HIV pre-exposure prophylaxis in the Southeastern United States. Player, MS., Cooper, NA., Perkins, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10927298/

Effectiveness of PrEPTECH: Findings From a 180-Day ... This randomized controlled trial of PrEPTECH, a telehealth intervention for the provision of HIV PrEP, seeks to assess its effects on PrEP access.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10668045/

Evaluation of the Impact and Outcomes of a Rapid ... Also, there were no significant differences in lab completion rates between in-clinic (n=140/140) and telePrEP clients (n=138/143) (P=0.06) and prescription ...

3. link.springer.com link.springer.com/article/10.1007/s10461-024-04366-3

Telehealth Models for PrEP Delivery: A Systematic Review ... Five studies reported retention in PrEP care at least 3 months after initiation. In the Iowa TelePrEP program, 56% (71/127) of participants were ...

4. researchprotocols.org researchprotocols.org/2023/1/e47932/

Effectiveness, Acceptability, and Feasibility of a Telehealth ... This study aims to assess the effectiveness, acceptability, and feasibility of a telehealth HIV PrEP care intervention, PrEPTECH, in increasing PrEP uptake.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749379724000631

Digital HIV Pre-Exposure Prophylaxis Interventions This systematic review found that digital PrEP adherence interventions improved both daily-use pill taking and retention in PrEP care.

6. teleprep.org teleprep.org/prep/

Teleprep is a safe sex program available now online TelePrEP is a safe sex program that provides Truvada as an HIV prevention method for individuals in the Texas and New Mexico region.

7. cdc.gov cdc.gov/hivnexus/hcp/prep/index.html

Clinical Guidance for PrEP | HIV Nexus ... data suggest that PrEP is safe and effective for HIV prevention among adolescent patients.35. Daily oral F/TDF and F/TAF are FDA-approved PrEP options for ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1931312820301840

PrEP for HIV Prevention: Evidence, Global Scale-up, and ... Antiretroviral pre-exposure prophylaxis (PrEP) for the prevention of HIV infection was demonstrated to be efficacious and safe earlier this decade from pivotal ...