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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The expansion of HIV pre-exposure prophylaxis (PrEP) care has been endorsed as a key strategy for reducing new HIV infections, however, PrEP trials among people who inject drugs (PWID) are rare and uptake of PrEP has been minimal, most notably in rural areas. Structural barriers to healthcare access, lack of providers, and inadequate infrastructure to deliver PrEP are challenges in many rural areas. In addition, PWID often have social determinant barriers to PrEP care. This study will integrate telehealth PrEP care within syringe services programs (SSPs), a venue already routinely accessed by PWID, to reduce structural barriers to evidence-based HIV prevention through co-located comprehensive PrEP services, and test this against a standard of care approach in a pilot randomized clinical trial. The primary objective is to examine preliminary efficacy and effect sizes of novel integrated telehealth care versus standard education and active referral on the primary outcome of PrEP initiation in HIV-negative participants who inject drugs.

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.

What data supports the effectiveness of the treatment TelePrEP for HIV prevention?

Research shows that using telehealth to provide PrEP (a daily medication to prevent HIV) can effectively expand access to this important prevention method, especially in areas where people might not have easy access to healthcare providers. In a study, 80% of participants completed a telePrEP program, and many preferred telemedicine for obtaining PrEP, indicating that telehealth can help more people at high risk of HIV get the prevention they need. ^{1 2 3 4 5}

Is telehealth delivery of PrEP safe for humans?

The studies on telehealth delivery of PrEP (pre-exposure prophylaxis) for HIV prevention do not report any specific safety concerns, suggesting it is generally safe for humans. Telehealth has been shown to be a useful way to expand access to PrEP, especially during the COVID-19 pandemic. ^{2 3 6 7 8}

How is the TelePrEP treatment for HIV prevention different from other treatments?

TelePrEP is unique because it uses telehealth (remote healthcare services via technology) to provide access to PrEP, making it easier for people in rural or underserved areas to receive HIV prevention care without needing to visit a clinic in person. This approach can increase access to PrEP and maintain high adherence rates, especially during situations like the COVID-19 pandemic when in-person visits are challenging. ^{1 2 3 6 9}

Research Team

Hilary L Surratt, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Identifying Ethical and Culturally Responsive Research Activities to Build Trust and Improve Participation of Black Sexual Minority Men in Pre-Exposure Prophylaxis Telehealth Clinical Trials: Qualitative Study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of a telemedicine pilot program for the provision of HIV pre-exposure prophylaxis in the Southeastern United States. [2023]

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

Iowa TelePrEP: A Public-Health-Partnered Telehealth Model for Human Immunodeficiency Virus Preexposure Prophylaxis Delivery in a Rural State. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

PrEP Echo: A National Interdisciplinary Telementoring Program for HIV Prevention Through Practice Transformation. [2023]

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

Evaluation of the Impact and Outcomes of a Rapid Transition to Telehealth PrEP Delivery at a Sexual Health Clinic During the COVID-19 Pandemic. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness, Acceptability, and Feasibility of a Telehealth HIV Pre-Exposure Prophylaxis Care Intervention Among Young Cisgender Men and Transgender Women Who Have Sex With Men: Protocol for a Randomized Controlled Trial. [2023]

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

Pre-exposure Prophylaxis Discontinuation During the COVID-19 Pandemic Among Men Who Have Sex With Men in a Multisite Clinical Cohort in the United States. [2023]

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

A Retrospective Comparison of HIV Pre-exposure Prophylaxis (PrEP) Outcomes Between a Pharmacist-led Telehealth Clinic and In-person Clinic in a Veteran Population. [2023]