The PROTECT (PrEP Optimization Through Telehealth Care and Treatment) Trial

NCT06845774 | Enrolling By Invitation DMC

• 2 other identifiers: 90392R34DA060087-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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. This study will integrate telehealth PrEP care within local health departments 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.

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (2)

• PrEP Initiation

  Number of participants initiating PrEP

  3 months post-baseline

• PrEP Initiation

  Number of participants initiating PrEP

  6 months post-baseline

Secondary Outcomes (4)

• PrEP Persistence

  3 months post-baseline

• PrEP Persistence

  6 months post-baseline

• PrEP adherence

  3 months post-baseline

• PrEP adherence

  6 months post-baseline

Other Outcomes (1)

• Intervention Acceptability

  2 weeks post-baseline

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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.

Behavioral: CDC PrEP with active referral

Integrated Telehealth Care

EXPERIMENTAL

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.

Behavioral: TelePrEP

Interventions

TelePrEP BEHAVIORAL

The TelePrEP intervention includes an initial one-on-one in person intervention session with trained study staff that: 1) engages in provides basic education on PrEP care tailored for PWID; 2) encourages participation in a telehealth clinical evaluation for PrEP; and, 3) offers the opportunity to participate in point of care baseline testing for PrEP. At the conclusion of session 1, for those who express readiness to link with PrEP care, study staff will immediately facilitate access to the telehealth platform onsite. Four telehealth visits will be offered to access initial and follow-up clinical care for PrEP.

Integrated Telehealth Care

CDC PrEP with active referral BEHAVIORAL

The single session SOC utilizes structured risk assessments and educational materials recommended by the CDC, based on the CDC PrEP 101 information, and delivered one-on-one by trained study staff in about 15 minutes. This will be followed by active referral to a local provider; local providers have been identified to receive study referrals in each community. This session will occur the same day or within one week of study enrollment.

Standard of Care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be at least 18 years of age
• report at least one occasion of injection drug use in the past month
• report an indication for PrEP in the past six months consistent with CDC guidelines for PrEP care
• be a documented client of the county health department-based SSP at the time of study entry
• express willingness to participate in a multi-session intervention and follow-up

You may not qualify if:

• HIV-positive status
• current PrEP care.

Sponsors & Collaborators

• Hilary L Surratt, PhD: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Study Officials

• Hilary L Surratt, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): January 13, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study team will submit a de-identified and cleaned survey and clinical dataset to Dataverse at the completion of the project period, April 2027, or at publication of the primary outcomes paper, whichever is first.
• Access Criteria: Data will be made available on the Harvard Dataverse, for which the University of Kentucky has an institutional account. The Harvard Dataverse Repository is a free data repository open to all researchers from any discipline, both inside and outside of the Harvard community, where investigators can share, archive, cite, access, and explore research data.

Locations

US (1)