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

Optimizing Low Threshold TelePrEP Care for People Who Inject Drugs in Appalachia

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: HIV Prevention
• Intervention / Treatment: Behavioral: CDC PrEP with active referral; Behavioral: TelePrEP

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• HIV-positive status
• current PrEP care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; 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; 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.
Experimental: Integrated Telehealth Care; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Initiation	Number of participants initiating PrEP	3 months post-baseline
PrEP Initiation	Number of participants initiating PrEP	6 months post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Persistence	Number of participants with PrEP prescription refill	3 months post-baseline
PrEP Persistence	Number of participants with PrEP prescription refill(s)	6 months post-baseline
PrEP adherence	Number of participants with tenofovir (TFV) detected in dried blood spot testing	3 months post-baseline
PrEP adherence	Number of participants with tenofovir (TFV) detected in dried blood spot testing	6 months post-baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Acceptability	Level of Intervention Acceptability for the experimental arm; measured by 10 item Intervention Acceptability Questionnaire (IAQ) completed by participants post-intervention; range is 10-50, lower scores are higher satisfaction	2 weeks post-baseline

Collaborators and Investigators

• Sponsor: Hilary L Surratt, PhD
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Hilary L Surratt, PhD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2025
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): January 13, 2027

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): February 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 90392; R34DA060087-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: REDCap de-identified survey data and clinical data from report forms will be preserved and shared.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No