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Enrolling by Invitation

NCT Number: NCT06845774

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

Enrolling by Invitation

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Key information

Conditions

HIV Prevention

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. PrEP Initiation

    Time frame: 3 months post-baseline

    Number of participants initiating PrEP

  2. PrEP Initiation

    Time frame: 6 months post-baseline

    Number of participants initiating PrEP

Secondary outcomes

  1. PrEP Persistence

    Time frame: 3 months post-baseline

    Number of participants with PrEP prescription refill

  2. PrEP Persistence

    Time frame: 6 months post-baseline

    Number of participants with PrEP prescription refill(s)

  3. PrEP adherence

    Time frame: 3 months post-baseline

    Number of participants with tenofovir (TFV) detected in dried blood spot testing

  4. PrEP adherence

    Time frame: 6 months post-baseline

    Number of participants with tenofovir (TFV) detected in dried blood spot testing

Other outcomes

  1. Intervention Acceptability

    Time frame: 2 weeks post-baseline

    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

Sponsors and collaborators

Lead sponsor

Hilary L Surratt, PhD

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: PROTECT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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