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NCT06845774 | NOT YET RECRUITING | HIV Prevention


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

Hilary L Surratt, PhD

Information provided by (Responsible Party):

Hilary L Surratt, PhD

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. 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.

Condition or disease

HIV Prevention

Intervention/treatment

CDC PrEP with active referral

TelePrEP

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Optimizing Low Threshold TelePrEP Care in Syringe Service Programs for People Who Inject Drugs in Appalachia
Actual Study Start Date : 2025-05-15
Estimated Primary Completion Date : 2026-11-15
Estimated Study Completion Date : 2026-11-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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 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.

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

Location Details

NCT06845774


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, Kentucky

University of Kentucky

Lexington, Kentucky, United States, 40536

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