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HIV Prevention Study

The purpose of this study is learn if a new investigational long acting HIV prevention medication is as effective as daily Truvada or Descovy. The investigational medication is called Lenacapavir and will be given by injection every 6 months.

Age & Gender

16 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

Participants are randomized to receive investigational Lenacapavir as an injection once every 6 months OR FDA-approved Truvada as a daily oral pill. Most visits will involve a safety check, blood draw, HIV test, and questionnaires with a licensed study nurse.

Incentives

$50 per visit, with an additional $50 per injection visit, Study medication and study labs will be provided at no cost, and mileage reimbursement will be considered,

In-person visits:
8 visits in the first year, and then 4 study visits per year

Total length of participation:
5 years

Looking for Specific Volunteers

Able to participate:

You are at least 16 years old
You are a cisgender man, transgender or gender nonbinary individual who has receptive anal sex
You have not taken oral PrEP in the past 12 weeks or any prior use of long-acting systemic PrEP

Not eligible if:

You have been tested for HIV in the past 3 months
Identify as a cisgender female

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Visit Study Website

Primary Visit Location

Clinical and Translational Research Center (CTRC)
Burnett-Womack Building (UNC-Chapel Hill)
160 Dental Cir, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Joseph Eron
Medicine-Infectious Diseases

Study Type

Clinical or Medical
Interventional

Study Topics

Healthy Volunteer or General Population
HIV/AIDS
Immune System/Infections
LGBTQIA+
Minority Health
Sexual and/or Reproductive Health
Women's Health
Men's Health
UNC or UNC Health employees
UNC Students (undergrad, grad, professional)

IRB Number

21-1349

ClinicalTrials.gov

NCT04925752

Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH. This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

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Questions?

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