Pre-exposure Prophylaxis (PrEP) at Home
Completed · Not applicable
Conditions studied: HIV/AIDS
In brief
This study is a randomized clinical trial of PrEP@Home, a home care system for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PrEP). Individuals entering into PrEP care at an initial in-person study visit will be randomized to the PrEP@Home system for home-based PrEP care follow-up visits or to the control standard of care for clinic-based follow-up visits. The primary aim of this study is to assess protective levels of PrEP medication for the intervention arm compared to the control arm.
Key facts
- Study ID
- NCT03569813
- Run by
- Emory University
- People needed
- 318
- Starts
- 2019-04-26
- Expected to finish
- 2023-04-15
- Last updated by the study team
- 2024-09-26
Who can join
Age: 18 and older, up to 49. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Male at birth
- Report anal sex with a man in the past 6 months
- Are able to complete survey instruments in English
- Live in the metropolitan area of a study site
- Are willing to provide at least 2 means of alternate contact
- Willing to not enroll in another HIV prevention trial
- HIV-negative (self-reported and lab confirmed)
- Own and willing to use a smartphone for the duration of the study
- Willing to download the study app
- Willing to take a photo of a PrEP prescription label
- Behaviorally indicated for PrEP (per Centers for Disease Control and Prevention (CDC) guidance) or African American men who have sex with men (MSM) who report anal sex in the last six months
- PrEP naïve or < 3 months lifetime experience of PrEP use or stopped taking PrEP >6 months ago
- Willing to take PrEP, including adherence to daily dosing
- Willing to use, as needed, study-provided PrEP navigation services to obtain coverage for PrEP medication
- Able to work with the study site to develop a plan to cover the financial cost of PrEP if not covered through insurance or Gilead financial assistance
- Willing to use a home kit that will include a self-administered collection of urine, rectal and pharyngeal swabs, and finger prick blood.
You may not qualify if…
- Reports having genital reassignment surgery
- <18 or ≥ 50 years of age
- Currently enrolled in another HIV prevention trial
- Symptoms of acute HIV infection, or being evaluated for acute infection because of recent high-risk exposure
- Currently taking PEP
- Creatinine clearance <60 ml/min
- Contraindications to taking tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC)
- History of hemophilia
- Unable to conduct finger prick at a study site
- Multiple screening attempts
Where it is running
- Emory University, PRISM Health — Atlanta, Georgia, United States
- The Fenway Institute — Boston, Massachusetts, United States
- Open Arms Health Care Center — Jackson, Mississippi, United States
- Washington University AIDS Clinical Trial Unit — St Louis, Missouri, United States
- MetroHealth — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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