N/A
N=318
Pre-exposure Prophylaxis (PrEP) at Home
HIV/AIDS
Bottom Line
View on ClinicalTrials.gov: NCT03569813 ↗Enrolled (actual)
318
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 6-month Follow-up — 78; 39 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PrEP@Home System (Behavioral); Standard of Care (Other)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Emory University
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 6-month Follow-up |
78; 39 | — |
| SECONDARY Retention in PrEP Care |
132; 55 | — |
| SECONDARY Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 12-month Follow-up |
56; 36 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03569813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.