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NCT03569813 · ClinicalTrials.gov registry record · NA
Pre-exposure Prophylaxis (PrEP) at Home
A NA study, sponsored by Emory University.
- Completed
- Registry status
- NA
- Development phase
- 318
- Enrollment target
NCT03569813: Completed NA study, sponsored by Emory University.
NCT03569813 is a NA study that has completed, run by Emory University. The registered enrollment target is 318 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03569813, a NA study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- NA
- Development phase
- 318 participants
- Enrollment target
Study 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.
Primary Outcome
Adherence to study medications was measured using blood TFV-DP levels. For participants taking emtricitabine/tenofovir disoproxil fumarate, TFV-DP levels \>1000 femtomole per blood spot (fmol/punch) indicated adherence of \>4 doses per week. For those taking emtricitabine/tenofovir alafenamide, TFV-DP levels \>140 femtomole per blood spot (fmol/punch) indicated adherence of \>4 doses per week. Participants achieving these levels were considered to have adhered appropriately (\>4 doses per week).
Interventions
- OTHER Standard of Care
- BEHAVIORAL PrEP@Home System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 318 participants |
| Start Date | 2019-04-26 |
| Est. Completion | 2023-04-15 |
| Phase | NA |
What the finished NCT03569813 record still lists
NCT03569813 is an interventional study that assigns participants to a tested intervention. The registered 318 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT03569813 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03569813 about?
NCT03569813 is a clinical study titled "Pre-exposure Prophylaxis (PrEP) at Home". 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 vis...
What is the current status of trial NCT03569813?
This trial is currently completed. It is a NA study. The enrollment target is 318 participants. The study started on 2019-04-26. Estimated completion is 2023-04-15.
What interventions are being tested in trial NCT03569813?
The interventions under investigation include: Standard of Care (OTHER), PrEP@Home System (BEHAVIORAL).
Who is sponsoring clinical trial NCT03569813?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03569813's enrollment target sits among peer trials
318 321st of 2000 higher than 1,680 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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