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NCT04509076 · ClinicalTrials.gov registry record · NA
PrEP iT! Mobile App Intervention
A NA study of Treatment Adherence and Compliance, sponsored by San Diego State University.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT04509076: Completed NA study of Treatment Adherence and Compliance, sponsored by San Diego State University.
NCT04509076 is a NA study of Treatment Adherence and Compliance that has completed, run by San Diego State University. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04509076, a NA study of Treatment Adherence and Compliance, has completed, sponsored by San Diego State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
The long-term goal of this research is to create an effective and sustainable program to support retention in PrEP care and PrEP adherence among 18-29 year old men who have sex with men (MSM). To reach this goal, we will develop and pilot test a mobile intervention tailored to young MSM, called PrEP iT! Primary aims include: Aim 1: Develop the PrEP iT! mobile intervention through focus groups with young MSM and refine iterations through input from a community advisory board (CAB). Aim 2: Conduct a pilot randomized controlled trial to assess the feasibility, acceptability and preliminary impact of the PrEP iT! intervention for young MSM.
Primary Outcome
Adherence thresholds estimated through analysis of tenofovir diphosphate (TVF-DP) levels from dried blood spot (DBS) specimens were used to categorize each participant as having a high protective level (i.e., a high likelihood of protection from HIV) of PrEP (800 or greater of emtricitabine-tenofovir disoproxil fumarate \[FTC-TDF\] and 950 or greater of FTC-tenofovir alafenamide \[FTC-TAF\]) or not. Results reported here are for high protective levels of PrEP.
Conditions Studied
Interventions
- BEHAVIORAL PrEP iT! (plus usual PrEP care)
- BEHAVIORAL Usual PrEP care
Study Locations (1)
Minnesota
- Hennepin County Medical Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2022-04-15 |
| Phase | NA |
What the finished NCT04509076 record still lists
NCT04509076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Treatment Adherence and Compliance appearing as the primary indexed condition, and to 2 interventions - of which PrEP iT! (plus usual PrEP care) is the first listed.
NCT04509076 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT04509076 about?
NCT04509076 is a clinical study titled "PrEP iT! Mobile App Intervention". The long-term goal of this research is to create an effective and sustainable program to support retention in PrEP care and PrEP adherence among 18-29 year old men who have sex with men (MSM). To reach this goal, we will develop and pilot test a mobile intervention tailored to young MSM, called PrEP...
What is the current status of trial NCT04509076?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2021-03-01. Estimated completion is 2022-04-15.
What conditions does trial NCT04509076 study?
This clinical trial studies the following conditions: Treatment Adherence and Compliance.
What interventions are being tested in trial NCT04509076?
The interventions under investigation include: PrEP iT! (plus usual PrEP care) (BEHAVIORAL), Usual PrEP care (BEHAVIORAL).
Who is sponsoring clinical trial NCT04509076?
This trial is sponsored by San Diego State University, which has 118 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04509076 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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