N/A
Completed N=80
PrEP iT! Mobile App Intervention
Treatment Adherence and Compliance
Source: ClinicalTrials.gov NCT04509076 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: High Protective Level of PrEP Adherence From Tenofovir Diphosphate (TVF-DP) Levels — 13; 15 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY High Protective Level of PrEP Adherence From Tenofovir Diphosphate (TVF-DP) Levels |
13; 15 | — |
| PRIMARY Proportion of Participants With High Self-reported PrEP Adherence in the Past 7 Days |
27; 22 | — |
Eligibility Criteria
Inclusion criteria for the pilot RCT are:
- Prescribed PrEP by a healthcare provider;
- Self-reported 18-29 years of age;
- Assigned male at birth;
- Current male gender identification;
- Gay, bisexual or other non-heterosexual identity or has had sex with a man in the past year;
- Confirmed HIV-negative status (before starting PrEP);
- Started PrEP in the past 6 months (either taking PrEP for the first time or restarting PrEP after prior use) and has a current PrEP prescription;
- English-speaking (as the intervention will be built in English);
- Able to meet with project staff at baseline and follow-up visits;
- Regular access to SMS or the internet, either through a mobile device, tablet computer, and/or desktop or laptop computer
Data sourced from ClinicalTrials.gov (NCT04509076). 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. Informational only — not medical advice.