Health TrialsbyHealthPanel

PrEPsmart 2-1-1 Pilot

ConditionHIV-1-infection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorPublic Health Foundation Enterprises, Inc.

About this trial

This is a pilot study to assess the feasibility, acceptability, and preliminary effectiveness of pre-exposure prophylaxis (PrEP)smart among cisgender sexual minority males (SMM) taking on-demand PrEP over a 6-month period.

Upon project completion, the investigators will have developed a highly innovative tool to support men who have sex with men (MSM) using on-demand PrEP ready for testing in a larger efficacy trial

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 years or older

Cisgender-male who reports sex with persons assigned male at birth

Willing and able to provide written informed consent

HIV-uninfected by negative 4th generation HIV test during screening (prescribed group)

Disqualifiers

Repeatedly reactive HIV test at screening or enrollment or self-reported reactive HIV test (prescribed group)

Signs or symptoms of acute HIV infection at screening or enrollment

Currently enrolled in another PrEP intervention study.

Unable to commit to study participation for the duration of the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • PrEPsmart mobile app

    Device

    The PrEPsmart mobile app is an innovative and comprehensive app to support sexual minority men (SMM) using on-demand pre-exposure prophylaxis (PrEP) or daily PrEP. The PrEPsmart app consists of the following components: 1. PrEP 211 dosing/sex diary and reminders 2. Feedback on PrEP protection levels 3. Quick tips 4. Bi-directional secure messaging

  • Truvada

    Drug

    Combination medication used in Human immunodeficiency virus (HIV) prevention, it blocks virus pathways to infection.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: PrEPsmart intervention (N=40)Experimental treatment 2 interventions
Group B: control (N=20)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Acceptability of the PrEPsmart mobile app

Acceptability will be measured using the Client Satisfaction Questionnaire (CSQ-8) adapted for use in PrEPsmart pilot. The study team will also assess interest in future use of the app at study completion.

Time frame
6 months
2

Usability of the PrEPsmart mobile app

Usability will be measured using the System Usability Scale (SUS) adapted for use in PrEPsmart pilot. A score \>50 (out of 100) on the SUS indicates the app is acceptable.

Time frame
6 months

Secondary outcomes

1

To compare PrEP coverage of sex acts as measured by weekly urine tenofovir test strips among SMM in the PrEPsmart vs. control arms

PrEP coverage will be primarily defined as self-reported sex acts in which the participant reported at least one pill taken within 24 hours before sex and one pill taken within 24 hours after sex, as defined in the Ipergay study. Additionally, the study team will conduct an analysis in which weekly PrEP dosing is confirmed by having a detectable TFV urine test within 7 days of reported sex.

Time frame
6 months
2

To compare switching of PrEP regimens among SMM in the PrEPsmart vs. control arms

The proportion of participants who switch from on-demand PrEP to daily PrEP (or another regimen, e.g. injectable PrEP) will be calculated and compared between arms using chi-square tests.

Time frame
6 months
3

To compare rates of PrEP discontinuation among SMM in the PrEPsmart vs. control arm

PrEP discontinuation and retention rates will be calculated, with 95% binomial confidence intervals, and compared between arms using log-binomial models. The study team will also estimate and compare time to discontinuation using Kaplan Meier methods and the log-rank test, accounting for censoring by end of study or dropout.

Time frame
6 months
4

Elicit feedback on areas for improvement for PrEPsmart to guide further app refinement

Ideas for improvement of PrEPsmart elicited through exit interviews will be tabulated, discussed with the protocol team, and prioritized for development.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Public Health Foundation Enterprises, Inc.

Lead sponsor

Gilead Sciences

Collaborator

Source ClinicalTrials.gov
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