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Antiretroviral

PrEPsmart + Truvada for HIV Prevention

Phase 2

Recruiting

Led By Albert Liu

Research Sponsored by Public Health Foundation Enterprises, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No evidence of chronic HBV infection based on testing done during screening (prescribed group)

Age 18 years or older

Must not have

Signs or symptoms of acute HIV infection at screening or enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new tool called PrEPsmart for cisgender sexual minority males who are using on-demand PrEP for 6 months. The researchers will assess how well the tool works and

Who is the study for?

This trial is for cisgender sexual minority males (SMM) who are interested in using a mobile app to help manage on-demand pre-exposure prophylaxis (PrEP) over six months. Participants should be men who have sex with men (MSM), but specific inclusion and exclusion criteria details were not provided.

What is being tested?

The PrEPsmart pilot study is testing the use of a mobile app designed to support MSM taking Truvada as on-demand PrEP against HIV. The goal is to see if the app is easy to use, acceptable to participants, and effective at supporting medication management.

What are the potential side effects?

While side effects are not detailed here, Truvada may commonly cause headache, stomach discomfort, weight loss, and sometimes more serious kidney or bone problems. The PrEPsmart app itself does not have physical side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have chronic hepatitis B.

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I am 18 years old or older.

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My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or higher.

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I am a cisgender male who has sex with males.

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I am considering or currently using on-demand PrEP with TDF/FTC.

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I have no health issues that prevent me from taking TDF/FTC.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am showing signs of a recent HIV infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of the PrEPsmart mobile app

Usability of the PrEPsmart mobile app

Secondary study objectives

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

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

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

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PrEPsmart intervention (N=40)Experimental Treatment2 Interventions

Participants will be randomized in a 2:1 ratio to the intervention (N=40) For the pre-exposure prophylaxis (PrEP)smart intervention group, a study clinician will perform a medical history and limited physical exam to confirm eligibility to enroll in the study, a 4th generation rapid Human immunodeficiency virus (HIV) test will be performed, and labs drawn for creatinine, sexual transmitted infection (STI) testing (Neisseria gonorrhoeae/Chlamydia trachomatis (GC/CT)), syphilis), and hepatitis B testing. For participants newly starting 2-1-1 PrEP (PrEPsmart intervention group), study drug will be offered to participants to ensure that they will have access to PrEP during the study to be able to adequately test the app.

Group II: control (N=20)Active Control1 Intervention

For the non-prescribed group, study staff will request documentation of an HIV-negative test within the last 3 months OR evidence of pre-exposure prophylaxis (PrEP) prescription within the last 6 months from medical records or pharmacy/provider communication. Additionally, study staff will confirm via self-report that the participant's 2-1-1 PrEP use will be clinically monitored by another clinician or clinic for the duration of the study. Any individual with a positive HIV test will have a confirmation test sent to the lab and be referred immediately for HIV care and initiation of treatment. For participants already on PrEP (control group) may choose to continue to use their own supply of Truvada (tenofovir disoproxil fumarate/emtricitabine, or TDF/FTC).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Truvada

2016

Completed Phase 4

~6920

0 / 7Eligibility criteria met