Recruiting
Phase 2

PrEPsmart

Sponsor:

Public Health Foundation Enterprises, Inc.

Code:

NCT06631365

Conditions

HIV-1-infection

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

PrEPsmart mobile app

Truvada

Study Details

Brief summary:

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

Conditions

HIV-1-infection

Study ID

NCT06631365

Start date

Oct 2, 2023

Status verified date

Oct, 2024

Completion date

Apr 1, 2025

Anticipated

Primary completion date

Jan 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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)
  • Documentation of negative HIV test within the last 3 months by outside laboratory OR evidence of PrEP prescription within the last 6 months based on medical records or pharmacy/provider communication
  • Owns an iOS or Android mobile phone with a camera and has private access to the internet
  • Able to understand, read, and speak English
  • Able to attend study visits at a local research site in San Francisco (Bridge HIV) (prescribed and non-prescribed groups) or virtual visits via a HIPAA-compliant teleconferencing platform (non-prescribed group)
  • Interested in starting or currently taking on-demand PrEP with TDF/FTC
  • Report having anal sex at least once a month and expecting to maintain at least this frequency of anal sex during study participation by self-report
  • Creatinine clearance ≥60 mL/min based on testing done during screening (prescribed group)
  • Have PrEP clinical and laboratory monitoring by another provider or clinic by self-report (non-prescribed group)
  • No contraindications to TDF/FTC use
  • No evidence of chronic HBV infection based on testing done during screening (prescribed group)
  • Willing to self-collect urine samples weekly

Exclusion Criteria:

  • 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
  • Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PrEPsmart intervention (N=40)

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.

no intervention: control (N=20)

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).

Interventions

PrEPsmart mobile app

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

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

Primary outcome measure

  • Acceptability of the PrEPsmart mobile app [ Time Frame: 6 months ]
  • Usability of the PrEPsmart mobile app [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Juwann Moss

628-217-7443Juwann.moss@sfdph.org

Locations

Bridge HIV, San Francisco Department of Public Health

Recruiting

San Francisco, California, United States, 94134

Contacts

Juwann Moss

628-217-7443juwann.moss@sfdph.org

Alicia Stephens

628-217-7439

More Information

Sponsor

Public Health Foundation Enterprises, Inc.

Last update posted

Oct 8, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Public Health Foundation Enterprises, Inc. on 2024-10-08.