PrEPsmart 2-1-1 Pilot

Public Health Foundation Enterprises, Inc.

Status and phase: Enrolling; Phase 2

Conditions: HIV-1-infection

Treatments: Device: PrEPsmart mobile app; Drug: Truvada

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06631365

23-38355

Details and patient eligibility

About

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

Full description

This study is designed to enroll a diverse population of English-speaking cisgender sexual minority males (SMM) in the United States. The study team will enroll up to 60 participants who are taking or are interested in taking on-demand pre-exposure prophylaxis (PrEP). Participants will be randomized 2:1 to receive (intervention arm) or not receive (control arm) the PrEPsmart app at enrollment. Participants will complete follow-up visits at 3 and 6 months.

Participants newly starting 2-1-1 PrEP will be seen at the Bridge HIV clinic (prescribed group), while those already on PrEP may be seen at the clinic or complete visits virtually (non-prescribed group). Although no restrictions are put on the racial/ethnic make-up of the study participants, the site will strive to enroll at least 50% African American or Latino SMM into this study. The study will also strive to enroll at least 30% of participants who are newly starting or restarting 2-1-1 PrEP. Upon project completion, the study team 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

PrEPsmart intervention (N=40)

Experimental group

Description:

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.

Treatment:

Drug: Truvada

Device: PrEPsmart mobile app

control (N=20)

No Intervention group

Description:

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).