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PrEPsmart Pilot: a Trial to Evaluate a Mobile App to Support the Safe and Effective Use of On-demand Pre-exposure Prophylaxis (PrEP) Among Sexual Minority Men in the US

Status: Recruiting

Location: See location...

Intervention Type: Device, Drug

Study Type: Interventional

Study Phase: Phase 2

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

Eligibility

Participation Requirements

Sex: Male

Minimum Age: 18

Healthy Volunteers: t

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• 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

Locations

United States

California

Bridge HIV, San Francisco Department of Public Health

RECRUITING

San Francisco

Contact Information

Primary

Juwann Moss

Juwann.moss@sfdph.org

628-217-7443

Time Frame

Start Date: 2023-10-02

Estimated Completion Date: 2025-04-01

Participants

Target number of participants: 60

Treatments

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).

Related Therapeutic Areas

HIV/AIDS

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