Clinical trial NCT06631365: PrEPsmart 2-1-1 Pilot
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: HIV-1-infection
Lead sponsor: Public Health Foundation Enterprises, Inc.
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2024-10-08
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in a 2:1 ratio to the intervention (N=40) or control (N=20) conditions, using randomly-permuted blocks of randomly selected sizes 2 and 4, stratified by PrEP status (prescribed, non-prescribed). The randomization scheme will be generated and archived by the study statistician and implemented in RedCap.
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability of the PrEPsmart mobile app
timeFrame: 6 months
measure: Usability of the PrEPsmart mobile app
timeFrame: 6 months
Secondary outcomes:
measure: To compare PrEP coverage of sex acts as measured by weekly urine tenofovir test strips among SMM in the PrEPsmart vs. control arms
timeFrame: 6 months
measure: To compare switching of PrEP regimens among SMM in the PrEPsmart vs. control arms
timeFrame: 6 months
measure: To compare rates of PrEP discontinuation among SMM in the PrEPsmart vs. control arm
timeFrame: 6 months
measure: Elicit feedback on areas for improvement for PrEPsmart to guide further app refinement
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Bridge HIV, San Francisco Department of Public Health
state: California
Study officials:
affiliation: albert.liu@sfdph.org
name: Albert Liu
role: PRINCIPAL_INVESTIGATOR
References: