PrEPsmart 2-1-1 Pilot
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PrEPsmart mobile app, Truvada.
- Who it may be relevant to
- Registry conditions: HIV-1-infection. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device 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 - Drug Truvada
Combination medication used in Human immunodeficiency virus (HIV) prevention, it blocks virus pathways to infection.
Primary outcome measures
- Acceptability of the PrEPsmart mobile app [Time frame: 6 months]
- Usability of the PrEPsmart mobile app [Time frame: 6 months]
Secondary outcome measures (4)
- To compare PrEP coverage of sex acts as measured by weekly urine tenofovir test strips among SMM in the PrEPsmart vs. control arms [Time frame: 6 months]
- To compare switching of PrEP regimens among SMM in the PrEPsmart vs. control arms [Time frame: 6 months]
- To compare rates of PrEP discontinuation among SMM in the PrEPsmart vs. control arm [Time frame: 6 months]
- Elicit feedback on areas for improvement for PrEPsmart to guide further app refinement [Time frame: 6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Bridge HIV, San Francisco Department of Public Health — San Francisco
Identifiers
NCT: NCT06631365 · 23-38355