PrEPsmart 2-1-1 Pilot

NCT06631365 | Recruiting Phase 2 FDA Device

• 1 other identifier: 23-38355
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Acceptability of the PrEPsmart mobile app

  Acceptability will be measured using the Client Satisfaction Questionnaire (CSQ-8) adapted for use in PrEPsmart pilot. The study team will also assess interest in future use of the app at study completion.

  6 months

• Usability of the PrEPsmart mobile app

  Usability will be measured using the System Usability Scale (SUS) adapted for use in PrEPsmart pilot. A score \>50 (out of 100) on the SUS indicates the app is acceptable.

  6 months

Secondary Outcomes (4)

• To compare PrEP coverage of sex acts as measured by weekly urine tenofovir test strips among SMM in the PrEPsmart vs. control arms

  6 months

• To compare switching of PrEP regimens among SMM in the PrEPsmart vs. control arms

  6 months

• To compare rates of PrEP discontinuation among SMM in the PrEPsmart vs. control arm

  6 months

• Elicit feedback on areas for improvement for PrEPsmart to guide further app refinement

  6 months

Study Arms (2)

PrEPsmart intervention (N=40)

EXPERIMENTAL

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.

Device: PrEPsmart mobile app; Drug: Truvada

control (N=20)

NO INTERVENTION

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 DEVICE

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

PrEPsmart intervention (N=40)

Truvada DRUG

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

Also known as: Emtricitabine, Tenofovir disoproxil fumarate

PrEPsmart intervention (N=40)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender-male who reports sex with persons assigned male at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Public Health Foundation Enterprises, Inc.: lead
• Gilead Sciences: collaborator

Study Sites (1)

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, 94134, United States

RECRUITING

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Tenofovir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Albert Liu

  albert.liu@sfdph.org

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juwann Moss

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: October 8, 2024
• Study Start: October 2, 2023
• Primary Completion: January 1, 2025
• Study Completion: April 1, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)