AzTrials
AzTrials

HIV-1-infectionPhase 2NCT06631365

PrEPsmart 2-1-1 Pilot

A Phase 2 study testing PrEPsmart mobile app and Truvada in people with HIV-1-infection, run by Public Health Foundation Enterprises, Inc. at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
HIV-1-infection
What is being tested?
PrEPsmart mobile app and Truvada
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
2 Oct 2023to 1 Apr 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Juwann Moss contact

628-217-7443

Juwann.moss@sfdph.org

United States1 site, 1 recruiting

  • Bridge HIV, San Francisco Department of Public Health

    San Francisco, California, 94134

    Juwann Moss, 628-217-7443, juwann.moss@sfdph.org

    Alicia Stephens, 628-217-7439

    Recruiting

Other trials in United States

About this study

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

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

Read the 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.

Conditions
HIV-1-infection
Being tested
PrEPsmart mobile app, Truvada

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrEPsmart mobile appDevice

    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

  • TruvadaDrug

    Also called Emtricitabine, Tenofovir disoproxil fumarate

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

Study groups in NCT06631365
Study groupRoleWhat they receive
PrEPsmart intervention (N=40)ExperimentalParticipants 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.
Receives: Device: PrEPsmart mobile app; Drug: Truvada
control (N=20)No interventionFor 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

Secondary outcomes (4)

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

    PrEP coverage will be primarily defined as self-reported sex acts in which the participant reported at least one pill taken within 24 hours before sex and one pill taken within 24 hours after sex, as defined in the Ipergay study. Additionally, the study team will conduct an analysis in which weekly PrEP dosing is confirmed by having a detectable TFV urine test within 7 days of reported sex.

    Measured: 6 months

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

    The proportion of participants who switch from on-demand PrEP to daily PrEP (or another regimen, e.g.

    injectable PrEP) will be calculated and compared between arms using chi-square tests.

    Measured: 6 months

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

    PrEP discontinuation and retention rates will be calculated, with 95% binomial confidence intervals, and compared between arms using log-binomial models. The study team will also estimate and compare time to discontinuation using Kaplan Meier methods and the log-rank test, accounting for censoring by end of study or dropout.

    Measured: 6 months

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

    Ideas for improvement of PrEPsmart elicited through exit interviews will be tabulated, discussed with the protocol team, and prioritized for development.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start2 Oct 2023
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06631365
Sponsor's protocol ID
23-38355
Status last verified
Oct 2024
First submitted
1 Aug 2024
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PrEPsmart mobile app and Truvada in people with HIV-1-infection, run by Public Health Foundation Enterprises, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Juwann Moss (628-217-7443, Juwann.moss@sfdph.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of the PrEPsmart mobile app (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06631365.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in