RECRUITING

PrEPsmart 2-1-1 Pilot

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Conditions

HIV-1-infection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-10-02
Study Completion:2025-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06631365

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * Cisgender-male who reports sex with persons assigned male at birth
  3. * Willing and able to provide written informed consent
  4. * HIV-uninfected by negative 4th generation HIV test during screening (prescribed group)
  5. * 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
  6. * Owns an iOS or Android mobile phone with a camera and has private access to the internet
  7. * Able to understand, read, and speak English
  8. * 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)
  9. * Interested in starting or currently taking on-demand PrEP with TDF/FTC
  10. * 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
  11. * Creatinine clearance ≥60 mL/min based on testing done during screening (prescribed group)
  12. * Have PrEP clinical and laboratory monitoring by another provider or clinic by self-report (non-prescribed group)
  13. * No contraindications to TDF/FTC use
  14. * No evidence of chronic HBV infection based on testing done during screening (prescribed group)
  15. * Willing to self-collect urine samples weekly
  1. * Repeatedly reactive HIV test at screening or enrollment or self-reported reactive HIV test (prescribed group)
  2. * Signs or symptoms of acute HIV infection at screening or enrollment
  3. * Currently enrolled in another PrEP intervention study.
  4. * Unable to commit to study participation for the duration of the study
  5. * 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.

Contacts and Locations

Study Contact

Juwann Moss
CONTACT
628-217-7443
Juwann.moss@sfdph.org

Principal Investigator

Albert Liu
PRINCIPAL_INVESTIGATOR
albert.liu@sfdph.org

Study Locations (Sites)

Bridge HIV, San Francisco Department of Public Health
San Francisco, California, 94134
United States

Collaborators and Investigators

Sponsor: Public Health Foundation Enterprises, Inc.

  • Albert Liu, PRINCIPAL_INVESTIGATOR, albert.liu@sfdph.org

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-02
Study Completion Date2025-04-01

Study Record Updates

Study Start Date2023-10-02
Study Completion Date2025-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • HIV-1-infection