This study is not yet accepting patients

Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy

a study on HIV/AIDS Sexually Transmitted Infections PrEP Immunodeficiency Hepatitis B

Summary

Eligibility
for males ages 18-29 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Los Angeles, California and other locations
Dates
study started
study ends around
Principal Investigator
by Jesse Clark, MD

Description

Summary

Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV pre-exposure prophylaxis (PrEP) and sexually transmitted infection (STI) post-exposure prophylaxis (PEP) for Young Men

Official Title

Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV PrEP and STI PEP for Young Men

Details

This study will test a suite of mHealth tools to increase HIV pre-exposure prophylaxis (PrEP) uptake and adherence among young men in communities most affected by the HIV epidemic and evaluate the uptake, adherence, and acceptability of doxycycline for sexually transmitted infection (STI) post-exposure prophylaxis (doxy-PEP).

Keywords

HIV Infection, Sexually Transmitted Infection, Human Immunodeficiency Virus (HIV), Sexually Transmitted Infection (STI), Pre-Exposure Prophylaxis (PrEP), Post-Exposure Prophylaxis (PEP), Integrated Strategy, Young Men, Doxycycline for STI Post-Exposure Prophylaxis (Doxy-PEP), Chlamydia Trachomatis (CT), Neisseria Gonorrhea (NG), Hepatitis B (HBV), Mobile Health Tools (mHealth), MyPrEP + PrEPmate + PrEPsmart Tools (3P), HIV Infections, Sexually Transmitted Diseases, Acquired Immunodeficiency Syndrome, Hepatitis B, STI PEP - Doxycycline as Doxy-PEP, 3P mHealth package, Handout about HIV PrEP options available at the site

Eligibility

You can join if…

Open to males ages 18-29

  1. Men ages 18 - 29 years
  2. Men who are in communities most affected by the HIV epidemic
  3. Willing and able to provide informed consent
  4. Reports having anal sex with men in the last 6 months
  5. Have certain risk factors for HIV acquisition, defined as any of the following in the past 6 months:
    1. Any condomless anal sex with a man; not including within a monogamous relationship with an HIV-negative partner or an HIV-positive partner who is virally suppressed
    2. Reporting 2 or more male partners, regardless of condom use
    3. Reporting gonorrhea, chlamydia, or syphilis diagnosis
    4. Any stimulant use (e.g., cocaine, amphetamines)
  6. Not on PrEP within the past 3 months due to participant choice
  7. Interested in learning more about PrEP or starting PrEP
  8. No evidence of HIV infection at Screening and Enrollment, based on the HIV testing algorithm
  9. Owns an iOS or Android mobile phone and able to successfully download mobile apps and send and receive text messages
  10. Must not share the mobile phone used for their participation in the study
  11. Able to read and write

You CAN'T join if...

  1. Participated in HPTN 113-01
  2. Currently participating in another interventional trial of PrEP agents, or prior enrollment in studies of long-acting PrEP, including HPTN 083
  3. Plans to move away from the study area within the next year
  4. Currently on doxycycline for STI PEP
  5. Has ever used CAB-LA or other long-acting PrEP agent
  6. Tetracycline allergy
  7. Prior diagnosis of HIV infection
  8. Reactive HIV rapid test at Screening or reactive HIV Ag/Ab rapid test at Enrollment, regardless of subsequent HIV test results
  9. Any other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable/unwilling to comply with the study requirements

Locations

  • UCLA Vine Street Clinic
    Los Angeles California 90095 United States
  • Bronx Prevention Research Center CRS
    The Bronx New York 10451 United States

Lead Scientist at UCLA

  • Jesse Clark, MD
    Professor-in-Residence, Medicine. Authored (or co-authored) 59 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
HIV Prevention Trials Network
ID
NCT07658976
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 400 study participants
Last Updated