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

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).

Inclusion Criteria:

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

Exclusion Criteria:

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

For studies within two years of primary objective(s) publication, de-identified individual participant data that underlie results in a publication, will be provided upon request. For studies more than two years from the primary objective(s) publication, de-identified datasets will be available upon request (Public Use Datasets).

Investigators may request de-identified datasets in order to duplicate published results, as required by specific journals. Otherwise, de-identified datasets will be made available upon request, two years following publication of the primary results manuscript.

Researchers may submit a request for access to data that has informed published results, by sending an email to HPTN-Data-Access@scharp.org. To access available de-identified datasets, investigators must complete the request form on the Atlas website. Researchers of approved requests will need to sign an HIV Prevention Trials Network (HPTN) Data Use Agreement before receiving the data and agree to use the provided acknowledgement statement.