The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China

This study aims to use a mini-application on the popular Chinese social media mobile platform, WeChat, to improve HIV pre-exposure prophylaxis (PrEP) uptake among at-risk men who have sex with men (MSM). UNC investigators will work in close partnership with a well-established HIV special hospital and the local MSM community to understand key barriers to PrEP use, and develop a mobile-based intervention to increase PrEP uptake among young MSM in Guangzhou, China.

This study includes two parts. Before the start of Part 1, a mini-app prototype for promoting HIV pre-exposure prophylaxis (PrEP) uptake will have been developed from a prior MSM community-driven hackathon contest. PrEP is an antiretroviral medicines-based prevention strategy against HIV infection, which has been proved save and effective.

Part 1 includes in-depth interviews with 40 HIV-negative young MSM (18 and above) with a brief survey to collect demographic data. The interview topics include PrEP-related perceptions and feedback on the design of a mini-app prototype. Findings from Part 1 will inform refining the mini-app before the start of Part 2.

In Part 2, a small two-arm randomized control trial with 70 young MSM (18 and above) will be conducted to evaluate the preliminary efficacy of the mini-app in improving PrEP-related perceptions and actual PrEP uptake, compared to a control group of standard of care.

Participants in Part 2 will be followed up for 12 weeks (8 week intervention and after-intervention follow-up at 12th week). A subgroup of participants (n=15) from both the intervention arm and the control arm will receive two rounds of in-depth interviews, separately at the 4th and 8th week, to share their experience of using the app and changed perceptions and/or behaviors related to PrEP.

Eligibility Criteria:
Inclusion Criteria:

* Part 1: HIV-negative men who have sex with men (MSM): must self-report: being assigned male sex at birth, HIV-negative, age 18 and above, ever having had anal sex with another man, identify as a Chinese citizen, own a smartphone, able to being willing to sign written informed consent and participate in the study as procedures required.

Part 2: HIV-negative men who have sex with men (MSM): same characteristics as in Part 1.

AND, they must report :

* Having a smartphone with WeChat installed.
* Being assigned male sex at birth, HIV-negative, age 18 and above, ever having had anal sex with another man, currently reside in Guangzhou, China, identifying as a Chinese citizen, able to sign written informed consent and participate in the study as procedures require. AND
* At least one criterion associated with high risk of HIV infection in the past 6 months prior to enrollment as follows:

  * Unprotected (condomless) anal intercourse with male partner(s)
  * More than two male partners (regardless of condom use and HIV serostatus)
  * Reported STI, such as syphilis, Herpes Simplex Virus-2 (HSV-2), gonorrhea, chlamydia, chancroid, or lymphogranuloma venereum.
  * Reported use of post-exposure prophylaxis (PEP)
  * Have a sexual partner living with HIV

Exclusion Criteria:

* Part 1: Individuals who report any following status will be excluded from participating Part 1:

  * HIV-positive
  * Mental health issues which may compromise participant adherence or safety, including memory loss, cognitive impairment, intellectual disability, or communication disorders.
* Part 2:

  * HIV-positive (self-report or lab-confirmed)
  * Currently taking oral PrEP based on self-report
  * Symptoms of acute HIV infection within the prior 30 days
  * Contradictions to taking oral PrEP
  * Personal diagnosis or family history of hemophilia
  * Chronic Hepatitis B (self-report)
  * Participating in another research study related to HIV and antiretroviral therapy or other intervention study
  * Having serious chronic disease, including metabolic diseases (such as diabetes), neurological, and psychiatric disorders
  * Mental health issues which may compromise participant adherence or safety, including memory loss, cognitive impairment, intellectual disability, or communication disorders