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 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.

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