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

University of North Carolina (UNC)

Status: Completed

Conditions: Pre-exposure Prophylaxis; HIV

Treatments: Behavioral: Phone application

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04426656

19-3481

R01AI114310 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Part 2 Standard of Care

No Intervention group

Description:

Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STI(sexually transmitted infections) testing and referrals to local HIV/STI testing sites and prevention services.

Part 2 mini-app

Experimental group

Description:

In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.

Treatment:

Behavioral: Phone application