Clinical trial NCT04426656: The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China
Official title: IGHID 12001 - The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Pre-exposure Prophylaxis
Keywords: HIV
PrEP
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-06-11
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mixed methods study, including a 2-arm randomized controlled trial.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Change in Intention to Use PrEP Score
timeFrame: Baseline and up to 12 weeks
measure: Number of Participants Who Initiate PrEP by Week 8
timeFrame: Up to 8 weeks
measure: Number of Participants at Different Change Stages to PrEP Initiation at Baseline
timeFrame: Baseline
measure: Number of Participants at Different Change Stages to PrEP Initiation at Week 4
timeFrame: Week 4
measure: Number of Participants at Different Change Stages to PrEP Initiation at Week 8
timeFrame: Week 8
measure: Number of Participants at Different Change Stages to PrEP Initiation at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change in PrEP Knowledge Score at Week 4, 8 and 12
timeFrame: Baseline and up to 12 weeks
measure: Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
timeFrame: Up to 12 weeks
measure: Change in PrEP Self-Efficacy Score
timeFrame: Baseline and up to 12 weeks
measure: Change in PrEP Attitude Score
timeFrame: Baseline and up to 12 weeks
measure: Change in PrEP Stigma Score
timeFrame: Baseline and up to 12 weeks
measure: Number of Participants Who Ordered At-home HIV/Syphilis Tests
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou No. 8 People's Hospital
Study officials:
affiliation: University of North Carolina
name: Chunyan Li, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: Joseph D Tucker, MD
role: STUDY_DIRECTOR
References:
citation: Li C, Xiong Y, Muessig KE, Tang W, Huang H, Mu T, Tong X, Yu J, Yang Z, Sherer R, Hazra A, Lio J, Matthews DD, Fisher EB, Li L, Tucker JD. Community-engaged mHealth intervention to increase uptake of HIV pre-exposure prophylaxis (PrEP) among gay, bisexual and other men who have sex with men in China: study protocol for a pilot randomised controlled trial. BMJ Open. 2022 May 10;12(5):e055899. doi: 10.1136/bmjopen-2021-055899.