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N/A Completed N=70 Randomized Other

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

HIV · Pre-exposure Prophylaxis
Source: ClinicalTrials.gov NCT04426656 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Change in Intention to Use PrEP Score — 0.19; 0.00; 0.57; -0.09 score on a scale — p=0.85

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Intention to Use PrEP Score
0.19; 0.00; 0.57; -0.09; 1.00; -0.40 0.85
PRIMARY
Number of Participants Who Initiate PrEP by Week 8
5; 8 0.72
PRIMARY
Number of Participants at Different Change Stages to PrEP Initiation at Baseline
9; 15; 8; 24; 4; 4 0.318
PRIMARY
Number of Participants at Different Change Stages to PrEP Initiation at Week 4
10; 15; 5; 12; 6; 12 0.527
PRIMARY
Number of Participants at Different Change Stages to PrEP Initiation at Week 8
8; 20; 4; 7; 4; 8 0.928
PRIMARY
Number of Participants at Different Change Stages to PrEP Initiation at Week 12
8; 17; 3; 11; 5; 7 0.678
SECONDARY
Change in PrEP Knowledge Score at Week 4, 8 and 12
0.33; 0.13; 0.33; 0.16; 0.38; 0.19 0.26
SECONDARY
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
0; 6; 0; 0; 0; 4 0.08
SECONDARY
Change in PrEP Self-Efficacy Score
0.05; 0.07; 0.08; 0.03; 0.10; 0.13 0.03 sig
SECONDARY
Change in PrEP Attitude Score
0.06; 0.07; 0.23; 0.01; 0.02; 0.02 0.58
SECONDARY
Change in PrEP Stigma Score
0.06; -0.02; 0.23; 0.09; 0.02; 0.03 0.85
SECONDARY
Number of Participants Who Ordered At-home HIV/Syphilis Tests
13

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04426656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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