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

NCT04426656 | Completed Results

• 2 other identifiers: 19-3481R01AI114310
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Pre-exposure Prophylaxis

Keywords

HIV; PrEP

Outcome Measures

Primary Outcomes (6)

• Change in Intention to Use PrEP Score

  Individual perceived likelihood to start using PrEP, measured by a one-item question with a bipolar response scale (-3 to 3). Higher score indicates higher intention to use.

  Baseline and up to 12 weeks

• Number of Participants Who Initiate PrEP by Week 8

  Individual's self-reported whether starting use of PrEP medication (binary: Yes/No)

  Up to 8 weeks

• Number of Participants at Different Change Stages to PrEP Initiation at Baseline

  Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.

  Baseline

• Number of Participants at Different Change Stages to PrEP Initiation at Week 4

  Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.

  Week 4

• Number of Participants at Different Change Stages to PrEP Initiation at Week 8

  Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.

  Week 8

• Number of Participants at Different Change Stages to PrEP Initiation at Week 12

  Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.

  Week 12

Secondary Outcomes (6)

• Change in PrEP Knowledge Score at Week 4, 8 and 12

  Baseline and up to 12 weeks

• Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP

  Up to 12 weeks

• Change in PrEP Self-Efficacy Score

  Baseline and up to 12 weeks

• Change in PrEP Attitude Score

  Baseline and up to 12 weeks

• Change in PrEP Stigma Score

  Baseline and up to 12 weeks

Study Arms (2)

Part 2 Standard of Care

NO INTERVENTION

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

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.

Behavioral: Phone application

Interventions

Phone application BEHAVIORAL

The mini-app (used in Part 2) has four main functions: 1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese; 2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time); 3. an asynchronous message function that allows users to chat with a study staff (C.Li); and 4. a user profile page where users can manage all HIV test orders.

Also known as: mini-app

Part 2 mini-app

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: This is a tailored intervention pilot study for MSM in China
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Guangzhou No. 8 People's Hospital

Guangzhou, China

Location

Related Publications (2)

• Li C, Xiong Y, Maman S, Matthews DD, Fisher EB, Tang W, Huang H, Mu T, Tong X, Yu J, Yang Z, Sherer R, Hazra A, Lio J, Li L, Tucker JD, Muessig KE. An instant messaging mobile phone application for promoting HIV pre-exposure prophylaxis uptake among Chinese gay, bisexual and other men who have sex with men: A mixed methods feasibility and piloting randomized controlled trial study. PLoS One. 2023 Nov 13;18(11):e0285036. doi: 10.1371/journal.pone.0285036. eCollection 2023.

  PMID: 37956177 DERIVED

• 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.

  PMID: 35537794 DERIVED

Results Point of Contact

• Title: Chunyan Li, MSc
• Organization: University of North Carolina at Chapel Hill

chunyli@live.unc.edu

919-966-6695

Study Officials

• Chunyan Li, MS

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• Joseph D Tucker, MD

  University of North Carolina

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mixed methods study, including a 2-arm randomized controlled trial.

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: July 8, 2020
• Primary Completion: April 2, 2021
• Study Completion: April 2, 2021
• Last Updated: March 2, 2022
• Results First Posted: March 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 and ending 36 months following article publication.
• Access Criteria: Investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Locations

CN (1)