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

February 28, 2022 updated by: University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China
        • Guangzhou No. 8 People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Part 2 Standard of Care
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.
Experimental: Part 2 mini-app
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

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.
Other Names:
  • mini-app

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Intention to Use PrEP Score
Time Frame: Baseline and up to 12 weeks
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
Time Frame: Up to 8 weeks
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in PrEP Knowledge Score at Week 4, 8 and 12
Time Frame: Baseline and up to 12 weeks
Individual's understanding of PrEP, measured by a 5-item True/False quiz. Values range from 0-5. Higher score indicates better PrEP knowledge.
Baseline and up to 12 weeks
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Time Frame: Up to 12 weeks
Willingness to pay for PrEP ranging from 0-100% of monthly income. Amount spent will be assessed at Baseline, Weeks 4, 8, and 12.
Up to 12 weeks
Change in PrEP Self-Efficacy Score
Time Frame: Baseline and up to 12 weeks
Self-Efficacy will be assessed at Baseline, Weeks 4, 8, and 12 using an 8-item PrEP self-efficacy scale. Values range from 0-5. Higher scores indicate higher self-efficacy to use PrEP.
Baseline and up to 12 weeks
Change in PrEP Attitude Score
Time Frame: Baseline and up to 12 weeks
Individual's attitude towards PrEP, measured by a 5-item scale. Values range from 0-5. Higher scores indicate more positive attitude toward PrEP. The PrEP Attitude will be assessed at Baseline, Weeks 4, 8, and 12.
Baseline and up to 12 weeks
Change in PrEP Stigma Score
Time Frame: Baseline and up to 12 weeks
Individual's perceived stigma related to PrEP, measured by 5-item PrEP stigma scale. Values range from 0-5. Higher score indicates higher perceived stigma related to PrEP. The PrEP Stigma will be assessed at Baseline, Weeks 4, 8, and 12.
Baseline and up to 12 weeks
Number of Participants Who Ordered At-home HIV/Syphilis Tests
Time Frame: 12 weeks
Number of participants who ordered at-home HIV/syphilis tests through the mini-app based on the study record. Values range from 0 to greater than 0. Higher indicates higher frequency of participants who ordered HIV/syphilis tests completed through the study.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chunyan Li, MS, University of North Carolina
  • Study Director: Joseph D Tucker, MD, University of North Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 2, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 2, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-3481
  • R01AI114310 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the 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.

IPD Sharing Time Frame

Beginning 9 and ending 36 months following article publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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