- ICH GCP
- US Clinical Trials Registry
- 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
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Guangzhou, China
- Guangzhou No. 8 People's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
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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.
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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.
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The mini-app (used in Part 2) has four main functions:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Intention to Use PrEP Score
Time Frame: Baseline and up to 12 weeks
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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.
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Baseline and up to 12 weeks
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Number of Participants Who Initiate PrEP by Week 8
Time Frame: Up to 8 weeks
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Individual's self-reported whether starting use of PrEP medication (binary: Yes/No)
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Up to 8 weeks
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Number of Participants at Different Change Stages to PrEP Initiation at Baseline
Time Frame: Baseline
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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.
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Baseline
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Number of Participants at Different Change Stages to PrEP Initiation at Week 4
Time Frame: Week 4
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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.
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Week 4
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Number of Participants at Different Change Stages to PrEP Initiation at Week 8
Time Frame: Week 8
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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.
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Week 8
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Number of Participants at Different Change Stages to PrEP Initiation at Week 12
Time Frame: Week 12
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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.
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Week 12
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Secondary Outcome Measures
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
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Individual's understanding of PrEP, measured by a 5-item True/False quiz.
Values range from 0-5.
Higher score indicates better PrEP knowledge.
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Baseline and up to 12 weeks
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Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Time Frame: Up to 12 weeks
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Willingness to pay for PrEP ranging from 0-100% of monthly income.
Amount spent will be assessed at Baseline, Weeks 4, 8, and 12.
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Up to 12 weeks
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Change in PrEP Self-Efficacy Score
Time Frame: Baseline and up to 12 weeks
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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.
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Baseline and up to 12 weeks
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Change in PrEP Attitude Score
Time Frame: Baseline and up to 12 weeks
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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.
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Baseline and up to 12 weeks
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Change in PrEP Stigma Score
Time Frame: Baseline and up to 12 weeks
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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.
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Baseline and up to 12 weeks
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Number of Participants Who Ordered At-home HIV/Syphilis Tests
Time Frame: 12 weeks
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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.
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12 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Chunyan Li, MS, University of North Carolina
- Study Director: Joseph D Tucker, MD, University of North Carolina
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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