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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI114310 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phone application | Behavioral | The mini-app (used in Part 2) has four main functions:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PrEP Knowledge Score at Week 4, 8 and 12 | 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 |
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Inclusion Criteria:
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:
Exclusion Criteria:
Part 1: Individuals who report any following status will be excluded from participating Part 1:
Part 2:
This is a tailored intervention pilot study for MSM in China
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| Name | Affiliation | Role |
|---|---|---|
| Chunyan Li, MS | University of North Carolina | Principal Investigator |
| Joseph D Tucker, MD | University of North Carolina | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou No. 8 People's Hospital | Guangzhou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37956177 | Derived | 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. | |
| 35537794 |
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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.
Beginning 9 and ending 36 months following article publication.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 2 Standard of Care | Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services. |
| FG001 | 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. Phone application: The mini-app (used in Part 2) has four main functions:
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 2 Standard of Care | Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services. |
| BG001 | Part 2 Mini-app |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and up to 12 weeks |
|
From the time of signing informed consent through the end of the study, a total of approximately 12 to 16 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 2 Standard of Care | Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chunyan Li, MSc | University of North Carolina at Chapel Hill | 919-966-6695 | chunyli@live.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 2, 2020 | Jan 31, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 27, 2020 | Jan 31, 2022 | ICF_001.pdf |
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Mixed methods study, including a 2-arm randomized controlled trial.
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|
|
| 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 |
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 | 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 | 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 | 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 | 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 |
| 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. |
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. Phone application: The mini-app (used in Part 2) has four main functions:
|
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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|
|
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| Primary | Number of Participants Who Initiate PrEP by Week 8 | Individual's self-reported whether starting use of PrEP medication (binary: Yes/No) | Posted | Count of Participants | Participants | Up to 8 weeks |
|
|
|
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| Primary | 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. | Only participants with no missing data were included in this analysis. | Posted | Count of Participants | Participants | Baseline |
|
|
|
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| Primary | 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. | Only participants with no missing data were included in this analysis. | Posted | Count of Participants | Participants | Week 4 |
|
|
|
|
| Primary | 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. | Only participants with no missing data were included in this analysis. | Posted | Count of Participants | Participants | Week 8 |
|
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Week 12 |
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|
|
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| Secondary | Change in PrEP Knowledge Score at Week 4, 8 and 12 | Individual's understanding of PrEP, measured by a 5-item True/False quiz. Values range from 0-5. Higher score indicates better PrEP knowledge. | Participants analyzed here only include those with complete data at a certain follow-up week. | Posted | Mean | Standard Deviation | score on a scale | Baseline and up to 12 weeks |
|
|
|
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| Secondary | Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP | Willingness to pay for PrEP ranging from 0-100% of monthly income. Amount spent will be assessed at Baseline, Weeks 4, 8, and 12. | Posted | Count of Participants | Participants | Up to 12 weeks |
|
|
|
|
| Secondary | Change in PrEP Self-Efficacy Score | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and up to 12 weeks |
|
|
|
|
| Secondary | Change in PrEP Attitude Score | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and up to 12 weeks |
|
|
|
|
| Secondary | Change in PrEP Stigma Score | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and up to 12 weeks |
|
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|
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| Secondary | Number of Participants Who Ordered At-home HIV/Syphilis Tests | 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. | This outcome is only applicable to the participants in the Part 2 mini-app arm who had access to the At-home HIV/syphilis tests per protocol. | Posted | Count of Participants | Participants | 12 weeks |
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|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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. Phone application: The mini-app (used in Part 2) has four main functions:
| 0 | 46 | 0 | 46 | 0 | 46 |
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| Preparation |
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| Action |
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| Preparation |
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| Action |
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| Preparation |
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| Action |
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| Preparation |
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| Action |
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| Baseline to Week 12 |
|
| 15-25% |
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| 10-15% |
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| < 10% |
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| Not any |
|
| Not sure |
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| Other |
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| Week 4 |
|
| Week 8 |
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| Week 12 |
|
| Baseline to Week 12 |
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| Baseline to Week 12 |
|
| Baseline to Week 12 |
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