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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of Participants at Different Change Stages to PrEP Initiation at Week 4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •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.
- •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
结局指标
主要结局
Number of Participants at Different Change Stages to PrEP Initiation at Week 4
时间窗: 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.
Number of Participants at Different Change Stages to PrEP Initiation at Week 12
时间窗: 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.
Change in Intention to Use PrEP Score
时间窗: 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.
Number of Participants at Different Change Stages to PrEP Initiation at Week 8
时间窗: 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.
Number of Participants Who Initiate PrEP by Week 8
时间窗: Up to 8 weeks
Individual's self-reported whether starting use of PrEP medication (binary: Yes/No)
Number of Participants at Different Change Stages to PrEP Initiation at Baseline
时间窗: 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.
次要结局
- Change in PrEP Self-Efficacy Score(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 Stigma Score(Baseline and up to 12 weeks)
- Change in PrEP Knowledge Score at Week 4, 8 and 12(Baseline and up to 12 weeks)
- Change in PrEP Attitude Score(Baseline and up to 12 weeks)
- Number of Participants Who Ordered At-home HIV/Syphilis Tests(12 weeks)