Evaluating the Effectiveness of a Mobile HIV Prevention Application to Increase HIV and STI Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 473
- 试验地点
- 1
- 主要终点
- PrEP initiation
研究概览
简要总结
The goal of this clinical trial is to test the efficacy of a mobile app, Combine, to increase the uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP) over 24 months and to assess the effects of different implementation strategies on intervention maintenance among GBMSM in rural southern United States. The main aims of the study are:
- To assess the relative effects of three treatment conditions on gains in engagement in HIV prevention compared to a modified standard of care control condition
- Measure and assess secondary factors affecting app implementation
- Refine implementation strategies and coordinate with potential funders Participants will download an HIV prevention smartphone app and be randomly assigned to one of four groups:
- Control: App access only
- Self-testing: App access + ability to order HIV and STI self-test kits
- Motivational interview: App access + motivational interview to develop plans to use app effectively.
- Self-testing + motivational interview: App access + ability to order HIV and STI self-test kits + motivational interview to develop plans to use app effectively.
Researchers will compare each of the latter three groups to the control condition to see if HIV and STI testing increase in these groups
详细描述
The uptake of HIV and STI testing among gay and bisexual men who have sex with men (GBMSM) in the rural southern US is low. However, HIV and STI testing is a fundamental gateway to preventive services, such as PrEP, and treatment provision. Thus, the research team must identify methods to increase the uptake of HIV and STI testing among this population that experiences disproportionate HIV and STI incidence. The research team has developed an app, Combine, that is an adaptation of HealthMindr, an app that has demonstrated efficacy in increasing the uptake of HIV testing among urban GBMSM. Combine was adapted using input from GBMSM in rural areas to address issues specific to this population such as increased experiences of stigma and reduced access to culturally competent care. The investigator proposes to conduct a Type 2 Hybrid Effectiveness-Implementation randomized controlled trial to test the efficacy of Combine to increase uptake of HIV and STI testing over 24 months of follow-up and to examine the effect of different implementation strategies among GBMSM in the rural South. Combine will include components for self-administered risk assessments, developing and supporting a plan for frequent HIV and STI testing, information about PrEP, and PrEP and HIV/STI testing provider locators. Previous trials of app-based HIV prevention have included the ability to order free HIV and STI self-test kits. However, there is no consensus among health officials around whether at-home self-tests are an optimal solution for increasing HIV and STI testing. Additionally, despite the availability of free HIV and STI self-test kits in previous studies, large proportions of men still do not complete HIV tests, and even fewer complete STI tests. Thus, the investigator will evaluate the effect of two different intervention components on HIV and STI uptake in a 2x2 factorial trial design: availability of HIV and STI self-test kits ordered through the app and a motivational interview designed to enhance the existing app content, increased self-efficacy to develop and follow through with a testing plan, and develop strategies to deal with experiences of stigma.
The investigator will assess the main effects of the availability of HIV and STI self-test kits and the motivational interview on HIV and STI testing uptake, PrEP initiation, and intervention maintenance over 24 months of follow-up. The investigator's community-based partner, Engaging Arkansas Communities, will work with the research team through all stages of the project to ensure that the team is obtaining the necessary data to inform future implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Assigned male at birth and currently identifies as male
- •Age 18-45 years, inclusive
- •Reside in the U.S. South as defined by the Census Bureau or in Missouri
- •Reside in a county classified as rural using the Index of Relative Rurality
- •Have an Android or iPhone operating system (iOS) phone with active service
- •Willing to download a study app to their phone
- •English speaker
- •Report anal sex with a man in the past 12 months
- •HIV-negative or unknown serostatus
- •Not currently using PrEP
排除标准
- •- Unable to provide consent
研究组 & 干预措施
Combine app with all features except the ability to order self-test kits
Participants will receive a modified standard of care which consists of the Combine app with all features except the ability to order self-test kits. The HIV/STI testing locator in the app will be available.
干预措施: Combine mobile app (Behavioral)
Combine app + motivational interview
In addition to the other Combine app features, participants will receive a motivational interview within 4 weeks of downloading the app.
干预措施: Combine mobile app (Behavioral)
Combine app + motivational interview
In addition to the other Combine app features, participants will receive a motivational interview within 4 weeks of downloading the app.
干预措施: Motivational interview (Behavioral)
Combine app + ability to order up 2 free HIV/STI self-test kits
In addition to the other Combine app features, participants in this arm will be able to order up to two HIV/STI self-test kits at no charge during each year of follow-up.
干预措施: Combine mobile app (Behavioral)
Combine app + ability to order up 2 free HIV/STI self-test kits
In addition to the other Combine app features, participants in this arm will be able to order up to two HIV/STI self-test kits at no charge during each year of follow-up.
干预措施: HIV/STI testing (Behavioral)
Combine app + motivational interview + ability to order HIV/STI test kits via the app
In addition to the other Combine app features, participants in this arm will receive both the motivational interview and the ability to order HIV/STI test kits via the app.
干预措施: Combine mobile app (Behavioral)
Combine app + motivational interview + ability to order HIV/STI test kits via the app
In addition to the other Combine app features, participants in this arm will receive both the motivational interview and the ability to order HIV/STI test kits via the app.
干预措施: Motivational interview (Behavioral)
Combine app + motivational interview + ability to order HIV/STI test kits via the app
In addition to the other Combine app features, participants in this arm will receive both the motivational interview and the ability to order HIV/STI test kits via the app.
干预措施: HIV/STI testing (Behavioral)
结局指标
主要结局
PrEP initiation
时间窗: Screening, Month 6, Month 12, Month 18, Month 24
The investigator will look at the change in number of participants taking PrEP over the course of the study. PrEP initiation will be defined as obtaining a new PrEP prescription for the first time or after a period of non-use of at least three months
Uptake of HIV testing
时间窗: Screening, Month 6, Month 12, Month 18, Month 24
The investigator will look at the change in number of participants getting tested for HIV by using online surveys. Uptake of testing will be defined as ordering, using, and returning a kit for laboratory analysis or obtaining a test at an in-person provider and reporting the result.
Uptake of STI testing
时间窗: Screening, Month 6, Month 12, Month 18, Month 24
The investigator will look at the change in number of participants getting tested for STIs by using online surveys. Uptake of testing will be defined as ordering, using, and returning a kit for laboratory analysis or obtaining a test at an in-person provider and reporting the result.
次要结局
未报告次要终点
