跳至主要内容
临床试验/NCT04135443
NCT04135443已完成不适用

Mobile App Promoting Sexual Health for Young Black Men Who Have Sex With Men

ETR Associates1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2021年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
178
试验地点
1
主要终点
Condomless Anal Intercourse or Condomless Vaginal Intercourse

研究概览

简要总结

This study features a 2-arm randomized controlled trial with approximately 300 young black men who have sex with men (YBMSM) to assess the effectiveness of the 3T mobile app. To be eligible participants will be required to identify as male; Black, African-American, or biracial Black/African American; age 14-19 at baseline; self-identify as gay, bisexual, fluid, or sexually attracted to men; own a smartphone, and reside in any state in the United States. Those in the treatment arm will be provided with the 3T app and those in the control group will be given access to a website with general health materials. Participants will complete brief online surveys at baseline and at 3-months following the baseline to assess effectiveness in changing sexual risk behaviors and communication and condom use behaviors and attitudes.

详细描述

The overarching aim of this proposed Phase II research project is to fill a gap in prevention by completing the development and establishing the effectiveness of 3T: Tune in, Turn on, Turn up, a multimedia interactive sex-positive smartphone app-delivered HIV and other sexually transmitted infection (STI) intervention designed for use by YBMSM ages 14-19. The larger and longer term aims of developing an intervention specifically tailored to this population, utilizing a technology platform to reach youth where they are, is to contribute to a reduction in HIV/STI risk, increase HIV testing, and an increase in the quality of overall sexual health and relationships among YBMSM. To do this 3T emphasizes partner reduction, avoidance of concurrent partners, use of condoms if having anal or vaginal sex, and getting HIV/STI tests. 3T also focuses on improving quality of sexual experience and relationships, helping participants become clearer about what they do/don't want to do sexually, communicating their choices, and learning ways to enhance sexual experience without increasing HIV/STI risk. dfusion and its research partner, ETR, will meet the following specific Phase II aims:

  • In conjunction with advisory panel members, develop content and corresponding storyboards for all activities. The curriculum will include content on risk reduction, sexual health and the quality of sexual experiences, and developing healthy relationships;
  • Successful development of the first mobile app-delivered STI/HIV prevention program specifically designed for YBMSM aged 14-19. Reaching this aim requires continued development of the app technology, including the multimedia interactive activities, games, data collection, activity randomization, and an asynchronous forum. Research shows that YBMSM use the Internet to find information related to sex and sexuality, find friends and sexual partners, and YBMSM are increasingly using mobile apps, such as Grindr, to meet sex partners.20 The reliance on mobile devices for education and entertainment make it the ideal technology platform for reaching the YBMSM audience;
  • Conduct a rigorous evaluation to determine the effectiveness of the intervention to reduce HIV/STI risk.

The evaluation features a 2-arm randomized controlled trial with approximately 300 young black men who have sex with men (YBMSM) to assess the effectiveness of the 3T mobile app. To be eligible participants will be required to identify as male; Black, African-American, or biracial Black/African American; age 14-19 at baseline; self-identify as gay, bisexual, fluid, or sexually attracted to men; own a smartphone, and reside in any state in the United States. Those in the treatment arm will be provided with the 3T app and those in the control arm will be asked to use a website with general health information. Participants will complete brief online surveys at baseline and at 3-months following the baseline to assess effectiveness in changing sexual risk behaviors and relationship and communication behaviors and attitudes.

Recruitment. We will use multiple methods to recruit participants: 1) Engaging Organizations. Approximately 15-20 organizations from across the U.S. that serve YBMSM will be approached to help recruit participants through social media and in-person 2) Using Social Media Advertising including targeted advertising on social media sites and sponsoring study posts with social media influencers in the YBMSM community.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

Participants are randomly assigned to their condition without being made aware of their assigned condition as "attention control" or "intervention." Each condition accesses materials online.

入排标准

年龄范围
14 Years 至 19 Years(Child, Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •self-identification of being aged 14-19;
  • •ownership of an iphone or Android smartphone
  • •self-identification of racial identity as black, African American, or biracial; and
  • •self-identifying as gay, bisexual, same gender loving, or sexually attracted to the same gender.
  • •capacity to assent, based on formal assessment
  • •a willingness to participate after complete understanding of the topics of study, as indicated by a completed assent form
  • •resides in the US

排除标准

  • •Anyone not meeting inclusion criteria

研究组 & 干预措施

3T Tune in! Turn on! Turn up!

Experimental

The intervention is a mobile app delivered sexual health promotion program designed specifically for young black men who have sex with men or who are attracted to men. The mobile app includes 36 interactive activities including resource maps, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) content, and an asynchronous communication forum. The app helps participants to become clearer about what they do/don't want to do sexually, to communicate their choices. It also focuses on ways to increase healthy relationships, enhance sexual experience if having sex while reducing HIV/STI risk.

干预措施: 3T Tune in! Turn on! Turn up! (Behavioral)

General Health Website Materials

Active Comparator

The control intervention features a website containing seven health promotion materials in online pamphlet or poster formats focusing on mental health (2 pamphlets), nutrition (2 pamphlets), relationships (2 pamphlets) and COVID (1 poster).

干预措施: General Health Materials Website (Behavioral)

结局指标

主要结局

Condomless Anal Intercourse or Condomless Vaginal Intercourse

时间窗: 3-months post baseline

Engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months

次要结局

  • Sexual Partners, no Condom, in the Last 3 Months(3-months post baseline)
  • Self-reported STI/HIV Testing in Last Three Months(3-months post baseline)
  • Dyadic Communication Scale(3-months post baseline)
  • Condom Attitudes Scale(3-months post baseline)
  • Condom Self-Efficacy Scale(3-months post baseline)
  • Attitudes Towards Lube(3-months post baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Evaluation of 3T, a Sex-Positive HIV/STI Mobile App... | 临床试验