Efficacy of Internet-based HIV Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 901
- 试验地点
- 3
- 主要终点
- Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months
研究概览
简要总结
Young men who have sex with men (YMSM) account for almost 70% of HIV diagnoses among all young people in the U.S. and are alone in facing an increasing rate of infections. Because YMSM are less likely to receive relevant sexual health education in traditional settings (e.g. schools, community), the Internet is a unique route of reaching and helping YMSM.
The purpose of this study is to compare two different versions of an online HIV prevention program for YMSM. The study is being conducted by researchers at Northwestern University in Chicago, Hunter College in New York City, and Emory University in Atlanta. A total of 900 YMSM will be enrolled into this study from the clinics of community partners in Chicago, New York, and Atlanta.
Participants will be randomly assigned to one of two versions of the program. Some topics in the program include HIV facts and myths, sexually transmitted infections (STIs), and condom use. All participants, regardless of the program version they receive, will also take at-home urine and rectal tests for the STIs chlamydia and gonorrhea. After completing the program, participants will be contacted three more times over the course of a year for follow-up sessions and surveys.
The research team hypothesizes that the YMSM-specific prevention program will lead to a significant reduction in the frequency of unprotected anal sex acts and new STI infections compared to the HIV knowledge program that is for a general audience. The YMSM-specific program will also lead to improvements in secondary knowledge, motivation, and skills outcomes.
In order for the research team to measure the effectiveness of the YMSM-specific prevention program and determine if the study hypothesis is correct, participants will be asked questions about themselves, including questions about their sexual orientation, sexual experiences, health practices, including drug use, health knowledge, and questions about their feelings and emotions. Based on this information, the research team hopes to later change, improve, or expand the program to better address the needs of YMSM.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Birth male who identifies as male and reports sexual contact with another male
- •Received an HIV negative test result from a participating clinic/recruitment site
- •Unprotected anal sex with another male in the last 6 months
- •Ability to read English at 8th grade level
排除标准
- •HIV positive
- •Female or Transgender
- •No email address for contact
- •Currently in a monogamous relationship lasting longer than 6 months
- •Participated in previous versions of KIU!
研究组 & 干预措施
Keep It Up! Intervention
The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete.
干预措施: Keep It Up! (Behavioral)
HIV Knowledge Control
The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days).
干预措施: HIV Knowledge Control (Behavioral)
结局指标
主要结局
Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months
时间窗: Baseline, 3 Months
Change in self-report of condomless anal sex acts at three months.
Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months
时间窗: Baseline, 6 Months
Change in self-report of condomless anal sex acts at six months.
Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months
时间窗: 12 months
The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at twelve months.
Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline
时间窗: Baseline
The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at baseline.
Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months
时间窗: Baseline, 12 Months
Change in self-report of condomless anal sex acts at twelve months.
次要结局
- Mean Score of Condom Errors at Baseline and 3 Months(Baseline, 3 Months)
- Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months(Baseline, 12 Month)
- Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months(Baseline, 3 Months)
- Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months(Baseline, 3 Months)
- Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months(Baseline, 6 Months)
- Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months(Baseline, 6 Months)
- Mean Score of Health Protective Communication Skills at Baseline and 6 Months(Baseline, 6 Months)
- Mean Score of Condom Errors at Baseline and 12 Months(Baseline, 12 Months)
- Mean Score of Condom Errors at Baseline and 6 Months(Baseline, 6 Months)
- Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months(Baseline, 12 Months)
- Mean Score of Health Protective Communication Skills at Baseline and 3 Months(Baseline, 3 Months)
- Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months(Baseline, 12 Months)
- Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months(Baseline, 12 Months)
- Mean Score of Health Protective Communication Skills at Baseline and 12 Months(Baseline, 12 Months)
研究者
Brian Mustanski
Associate Professor, Department of Medical Social Sciences; Director, IMPACT Program
Northwestern University