Effectiveness and Implementation of Text Messaging to Improve Human Immunodeficiency Virus (HIV) Testing in Adolescents
概览
- 阶段
- 不适用
- 干预措施
- Information, motivation, behavioral skills treatment arm
- 疾病 / 适应症
- HIV
- 发起方
- Northwestern University
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- HIV/STI testing
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
This study will test the effectiveness of a text message-based intervention on human immunodeficiency virus (HIV) testing behaviors among adolescent (13-19 year old). To test the effectiveness on HIV testing behaviors we will randomize participants to the treatment or an attention matched information only control arm and asses our primary effectiveness outcome of objective HIV testing (e.g., photo of test results).
详细描述
Adolescents (ages 13-19) are disproportionately affected by HIV, accounting for 21% of all new infections in the U.S. in 2019. Although CDC and USPTF recommend HIV screening among adolescents, testing rates are very low (\<10% have ever been tested). Furthermore, in the U.S., 44% of 13-24-year-olds who are HIV-positive are unaware of their status - the highest percentage of undiagnosed infections of all age groups. As such there is a need for interventions that aim to increase HIV testing in adolescents. This study builds upon the work of a previous text-based sexual health intervention program called G2G. The G2G pilot randomized controlled trial showed adolescents in the active treatment arm were \>3x more likely to report being tested for HIV at follow-up compared to those in the control arm. Given the success of HIV testing behaviors in G2G this current study will aim to update G2G with the latest HIV prevention and testing science, tailor the intervention content so it is modern and inclusive of all adolescents, and test its effectiveness on the outcome of validated HIV testing (e.g., photo of HIV test result). We will test this in a nationwide randomized controlled trial with 360 adolescents aged 13-19. The primary efficacy outcome measure is HIV/STI testing via self report and objective evidence (e.g., photo of their test results) at 3 month and 6 month follow up surveys. Our study hypothesizes that participants assigned to the treatment arm of the intervention will have higher odds of having received an HIV test at 3 and 6 month follow up compared to those in the control arm. Ultimately, increased HIV testing in this group will mitigate transmission rates and improve the HIV prevention and care continua in this population.
研究者
Kathryn Macapagal
Associate Professor
Northwestern University
入排标准
入选标准
- •Have penetrative or oral sex in their lifetime
- •13-19 years old
- •reads in English at a 8th grade level
- •HIV negative or unknown status
- •own a cell phone with an unlimited MMS plan and plan to have the same number during the study
- •can provide informed assent, as shown on a capacity to consent assessment
- •live in the U.S. or territories.
排除标准
- •Previous lifetime testing for HIV or an STI OR no testing since last sexual experience
- •HIV positive
- •Currently on PrEP
研究组 & 干预措施
Information, motivation, behavioral skills treatment arm
The active treatment arm consists of text messages with information, motivation, and behavioral skill based text messages aimed at increasing HIV testing, our primary outcome. Secondary outcomes include STI testing, PrEP uptake, condomless sex, and discussions with providers about PrEP/HIV care. Hypothesized mediators of HIV testing include testing/prevention information, motivation, and behavioral skills. All participants will receive 8-10 messages/day for 6 weeks, with a 1 week booster session following the intervention. In the active treatment arm, participants will have full access to interactive features such as quizzes, badges, an external chatbot feature, a website with sexual health resources, and a group chat feature (a group of 3-5 total participants with whom participants can discuss program content) to promote engagement and enhance learning and skills acquisition.
干预措施: Information, motivation, behavioral skills treatment arm
Information only control
The attention matched control arm will include information based text messages about general health and sexual health topics such as human immunodeficiency virus (HIV), sexually transmitted infections (STIs), relationships, and biomedical methods of HIV prevention (e.g., Pre-exposure prophylaxis (PrEP), Post-exposure prophylaxis (PEP)). No motivational or behavioral skill based text messages aimed at increasing HIV testing or reducing HIV risk behavior will be included. All participants will receive 8-10 messages/day for 6 weeks, with a 1 week booster. Participants in the control arm will have modified access to the interactive features such as quizzes, badges, an external chatbot feature, a website with sexual health resources and a group chat feature (a group of 3-5 total participants with whom participants can discuss program content).
干预措施: Information only control arm
结局指标
主要结局
HIV/STI testing
时间窗: Baseline, 3-months post-intervention, 6-months post-intervention
Participants asked to self-report their history of HIV testing; scale item (No, I have never been tested for HIV/Yes, I have been tested HIV/ I do not know or not sure)
Most recent HIV test
时间窗: Baseline, 3-months post-intervention, 6-months post-intervention
Participants asked to provide date (open-ended) and outcome of most recent HIV test (scale item: negative/positive/I did not get the result)
Objective proof of HIV testing
时间窗: through study completion, an average of 9 months, 3-months post-intervention, 6-months post-intervention
Participants are asked to upload image of proof of most recent HIV test; open-ended (upload image)
次要结局
- Lifetime STI testing(Baseline, 3-months post-intervention, 6-months post-intervention)
- Lifetime number of sexual partners someone has had condom-less sex with(baseline, 3-months post-intervention, 6-months post-intervention)
- Ever taken PrEP(baseline, 3-months post-intervention, 6-months post-intervention)
- Currently taking PrEP(baseline, 3-months post-intervention, 6-months post-intervention)
- Sexual Health Communications Scale(baseline, 3-months post-intervention, 6-months post-intervention)