Text Messaging for Human Immunodeficiency Virus (HIV) Testing in Sexual and Gender Minority (SGM) Teens
- Conditions
- HIV
- Interventions
- Behavioral: Information only control armBehavioral: Information, motivation, behavioral skills treatment arm
- Registration Number
- NCT06096519
- Lead Sponsor
- Northwestern University
- Brief Summary
This study will test the effectiveness of a text message-based intervention on human immunodeficiency virus (HIV) testing behaviors among adolescent (13-18 year old) sexual minority men and transgender and gender diverse teens (ASMM/TGD). 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).
- Detailed Description
Adolescent sexual minority males, transgender girls, and gender diverse teens (ASMM/TGD; ages 13-18) are disproportionately affected by HIV, accounting for 79% of new infections among this age group. 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. Most of these infections occur among ASMM/TGD. Although the Center for Disease Control (CDC) recommends screening teens at risk for HIV at least annually, testing rates in this age group are extremely low.
As such there is a need for interventions that aim to increase HIV testing in ASMM/TGD. 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 TGD teens, 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 ASMM/TGD aged 13-18.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 360
- male identified or male sex at birth
- Have penetrative (vaginal/anal) sex with partners assigned male at birth within the past 12 months
- SGM identity including people who are "questioning" "unsure" or "exploring". Cis-gender heterosexual men are eligible if they report having sex with a male/male-identified partner
- 13-18 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.
- Previous lifetime testing for HIV or an STI
- HIV positive
- Currently on PrEP
- cisgender female
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Information only control Information only control arm 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). Information, motivation, behavioral skills treatment arm 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.
- Primary Outcome Measures
Name Time Method HIV/STI testing 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 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 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)
- Secondary Outcome Measures
Name Time Method Lifetime STI testing Baseline, 3-months post-intervention, 6-months post-intervention Participants asked to self-report their history of STI testing; outcomes assessed via scale items (No, I have never been tested for any STI/Yes, I have been tested for at least one STI/ I do not know or not sure)
Lifetime number of sexual partners someone has had condom-less sex with baseline, 3-months post-intervention, 6-months post-intervention Incidence of Condomless Sex
Ever taken PrEP baseline, 3-months post-intervention, 6-months post-intervention Binary-scale item (yes/no)
Currently taking PrEP baseline, 3-months post-intervention, 6-months post-intervention Binary-scale item (yes/no)
Sexual Health Communications Scale baseline, 3-months post-intervention, 6-months post-intervention This is a 7-item select all that apply question which asks participants about their communicative experiences as an LGBTQ person receiving services from medical healthcare providers, specifically around HIV testing, PrEP, STI and HIV prevention, and an individual's LGBTQ identity. Question adapted from the Sexual Health Communications Scale (Fisher et al., 2018). More selected options indicate better outcomes.
Trial Locations
- Locations (1)
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States