Text Messaging for Human Immunodeficiency Virus (HIV) Testing in Sexual and Gender Minority (SGM) Teens

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness and Implementation of Text Messaging to Improve Human Immunodeficiency Virus (HIV) Testing in Sexual and Gender Minority Adolescents

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Information, motivation, behavioral skills treatment arm
* Behavioral: Information only control arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Previous lifetime testing for HIV or an STI HIV positive Currently on PrEP cisgender female

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Information only control<br>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 3-4 total participants with whom participants can discuss program content). | Behavioral: Information only control arm<br>* This information only control arm will consist of content and text messages focused on health behavior information, including mood, sexual health, substance use, and other health behaviors. It will be identical in length to the intervention arm.<br>|
| Experimental: Information, motivation, behavioral skills treatment arm<br>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 3-4 total participants with whom participants can discuss program content) to promote engagement and enhance learning and skills acquisition. | Behavioral: Information, motivation, behavioral skills treatment arm<br>* Our intervention will be an updated version of (Guy2Guy) G2G, a 2014 text messaging-based healthy sexuality and HIV prevention program specifically for 14-18 year old gay, bisexual, and queer (GBQ) adolescent males. The treatment arm of G2G was guided by the Information-Motivation-Behavioral Skills (IMB) model and proved to be efficacious at increasing HIV testing in 13-18 year old GBQ adolescent males. In this updated version we will continue to utilize the IMB model, but modernize the content to include updated HIV prevention information (e.g., novel methods of HIV testing, PrEP, PEP) and tailor the text-message content to meet the needs of adolescent sexual minority men and transgender and gender diverse adolescents.<br>* Other names: Guy2Guy (G2G);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV/STI testing | 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) | Baseline, 3-months post-intervention, 6-months post-intervention | 
| Most recent HIV test | Participants asked to provide date (open-ended) and outcome of most recent HIV test (scale item: negative/positive/I do not know) | Baseline, 3-months post-intervention, 6-months post-intervention | 
| Objective proof of HIV testing | Participants are asked to upload image of proof of most recent HIV test; open-ended (upload image) | through study completion, an average of 9 months, 3-months post-intervention, 6-months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lifetime STI testing | 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) | Baseline, 3-months post-intervention, 6-months post-intervention | 
| Lifetime number of sexual partners someone has had condom-less sex with | Incidence of Condomless Sex | baseline, 3-months post-intervention, 6-months post-intervention | 
| Ever taken PrEP | Binary-scale item (yes/no) | baseline, 3-months post-intervention, 6-months post-intervention | 
| Currently taking PrEP | Binary-scale item (yes/no) | baseline, 3-months post-intervention, 6-months post-intervention | 
| Sexual Health Communications Scale | This is a 4-item Likert scale (1=Never - 5= Always) 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. Scale adapted from the Sexual Health Communications Scale (Fisher et al., 2018). Minimum value on the adapted version used in this study is a 4 (four) and the maximum value is a 20 (twenty). HIgher scores indicate better outcomes. | baseline, 3-months post-intervention, 6-months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human immunodeficiency virus, Adolescents, Sexual and gender minority, Lesbian, gay, bisexual, and transgender, Sexually transmitted infections, Sexual health