Purpose

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).

Condition

Eligibility

Eligible Ages
Between 13 Years and 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
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).
  • Behavioral: Information only control arm
    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.
Experimental
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.
  • Behavioral: Information, motivation, behavioral skills treatment arm
    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.
    Other names:
    • Guy2Guy (G2G)

Recruiting Locations

Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611
Contact:
Andrés Alvarado Avila, B.A
3125036519
andres.avila@northwestern.edu

More Details

Status
Recruiting
Sponsor
Northwestern University

Study Contact

Kathryn Macapagal, PhD
3125033605
kathryn.macapagal@northwestern.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.