Effectiveness and Implementation of Text Messaging to Improve HIV Testing in Adolescents

Not Applicable

Recruiting

• Conditions: HIV

• 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). 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

Adolescents (ages 13-18) 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 13-18.

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.

Study Timeline

• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-23
• Study Start: 2024-06-13
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-01
• Last Update Posted: 2025-08-06
• Primary Completion: 2026-03-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Have penetrative or oral sex in their lifetime
• 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 OR no testing since last sexual experience
• HIV positive
• Currently on PrEP

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)
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)
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 adolescent receiving services from medical healthcare providers, specifically around HIV testing, PrEP, STI and HIV prevention. 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