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Active, Not Recruiting

NCT Number: NCT06096519

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Disease Attributes Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Previous lifetime testing for HIV or an STI OR no testing since last sexual experience
  • HIV positive
  • Currently on PrEP

Treatment and study plan

Information, motivation, behavioral skills treatment arm

Behavioral

Our intervention will be an updated version of (Guy2Guy) G2G, a 2014 text messaging-based healthy sexuality and HIV prevention program specifically for 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 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 all adolescents.

Other names: Guy2Guy (G2G)

Information only control arm

Behavioral

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.

Primary outcomes

  1. HIV/STI testing

    Time frame: 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)

  2. Most recent HIV test

    Time frame: 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)

  3. Objective proof of HIV testing

    Time frame: 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 outcomes

  1. Lifetime STI testing

    Time frame: 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)

  2. Lifetime number of sexual partners someone has had condom-less sex with

    Time frame: baseline, 3-months post-intervention, 6-months post-intervention

    Incidence of Condomless Sex

  3. Ever taken PrEP

    Time frame: baseline, 3-months post-intervention, 6-months post-intervention

    Binary-scale item (yes/no)

  4. Currently taking PrEP

    Time frame: baseline, 3-months post-intervention, 6-months post-intervention

    Binary-scale item (yes/no)

  5. Sexual Health Communications Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institutes of Health (NIH)

Registry information

Official study title

Effectiveness and Implementation of Text Messaging to Improve Human Immunodeficiency Virus (HIV) Testing in Adolescents

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 23, 2023
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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