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

NCT06096519 | Recruiting DMC

• 2 other identifiers: STU002173585R01MH129207
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

HIV

Keywords

Human immunodeficiency virus; Adolescents; Sexually transmitted infections; Sexual health

Outcome Measures

Primary Outcomes (3)

• 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 did not get the result)

  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 Outcomes (5)

• Lifetime STI testing

  Baseline, 3-months post-intervention, 6-months post-intervention

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

  baseline, 3-months post-intervention, 6-months post-intervention

• Ever taken PrEP

  baseline, 3-months post-intervention, 6-months post-intervention

• Currently taking PrEP

  baseline, 3-months post-intervention, 6-months post-intervention

• Sexual Health Communications Scale

  baseline, 3-months post-intervention, 6-months post-intervention

Study Arms (2)

Information only control

PLACEBO COMPARATOR

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

Information, motivation, behavioral skills treatment arm

EXPERIMENTAL

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

Interventions

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.

Information only control

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.

Also known as: Guy2Guy (G2G)

Information, motivation, behavioral skills treatment arm

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Have penetrative or oral sex in their lifetime
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kathryn Macapagal, PhD

CONTACT

3125033605; kathryn.macapagal@northwestern.edu

Andrés Alvarado Avila, MPH

CONTACT

3125035446; andres.avila@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: October 23, 2023
• Study Start: June 13, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)