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

January 31, 2024 updated by: Kathryn Macapagal, Northwestern University

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 3-4 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 3-4 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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, 3-months post-intervention, 6-months post-intervention
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 do not know)
Baseline, 3-months post-intervention, 6-months post-intervention
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)
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
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)
Baseline, 3-months post-intervention, 6-months post-intervention
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
baseline, 3-months post-intervention, 6-months post-intervention
Ever taken PrEP
Time Frame: baseline, 3-months post-intervention, 6-months post-intervention
Binary-scale item (yes/no)
baseline, 3-months post-intervention, 6-months post-intervention
Currently taking PrEP
Time Frame: baseline, 3-months post-intervention, 6-months post-intervention
Binary-scale item (yes/no)
baseline, 3-months post-intervention, 6-months post-intervention
Sexual Health Communications Scale
Time Frame: baseline, 3-months post-intervention, 6-months post-intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

May 18, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00217358
  • 5R01MH129207-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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