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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06096519
• Other study ID #: STU00217358
• Secondary ID: 5R01MH129207-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: October 31, 2025

Study information

• Verified date: January 2024
• Source: Northwestern University
• Contact: Kathryn Macapagal, PhD
• Phone: 3125033605
• Email: kathryn.macapagal[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: October 31, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Mental Health (NIMH)

References & Publications (3)

Fisher CB, Fried AL, Macapagal K, Mustanski B. Patient-Provider Communication Barriers and Facilitators to HIV and STI Preventive Services for Adolescent MSM. AIDS Behav. 2018 Oct;22(10):3417-3428. doi: 10.1007/s10461-018-2081-x. — View Citation

Ybarra ML, Prescott T, Mustanski B, Parsons J, Bull SS. Feasibility, Acceptability, and Process Indicators for Guy2Guy, an mHealth HIV Prevention Program for Sexual Minority Adolescent Boys. J Adolesc Health. 2019 Sep;65(3):417-422. doi: 10.1016/j.jadohealth.2019.04.025. Epub 2019 Jul 2. — View Citation

Ybarra ML, Prescott TL, Phillips GL 2nd, Bull SS, Parsons JT, Mustanski B. Pilot RCT Results of an mHealth HIV Prevention Program for Sexual Minority Male Adolescents. Pediatrics. 2017 Jul;140(1):e20162999. doi: 10.1542/peds.2016-2999. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Most recent HIV test	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
Primary	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	Lifetime STI testing	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
Secondary	Lifetime number of sexual partners someone has had condom-less sex with	Incidence of Condomless Sex	baseline, 3-months post-intervention, 6-months post-intervention
Secondary	Ever taken PrEP	Binary-scale item (yes/no)	baseline, 3-months post-intervention, 6-months post-intervention
Secondary	Currently taking PrEP	Binary-scale item (yes/no)	baseline, 3-months post-intervention, 6-months post-intervention
Secondary	Sexual Health Communications Scale	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