Clinical trial NCT06096519: Text Messaging for Human Immunodeficiency Virus (HIV) Testing in Sexual and Gender Minority (SGM) Teens
Official title: Effectiveness and Implementation of Text Messaging to Improve Human Immunodeficiency Virus (HIV) Testing in Sexual and Gender Minority Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Keywords: Human immunodeficiency virus
Adolescents
Sexual and gender minority
Lesbian, gay, bisexual, and transgender
Sexually transmitted infections
Sexual health
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Mental Health (NIMH)
First posted: 2023-10-23
Enrollment: 360
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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) 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: HIV/STI testing
timeFrame: Baseline, 3-months post-intervention, 6-months post-intervention
measure: Most recent HIV test
timeFrame: Baseline, 3-months post-intervention, 6-months post-intervention
measure: Objective proof of HIV testing
timeFrame: through study completion, an average of 9 months, 3-months post-intervention, 6-months post-intervention
Secondary outcomes:
measure: Lifetime STI testing
timeFrame: Baseline, 3-months post-intervention, 6-months post-intervention
measure: Lifetime number of sexual partners someone has had condom-less sex with
timeFrame: baseline, 3-months post-intervention, 6-months post-intervention
measure: Ever taken PrEP
timeFrame: baseline, 3-months post-intervention, 6-months post-intervention
measure: Currently taking PrEP
timeFrame: baseline, 3-months post-intervention, 6-months post-intervention
measure: Sexual Health Communications Scale
timeFrame: baseline, 3-months post-intervention, 6-months post-intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
References:
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.
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.
citation: 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.