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

Northwestern University

Status: Enrolling

Conditions: HIV

Treatments: Behavioral: Information, motivation, behavioral skills treatment arm; Behavioral: Information only control arm

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06096519

5R01MH129207 (U.S. NIH Grant/Contract)

STU00217358

Details and patient eligibility

About

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). 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).

Full description

Adolescents (ages 13-18) 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 13-18.

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 13 to 19 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Have penetrative or oral sex in their lifetime
• 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 OR no testing since last sexual experience
• HIV positive
• Currently on PrEP

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups, including a placebo group

Information only control

Placebo Comparator group

Description:

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).

Treatment:

Behavioral: Information only control arm

Information, motivation, behavioral skills treatment arm

Experimental group

Description:

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.

Treatment:

Behavioral: Information, motivation, behavioral skills treatment arm