Preventing HIV/STI in Urban Adolescents Via an mHealth Primary Care Intervention

Study Overview
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Brief Summary
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The study evaluates the preliminary efficacy of an innovative mobile-health (mHealth) intervention (hereon referred to as S4E) to improve human immunodeficiency virus and sexually transmitted infection testing and reduce HIV/STI risk behaviors in a clinic sample (n=100) of at-risk youth ages 14-21 living in Southeast Michigan. A Stage I randomized control trial will be conducted to examine the preliminary efficacy of S4E, relative to Usual Care (UC), over a period of six months.

Detailed Description
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HIV/STI and drug abuse remain significant public health priorities in the US and youth are disproportionately affected. Youth between the ages of 15 - 24 constitute 25% of the sexually experienced population, yet account for 46% and 50% of HIV infections and new STIs, respectively. National surveillance data indicate that youth disproportionately engage in HIV/STI risk behaviors, including condomless sex and licit and illicit drug use, which increase their risk for HIV/STI infection. Despite the disproportionately high rates of HIV/STI infection and risk behaviors in youth, fewer than 14% report having ever been tested for HIV and many are not routinely screened for asymptomatic STIs as recommended by the Center for Disease Control. In Southeast Michigan, HIV/STI are disproportionately high. To address these significant public health concerns, a mobile-health (mHealth) intervention was developed for health clinic settings. The proposed research aims to develop a cross-platform and universal version of S4E. The cross-platform and universal version of S4E will be compatible with both IOS and Android operating systems, and multiple mobile devices, aimed at providing adolescents with ongoing access to the intervention once they leave the clinic. The proposed research will also evaluate the preliminary efficacy of S4E to improve HIV/STI testing and reduce HIV/STI risk behaviors in a clinic sample (n=100) of at-risk youth ages 14-21 living in Southeast Michigan by conducting a Stage I RCT to examine the preliminary efficacy of S4E, relative to Usual Care, among a sample of 100 at-risk youth over six months.

Official Title
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Preventing HIV/STI in Urban Adolescents Via an mHealth Primary Care Intervention

Conditions
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HIV/AIDS and Infections, Drug Abuse, Adolescent Behavior, Drug Usage

Intervention / Treatment
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* Behavioral: S4E
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male youth 14-21 years of age Sexually active Live in Southeast Michigan Have access to a smartphone or tablet Youth must see an enrolled clinician to participate in the study. Exclusion Criteria: Report of prior psychiatric hospitalization by adolescent Visible cognitive impairment due to drug use Adolescent reports (tentative or firm) plans to move out of the Southeast Michigan area during the study

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: To test the preliminary efficacy of S4E, we will conduct a Stage I RCT and use a mixed between/within-subjects design with two levels of intervention (S4E and Usual Care) as the between-subjects factor and three repeated measures assessments (Baseline, 3-, and 6-months post-Baseline) as the within-subjects factor.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S4E App Intervention<br>Participants in the S4E condition will first receive the intervention in the waiting area via iPads provided for them. Content includes the theoretically driven components of Storytelling for Empowerment: (a) Storytelling scenarios, (b) drug use and HIV/STI knowledge development, (c) interactive activities, (d) increasing self-efficacy to prevent/reduce sexual risk and drug use behaviors, and increase HIV/STI testing, (e) clinician-youth communication, and (f) highlighting prevention principles | Behavioral: S4E<br>* S4E application was developed in collaboration with youth in Southeast Michigan. S4E aims to prevent and reduce HIV/STI risk behaviors, including drug use and sexual risk behaviors, and increase HIV/STI testing among youth. Content produced for the application is based on scientific prevention principles in conjunction with youth input. To date, we have developed modules focused on youth alcohol & drug use, HIV & STIs and a forthcoming module on tobacco prevention and cessation.<br>|
| Placebo Comparator: Usual Care Condition<br>Participants in Usual Care (i.e., Control Condition) will not receive the S4E intervention. The Clinic's usual care includes a standard risk behaviors intake form, pamphlets highlighting resources, and reproductive and healthcare services. | Behavioral: Usual Care<br>* Participants in Usual Care (i.e., Control Condition) will not receive the S4E intervention from the study staff. The Clinic's usual care includes a standard risk behaviors intake form, pamphlets highlighting resources, and reproductive and healthcare services.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Adolescent HIV Testing | Post-intervention, we will assess whether youths requested to receive HIV testing at the clinic, and at 3 and 6 months post-baseline (yes/no). | baseline, 3 and 6 month post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in condomless sex behaviors | Adolescent unsafe sexual behavior will be measured (time points 1-3) using items extracted from Jemmott, Jemmott, and Fong's Sexual Behavior instrument. This gated instrument will assess the adolescent's past 90-day condom use, number of sexual partners, and contraceptive use (non-condom). | 3 and 6 month post-baseline | 
| Change in drug use behaviors | Licit and illicit drug use behaviors will be assessed (time points 1-3) using items from the Monitoring the Future Study. Youth will be asked whether or not they have used licit or illicit drugs in their lifetime and the past 90 days. Youth who report Yes to past 90-day sex will be asked to report the frequency of drug use before sex. These measures have been used in our formative research. | baseline, 3 and 6 month post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mhealth, preventive intervention, primary health care