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

Not Applicable

Completed

• Conditions: Drug Abuse; Adolescent Behavior; HIV/AIDS and Infections; Drug Usage
• Interventions: Behavioral: Usual Care; Behavioral: S4E

• Registration Number: NCT03368456
• Lead Sponsor: University of Michigan

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-11
• Study Start: 2018-05-01
• Primary Completion: 2020-08-12
• Study Completion: 2020-08-12
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-26
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care Condition	Usual Care	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.
S4E App Intervention	S4E	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

Primary Outcome Measures

Name	Time	Method
Change in Adolescent HIV Testing	baseline, 3 and 6 month post-baseline	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).

Secondary Outcome Measures

Name	Time	Method
Change in drug use behaviors	baseline, 3 and 6 month post-baseline	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.
Change in condomless sex behaviors	3 and 6 month post-baseline	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).

Trial Locations

Locations (1)

Corner Health Center; 🇺🇸 Ypsilanti, Michigan, United States