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

University of Michigan

Status: Completed

Conditions: Drug Usage; Drug Abuse; HIV/AIDS and Infections; Adolescent Behavior

Treatments: Behavioral: S4E; Behavioral: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03368456

Previous HUM00118704 (Other Identifier)

HUM00158089

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 14 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

S4E App Intervention

Experimental group

Description:

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

Treatment:

Behavioral: S4E

Usual Care Condition

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care