Clinical trial NCT03855410: Preventing Cigarette Use Among Urban Youth Via an M-Health Primary Care Preventive Intervention
Official title: Preventing Substance Use and HIV/STI Among Urban Youth Via an M-Health Primary Care Preventive Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Drug Use
Adolescent Behavior
Alcohol Use
Sexual Risk Behavior
Keywords: mHealth
preventive intervention
substance use
youth
eHealth
technology-based
HIV/STI
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 50
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To test the preliminary efficacy of S4E, we will conduct a stage 1 randomized control trial (RCT) and use a mixed between/within-subjects design with two levels of intervention (S4E and Attention-Matched Control) as the between-subjects factor and a repeated measure assessment at 30 days post-Baseline as the within-subject factor.
Primary purpose: PREVENTION

Brief summary: The study aims to develop tobacco modules to be included in an innovative mobile-health (mHealth) intervention (hereon referred to as S4E) and to determine the feasibility and preliminary efficacy of the updated version of S4E in an urban youth-centered community health clinic in Southeast Michigan.

Detailed description: Tobacco use remains a significant public health concern in the US, and youth are disproportionately affected. Among high school youth , 38% report lifetime cigarette use, and 9.3% report having smoked a whole cigarette before the age of 13. In Southeast Michigan, African-American youth are at disproportionate risk of engaging in tobacco use and co-occuring substance use and other risk behaviors. To address these significant public health concerns, we developed Storytelling 4 Empowerment (S4E), a targeted and tailored mobile-health (mHealth) application (app) intervention to be delivered in health clinic settings. The proposed research aims to develop culturally congruent and developmentally appropriate modules focused on tobacco use prevention and risk reduction to be included as part of the S4E mHealth app. The proposed research will also determine the preliminary efficacy of S4E in reducing tobacco use, alcohol and other drug use, sexual risk behaviors, and improving HIV/STI testing in a sample (n=50) of youth ages 13-21 living in Southeast Michigan.

Eligibility criteria: Inclusion Criteria:

* Female, Male, and Transgender adolescents
* Adolescents 13-21 years of age
* Adolescents must live in Southeast Michigan
* Adolescents must provide assent and consent

Exclusion Criteria:

* Report of a prior psychiatric hospitalization by adolescent or caregiver
* Adolescent reports (tentative or firm) plans to move out of the Southeast Michigan area during the study.

Primary outcomes:
measure: Change in Tobacco Use from baseline to 30 days
timeFrame: baseline and 30 days post-baseline
Secondary outcomes:
measure: Change in Drug Use from baseline to 30 days
timeFrame: baseline and 30 days post-baseline
measure: Change in contraception (non-condom) use from baseline to 30 days
timeFrame: baseline and 30 days post-baseline
measure: Change in Number of sexual partners from baseline to 30 days
timeFrame: baseline and 30 days post-baseline
measure: Change in Alcohol Use from baseline to 30 days
timeFrame: baseline and 30 days post-baseline
measure: Change in Binge Drinking from baseline to 30 days
timeFrame: baseline and 30 days post-baseline
measure: Change in Unprotected sex from baseline to 30 days
timeFrame: baseline and 30 days post-baseline
measure: Change in alcohol or drug use before sex from baseline to 30 days
timeFrame: baseline and 30 days post-baseline
measure: Change in HIV/STI testing from baseline to immediately post-intervention and 30 day post-intervention
timeFrame: baseline, immediately post-intervention, and 30 days post-intervention
Other outcomes:
measure: Change in Clinician-Youth Communication for Clinicians from baseline to immediately post-intervention and 30 days post-intervention
timeFrame: baseline, immediately post-intervention, and 30 days-post baseline
measure: Change in Clinician-Youth Communication for Youth from baseline to immediately post-intervention and 30 days post-intervention
timeFrame: baseline, immediately post-intervention, and 30 days-post baseline
measure: Change in Youth Self-Efficacy as measured by the Condom Self-Efficacy Scale from baseline to immediately post-intervention and 30 days post-intervention
timeFrame: baseline, immediately post-intervention, and 30 days-post baseline
measure: Change in Youth Self-Efficacy as measured by Drug Use Resistance Self-Efficacy Scale from baseline to immediately post-intervention and 30 days post-intervention
timeFrame: baseline, immediately post-intervention, and 30 days-post baseline
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Ypsilanti
country: United States
facility: Corner Health Center
state: Michigan
Study officials:
References:
citation: Cordova D, Alers-Rojas F, Lua FM, Bauermeister J, Nurenberg R, Ovadje L, Fessler K, Delva J, Salas-Wright CP, Council YL. The Usability and Acceptability of an Adolescent mHealth HIV/STI and Drug Abuse Preventive Intervention in Primary Care. Behav Med. 2018 Jan-Mar;44(1):36-47. doi: 10.1080/08964289.2016.1189396. Epub 2016 Jul 15.
citation: Cordova D, Bauermeister JA, Fessler K, Delva J, Nelson A, Nurenberg R, Mendoza Lua F, Alers-Rojas F, Salas-Wright CP; Youth Leadership Council. A Community-Engaged Approach to Developing an mHealth HIV/STI and Drug Abuse Preventive Intervention for Primary Care: A Qualitative Study. JMIR Mhealth Uhealth. 2015 Dec 18;3(4):e106. doi: 10.2196/mhealth.4620.
citation: Cordova D, Lua FM, Ovadje L, Fessler K, Bauermeister JA, Salas-Wright CP, Vaughn MG, Leadership Council Y. Adolescent Experiences of Clinician-Patient HIV/STI Communication in Primary Care. Health Commun. 2018 Sep;33(9):1177-1183. doi: 10.1080/10410236.2017.1339379. Epub 2017 Jul 7.
citation: Cordova D, Munoz-Velazquez J, Mendoza Lua F, Fessler K, Warner S, Delva J, Adelman N; Youth Leadership Council; Fernandez A, Bauermeister J. Pilot Study of a Multilevel Mobile Health App for Substance Use, Sexual Risk Behaviors, and Testing for Sexually Transmitted Infections and HIV Among Youth: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Mar 17;8(3):e16251. doi: 10.2196/16251.