Preventing HIV/STI in Urban Adolescents Via an mHealth Primary Care Intervention
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|ClinicalTrials.gov Identifier: NCT03368456|
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS and Infections Drug Abuse Adolescent Behavior Drug Usage||Behavioral: S4E Behavioral: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Official Title:||Preventing HIV/STI in Urban Adolescents Via an mHealth Primary Care Intervention|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||July 31, 2019|
Experimental: S4E App Intervention
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
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.
Placebo Comparator: Usual Care Condition
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
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.
- Change in Adolescent HIV Testing [ Time Frame: 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).
- Change in condomless sex behaviors [ Time Frame: 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).
- Change in drug use behaviors [ Time Frame: 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 Clinician-Youth Communication [ Time Frame: baseline, 3 and 6 month post-baseline ]Completed by both the clinician (α =.70) and youth (α =.69), clinician-youth communication will be assessed (time points 1-3) using items adapted from the Matched Pair Instrument (19 items; MPI). MPI assesses process and content of communication, including verbal and action-related behaviors performed by clinicians. Responses range from "1=strongly disagree," to "5=strongly agree," on a five-point Likert scale. A sample statement for clinicians and youths is, "Encouraged the patient/me to express his or her/my thoughts concerning drug use behaviors."
- Youth Self-Efficacy [ Time Frame: baseline, 3 and 6 month post-baseline ]Youth's self-efficacy will be assessed (time points 1-3) using two scales, including the Condom Self-Efficacy Scale (19 items, α =.85), and Drug Use Resistance Self-Efficacy (24 items, α =.98). Responses range from "1=not sure at all," to "4=definitely sure," on a four-point Likert scale. A sample question for the youth is, "How sure are you that you can refuse if a friend offers you marijuana at a party and you do not want it?"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368456
|Contact: David Cordova, PhDemail@example.com|
|United States, Michigan|
|Corner Health Center||Recruiting|
|Ypsilanti, Michigan, United States, 48198|
|Contact: David Cordova, PhD 734-763-6201 firstname.lastname@example.org|
|Principal Investigator:||David Cordova, PhD||University of Michigan|