An interventional study of S4E and Usual Care in HIV/AIDS and Infections, Drug Abuse and Adolescent Behavior, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 14 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-31.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
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.
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.
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This study's enrollment of 100 is close to the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
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Exclusion Criteria:
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
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
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.
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
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).
Time frame: baseline, 3 and 6 month post-baseline
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).
Time frame: 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.
Time frame: baseline, 3 and 6 month post-baseline
Change in Clinician-Youth Communication
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."
Time frame: baseline, 3 and 6 month post-baseline
Youth Self-Efficacy
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?"
Time frame: baseline, 3 and 6 month post-baseline
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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