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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 : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
David Cordova, 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.

Condition or disease Intervention/treatment Phase
HIV/AIDS and Infections Drug Abuse Adolescent Behavior Drug Usage Behavioral: S4E Behavioral: Usual Care Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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: Double (Participant, Investigator)
Primary Purpose: Prevention
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, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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
Behavioral: S4E
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.


Other Outcome Measures:
  1. 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."

  2. 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?"



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: David Cordova, PhD 7347636201 cordovad@umich.edu

Locations
United States, Michigan
Corner Health Center Recruiting
Ypsilanti, Michigan, United States, 48198
Contact: David Cordova, PhD    734-763-6201    cordovad@umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: David Cordova, PhD University of Michigan

Publications:
Responsible Party: David Cordova, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03368456     History of Changes
Other Study ID Numbers: HUM00118704
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Cordova, University of Michigan:
mhealth
preventive intervention
primary health care

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders