Adolescent Behavior Clinical Trial
Official title:
Preventing HIV/STI in Urban Adolescents Via an mHealth Primary Care Intervention
Verified date | August 2022 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | August 12, 2020 |
Est. primary completion date | August 12, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 21 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Corner Health Center | Ypsilanti | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Clinician-Youth Communication | Completed by both the clinician (a =.70) and youth (a =.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." | baseline, 3 and 6 month post-baseline | |
Other | 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, a =.85), and Drug Use Resistance Self-Efficacy (24 items, a =.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?" | baseline, 3 and 6 month post-baseline | |
Primary | 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). | baseline, 3 and 6 month post-baseline | |
Secondary | 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). | 3 and 6 month post-baseline | |
Secondary | 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. | baseline, 3 and 6 month post-baseline |
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