Clinical trial NCT03368456: Preventing HIV/STI in Urban Adolescents Via an mHealth Primary Care Intervention
Official title: Preventing HIV/STI in Urban Adolescents Via an mHealth Primary Care Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS and Infections
Drug Abuse
Adolescent Behavior
Drug Usage
Keywords: mhealth
preventive intervention
primary health care
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 14
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 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.
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Adolescent HIV Testing
timeFrame: baseline, 3 and 6 month post-baseline
Secondary outcomes:
measure: Change in condomless sex behaviors
timeFrame: 3 and 6 month post-baseline
measure: Change in drug use behaviors
timeFrame: baseline, 3 and 6 month post-baseline
Other outcomes:
measure: Change in Clinician-Youth Communication
timeFrame: baseline, 3 and 6 month post-baseline
measure: Youth Self-Efficacy
timeFrame: baseline, 3 and 6 month post-baseline
Locations:
city: Ypsilanti
country: United States
facility: Corner Health Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: David Cordova, PhD
role: PRINCIPAL_INVESTIGATOR
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.