Preventing HIV/STI in Urban Adolescents Via an mHealth Primary Care Intervention

NCT03368456 | Completed DMC

• 2 other identifiers: HUM00158089Previous HUM00118704
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS and Infections; Drug Abuse; Adolescent Behavior; Drug Usage

Keywords

mhealth; preventive intervention; primary health care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in condomless sex behaviors

  3 and 6 month post-baseline

• Change in drug use behaviors

  baseline, 3 and 6 month post-baseline

Other Outcomes (2)

• Change in Clinician-Youth Communication

  baseline, 3 and 6 month post-baseline

• Youth Self-Efficacy

  baseline, 3 and 6 month post-baseline

Study Arms (2)

S4E App Intervention

EXPERIMENTAL

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

Usual Care Condition

PLACEBO COMPARATOR

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

Interventions

S4E BEHAVIORAL

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.

S4E App Intervention

Usual Care BEHAVIORAL

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.

Usual Care Condition

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Corner Health Center

Ypsilanti, Michigan, 48198, United States

Location

Related Publications (3)

• 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.

  PMID: 27223646 BACKGROUND

• 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.

  PMID: 26685288 BACKGROUND

• Cordova D, Bauermeister JA, Warner S; Youth Leadership Council; Wells P, MacLeod J, Neilands TB, Mendoza Lua F, Delva J, Fessler KB, Smith V Jr, Khreizat S, Boyer C. Efficacy of a Digital Health Preventive Intervention for Adolescents With HIV or Sexually Transmitted Infections and Substance Use Disorder: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 19;13:e47216. doi: 10.2196/47216.

  PMID: 38373025 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Infections; Substance-Related Disorders; Adolescent Behavior

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• David Cordova, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 11, 2017
• Study Start: May 1, 2018
• Primary Completion: August 12, 2020
• Study Completion: August 12, 2020
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)