A Community-University Approach to Preventing HIV

NCT03938077 | Withdrawn DMC

• 1 other identifier: HUM00151011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Examine the feasibility and acceptability of delivering the S4E intervention to 20 African-American youths between the ages 16-21 in Flint, Michigan. The investigators will examine the preliminary efficacy of the S4E intervention in improving the uptake of HIV self-testing immediately post-intervention.

Conditions

HIV/AIDS and Infections; Drug Abuse; Adolescent Behavior; Drug Usage; Alcohol Use; Mental Health; Tobacco Use; HIV Testing

Keywords

mHealth; prevention intervention; primary health care

Outcome Measures

Primary Outcomes (3)

• Lifetime HIV Testing

  At baseline we will assess binary outcome of participant's lifetime HIV testing and collect date of most recent HIV test using an item adapted from the Centers for Disease Control (CDC) Youth Behavior Risk Survey (YRBS). A sample question for youth is "Have you every been tested for HIV?". Responses consist of "1=Yes", "0=No", and "98=Refuse to Answer".

  Baseline

• HIV Self-Testing

  Immediately post-intervention, we will assess the binary outcome of HIV self-testing using items adopted from Lightfoot and colleagues (2018).

  Immediately post-intervention

• HIV Self-Test Results Disclosure

  Post-intervention we will asses the percentage of youth that disclose their HIV self-test results to the Near Peer.

  Immediately post-intervention

Secondary Outcomes (14)

• Change in Sexual Risk Beliefs from baseline to immediately post-intervention

  baseline and immediatly post-intervention

• Change in Sexual Risk Attitudes from baseline to immediately post-intervention

  baseline and immediatly post-intervention

• Change in Future intentions regarding sexual risk from baseline to immediately post-intervention

  baseline and immediatly post-intervention

• Linkage to Care and Prevention

  immediately post-intervention

• Eligibility rates for the Near Peer

  enrollment period pre-intervention

Other Outcomes (4)

• Change in Near Peer-Youth Communication for Near Peers from baseline to immediately post-intervention

  baseline and immediately post-intervention

• Change in Near Peer-Youth Communication for Youth from baseline to immediately post-intervention

  baseline and immediately post-intervention

• Change in Youth Self-Efficacy as measured by Drug Use Resistance Self-Efficacy Scale from baseline to immediately post-intervention

  baseline and immediately post-intervention

Study Arms (1)

S4E App intervention

EXPERIMENTAL

Youth will receive the S4E intervention via provided iPads. The intervention will last approximately 60. Content includes: (a) storytelling scenarios, (b) drug use and HIV/STI knowledge, (c) interactive activities, (d) increasing self-efficacy to prevent/reduce sexual and drug use risk behaviors and increase HIV self-testing, (e) Near Peer-youth communication, and (f) highlighting prevention principles. The youth will participate in a Near Peer-initiated prevention and risk reduction encounter which includes (a) reinforcement of HIV solutions that youth learned in the S4E app, (b) promotion of HIV self-tests, and (c) linkage to care and prevention services. Youth have the option to take a HIV self-test. We will determine the acceptability of youth disclosing their results to their Near Peer and linkage to resources. The research staff will also conduct in-depth qualitative interviews with both youth and Near Peer participants to assess feasibility and acceptability of S4E.

Device: Storytelling 4 Empowerment

Interventions

Storytelling 4 Empowerment DEVICE

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 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 tobacco prevention and cessation.

S4E App intervention

Eligibility Criteria

• Age: 16 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age
• Sexually Active
• African American
• Live in Flint Michigan

You may not qualify if:

• Report of prior psychiatric hospitalization by adolescent
• Visible cognitive impairment due to drug use

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

YOUR Center

Flint, Michigan, 48504, 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, Lua FM, Ovadje L, Fessler K, Bauermeister JA, Salas-Wright CP, Vaughn MG, Leadership Council Y. Adolescent Experiences of Clinician-Patient HIV/STI Communication in Primary Care. Health Commun. 2018 Sep;33(9):1177-1183. doi: 10.1080/10410236.2017.1339379. Epub 2017 Jul 7.

  PMID: 28686489 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Infections; Substance-Related Disorders; Adolescent Behavior; Alcohol Drinking; Psychological Well-Being; Tobacco Use

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; Drinking Behavior; Personal Satisfaction

Study Officials

• David Cordova, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: To examine the preliminary efficacy of the S4E intervention in improving the uptake of HIV self-testing immediately post-intervention and the feasibility(e.g., enrollment rates, eligibility) and acceptability (e.g., satisfaction) of S4E .

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: May 6, 2019
• Study Start: October 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)