A Community-University Approach to Preventing HIV

Not Applicable

Withdrawn

• Conditions: Adolescent Behavior; Alcohol Use; Mental Health; HIV Testing; HIV/AIDS and Infections; Drug Abuse; Tobacco Use; Drug Usage
• Interventions: Device: Storytelling 4 Empowerment

• Registration Number: NCT03938077
• Lead Sponsor: University of Michigan

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.

Detailed Description

HIV is a significant public health concern in the US, and African American youth (defined as the adolescent and young adults 16-21 years of age) are disproportionately affected. Furthermore, HIV risk behaviors, including substance use and sexual risk behaviors are prominent. Despite the disproportionately high rates of HIV infection and risk behaviors in youth, few youth report having ever been tested for HIV and many are not routinely screened for asymptomatic STIs as recommended by the Center for Disease Control. To address these significant public health concerns, a mobile-health (mHealth) intervention, Storytelling 4 Empowerment (S4E) was developed for health clinic settings. S4E has demonstrated high feasibility, acceptability, and preliminary efficacy among youth in clinic settings. The proposed research will determine the feasibility and acceptability of delivering S4E via near peers, as well as determine the preliminary efficacy of S4E to improve HIV self-testing immediately post-intervention in a community sample (n=20) of at-risk youth ages 16-21 living in Flint, Michigan by conducting a phase I, one-arm pilot study to examine the feasibility and preliminary efficacy of S4E in improving the uptake of HIV self-testing immediately post-intervention. A University-Community approach was taken to employ principles of Community Based Participatory Research (CBPR) to determine the accessibility and acceptability of S4E when delivered by Near Peers.

Study Timeline

• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-06
• Study Start: 2019-10-01
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-06
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 16-21 years of age
• Sexually Active
• African American
• Live in Flint Michigan

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
S4E App intervention	Storytelling 4 Empowerment	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.

Primary Outcome Measures

Name	Time	Method
HIV Self-Testing	Immediately post-intervention	Immediately post-intervention, we will assess the binary outcome of HIV self-testing using items adopted from Lightfoot and colleagues (2018).
Lifetime HIV Testing	Baseline	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".
HIV Self-Test Results Disclosure	Immediately post-intervention	Post-intervention we will asses the percentage of youth that disclose their HIV self-test results to the Near Peer.

Secondary Outcome Measures

Name	Time	Method
Eligibility rates for the Youth	enrollment period pre-intervention	Immediately post-intervention, we will assess the percentage of participants who meet eligibility criteria for our study.
Linkage to Care and Prevention	immediately post-intervention	The percent of youth who are referred to substance use, mental health, and sexual health services will be assessed.
Change in Sexual Risk Beliefs from baseline to immediately post-intervention	baseline and immediatly post-intervention	Beliefs regarding sexual behaviors (e.g., intended sex, condom use, and other contraceptives) will be assessed. A sample question for the youth is, "Condoms help prevent pregnancy." Responses range from "1=Strongly disagree" to "5=Strongly Agree".
Change in Future intentions regarding sexual risk from baseline to immediately post-intervention	baseline and immediatly post-intervention	Change in future intentions of sexual behaviors (e.g., intended sex, condom use, and other contraceptives) will be assessed. A sample question for the youth is, "How likely is it that you will decide to have sex in the next 90 days?"." Responses range from "1=Very Unlikely" to "5=Very Likely".
Eligibility rates for the Near Peer	enrollment period pre-intervention	During the recruitment period of Near Peers, we will monitor and record the percentage of potential near peer participants who meet eligibility criteria to be enrolled in the study.
Change in Sexual Risk Attitudes from baseline to immediately post-intervention	baseline and immediatly post-intervention	Attitudes about sexual behaviors (e.g., intended sex, condom use, and other contraceptives) will be assessed. A sample question for the youth is "If I used a condom, sex would not feel as good." Responses range from "1=Strongly disagree" to "5=Strongly Agree".
Near Peer Satisfaction of the S4E app: Client Satisfaction Questionnaire (CSQ)	immediately-post intervention	Satisfaction is defined as how much the Near Peer enjoyed using the app and will be measured by the Client Satisfaction Questionnaire (CSQ). The CSQ is a eight item survey adapted from Larsen and colleagues (1979) that has been shown to be reliable and valid, and was previously used in a primary care intervention (Cordova et al., 2018). In our previous studies the alphas have ranged from 0.87 to 0.92. A sample question is "How would you rate the app you have received?". Responses range from "1=Poor" to "4=Excellent".
Acceptability of S4E Session for Near Peer: Session Evaluation Form (SEF)	immediately-post intervention	Acceptability is defined as how much the Near Peer enjoyed the intervention and will be measured by the Session Evaluation Form (SEF). The SEF is a 13-item survey, modified from Harper and colleagues (2008), that has been shown to be reliable and valid, and was previously used in a primary care intervention (Cordova et al., 2018). In our previous studies the alpha of SEF was 0.89. A sample question is "The session was enjoyable". Responses range from "1=Strongly Agree" to "4=Strongly Disagree".
Youth Satisfaction of the S4E app: Client Satisfaction Questionnaire (CSQ	immediately-post intervention	Satisfaction is defined as how much the youth enjoyed using the app and will be measured by the Client Satisfaction Questionnaire (CSQ). The CSQ is a eight item survey adapted from Larsen and colleagues (1979) that has been shown to be reliable and valid, and was previously used in a primary care intervention (Cordova et al., 2018). In our previous studies the alphas have ranged from 0.87 to 0.92. A sample question is "How would you rate the app you have received?". Responses range from "1=Poor" to "4=Excellent".
Percent of Enrollment for Near Peer	enrollment period pre-intervention	During the recruitment period of Near Peers, we will monitor and record the percentage of those potential near peers eligible to participate who decide to enroll in the study.
Percent of Enrollment for Youth	enrollment period pre-intervention	We will assess the percentage of those youth eligible to participate who are enrolled in the study.
Intervention Completion Rates for Youth	immediately post-intervention	Immediately post intervention, we will assess the rate of intervention completion of youth participants.
Intervention Completion Rates for Near Peer	immediately-post intervention	Immediately post intervention we will assess the rate of intervention completion of Near Peers.
Acceptability of S4E Session for Youth: Session Evaluation Form (SEF)	immediately-post intervention	Acceptability is defined as how much the youth enjoyed the interview session and will be measured by the Session Evaluation Form (SEF). The SEF is a 13-item survey, modified from Harper and colleagues (2008), that has been shown to be reliable and valid, and was previously used in a primary care intervention (Cordova et al., 2018). In our previous studies the alpha of SEF was 0.89. A sample question is "The session was enjoyable". Responses Range from "1=Strongly Agree" to "4=Strongly Disagree".

Trial Locations

Locations (2)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

YOUR Center; 🇺🇸 Flint, Michigan, United States