A Community-University Approach to Preventing HIV

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Community-University Approach to Preventing HIV

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

Intervention / Treatment
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* Device: Storytelling 4 Empowerment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 16-21 years of age Sexually Active African American Live in Flint Michigan Exclusion Criteria: Report of prior psychiatric hospitalization by adolescent Visible cognitive impairment due to drug use

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: 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 .
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S4E App intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sexual Risk Beliefs from baseline to immediately 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. | baseline and immediatly post-intervention | 
| Change in Sexual Risk Attitudes from baseline to immediately 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. | baseline and immediatly post-intervention | 
| Change in Future intentions regarding sexual risk from baseline to immediately 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. | baseline and immediatly post-intervention | 
| Linkage to Care and Prevention | The percent of youth who are referred to substance use, mental health, and sexual health services will be assessed. | immediately post-intervention | 
| Eligibility rates for the Near Peer | 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. | enrollment period pre-intervention | 
| Percent of Enrollment for Near Peer | 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. | enrollment period pre-intervention | 
| Intervention Completion Rates for Near Peer | Immediately post intervention we will assess the rate of intervention completion of Near Peers. | immediately-post intervention | 
| Eligibility rates for the Youth | Immediately post-intervention, we will assess the percentage of participants who meet eligibility criteria for our study. | enrollment period pre-intervention | 
| Percent of Enrollment for Youth | We will assess the percentage of those youth eligible to participate who are enrolled in the study. | enrollment period pre-intervention | 
| Intervention Completion Rates for Youth | Immediately post intervention, we will assess the rate of intervention completion of youth participants. | immediately post-intervention | 
| Near Peer Satisfaction of the S4E app: Client Satisfaction Questionnaire (CSQ) | 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. | immediately-post intervention | 
| Acceptability of S4E Session for Near Peer: Session Evaluation Form (SEF) | 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. | immediately-post intervention | 
| Youth Satisfaction of the S4E app: Client Satisfaction Questionnaire (CSQ | 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. | immediately-post intervention | 
| Acceptability of S4E Session for Youth: Session Evaluation Form (SEF) | 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. | immediately-post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, prevention intervention, primary health care