A Community-University Approach to Preventing HIV

December 6, 2019 updated by: David Cordova, University of Michigan
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.

Study Overview

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Flint, Michigan, United States, 48504
        • YOUR Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S4E App intervention

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lifetime HIV Testing
Time Frame: 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".
Baseline
HIV Self-Testing
Time Frame: Immediately post-intervention
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
Time Frame: Immediately post-intervention
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
Time Frame: 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".
baseline and immediatly post-intervention
Change in Sexual Risk Attitudes from baseline to immediately post-intervention
Time Frame: 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".
baseline and immediatly post-intervention
Change in Future intentions regarding sexual risk from baseline to immediately post-intervention
Time Frame: 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".
baseline and immediatly post-intervention
Linkage to Care and Prevention
Time Frame: immediately post-intervention
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
Time Frame: 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.
enrollment period pre-intervention
Percent of Enrollment for Near Peer
Time Frame: 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.
enrollment period pre-intervention
Intervention Completion Rates for Near Peer
Time Frame: immediately-post intervention
Immediately post intervention we will assess the rate of intervention completion of Near Peers.
immediately-post intervention
Eligibility rates for the Youth
Time Frame: enrollment period pre-intervention
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
Time Frame: enrollment period pre-intervention
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
Time Frame: immediately post-intervention
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)
Time Frame: 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".
immediately-post intervention
Acceptability of S4E Session for Near Peer: Session Evaluation Form (SEF)
Time Frame: 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".
immediately-post intervention
Youth Satisfaction of the S4E app: Client Satisfaction Questionnaire (CSQ
Time Frame: 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".
immediately-post intervention
Acceptability of S4E Session for Youth: Session Evaluation Form (SEF)
Time Frame: 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".
immediately-post intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Near Peer-Youth Communication for Near Peers from baseline to immediately post-intervention
Time Frame: baseline and immediately post-intervention

Completed by the Near Peer, Near Peer-youth communication will be assessed post-baseline using items adapted from the Matched Pair Instrument (19 items; MPI). MPI assesses process and content of communication, including verbal and action-related behaviors performed by Near Peers. Responses range from "1=strongly disagree," to "5=strongly agree," on a five-point Likert scale. A sample statement for Near Peers and youths is, " I encouraged the youth to express his or her thoughts concerning drug use behaviors."

The Adolescent Patient-Provider Interaction Scale will also be used to assess Near Peer- youth interaction for accessing sexual and reproductive health care (e.g., the Near Peer explained everything youth needed to know).

baseline and immediately post-intervention
Change in Near Peer-Youth Communication for Youth from baseline to immediately post-intervention
Time Frame: baseline and immediately post-intervention

Completed by the youth, Near Peer-youth communication will be assessed post-baseline using items adapted from the Matched Pair Instrument (19 items; MPI). MPI assesses process and content of communication, including verbal and action-related behaviors performed by Near Peers. Responses range from "1=strongly disagree," to "5=strongly agree," on a five-point Likert scale. A sample statement for Near Peers and youths is, "I was encouraged to express my thoughts concerning drug use behaviors."

The Adolescent Patient-Provider Interaction Scale will also be used to assess Near Peer- youth interaction for accessing sexual and reproductive health care (e.g., the Near Peer explained everything youth needed to know).

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
Time Frame: baseline and immediately post-intervention
Youth's self-efficacy will be assessed using two scales, including the Condom Self-Efficacy Scale (19 items, α =.85), and Drug Use Resistance Self-Efficacy (24 items, α =.98). Responses range from "1=not sure at all," to "4=definitely sure," on a four-point Likert scale. A sample question for the youth is, "How sure are you that you can refuse if a friend offers you marijuana at a party and you do not want it?"
baseline and immediately post-intervention
Change in Youth Self-Efficacy as measured by the Condom Self-Efficacy Scale from baseline to immediately post-intervention
Time Frame: baseline and immediately post-intervention
Youth's self-efficacy will be assessed using two scales, including the Condom Self-Efficacy Scale (19 items, α =.85), and Drug Use Resistance Self-Efficacy (24 items, α =.98). Responses range from "1=not sure at all," to "4=definitely sure," on a four-point Likert scale. A sample question for the youth is, "How sure are you that you can refuse if a friend offers you marijuana at a party and you do not want it?"
baseline and immediately post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: David Cordova, PhD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (Actual)

May 6, 2019

Study Record Updates

Last Update Posted (Actual)

December 10, 2019

Last Update Submitted That Met QC Criteria

December 6, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • HUM00151011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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