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A Community-University Approach to Preventing HIV

Primary Purpose

HIV/AIDS and Infections, Drug Abuse, Adolescent Behavior

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Storytelling 4 Empowerment
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS and Infections focused on measuring mHealth, prevention intervention, primary health care

Eligibility Criteria

16 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan
  • YOUR Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

S4E App intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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".
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".
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".
Linkage to Care and Prevention
The percent of youth who are referred to substance use, mental health, and sexual health services will be assessed.
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.
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.
Intervention Completion Rates for Near Peer
Immediately post intervention we will assess the rate of intervention completion of Near Peers.
Eligibility rates for the Youth
Immediately post-intervention, we will assess the percentage of participants who meet eligibility criteria for our study.
Percent of Enrollment for Youth
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, we will assess the rate of intervention completion of youth participants.
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".
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".
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".
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".

Full Information

First Posted
April 15, 2019
Last Updated
December 6, 2019
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03938077
Brief Title
A Community-University Approach to Preventing HIV
Official Title
A Community-University Approach to Preventing HIV
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Unfortunately, the co-PI and lead community partner relocated out of the target area. Therefore, recruiting participants from the target area was not feasible.
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S4E App intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Storytelling 4 Empowerment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lifetime HIV Testing
Description
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".
Time Frame
Baseline
Title
HIV Self-Testing
Description
Immediately post-intervention, we will assess the binary outcome of HIV self-testing using items adopted from Lightfoot and colleagues (2018).
Time Frame
Immediately post-intervention
Title
HIV Self-Test Results Disclosure
Description
Post-intervention we will asses the percentage of youth that disclose their HIV self-test results to the Near Peer.
Time Frame
Immediately post-intervention
Secondary Outcome Measure Information:
Title
Change in Sexual Risk Beliefs from baseline to immediately post-intervention
Description
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".
Time Frame
baseline and immediatly post-intervention
Title
Change in Sexual Risk Attitudes from baseline to immediately post-intervention
Description
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".
Time Frame
baseline and immediatly post-intervention
Title
Change in Future intentions regarding sexual risk from baseline to immediately post-intervention
Description
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".
Time Frame
baseline and immediatly post-intervention
Title
Linkage to Care and Prevention
Description
The percent of youth who are referred to substance use, mental health, and sexual health services will be assessed.
Time Frame
immediately post-intervention
Title
Eligibility rates for the Near Peer
Description
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.
Time Frame
enrollment period pre-intervention
Title
Percent of Enrollment for Near Peer
Description
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.
Time Frame
enrollment period pre-intervention
Title
Intervention Completion Rates for Near Peer
Description
Immediately post intervention we will assess the rate of intervention completion of Near Peers.
Time Frame
immediately-post intervention
Title
Eligibility rates for the Youth
Description
Immediately post-intervention, we will assess the percentage of participants who meet eligibility criteria for our study.
Time Frame
enrollment period pre-intervention
Title
Percent of Enrollment for Youth
Description
We will assess the percentage of those youth eligible to participate who are enrolled in the study.
Time Frame
enrollment period pre-intervention
Title
Intervention Completion Rates for Youth
Description
Immediately post intervention, we will assess the rate of intervention completion of youth participants.
Time Frame
immediately post-intervention
Title
Near Peer Satisfaction of the S4E app: Client Satisfaction Questionnaire (CSQ)
Description
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".
Time Frame
immediately-post intervention
Title
Acceptability of S4E Session for Near Peer: Session Evaluation Form (SEF)
Description
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".
Time Frame
immediately-post intervention
Title
Youth Satisfaction of the S4E app: Client Satisfaction Questionnaire (CSQ
Description
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".
Time Frame
immediately-post intervention
Title
Acceptability of S4E Session for Youth: Session Evaluation Form (SEF)
Description
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".
Time Frame
immediately-post intervention
Other Pre-specified Outcome Measures:
Title
Change in Near Peer-Youth Communication for Near Peers from baseline to immediately post-intervention
Description
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).
Time Frame
baseline and immediately post-intervention
Title
Change in Near Peer-Youth Communication for Youth from baseline to immediately post-intervention
Description
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).
Time Frame
baseline and immediately post-intervention
Title
Change in Youth Self-Efficacy as measured by Drug Use Resistance Self-Efficacy Scale from baseline to immediately post-intervention
Description
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?"
Time Frame
baseline and immediately post-intervention
Title
Change in Youth Self-Efficacy as measured by the Condom Self-Efficacy Scale from baseline to immediately post-intervention
Description
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?"
Time Frame
baseline and immediately post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Cordova, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
YOUR Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27223646
Citation
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.
Results Reference
background
PubMed Identifier
26685288
Citation
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.
Results Reference
background
PubMed Identifier
28686489
Citation
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.
Results Reference
background

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A Community-University Approach to Preventing HIV

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