Clinical trial NCT03938077: A Community-University Approach to Preventing HIV
Official title: A Community-University Approach to Preventing HIV
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
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
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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 .
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Lifetime HIV Testing
timeFrame: Baseline
measure: HIV Self-Testing
timeFrame: Immediately post-intervention
measure: HIV Self-Test Results Disclosure
timeFrame: Immediately post-intervention
Secondary outcomes:
measure: Change in Sexual Risk Beliefs from baseline to immediately post-intervention
timeFrame: baseline and immediatly post-intervention
measure: Change in Sexual Risk Attitudes from baseline to immediately post-intervention
timeFrame: baseline and immediatly post-intervention
measure: Change in Future intentions regarding sexual risk from baseline to immediately post-intervention
timeFrame: baseline and immediatly post-intervention
measure: Linkage to Care and Prevention
timeFrame: immediately post-intervention
measure: Eligibility rates for the Near Peer
timeFrame: enrollment period pre-intervention
measure: Percent of Enrollment for Near Peer
timeFrame: enrollment period pre-intervention
measure: Intervention Completion Rates for Near Peer
timeFrame: immediately-post intervention
measure: Eligibility rates for the Youth
timeFrame: enrollment period pre-intervention
measure: Percent of Enrollment for Youth
timeFrame: enrollment period pre-intervention
measure: Intervention Completion Rates for Youth
timeFrame: immediately post-intervention
measure: Near Peer Satisfaction of the S4E app: Client Satisfaction Questionnaire (CSQ)
timeFrame: immediately-post intervention
measure: Acceptability of S4E Session for Near Peer: Session Evaluation Form (SEF)
timeFrame: immediately-post intervention
measure: Youth Satisfaction of the S4E app: Client Satisfaction Questionnaire (CSQ
timeFrame: immediately-post intervention
measure: Acceptability of S4E Session for Youth: Session Evaluation Form (SEF)
timeFrame: immediately-post intervention
Other outcomes:
measure: Change in Near Peer-Youth Communication for Near Peers from baseline to immediately post-intervention
timeFrame: baseline and immediately post-intervention
measure: Change in Near Peer-Youth Communication for Youth from baseline to immediately post-intervention
timeFrame: baseline and immediately post-intervention
measure: Change in Youth Self-Efficacy as measured by Drug Use Resistance Self-Efficacy Scale from baseline to immediately post-intervention
timeFrame: baseline and immediately post-intervention
measure: Change in Youth Self-Efficacy as measured by the Condom Self-Efficacy Scale from baseline to immediately post-intervention
timeFrame: baseline and immediately post-intervention
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Flint
country: United States
facility: YOUR Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: David Cordova, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.