Ignite Creation Date:
2024-05-05 @ 10:50 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01195220
Status:
WITHDRAWN
Last Update Posted:
2015-05-08
First Post:
2010-09-03
Brief Title:
Project AWARE Using the Emergency Department ED to Prevent Sexually Transmitted Infections STIs in Youth
Sponsor:
North Bronx Healthcare Network
Organization:
North Bronx Healthcare Network
Study Overview
Official Title:
Project AWARE Using the ED to Prevent STIs in Youth
Status:
WITHDRAWN
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We could not obtain proper funding to complete this study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AWARE
Brief Summary:
Project Aware introduces a sexually transmitted infection STI screening model for sexually experienced adolescents aged 14 to 21 in a large inner-city Emergency Department ED in the Bronx NY Project Aware will scaffold routine rapid testing and counseling for Chlamydia trachomatis CT and Neisseria gonorrhoeae GC onto an existing successful ED-based HIV testing and counseling program Project BRIEF Project Aware will educate and motivate youth to use condoms with the aid of a theory-based youth-friendly multimedia behavioral intervention proven to be effective during the investigators K23 training Through Project Aware the investigators propose to change the paradigm of STI testing Whereas a view of HIV exceptionalism has persisted in US health policies on STI testing the investigators propose a comprehensive approach in which efforts to identify treat and prevent multiple STIs coalesce in one program The research study has two phases In the production phase new STI material will be added to the multimedia intervention currently used for HIV education In the evaluation phase a randomized controlled trial RCT will be conducted to assess the effectiveness of Project Aware in identifying treating and preventing new STI infections among high-risk adolescents The RCT is designed to test the incremental effectiveness of three STI prevention methods 1 HIV testing and counseling TC 2 HIV TC and STI testing and 3 HIVSTI Testing plus a point-of-service risk reduction video that incorporates both HIV and STI counseling and education The study is powered to examine three STI prevention outcomes 1 the number of STI infections identified and treated successfully at baseline 2 the number of new STI infections over the 12 months following study entry identified by a performing STI testing at each follow-up assessment and b obtaining anonymized rate data on STIs reported to the New York City Department of Health 3 condom use behavior 600 youth aged 14-21 will be enrolled in the RCT Youth will be approached in the ED waiting room and recruited by Public Health Advocates All will complete a survey to screen for eligibility eligible youth will complete the baseline measures and be randomized The follow-up data points and measures will be followed at 4 8 and 12 months 4 time points and STI testing will be included
Detailed Description:
Almost half of all new sexually transmitted infections STIs occur in young people aged 15-241 The vast majority 88 consists of chlamydia CT gonorrhea GC human papilloma virus HPV and trichomoniasis1 Additionally the Centers for Disease Control and Prevention CDC reported that young people aged 15-24 accounted for 7297 new HIV diagnoses in 2008 177 of all new diagnoses for the year2 Inner-city sexually active adolescents are exceptionally vulnerable to contracting HIV and STIs3 In 2008 the Bronx had the highest proportion of AIDS cases of any borough in New York City5 For Bronx females aged 15 to 19 the CT infection case rate was 7621 per 100000 and 812 per 100000 for GC the highest in this age group in New York City4 The infection rate among young men aged 15-19 in the Bronx is also the highest in New York City the case rate was 2092 for CT and 458 for GC4
Based on its concern about adolescent HIV risk the CDC changed the HIV testing paradigm by recommending routine HIV testing for all adolescents It also recommended routine HIV screening for all patients seeking STI testing and treatment at STI clinics6 However universal STI screening in adolescents is not routine in other medical settings even though most STIs are asymptomatic and therefore undiagnosed We believe that screening youth for HIV provides an opportunity to screen for STIs as well and that testing should be combined with harm reduction interventions This project will evaluate the efficacy of Project AWARE in diagnosing treating and preventing HIV and STI infections in a Bronx Emergency Department ED
This proposal is based on eight years of research and experience developing and testing a successful ED-based multimedia program for HIV prevention7 The first four years focused on developing videos that educated adult ED patients and encouraged them to be tested for HIV Project BRIEF-A has achieved high acceptance 95 for adult HIV testing and has linked 85 of HIV patients into specialized medical care89 The last 4 years developed Project BRIEF-T an efficient youth-friendly theory-based harm reduction video intervention for teens10 It delivered different short video interventions to youth based on their stage of change Results are promising Project BRIEF-T was effective in moving youth to the next stage of change in their intentions to use condoms We propose in this application to test Project AWARE which will add universal STI testing to Project BRIEF-T and evaluate the effects of the theory-based video intervention on condom use at 4 8 and 12 months post-testing
Project AWARE will be evaluated using a three group randomized trial Group 1 the control will be the current standard of care consenting video and testing for HIV alone HIV-T Group 2 will add routine STI testing for CT and GC STIHIV-T Group 3 in addition to combined STIHIV testing will add a behavioral video encouraging safer sex which is chosen for participants based on their answers to a brief measure on stage of change STIHIV-PLUS Comparing Group 1 to Group 2 will identify the number of new STI infections identified through routine testing to establish whether routine screening successfully identified a substantial number of new cases over and above routine care Comparing Group 1 to Group 3 will identify whether the addition of the Stages of Change intervention significantly increases condom use among teens
Specific Aims
1 To compare the efficacy of the three study arms and to test for significant differences at the 4 month follow up in order to provide information to programs concerning efficient use of resources
2 To study the persistence of the intervention effects over time between 4 and 12 months on the primary outcome as well as to examine the intervention effect on condom use intentions condom self-efficacy and condom outcome expectancy and reduce sexual risk behavior at each follow up time point
3 To estimate the prevalence of STIs at baseline
The project is explicitly translational If Project AWARE efficiently identifies and treats asymptomatic HIV and STIs and successfully reduces subsequent sexual risk behavior among teens it can be implemented in EDs at relatively low cost Given the new emphasis in the US on efficient preventive care this project can provide an exemplary portable intervention tool that can reach many high risk youth with asymptomatic STIs and HIV who do not access routine primary care The studys results might also contribute to the development of new screening policies to incorporate multiple STIs into existing HIV screening
Based on its concern about adolescent HIV risk the CDC changed the HIV testing paradigm by recommending routine HIV testing for all adolescents It also recommended routine HIV screening for all patients seeking STI testing and treatment at STI clinics6 However universal STI screening in adolescents is not routine in other medical settings even though most STIs are asymptomatic and therefore undiagnosed We believe that screening youth for HIV provides an opportunity to screen for STIs as well and that testing should be combined with harm reduction interventions This project will evaluate the efficacy of Project AWARE in diagnosing treating and preventing HIV and STI infections in a Bronx Emergency Department ED
This proposal is based on eight years of research and experience developing and testing a successful ED-based multimedia program for HIV prevention7 The first four years focused on developing videos that educated adult ED patients and encouraged them to be tested for HIV Project BRIEF-A has achieved high acceptance 95 for adult HIV testing and has linked 85 of HIV patients into specialized medical care89 The last 4 years developed Project BRIEF-T an efficient youth-friendly theory-based harm reduction video intervention for teens10 It delivered different short video interventions to youth based on their stage of change Results are promising Project BRIEF-T was effective in moving youth to the next stage of change in their intentions to use condoms We propose in this application to test Project AWARE which will add universal STI testing to Project BRIEF-T and evaluate the effects of the theory-based video intervention on condom use at 4 8 and 12 months post-testing
Project AWARE will be evaluated using a three group randomized trial Group 1 the control will be the current standard of care consenting video and testing for HIV alone HIV-T Group 2 will add routine STI testing for CT and GC STIHIV-T Group 3 in addition to combined STIHIV testing will add a behavioral video encouraging safer sex which is chosen for participants based on their answers to a brief measure on stage of change STIHIV-PLUS Comparing Group 1 to Group 2 will identify the number of new STI infections identified through routine testing to establish whether routine screening successfully identified a substantial number of new cases over and above routine care Comparing Group 1 to Group 3 will identify whether the addition of the Stages of Change intervention significantly increases condom use among teens
Specific Aims
1 To compare the efficacy of the three study arms and to test for significant differences at the 4 month follow up in order to provide information to programs concerning efficient use of resources
2 To study the persistence of the intervention effects over time between 4 and 12 months on the primary outcome as well as to examine the intervention effect on condom use intentions condom self-efficacy and condom outcome expectancy and reduce sexual risk behavior at each follow up time point
3 To estimate the prevalence of STIs at baseline
The project is explicitly translational If Project AWARE efficiently identifies and treats asymptomatic HIV and STIs and successfully reduces subsequent sexual risk behavior among teens it can be implemented in EDs at relatively low cost Given the new emphasis in the US on efficient preventive care this project can provide an exemplary portable intervention tool that can reach many high risk youth with asymptomatic STIs and HIV who do not access routine primary care The studys results might also contribute to the development of new screening policies to incorporate multiple STIs into existing HIV screening
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None