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Project AWARE: Using the Emergency Department (ED) to Prevent Sexually Transmitted Infections (STIs) in Youth (AWARE)

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ClinicalTrials.gov Identifier: NCT01195220
Recruitment Status : Withdrawn (We could not obtain proper funding to complete this study.)
First Posted : September 6, 2010
Last Update Posted : May 8, 2015
Sponsor:
Information provided by (Responsible Party):
Yvette Calderon,MD, MS, North Bronx Healthcare Network

Study Description
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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, N.Y. 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 investigator's K23 training. Through Project Aware, the investigators propose to change the paradigm of STI testing. Whereas a view of "HIV exceptionalism" has persisted in U.S. 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 (T&C), (2) HIV T&C and STI testing, and (3) HIV/STI 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.

Condition or disease Intervention/treatment Phase
Chlamydia Gonorrhea HIV Behavioral: HIV testing Behavioral: STI/HIV-T Behavioral: STI/HIV-Plus Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Project AWARE: Using the ED to Prevent STIs in Youth
Study Start Date : December 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : May 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: HIV-T

Group 1, the control, will be the current standard of care, consenting video and testing for HIV alone (HIV-T).

This is the current standard of care. It obtains consent for HIV vesting by a proven video, and provides rapid HIV testing on site. Informed consent video includes information about the test and its interpretation, as mandated by New York State Law. The the OraQuick ADVANCE® Rapid HIV- 1/2 Antibody Test

 Behavioral: HIV testing
This is the current standard of care. It obtains consent for HIV vesting by a proven video, and provides rapid HIV testing on site. Informed consent video includes information about the test and its interpretation, as mandated by New York State Law. The the OraQuick ADVANCE® Rapid HIV- 1/2 Antibody Test
Experimental: STI/HIV-T

Group 2 will add routine STI testing for CT and GC, (STI/HIV-T).

This intervention adds testing for GC and CT to HIV testing. The informed consent video will incorporate information for STIs to accompany information presented on HIV. GC and CT screening is conducted via a urine sample. The APTIMA Combo 2 Assay has been cleared by the Food and Drug Administration for sale in the US. It employs Gen-Probe's patented Transcription-Mediated Amplification (TMA) technology to detect CT and GC using urine specimens for both male and female patients. We will test urine for GC and CT at the ED visit using the hospital lab within the urban ED.

 Behavioral: STI/HIV-T
This intervention adds testing for GC and CT to HIV testing. The informed consent video will incorporate information for STIs to accompany information presented on HIV. GC and CT screening is conducted via a urine sample. The APTIMA Combo 2 Assay has been cleared by the Food and Drug Administration for sale in the US. It employs Gen-Probe's patented Transcription-Mediated Amplification (TMA) technology to detect CT and GC using urine specimens for both male and female patients. We will test urine for GC and CT at the ED visit using the hospital lab within the urban ED.
Experimental: STI/HIV-Plus

Group 3, in addition to combined STI/HIV 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 (STI/HIV-PLUS).

This intervention includes the combined STI/HIV testing, and adds the behavioral video that encourages safer sex and is targeted to the participants' stage of change. While patients wait for their HIV test result (20-30 minutes), patients will view these video vignettes

 Behavioral: STI/HIV-T
This intervention adds testing for GC and CT to HIV testing. The informed consent video will incorporate information for STIs to accompany information presented on HIV. GC and CT screening is conducted via a urine sample. The APTIMA Combo 2 Assay has been cleared by the Food and Drug Administration for sale in the US. It employs Gen-Probe's patented Transcription-Mediated Amplification (TMA) technology to detect CT and GC using urine specimens for both male and female patients. We will test urine for GC and CT at the ED visit using the hospital lab within the urban ED.

Behavioral: STI/HIV-Plus
This intervention includes the combined STI/HIV testing, and adds the behavioral video that encourages safer sex and is targeted to the participants' stage of change. While patients wait for their HIV test result (20-30 minutes), patients will view these video vignettes.


Outcome Measures
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Primary Outcome Measures :
  1. STI infections (GC and CT) [ Time Frame: 4-months post intervention ]

Secondary Outcome Measures :
  1. intentions for condom use [ Time Frame: immediately after intervention (baseline) ]
  2. Intention for condom use [ Time Frame: 4-months post intervention ]
  3. Intention for Condom Use [ Time Frame: 8 months post intervention ]
  4. Intentions for Condom Use [ Time Frame: 12 months post intervention ]
  5. STI infections (GC and CT) [ Time Frame: 8-months post intervention ]
  6. STI infections (GC and CT) [ Time Frame: 12 months post intervention ]

Eligibility Criteria
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Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 14-21 years old
  • Sexually active
  • English speaking

Exclusion Criteria:

  • medically unstable
  • unable to understand the consent process
  • tested for HIV/STI within the past 4 weeks
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01195220


Locations
United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
North Bronx Healthcare Network
Investigators
Principal Investigator: Yvette Calderon, MD, MS Jacobi Medical Center, Albert Einstein College of Medicine
More Information
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Responsible Party: Yvette Calderon,MD, MS, Director of the Urgent Care Clinic, North Bronx Healthcare Network
ClinicalTrials.gov Identifier: NCT01195220     History of Changes
Other Study ID Numbers: 2010-381
First Posted: September 6, 2010    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015

Keywords provided by Yvette Calderon,MD, MS, North Bronx Healthcare Network:
STI screening
Emergency Department
Chlamydia
Gonorrhea
 HIV
behavior
teenagers
intervention

Additional relevant MeSH terms:
Chlamydia Infections
Sexually Transmitted Diseases
Gonorrhea
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
 Sexually Transmitted Diseases, Bacterial
Infection
Genital Diseases, Male
Genital Diseases, Female
Virus Diseases
Neisseriaceae Infections