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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2010 by North Bronx Healthcare Network
Sponsor:
Collaborator:
Information provided by:
North Bronx Healthcare Network
ClinicalTrials.gov Identifier:
NCT01195220
First received: September 3, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

Project Aware introduces a novel 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 existing, successful, ED-based HIV testing and counseling programs, Project BRIEF and Project Control. 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. public 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. This model is necessary to further understanding about STIs and to prevent health conditions that enable health disparities within communities. The research study has two phases. In the production phase, new STI material will be added to the multimedia intervention currently used for adolescent 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 (number of unprotected sex acts, number of times condoms were used). 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, following procedures used for Project BRIEF and Project Control. All will complete a short 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 Intervention
Chlamydia
Gonorrhea
HIV
Behavioral: HIV testing
Behavioral: Combined HIV/STI screening
Behavioral: Theory-based risk reduction video counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Project AWARE: Using the ED to Prevent STIs in Youth

Resource links provided by NLM:


Further study details as provided by North Bronx Healthcare Network:

Primary Outcome Measures:
  • STI infections (GC and CT) [ Time Frame: 4-months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • intentions for condom use [ Time Frame: immediately after intervention (baseline) ] [ Designated as safety issue: No ]
  • Intention for condom use [ Time Frame: 4-months post intervention ] [ Designated as safety issue: No ]
  • Intention for Condom Use [ Time Frame: 8 months post intervention ] [ Designated as safety issue: No ]
  • Intentions for Condom Use [ Time Frame: 12 months post intervention ] [ Designated as safety issue: No ]
  • STI infections (GC and CT) [ Time Frame: 8-months post intervention ] [ Designated as safety issue: No ]
  • STI infections (GC and CT) [ Time Frame: 12 months post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 690
Study Start Date: December 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HIV-T
Group 1, the control, will be the current standard of care, consenting video and testing for HIV alone (HIV-T).
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).
Behavioral: Combined HIV/STI screening
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).
Behavioral: Combined HIV/STI screening
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: Theory-based risk reduction video counseling
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Yvette Calderon, North Bronx Healthcare Network
ClinicalTrials.gov Identifier: NCT01195220     History of Changes
Other Study ID Numbers: 2010-381, HD067106
Study First Received: September 3, 2010
Last Updated: September 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by North Bronx Healthcare Network:
STI screening
Emergency Department
Chlamydia
Gonorrhea
HIV
behavior
teenagers
intervention

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Genital Diseases, Female
Genital Diseases, Male
Sexually Transmitted Diseases, Bacterial
Virus Diseases
HIV Antibodies
Gonorrhea
Bacterial Infections
Gram-Negative Bacterial Infections
Infection
Neisseriaceae Infections
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014