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

Purpose

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	Intervention
Chlamydia Gonorrhea HIV	Behavioral: HIV testing Behavioral: STI/HIV-T Behavioral: STI/HIV-Plus


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:

MedlinePlus related topics: Chlamydia Infections Gonorrhea HIV/AIDS Sexually Transmitted Diseases

U.S. FDA Resources

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 ]


Enrollment:	0
Study Start Date:	December 2011
Study Completion Date:	May 2013
Primary Completion Date:	January 2013 (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). 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.

Show Detailed Description

Eligibility


Ages Eligible for Study:	14 Years to 21 Years (Child, Adult)
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


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
Study First Received:	September 3, 2010
Last Updated:	May 7, 2015
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:


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

ClinicalTrials.gov processed this record on September 23, 2016

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