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Withdrawn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

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 |
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.
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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.
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- STI infections (GC and CT) [ Time Frame: 4-months post intervention ]
- intentions for condom use [ Time Frame: immediately after intervention (baseline) ]
- Intention for condom use [ Time Frame: 4-months post intervention ]
- Intention for Condom Use [ Time Frame: 8 months post intervention ]
- Intentions for Condom Use [ Time Frame: 12 months post intervention ]
- STI infections (GC and CT) [ Time Frame: 8-months post intervention ]
- STI infections (GC and CT) [ Time Frame: 12 months post intervention ]

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

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
United States, New York | |
Jacobi Medical Center | |
Bronx, New York, United States, 10461 |
Principal Investigator: | Yvette Calderon, MD, MS | Jacobi Medical Center, Albert Einstein College of Medicine |
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 |