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

HIV Clinical Trial

— AWARE  

Official title:

Project AWARE: Using the ED to Prevent STIs in Youth

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01195220
• Other study ID #: 2010-381
• Status: Withdrawn
• Phase: N/A
• First received: September 3, 2010
• Last updated: May 7, 2015
• Start date: December 2011
• Est. completion date: May 2013

Study information

• Verified date: May 2015
• Source: North Bronx Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Almost half of all new sexually transmitted infections (STIs) occur in young people aged 15-24.1 The vast majority (88%) consists of chlamydia (CT), gonorrhea (GC), human papilloma virus (HPV), and trichomoniasis.1 Additionally, the Centers for Disease Control and Prevention (CDC) reported that young people aged 15-24 accounted for 7,297 new HIV diagnoses in 2008, 17.7% of all new diagnoses for the year.2 Inner-city, sexually active adolescents are exceptionally vulnerable to contracting HIV and STIs.3 In 2008, the Bronx had the highest proportion of AIDS cases of any borough in New York City.5 For Bronx females aged 15 to 19, the CT infection case rate was 7,621 per 100,000 and 812 per 100,000 for GC, the highest in this age group in New York City.4 The infection rate among young men aged 15-19 in the Bronx is also the highest in New York City: the case rate was 2,092 for CT and 458 for GC.4

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 clinics.6 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 prevention.7 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 care.8,9 The last 4 years developed Project BRIEF-T, an efficient, youth-friendly, theory-based harm reduction video intervention for teens.10 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, (STI/HIV-T). 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). 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 U.S. 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 study's results might also contribute to the development of new screening policies to incorporate multiple STIs into existing HIV screening.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 21 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chlamydia
• Gonorrhea
• HIV
• Sexually Transmitted Diseases

Intervention

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
• 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.
• 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.

Locations

Country	Name	City	State
United States	Jacobi Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
North Bronx Healthcare Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	STI infections (GC and CT)		4-months post intervention	No
Secondary	intentions for condom use		immediately after intervention (baseline)	No
Secondary	Intention for condom use		4-months post intervention	No
Secondary	Intention for Condom Use		8 months post intervention	No
Secondary	Intentions for Condom Use		12 months post intervention	No
Secondary	STI infections (GC and CT)		8-months post intervention	No
Secondary	STI infections (GC and CT)		12 months post intervention	No