Project AWARE: Using the Emergency Department (ED) to Prevent Sexually Transmitted Infections (STIs) in Youth
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 14 - 21 |
| Updated: | 4/13/2015 |
| Start Date: | December 2011 |
| End Date: | May 2016 |
Project AWARE: Using the ED to Prevent STIs in Youth
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.
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.
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.
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.
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
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