Enhancing Quality Interventions Promoting Healthy Sexuality



Status:Active, not recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:10 - 14
Updated:3/29/2019
Start Date:July 2012
End Date:May 2019

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As a nation, the U.S. invests heavily in community-based organizations to conduct
interventions, proven through research, to reduce the high rates of unplanned pregnancies and
sexually transmitted infections (STIs) and HIV among teens. Much less is invested in helping
communities implement these programs with quality. Although many research-based programs
exist to address teen pregnancy and STIs, communities face difficulty implementing them and
achieving the same outcomes as researchers. This "gap" is because resources are limited,
prevention is complex, and communities often lack the capacity—or the knowledge, attitudes,
and skills—needed to implement "off the shelf" programs well. Common ways to bridge this gap,
such as information dissemination, fail to change practice or outcomes at the local level in
part because it does not sufficiently address capacity of community practitioners. Therefore,
building a community's capacity is a method that could improve the quality of implementation
and outcomes. The proposed study will use a randomized controlled design and primary data
from middle school youth (960) and program staff from 32 cooperating Boys and Girls Clubs
(Clubs) to assess how a capacity building intervention called Getting To Outcomes (GTO)
augments the quality of implementation of a research-based intervention to improve teen
sexual health (Making Proud Choices, MPC). Specifically, the study will: (1) Assess the
utilization of and subsequent effects of GTO on program staff capacity to implement MPC; (2)
Assess the degree to which Clubs using GTO show greater improvements in MPC fidelity than
Clubs that are not using GTO; and (3) Assess the degree to which Clubs using GTO show greater
improvements on teen sexual health outcomes than the comparison Clubs. To address these aims
we will collect data on the delivery and utilization of GTO (e.g., method of delivery,
duration, topics); staff capacity to implement research-based interventions; observations of
program delivery (fidelity monitoring); and youth participants' sexual activity, pregnancy,
STIs, condom use, and knowledge/ attitudes towards sex. Analyses will examine differences
between intervention and control sites over time, accounting for clustering of youth within
site. These outcomes are important to NICHD's focus on providing opportunities for youth to
become healthy and productive adults.

Since 2005, there has been greater priority to improving teen sexual health outcomes because
of increasing teen pregnancy rates and high rates of teens reporting having sexual
intercourse (approximately 50% of all high school teens). In 2006, approximately 7% of U.S.
women under the age of 20 became pregnant—152.8 pregnancies per 1,000 women aged 15 to
193-which is the highest pregnancy rate among all industrialized nations. Adolescents who
have sex are at greater risk for sexually transmitted infections, including HIV. Practicing
unsafe sex and having children as a teen come with a great cost to society in terms of lost
productivity and increased health care spending because young parents and their children
experience a range of poor health and educational outcomes. Middle school, ages 11-14, is a
key time to focus on sexual health and pregnancy prevention as it is immediately prior to the
time when many youth become sexually active. Evidence-based programs (EBPs) for middle school
youth have been shown to improve teen sexual health outcomes, including increased use of
contraception, decreased numbers of sexual partners and pregnancies, and delays in first
sexual intercourse. However, community-based organizations face difficulty implementing EBPs
with fidelity because resources are limited, EBPs are complex to implement, and program staff
often lack the capacity—or the knowledge, attitudes, and skills—needed to adopt and implement
EBPs effectively. As a result, community-based organizations are unable to achieve the
outcomes demonstrated by researchers. Although the research evidence base is growing
quickly—with over 50 EBPs shown to improve teen sex outcomes16—the science needed to promote
successful implementation of these programs in community-based settings is poorly developed.
Previous efforts to help improve the adoption and implementation of EBPs to prevent teen
pregnancy either did not improve implementation of EBPs, or did not document how the support
provided to program implementers translated to improvements in teen sexual health outcomes.
Large community trials focused on the adoption and implementation of EBPs targeting teen
sexual health outcomes are needed to assess the type and amount of support that helps
community-based organizations to implement these EBPs with fidelity and achieve outcomes
similar to those achieved in research. Therefore, the goal for this 5-year study will be to
conduct a multi-state, communitybased trial to assess how a capacity-building intervention
called Getting To Outcomes affects three variables of interest: 32 Boys and Girls Clubs'
capacity to adopt and implement an EBP (Making Proud Choices or MPC), the fidelity of their
MPC implementation, and the sex outcomes of the middle school youth they serve.

The capacity building intervention for program staff called Getting To Outcomes (GTO)
provides techincal assistance, training, and a manual to improve community-based
practitioners' capacity to complete tasks associated with implementing an EBP, which in turn
leads to improved implementation fidelity. Improved implementation fidelity of EBPs like
Making Proud Choices leads to improved teen sexual health outcomes. In quasi-experimental and
case studies, GTO has been shown effective in helping community-based organizations implement
substance abuse prevention EBPs with fidelity and document outcomes. GTO was later adapted by
CDC in its 5-year Promoting Science Based Approaches to Teen Pregnancy Prevention Project
(PSBA-GTO). However, CDC did not evaluate GTO's impact on program fidelity or teen sexual
health outcomes. The proposed randomized, controlled trial would build on the tools developed
in PSBA-GTO and other GTO projects to compare staff capacity, program fidelity, and teen
sexual health outcomes across 16 Boys and Girls Clubs implementing MPC in the fashion typical
of community settings (8 in Atlanta, 8 in Alabama) with 16 Boys and Girls Clubs implementing
MPC augmented with GTO (also 8 in Atlanta, 8 in Alabama). The specific aims of this
investigator-initiated R01 are to:

1. Assess the (a) utilization of and (b) subsequent effects of GTO on program staff
capacity to implement EBPs

2. Assess the degree to which Boys and Girls Clubs using GTO show greater improvements in
MPC fidelity than Boys and Girls Clubs that are not using GTO

3. Assess the degree to which middle-school-aged youth enrolled in the Boys and Girls Clubs
using GTO show greater improvements in sexual health outcomes than Boys and Girls Clubs
that are not using GTO

This study has the potential to document, for the first time, how a capacity-building
intervention (GTO) can help community-based organizations implement EBPs and improve teen
sexual health outcomes. This information is critical as states and particularly the federal
government are allocating substantial funds to implement EBPs to prevent teen pregnancy in
community-based settings (e.g., in FY 2010 the Administration for Children and Families
Office of Adolescent Health dedicated $110 million). As such, the proposed study will inform
the ongoing debate about how to best improve the implementation of EBPs to achieve better
teen sexual health outcomes and educate policymakers' about the resources needed for
successful implementation of EBPs on a large scale.

Inclusion Criteria:

- Youth aged 10-14 who attend a participating Boys and Girls Club

Exclusion Criteria:

- Those who do not speak English
We found this trial at
4
sites
Atlanta, Georgia 30303
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Auburn, AL
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Huntsville, Alabama 35804
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Huntsville, AL
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Montgomery, Alabama 36104
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Montgomery, AL
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