- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01818791
Enhancing Quality Interventions Promoting Healthy Sexuality (EQUIPS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- Assess the (a) utilization of and (b) subsequent effects of GTO on program staff capacity to implement EBPs
- 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
- 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Auburn, Alabama, United States, 36830
- Boys & Girls Clubs of Greater Lee County
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Huntsville, Alabama, United States, 35804
- Boys & Girls Clubs of North Alabama
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Montgomery, Alabama, United States, 36104
- Boys & Girls Clubs of Montgomery
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Georgia
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Atlanta, Georgia, United States, 30303
- Atlanta Boys and Girls Club
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Youth aged 10-14 who attend a participating Boys and Girls Club
Exclusion Criteria:
- Those who do not speak English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Making Proud Choices alone
These sites will be trained in Making Proud Choices.
|
Making Proud Choices (MPC) is a well-established pregnancy and HIV/STI risk-reduction EBP with multiple trials demonstrating its effectiveness.
Using Social Cognitive Theory, the Theories of Reasoned Action, and Planned Behavior, MPC aims to influence adolescents' knowledge and beliefs about risk, efficacy, and control to change behavior.
MPC stresses the role of sexual responsibility, community, and pride in making safer sexual choices.
The program promotes abstinence first, but also provides information and skills needed for safer-sex decision-making and practices (e.g., condom use).
|
Experimental: Making Proud Choices+Getting To Outcomes
These sites will receive training in Making Proud Choices and receive the Getting To Outcomes intervention.
|
Making Proud Choices (MPC) is a well-established pregnancy and HIV/STI risk-reduction EBP with multiple trials demonstrating its effectiveness.
Using Social Cognitive Theory, the Theories of Reasoned Action, and Planned Behavior, MPC aims to influence adolescents' knowledge and beliefs about risk, efficacy, and control to change behavior.
MPC stresses the role of sexual responsibility, community, and pride in making safer sexual choices.
The program promotes abstinence first, but also provides information and skills needed for safer-sex decision-making and practices (e.g., condom use).
In addition to MPC, these sites receive the Getting To Outcomes(GTO) intervention, which builds capacity for EBPs by strengthening the knowledge, attitudes, and skills needed to choose, plan, implement, evaluate, and sustain those EBPs.
GTO poses ten "steps" that must be addressed and provides practitioners with the guidance necessary to address those steps with quality-i.e., as close to the ideal as possible.
Implementation of these ten steps is facilitated by three types of assistance: the GTO manual of text and tools originally published by the RAND Corporation and then applied to teen pregnancy (PSBA-GTO), face-to-face training, and onsite TA.
Consistent with social cognitive theories of behavioral change exposure to GTO training and TA leads to more knowledge about performing GTO-related activities, which leads to more positive attitudes towards these activities, which in turn leads to the execution of more GTO-related behaviors.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Youth sexual knowledge, attitudes, and behavior
Time Frame: Baseline, Post (8 weeks later), 6 month follow-up from baseline
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Several sets of outcomes are on the Youth Survey including sexual activity, STIs, condom use, and pregnancy.
In addition, the Youth Survey asks about attitudes and beliefs about sexual activity, condom use, and pregnancy, as well as knowledge about HIV, STIs, condom use, and pregnancy.
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Baseline, Post (8 weeks later), 6 month follow-up from baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interview about change in capacity
Time Frame: At baseline (prior to GTO), midpoint of GTO (after 1 year), post GTO (after 2 years), and after a year of no GTO (for GTO+MPC group) or after a year of GTO after not having it for the previous two years (for MPC only group).
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Investigators are using the Capacity Interview to assess BGC staff capacity to conduct high-quality teen pregnancy programming.
Although programs consist of individual people with varying levels of abilities, capacity ratings are made at the program level since programs operate as a unit.
The ratings are made using a structured interview with key program personnel at all 32 BGC sites.
The ratings reflect how well each BGC site is carrying out the tasks tied to each of the ten steps of the GTO model, from "highly faithful" to "highly divergent" from ideal practice.
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At baseline (prior to GTO), midpoint of GTO (after 1 year), post GTO (after 2 years), and after a year of no GTO (for GTO+MPC group) or after a year of GTO after not having it for the previous two years (for MPC only group).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fidelity
Time Frame: Twice per site in each of the two intervention years
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Adherence -Over the two year intervention period, trained local data collectors are visiting each BGC site and rating how closely BGC staff adhere to each MPC module as designed.
Dosage - BGC staff are recording how many of the eight modules each youth receives.
Quality of delivery - During site visits, local data collectors are rating BGC staff on their teaching style-communication skills, interactions with participants, enthusiasm, and pacing-using a standardized rating sheet.
Participant response - During site visits, local data collectors are rating student participation.
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Twice per site in each of the two intervention years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthew Chinman, PhD, RAND
Publications and helpful links
General Publications
- Chinman M, Acosta J, Ebener P, Driver J, Keith J, Peebles D. Enhancing Quality Interventions Promoting Healthy Sexuality (EQUIPS): a novel application of translational research methods. Clin Transl Sci. 2013 Jun;6(3):232-7. doi: 10.1111/cts.12031. Epub 2013 Apr 18.
- Chinman M, Acosta J, Ebener P, Malone PS, Slaughter ME. A Cluster-Randomized Trial of Getting To Outcomes' Impact on Sexual Health Outcomes in Community-Based Settings. Prev Sci. 2018 May;19(4):437-448. doi: 10.1007/s11121-017-0845-6.
- Chinman M, Acosta J, Ebener P, Malone PS, Slaughter ME. Can implementation support help community-based settings better deliver evidence-based sexual health promotion programs? A randomized trial of Getting To Outcomes(R). Implement Sci. 2016 May 31;11(1):78. doi: 10.1186/s13012-016-0446-y.
- Herman PM, Chinman M, Ebener P, Malone PS, Acosta J. Cost analysis of a randomized trial of Getting to Outcomes implementation support for a teen pregnancy prevention program offered in Boys and Girls Clubs in Alabama and Georgia. Prev Sci. 2020 Nov;21(8):1114-1125. doi: 10.1007/s11121-020-01162-y.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 5R01HD069427-03 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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