Enhancing Quality Interventions Promoting Healthy Sexuality

NCT01818791 | Completed Results

• 1 other identifier: 5R01HD069427-03
• Study Type: interventional
• Target: 909
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Pregnancy in Adolescence; HIV

Outcome Measures

Primary Outcomes (1)

• Abstinence Attitudes

  attitudes about abstinence - 5-point response scale (5= strongly agree to 1 = strongly disagree), higher score means more prosocial attitudes.

  Baseline, Post (8 weeks later)

Secondary Outcomes (1)

• Interview About Change in Capacity

  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).

Other Outcomes (1)

• Change in Fidelity

  Twice per site in each of the two intervention years

Study Arms (2)

Making Proud Choices alone

ACTIVE COMPARATOR

These sites will be trained in Making Proud Choices.

Behavioral: Making Proud Choices

Making Proud Choices+Getting To Outcomes

EXPERIMENTAL

These sites will receive training in Making Proud Choices and receive the Getting To Outcomes intervention.

Behavioral: Making Proud Choices; Behavioral: Making Proud Choices AND Getting To Outcomes

Interventions

Making Proud Choices BEHAVIORAL

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).

Making Proud Choices alone; Making Proud Choices+Getting To Outcomes

Making Proud Choices AND Getting To Outcomes BEHAVIORAL

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.

Making Proud Choices+Getting To Outcomes

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Those who do not speak English

Sponsors & Collaborators

• RAND: lead

Study Sites (4)

Boys & Girls Clubs of Greater Lee County

Auburn, Alabama, 36830, United States

Location

Boys & Girls Clubs of North Alabama

Huntsville, Alabama, 35804, United States

Location

Boys & Girls Clubs of Montgomery

Montgomery, Alabama, 36104, United States

Location

Atlanta Boys and Girls Club

Atlanta, Georgia, 30303, United States

Location

Related Publications (4)

• 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.

  PMID: 23751031 BACKGROUND

• 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.

  PMID: 32880842 RESULT

• 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.

  PMID: 27245158 RESULT

• 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.

  PMID: 28971273 RESULT

Results Point of Contact

• Title: Matthew Chinman
• Organization: RAND

chinman@rand.org

412 683-2300

Study Officials

• Matthew Chinman, PhD

  RAND

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 26, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: April 8, 2020
• Last Updated: March 11, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-02

Locations

US (4)