Enhancing Quality Interventions Promoting Healthy Sexuality

Part of paid clinical trials in Auburn, Alabama.

Sponsor
RAND
Study ID
NCT01818791
Status
Completed

Conditions

  • HIV
  • Pregnancy in Adolescence

Eligibility Criteria

Sex
ALL
Age
10 Years - 14 Years
Healthy Volunteers
Not accepted

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 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.

Study Details

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.

Key Dates

Start date
Jul 31, 2012
Status verified
Feb 2026
Primary completion
Dec 31, 2014
Completion
Apr 8, 2020

Study Design

Enrollment
909 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Making Proud Choices alone
    These sites will be trained in Making Proud Choices.
  • Experimental: Making Proud Choices+Getting To Outcomes
    These sites will receive training in Making Proud Choices and receive the Getting To Outcomes intervention.

Primary Outcome Measure

Abstinence Attitudes [ Time Frame: Baseline, Post (8 weeks later) ]

Locations (4)

FacilityCityStateZIP
Boys & Girls Clubs of Greater Lee CountyAuburnAlabama36830
Boys & Girls Clubs of North AlabamaHuntsvilleAlabama35804
Boys & Girls Clubs of MontgomeryMontgomeryAlabama36104
Atlanta Boys and Girls ClubAtlantaGeorgia30303

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