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N/A N=909 Randomized Prevention

Enhancing Quality Interventions Promoting Healthy Sexuality

Pregnancy in Adolescence · HIV

Enrolled (actual)
909
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Abstinence Attitudes — 4.18; 4.17; 4.17; 4.26 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Making Proud Choices (Behavioral); Making Proud Choices AND Getting To Outcomes (Behavioral)
Age
Pediatric · 10+ yrs
Sex
All
Sponsor
RAND
Primary completion
Dec 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Abstinence Attitudes
4.18; 4.17; 4.17; 4.26
SECONDARY
Interview About Change in Capacity

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Those who do not speak English
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01818791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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