Enhancing Quality Interventions Promoting Healthy Sexuality
NCT01818791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 909
Last updated 2026-03-11
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
Interventions
- BEHAVIORAL
-
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).
- BEHAVIORAL
-
Making Proud Choices AND Getting To Outcomes
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.
Sponsors & Collaborators
-
RAND
lead OTHER
Principal Investigators
-
Matthew Chinman, PhD · RAND
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 10 Years
- Max Age
- 14 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-07-31
- Primary Completion
- 2014-12-31
- Completion
- 2020-04-08
Countries
- United States
Study Locations
More Related Trials
-
Partner-Specific HIV Risk Reduction Intervention for Drug-Using Adolescents
NCT00831883 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of Integrating Prenatal Care in Reducing HIV/STDs Among Young Pregnant Women
NCT00628771 ·Status: COMPLETED ·Phase: PHASE4
-
All About Youth: Evaluation of Sexual Risk Avoidance and Risk Reduction Programs for Middle School Students
NCT00167505 ·Status: COMPLETED ·Phase: NA
-
Replication of Evidence-based Programs
NCT03533192 ·Status: COMPLETED ·Phase: NA
-
HORIZONS HIV Intervention
NCT00633906 ·Status: COMPLETED ·Phase: NA
-
Parents Matter!: Interventions to Promote Effective Parent-Child Communication
NCT00137943 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy of an Abstinence-Only HIV Risk-Reduction Intervention for Young African-American Adolescents
NCT00640653 ·Status: COMPLETED ·Phase: NA
-
Improving HIV Prevention Among Heterosexual Men Seeking STI Services in Malawi
NCT06200545 ·Status: COMPLETED ·Phase: NA
-
Intervention Development for Newly Diagnosed Youth With HIV
NCT00255892 ·Status: COMPLETED
-
Preventing HIV/Aids in Drug Abusing Youth
NCT00680719 ·Status: COMPLETED ·Phase: PHASE1
-
Reducing HIV Risk Among Mexican Youth
NCT01084395 ·Status: COMPLETED ·Phase: NA
-
Parent-focused Intervention to Reduce HIV Risk in Gay and Bisexual Adolescents
NCT05852600 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Peer-driven Intervention to Seek, Test & Treat Heterosexuals at High Risk for HIV
NCT01607541 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Comparative Effectiveness of Web-based Versus Traditional Adolescent HIV Prevention
NCT01142882 ·Status: UNKNOWN ·Phase: NA
-
Evaluation of the SafeSpace App Intervention
NCT06043596 ·Status: RECRUITING ·Phase: NA
-
Maintaining HIV Prevention Gains in Female Adolescents
NCT00161343 ·Status: COMPLETED ·Phase: PHASE2
-
Development of a Telehealth-delivered Peer Navigation and Coping Skills Intervention to Increase PrEP Use in Young Black MSM
NCT05769270 ·Status: TERMINATED ·Phase: NA
-
Intervention for Newly Diagnosed Youth With HIV
NCT00510237 ·Status: COMPLETED ·Phase: NA
-
We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples
NCT03551938 ·Status: COMPLETED ·Phase: NA
-
Optimizing PrEP Uptake for African American Women in the South by Empowering Women to Make Informed HIV Prevention and Sexual Health Choices
NCT07173816 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Evaluation of the Talking Matters Teen Pregnancy Prevention Program
NCT04970485 ·Status: COMPLETED ·Phase: NA
-
Understanding and Reducing HIV Risk Behavior and Substance Use Among Self-identified Bisexual Adolescent Men
NCT03409328 ·Status: COMPLETED ·Phase: NA
-
HIV and STD Prevention for High-Risk, Inner-City, African American Youth
NCT00353405 ·Status: COMPLETED ·Phase: PHASE3
-
Effectiveness and Implementation of Text Messaging to Improve HIV Testing in Adolescents
NCT06096519 ·Status: RECRUITING ·Phase: NA
-
HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response
NCT01169922 ·Status: WITHDRAWN ·Phase: NA