NCT01818791: EQUIPS

Enhancing Quality Interventions Promoting Healthy Sexuality

Completed NA Results posted Last updated 18 February 2026

What this trial tests

NA trial testing Making Proud Choices in Pregnancy in Adolescence in 909 participants. Completed in 8 April 2020.

Timeline

1 July 2012

Primary endpoint
1 December 2014

8 April 2020

Quick facts

Lead sponsor	RAND
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	909
Start date	1 July 2012
Primary completion	1 December 2014
Estimated completion	8 April 2020
Sites	4 locations across United States

Drugs / interventions tested

• Making Proud Choices
• Making Proud Choices AND Getting To Outcomes

Conditions studied

• Pregnancy in Adolescence — all drugs for Pregnancy in Adolescence →
• HIV — all drugs for HIV →

Sponsor

RAND — full company profile →

Who can join

Adults 10 to 14, any sex, with Pregnancy in Adolescence or HIV. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Abstinence Attitudes
  Time frame: Baseline, Post (8 weeks later)
  attitudes about abstinence - 5-point response scale (5= strongly agree to 1 = strongly disagree), higher score means more prosocial attitudes.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Can implementation support help community-based settings better deliver evidence-based sexual health promotion programs? A randomized trial of Getting To Outcomes®.
   Chinman M, Acosta J, Ebener P, Malone PS, et al · · 2016 · cited 36× · PMID 27245158 · DOI 10.1186/s13012-016-0446-y
2. 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.
   Herman PM, Chinman M, Ebener P, Malone PS, et al · · 2020 · cited 3× · PMID 32880842 · DOI 10.1007/s11121-020-01162-y