Enhancing Quality Interventions Promoting Healthy Sexuality (EQUIPS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01818791|
Recruitment Status : Active, not recruiting
First Posted : March 26, 2013
Last Update Posted : May 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy in Adolescence HIV||Behavioral: Making Proud Choices Behavioral: Making Proud Choices AND Getting To Outcomes||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||960 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enhancing Quality Interventions Promoting Healthy Sexuality|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Making Proud Choices alone
These sites will be trained in Making Proud Choices.
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).
Experimental: Making Proud Choices+Getting To Outcomes
These sites will receive training in Making Proud Choices and receive the Getting To Outcomes intervention.
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.
- Change in Youth sexual knowledge, attitudes, and behavior [ Time Frame: Baseline, Post (8 weeks later), 6 month follow-up from baseline ]Several sets of outcomes are on the Youth Survey including sexual activity, STIs, condom use, and pregnancy. In addition, the Youth Survey asks about attitudes and beliefs about sexual activity, condom use, and pregnancy, as well as knowledge about HIV, STIs, condom use, and pregnancy.
- Interview about change in capacity [ Time Frame: 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). ]Investigators are using the Capacity Interview to assess BGC staff capacity to conduct high-quality teen pregnancy programming. Although programs consist of individual people with varying levels of abilities, capacity ratings are made at the program level since programs operate as a unit. The ratings are made using a structured interview with key program personnel at all 32 BGC sites. The ratings reflect how well each BGC site is carrying out the tasks tied to each of the ten steps of the GTO model, from "highly faithful" to "highly divergent" from ideal practice.
- Change in Fidelity [ Time Frame: Twice per site in each of the two intervention years ]Adherence -Over the two year intervention period, trained local data collectors are visiting each BGC site and rating how closely BGC staff adhere to each MPC module as designed. Dosage - BGC staff are recording how many of the eight modules each youth receives. Quality of delivery - During site visits, local data collectors are rating BGC staff on their teaching style—communication skills, interactions with participants, enthusiasm, and pacing—using a standardized rating sheet. Participant response - During site visits, local data collectors are rating student participation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01818791
|United States, Alabama|
|Boys & Girls Clubs of Greater Lee County|
|Auburn, Alabama, United States, 36830|
|Boys & Girls Clubs of North Alabama|
|Huntsville, Alabama, United States, 35804|
|Boys & Girls Clubs of Montgomery|
|Montgomery, Alabama, United States, 36104|
|United States, Georgia|
|Atlanta Boys and Girls Club|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Matthew Chinman, PhD||RAND|