NCT02540304

Brief Summary

This study is evaluating the effectiveness of three evidence-based teen pregnancy prevention (TPP) programs in reducing sexual risk-taking behaviors of youth. The study is using an experimental design in which youth are randomly assigned to receive either TPP programming or services as usual.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,620

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 8, 2017

Status Verified

June 1, 2017

Enrollment Period

4.1 years

First QC Date

September 1, 2015

Last Update Submit

June 7, 2017

Conditions

Teen PregnancySexual Risk-taking Behaviors

Outcome Measures

Primary Outcomes (2)

  • Sexual activity in the last 90 days

    single dichotomous outcome on self-report questionnaire

    6 months after baseline

  • Sexual Risk in the last 90 days

    single dichotomous outcome on self-report questionnaire

    6 months after baseline

Secondary Outcomes (2)

  • Use of Birth Control in the last 90 days

    6 months after baseline

  • Knowledge of Sexually transmitted infections

    6 months after baseline

Study Arms (2)

TPP program

EXPERIMENTAL

Reducing the Risk, Safer Sex Intervention, Cuidate!

Behavioral: Reducing the Risk

Business as Usual

NO INTERVENTION

Business as usual

Interventions

Reducing the RiskBEHAVIORAL

Safer Sex is a clinic-based intervention intended to reduce the incidence of STIs and increase condom use among high-risk sexually active female adolescents and delivered in face-to-face individualized sessions by a female health educator. Reducing the Risk is a sexuality-education curriculum, most often delivered in a school setting that provides instruction and practice in the social skills needed to put into action what students learn about preventing pregnancy and reducing unsafe behavior in future high-risk situations. ¡Cuidate! is adapted from the Be Proud! Be Responsible! curriculum and culturally tailored for Latino youth. It aims to reduce HIV risk and unintended pregnancies by affecting sexual behaviors such as intercourse, number of partners, and condom use.

Also known as: Safer Sex Intervention, Cuidate!
TPP program

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • youth at risk active consent parent permission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Meredith C Kelsey, PhD

    Abt Associates Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 3, 2015

Study Start

September 1, 2012

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

June 8, 2017

Record last verified: 2017-06