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Evaluation of Respecting the Circle of Life on Pregnancy Prevention Outcomes Among American Indian Adolescents

NCT02904629 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1072

Last updated 2022-07-19

No results posted yet for this study

Summary

The objective of this research study is to evaluate a culturally tailored sexual and reproductive health intervention among American Indian (AI) youth. Specifically, the investigators aim to evaluate the impact of "Respecting the Circle of Life: Mind, Body and Spirit" on knowledge, attitude and behavioral outcomes associated with risk for unprotected sex, sexually transmitted infection (STI) and unintended pregnancy through a randomized controlled trial on the White Mountain Apache (WMA) reservation. The investigators will examine whether the RCL intervention effectively reduces risky sexual behavior among AI adolescents (11-19 years old), with long term goals of reducing teen pregnancy and incidence/prevalence of STIs. The evaluation will focus on well-established intermediate outcomes/risky sexual behaviors that predict long-term impact on teen pregnancy and STI incidence.

Conditions

  • Sex
  • Unprotected Sex
  • Contraception
  • Alcohol Use
  • Drug Use
  • Pregnancy

Interventions

BEHAVIORAL

Respecting the Circle of Life (RCL)

Intervention activities will consist of the delivery of RCL: an holistic sexual, reproductive health and teen pregnancy prevention curriculum. RCL was adapted in 2011 from an evidence-based intervention (EBI) for the prevention of HIV/AIDS called "Focus on Youth (FOY) + Informed Parents and Children Together (ImPACT)."

OTHER

Control Program

Control activities will consist of the delivery of educational lessons on nutrition, fitness, outdoor recreation, safety, environmental protection and nature.

Sponsors & Collaborators

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Allison Barlow, PhD · Center for American Indian Health

  • Lauren Tingey, PhD · Center for American Indian Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02904629 on ClinicalTrials.gov