NCT01698073

Brief Summary

Youth who participate in the Circle of Life (COL) program will report less sexual risk taking behavior compared to youth who do not receive the program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

2.5 years

First QC Date

September 25, 2012

Last Update Submit

January 7, 2016

Conditions

Teen Pregnancy Prevention

Keywords

Teen pregnancy preventionAmerican IndianGroup-randomized trial

Outcome Measures

Primary Outcomes (1)

  • Ever had sexual intercourse

    Ever had sexual intercourse is measured by youth self-reported answers in an online survey to a question on lifetime sexual activity. Specifically, youth are coded "1" if they report having had sex ever before in their lifetimes, "0" otherwise. This question is repeated at each data collection point with youth.

    Baseline, 3 months, 1 year

Study Arms (2)

mCOL

EXPERIMENTAL

mCircle of Life is a culturally-based HIV-prevention intervention designed for American Indian and Alaska Native 10-12 year-olds. It includes both online and facilitated material.

Behavioral: mCOL

AS+

ACTIVE COMPARATOR

After-School Science Plus is a curriculum designed for youth to teach science and literacy using everyday materials. It helps youth see how science is a part of everyday life and provides role models of scientists who come from different backgrounds and ethnicities.

Other: AS+

Interventions

mCOLBEHAVIORAL
Also known as: mCircle of Life
mCOL
AS+OTHER
Also known as: After-School Science Plus
AS+

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years old at baseline
  • A member of participating Native Boys and Girls Club
  • Signed Parental Consent Form
  • Signed Parental Permission Form
  • Signed Child Assent Form

You may not qualify if:

  • None Noted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

  • Kaufman CE, Litchfield A, Schupman E, Mitchell CM. Circle of Life HIV/AIDS-prevention intervention for American Indian and Alaska Native youth. Am Indian Alsk Native Ment Health Res. 2012;19(1):140-53. doi: 10.5820/aian.1901.2012.140.

    PMID: 22569729BACKGROUND

  • Kaufman CE, Whitesell NR, Keane EM, Desserich JA, Giago C, Sam A, Mitchell CM. Effectiveness of Circle of Life, an HIV-preventive intervention for American Indian middle school youths: a group randomized trial in a Northern Plains tribe. Am J Public Health. 2014 Jun;104(6):e106-12. doi: 10.2105/AJPH.2013.301822. Epub 2014 Apr 22.

    PMID: 24754555BACKGROUND

  • Black KJ, Morse B, Tuitt N, Big Crow C, Shangreau C, Kaufman CE. Beyond Content: Cultural Perspectives on Using the Internet to Deliver a Sexual Health Intervention to American Indian Youth. J Prim Prev. 2018 Feb;39(1):59-70. doi: 10.1007/s10935-017-0497-0.

    PMID: 29344773DERIVED

Study Officials

  • Carol E Kaufman, PhD

    University of Colorado Anschutz Medical Campus, Centers for American Indian and Alaska Native Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2012

First Posted

October 2, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

January 11, 2016

Record last verified: 2016-01

Locations

US(1)