NCT02904629: TPP

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

Completed NA Last updated 15 July 2022

What this trial tests

NA trial testing Respecting the Circle of Life (RCL) in Sex in 1,072 participants. Completed in 1 April 2022.

Timeline

1 May 2016

Primary endpoint
1 April 2022

1 April 2022

Quick facts

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,072
Start date	1 May 2016
Primary completion	1 April 2022
Estimated completion	1 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Respecting the Circle of Life (RCL)
• Control Program

Conditions studied

• Sex — all drugs for Sex →
• Unprotected Sex — all drugs for Unprotected Sex →
• Contraception — all drugs for Contraception →
• Alcohol Use — all drugs for Alcohol Use →

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

11 and older, any sex, with Sex or Unprotected Sex. Healthy volunteers can join.

What's being measured

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

• Condom use self efficacy as measured by the Condom Use Self-Efficacy Scale (range 1-5): Mean score on a 6-question Likert scale (1-5)
  Time frame: 3-month, 9-month, 12-month, 24-month, 36-month
  Mean difference in ability to correctly and consistently use condoms, between intervention and control groups at baseline, 3-month, 9-month, 12-month, 24-month, 36-month post-intervention.

Sponsor's own description

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.

Publications & conference data

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

1. Prevention of Sexually Transmitted Diseases and Pregnancy Prevention Among Native American Youths: A Randomized Controlled Trial, 2016-2018.
   Tingey L, Chambers R, Patel H, Littlepage S, et al · · 2021 · cited 10× · PMID 34529503 · DOI 10.2105/ajph.2021.306447
2. Rigorous evaluation of a pregnancy prevention program for American Indian youth and adolescents: study protocol for a randomized controlled trial.
   Tingey L, Chambers R, Goklish N, Larzelere F, et al · · 2017 · cited 10× · PMID 28241775 · DOI 10.1186/s13063-017-1842-6