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

Pregnancy Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

The investigators have the following research questions:

Confirmatory Research Question 1: Assess the effectiveness of the RCL intervention, compared to the control condition, on improving knowledge related to reproductive health, pregnancy, contraception and STIs. Outcome Measure 1: Knowledge Score (0-100%): Mean score on a 44-question reproductive and sexual health knowledge survey.

Confirmatory Research Question 2: Assess the effectiveness of the RCL intervention, compared to the control condition, on delaying initiation of sexual activity. Outcome Measure 2: Proportion of participants who report they have ever had sex.

Confirmatory Research Question 3: Assess effectiveness of the RCL intervention, compared to the control condition, on improving condom use self-efficacy. Outcome Measure 3: Condom Use Self-Efficacy Scale (range 1-5): Mean score on a 6-question Likert scale (1-5).

Confirmatory Research Question 4: Assess the effectiveness of the RCL intervention, compared to the control condition, on increasing intention to use a condom at next sex.

Outcome Measure 4: Proportion of participants who report they intend to use a condom at next sex.

Sub-Group Analysis Question 1: Assess the effectiveness of the RCL intervention, compared to the control condition, on increasing reported condom use at last sex among sexually active participants. Sub-Group Analysis Outcome Measure 1: Proportion sexually active participants who report using a condom at last sex.

Sub-Group Analysis Question 2: Assess the effectiveness of the RCL intervention, compared to the control condition, on reducing the number of sexual partners reported by sexually active participants in the past three months. Sub-Group Analysis Outcome Measure 2: Mean number of sexual partners reported in the past three months by sexually active participants.

Sub-Group Analysis Question 3: Assess the effectiveness of the RCL intervention, compared to the control condition, on reducing the number of times sexually active participants reported having sex without a condom in the past three months. Sub-Group Analysis Outcome Measure 3: 1) Proportion of sexually active participants who had sex without a condom in the past three months. 2) Mean number of times reported having sex without a condom in past three months by sexually active participants.

Sub-Group Analysis Question 4: Assess the effectiveness of the RCL intervention, compared to the control condition, on increasing contraceptive use among sexually active participants in the past three months. Sub-Group Analysis Outcome Measure 4: 1) Proportion sexually active participants who had sex without birth control in past three months. 2) Mean number of times reported having sex without birth control in past three months by sexually active participants.

The impact evaluation will also examine two exploratory research questions:

Exploratory Research Question 1: Examine whether the RCL intervention, compared to the control condition, improves parental engagement (communication and monitoring) among teen participants, and whether improved parental engagement is associated with decreased risky sexual behavior among those who are sexually active (as measured by confirmatory research question outcomes).

Exploratory Research Question 2: a) Explore differences in risky sexual behaviors between adolescent participants who do and do not report substance use, and whether the RCL intervention, compared to the control condition, impacts adolescent substance use. b) Examine whether the RCL intervention, compared to the control condition, reduces reported substance use immediately prior to and/or during sex among sexually active participants. ;

Related Conditions & MeSH terms

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

• NCT number: NCT02904629
• Study type: Interventional
• Source: Johns Hopkins Bloomberg School of Public Health
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Completion date: April 2022