Clinical trial NCT02904629: Evaluation of Respecting the Circle of Life on Pregnancy Prevention Outcomes Among American Indian Adolescents
Official title: Evaluation of Respecting the Circle of Life on Pregnancy Prevention Outcomes Among American Indian Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sex
Unprotected Sex
Contraception
Alcohol Use
Drug Use
Pregnancy
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 1072
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* American Indian ethnicity
* Membership in the White Mountain Apache community. (Although the investigators anticipate the vast majority of participants will be White Mountain Apache tribal members, study participation is open to all American Indian individuals who live on the Fort Apache Indian Reservation or on/near the border).
* Participants ages 11+ must have parent/legal guardian consent
* Adult participants must sign written informed consent

Exclusion Criteria:

* Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
* Unwilling to be randomized

Primary outcomes:
measure: 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)
timeFrame: 3-month, 9-month, 12-month, 24-month, 36-month
Secondary outcomes:
measure: Initiation of sexual activity as measured by the proportion of participants who report ever having sex
timeFrame: 3-month, 9-month, 12-month, 24-month, 36-month
measure: Knowledge of sexual and reproductive health as measured by the mean score on a 44-question reproductive and sexual health knowledge survey
timeFrame: 3-month, 9-month, 12-month, 24-month, 36-month
measure: Condom use intention as measured by the proportion of participants who report they intend to use a condom at next sex
timeFrame: 3-month, 9-month, 12-month, 24-month, 36-month
Other outcomes:
measure: Condom use at last sex as measured by the proportion of sexually active participants who report using a condom at last sex
timeFrame: 3-month, 9-month, 12-month, 24-month, 36-month
measure: Number of sexual partners as measured by the mean number of sexual partners reported in the past 3 months
timeFrame: 3-month, 9-month, 12-month, 24-month, 36-month
measure: Sexual activity without using a condom as measured by the proportion of participants who had sex without a condom in the past 3 months and the mean number of times reported having sex without a condom in the past 3 months
timeFrame: 3-month, 9-month, 12-month, 24-month, 36-month
measure: Contraceptive use as measured by the proportion of sexually active participants who had sex without birth control in the past 3 months and the mean number of times reported having sex without birth control in past 3 months
timeFrame: 3-month
measure: Parental engagement as measured by the Parent-Adolescent Communication Scale: (Mean Score on 39-item Likert Scale) and the Parental Monitoring Scale: (Mean Score on a 6-item Likert Scale)
timeFrame: 3-month, 9-month, 12-month, 24-month, 36-month
measure: Risky sexual behaviors as measured by the proportion who report having unprotected sex in the past 3 months among participants who use alcohol and drugs
timeFrame: 3-month
measure: Substance use during sex as measured by the proportion who use alcohol or drugs immediately prior to and/or during sex
timeFrame: 3-month, 9-month, 12-month, 24-month, 36-month
Locations:
city: Whiteriver
country: United States
facility: Johns Hopkins Center for American Indian Health
state: Arizona
Study officials:
affiliation: Center for American Indian Health
name: Allison Barlow, PhD
role: STUDY_DIRECTOR
affiliation: Center for American Indian Health
name: Lauren Tingey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tingey L, Chambers R, Patel H, Littlepage S, Lee S, Lee A, Susan D, Melgar L, Slimp A, Rosenstock S. Prevention of Sexually Transmitted Diseases and Pregnancy Prevention Among Native American Youths: A Randomized Controlled Trial, 2016-2018. Am J Public Health. 2021 Oct;111(10):1874-1884. doi: 10.2105/AJPH.2021.306447. Epub 2021 Sep 16.
citation: Tingey L, Chambers R, Goklish N, Larzelere F, Lee A, Suttle R, Rosenstock S, Lake K, Barlow A. Rigorous evaluation of a pregnancy prevention program for American Indian youth and adolescents: study protocol for a randomized controlled trial. Trials. 2017 Feb 27;18(1):89. doi: 10.1186/s13063-017-1842-6.