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

Pregnancy Clinical Trial

— TPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02904629
• Other study ID #: 6670
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: April 2022

Study information

• Verified date: July 2022
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1072
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Center for American Indian Health	Whiteriver	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Condom use at last sex as measured by the proportion of sexually active participants who report using a condom at last sex	Condom use at last sex among sexually active participants between intervention and controls groups at baseline, 3-month, 9-month, 12-month, 24-month, 36-month post-intervention	3-month, 9-month, 12-month, 24-month, 36-month
Other	Number of sexual partners as measured by the mean number of sexual partners reported in the past 3 months	Number of sexual partners among sexually active participants, between intervention and control groups at baseline, 3-month, 9-month, 12-month, 24-month, 36-month post-intervention	3-month, 9-month, 12-month, 24-month, 36-month
Other	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	Sexual activity without using a condom among sexually active participants between intervention and control groups at baseline, 3-month, 9-month, 12-month, 24-month, 36-month post-intervention.	3-month, 9-month, 12-month, 24-month, 36-month
Other	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	Contraceptive use among sexually active participants in past three months, by sexually active participants, between intervention and control groups at 3-month post-intervention.	3-month
Other	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)	Parental engagement with youth participants (communication and monitoring) between intervention and control groups at baseline, 3-month, 9-month, 12-month, 24-month, 36-month post-intervention.	3-month, 9-month, 12-month, 24-month, 36-month
Other	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	Risky sexual behavior in last 3 months among participants who use alcohol and drugs, between intervention and control groups.	3-month
Other	Substance use during sex as measured by the proportion who use alcohol or drugs immediately prior to and/or during sex	Substance use immediately prior and/or during sex, among sexually active participants between intervention and control groups at baseline, 3-month, 9-month, 12-month, 24-month and 36-month post-intervention	3-month, 9-month, 12-month, 24-month, 36-month
Primary	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)	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.	3-month, 9-month, 12-month, 24-month, 36-month
Secondary	Initiation of sexual activity as measured by the proportion of participants who report ever having sex	Delayed initiation of sexual activity between intervention and control groups at baseline, 3-month, 9-month, 12-month, 24-month, 36-month post-intervention.	3-month, 9-month, 12-month, 24-month, 36-month
Secondary	Knowledge of sexual and reproductive health as measured by the mean score on a 44-question reproductive and sexual health knowledge survey	Change in knowledge score (range 0-100%) related to sexual and reproductive health, pregnancy and contraception between intervention and control groups at between baseline, 3-month, 9-month, 12-month, 24-month, 36-month post-intervention.	3-month, 9-month, 12-month, 24-month, 36-month
Secondary	Condom use intention as measured by the proportion of participants who report they intend to use a condom at next sex	Change in intention to use a condom at next sex, between intervention and control groups at baseline, 3-month, 9-month, 12-month, 24-month, 36-month post-intervention	3-month, 9-month, 12-month, 24-month, 36-month