SexTPPNCT02904629
Evaluation of Respecting the Circle of Life on Pregnancy Prevention Outcomes Among American Indian Adolescents
A study testing Respecting the Circle of Life (RCL) in people with Sex and Unprotected Sex, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sex, Unprotected Sex, Contraception
- What is being tested?
- Respecting the Circle of Life (RCL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,072 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
- Unwilling to be randomized
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Center for American Indian Health
Whiteriver, Arizona, 85941
About this study
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.
Read the 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.
- Conditions
- Sex, Unprotected Sex, Contraception, Alcohol Use, Drug Use, Pregnancy
- Being tested
- Respecting the Circle of Life (RCL), Control Program
- Medical subject headings
- Coitus, Unsafe Sex, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respecting the Circle of Life (RCL)Behavioural
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)."
Control ProgramOther
Control activities will consist of the delivery of educational lessons on nutrition, fitness, outdoor recreation, safety, environmental protection and nature.
| Study group | Role | What they receive |
|---|---|---|
| RCL Intervention | Experimental | Respecting the Circle of Life (RCL) includes peer-group \& youth-parent components. The peer-group component has 8 educational lessons, each lasting 90-120 minutes, delivered to self-selected same-sex peer groups of 8-10 AI teens. RCL lessons are delivered once/day during an 8-day summer basketball camp. The youth-parent component is one educational lesson lasting 90-120 minutes delivered within 3 months after camp to a teen and parent together at home. Total RCL duration is 810-1,080 minutes over 3 months. All 8 days of the camp are "study days," in which RCL youth will receive one lesson each day. The investigators will evaluate RCL's impact on key sexual and reproductive health risk factors at 3-, 9-, 12-, 24-, and 36-month post-intervention follow-up time points. Receives: Behavioral: Respecting the Circle of Life (RCL) |
| Control | Other | The control program includes peer-group \& youth-parent components. The peer-group component has 8 educational lessons, each lasting 90-120 minutes, delivered to self-selected same-sex peer groups of 8-10 AI teens. Control lessons are delivered once/day during an 8-day summer basketball camp. The youth-parent component is one educational lesson lasting 90-120 minutes delivered within 3 months after camp to a teen and parent together at home. Total control duration is 810-1,080 minutes over 3 months. All 8 days of the camp are "study days," in which control youth will receive one lesson each day. The investigators will evaluate the control program's impact on key sexual and reproductive health risk factors at 3-, 9-, 12-, 24-, and 36-month post-intervention follow-up time points. Receives: Other: Control Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-month, 9-month, 12-month, 24-month, 36-month
Secondary outcomes (3)
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.
Measured: 3-month, 9-month, 12-month, 24-month, 36-month
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.
Measured: 3-month, 9-month, 12-month, 24-month, 36-month
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
Measured: 3-month, 9-month, 12-month, 24-month, 36-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startMay 2016
- Primary completionApr 2022
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SexStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,072 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Barlow, PhD, Study director, Center for American Indian HealthLauren Tingey, PhD, Principal investigator, Center for American Indian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904629
- Sponsor's protocol ID
- 6670
- Acronym
- TPP
- Status last verified
- Jul 2022
- First submitted
- 30 Aug 2016
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The funding body (Office of Adolescent Health) requires sharing of de-identified data.
Publications
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.
PubMed 34529503Tingey 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.
PubMed 28241775
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Respecting the Circle of Life on Pregnancy Prevention Outcomes Among American Indian Adolescents
- ClinicalTrials.gov ID
- NCT02904629
- Acronym / sponsor ID
- TPP / 6670
- Conditions
- Sex, Unprotected Sex, Contraception, Alcohol Use, Drug Use, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,072 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Apr 2022 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RCL Intervention | Experimental | Behavioral: Respecting the Circle of Life (RCL)Respecting the Circle of Life (RCL) includes peer-group \& youth-parent components. The peer-group component has 8 educational lessons, each lasting 90-120 minutes, delivered to self-selected same-sex peer groups of 8-10 AI teens. RCL lessons are delivered once/day during an 8-day summer basketball camp. The youth-parent component is one educational lesson lasting 90-120 minutes delivered within 3 months after camp to a teen and parent together at home. Total RCL duration is 810-1,080 minutes over 3 months. All 8 days of the camp are "study days," in which RCL youth will receive one lesson each day. The investigators will evaluate RCL's impact on key sexual and reproductive health risk factors at 3-, 9-, 12-, 24-, and 36-month post-intervention follow-up time points. |
| Control | Other | Other: Control ProgramThe control program includes peer-group \& youth-parent components. The peer-group component has 8 educational lessons, each lasting 90-120 minutes, delivered to self-selected same-sex peer groups of 8-10 AI teens. Control lessons are delivered once/day during an 8-day summer basketball camp. The youth-parent component is one educational lesson lasting 90-120 minutes delivered within 3 months after camp to a teen and parent together at home. Total control duration is 810-1,080 minutes over 3 months. All 8 days of the camp are "study days," in which control youth will receive one lesson each day. The investigators will evaluate the control program's impact on key sexual and reproductive health risk factors at 3-, 9-, 12-, 24-, and 36-month post-intervention follow-up time points. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
- Unwilling to be randomized
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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)." | Behavioural | RCL Intervention |
| Control ProgramControl activities will consist of the delivery of educational lessons on nutrition, fitness, outdoor recreation, safety, environmental protection and nature. | Other | Control |
Primary outcome
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.
3 secondary outcomes
Initiation of sexual activity as measured by the proportion of participants who report ever having sex
Time frame: 3-month, 9-month, 12-month, 24-month, 36-month
Knowledge of sexual and reproductive health as measured by the mean score on a 44-question reproductive and sexual health knowledge survey
Time frame: 3-month, 9-month, 12-month, 24-month, 36-month
Condom use intention as measured by the proportion of participants who report they intend to use a condom at next sex
Time frame: 3-month, 9-month, 12-month, 24-month, 36-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Derived from this study: PubMed 34529503Tingey 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.
- Derived from this study: PubMed 28241775Tingey 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.
- Individual participant dataSharing planned: Yes. The funding body (Office of Adolescent Health) requires sharing of de-identified data.
Related trials for Sex
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
PRP for Sexual Function
Female Sexual Dysfunction, Sexual Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Barlow, PhD study director
Center for American Indian Health
Lauren Tingey, PhD principal investigator
Center for American Indian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respecting the Circle of Life (RCL) in people with Sex and Unprotected Sex, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 3-month, 9-month, 12-month, 24-month, 36-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02904629, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.