Trial Outcomes & Findings for We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive Health Intervention for American Indian Youth (NCT NCT03694418)
NCT ID: NCT03694418
Last Updated: 2026-02-27
Results Overview
Number of protected acts of sex using a condom during vaginal and/or anal sex in the past 30 days is measured as proportion of condom use during vaginal/anal sex using 2 items (number of times condom used relative to number of times had vaginal/anal sex).
COMPLETED
NA
453 participants
Outcome measure time frame was 30 days from survey completion at 3 months post intervention.
2026-02-27
Participant Flow
Recruitment took place from January 2019 to May 2019. Recruitment included meetings with tribal and school leadership and letters to caregivers who had a child 14- to 18 years old and was attending school.
Participant milestones
| Measure |
Cluster 1: Baseline, Then 12 Months NE Intervention
Cluster 1 was implemented from September 2019 to September 2020. The Cluster 1 NE intervention took place from September 2019 to March 2020. The NE intervention was severely impacted by the COVID-19 pandemic and not implemented from March 2020 to May 2020. 12 month data was collected in September 2020.
|
Cluster 2: 12 Months Baseline, Then 12 Months NE Intervention
Cluster 2 was implemented from January 2021 to September 2021. Cluster 2 started 4 months later than planned due to the COVID-19 pandemic and the school being closed. In Cluster 2 the NE intervention was implemented from January 2021 to May 2021. 12 month data collection took place in September 2021. Although Cluster 2 had a late start date the intervention was completed as planned.
|
Cluster 3: 24 Months Baseline, Then 12 Months NE Intervention
Cluster 3 was implemented from September 2021 to September 2022. The NE intervention in Cluster 3 was implemented from September 2021 to May 2022. 12 month data collection was completed in September 2022.
|
Cluster 4: 24 Months Baseline, Then 12 Months NE Intervention
Cluster 4 was implemented from September 2021 to September 2022. Cluster 4 was implemented simultaneously with Cluster 3. The NE intervention was implemented from September 2021 to May 2022, at the same time as Cluster 3. 12 month collection was completed in September 2022.
|
Cluster 5: 36 Months Baseline, Then 12 Months NE Intervention
Cluster 5 was implemented from September 2022 to September 2023. The NE intervention was implemented from September 2022 to May 2023. 12 month data collection was completed in September 2023.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
210
|
41
|
23
|
29
|
150
|
|
Overall Study
COMPLETED
|
95
|
18
|
11
|
17
|
137
|
|
Overall Study
NOT COMPLETED
|
115
|
23
|
12
|
12
|
13
|
Reasons for withdrawal
| Measure |
Cluster 1: Baseline, Then 12 Months NE Intervention
Cluster 1 was implemented from September 2019 to September 2020. The Cluster 1 NE intervention took place from September 2019 to March 2020. The NE intervention was severely impacted by the COVID-19 pandemic and not implemented from March 2020 to May 2020. 12 month data was collected in September 2020.
|
Cluster 2: 12 Months Baseline, Then 12 Months NE Intervention
Cluster 2 was implemented from January 2021 to September 2021. Cluster 2 started 4 months later than planned due to the COVID-19 pandemic and the school being closed. In Cluster 2 the NE intervention was implemented from January 2021 to May 2021. 12 month data collection took place in September 2021. Although Cluster 2 had a late start date the intervention was completed as planned.
|
Cluster 3: 24 Months Baseline, Then 12 Months NE Intervention
Cluster 3 was implemented from September 2021 to September 2022. The NE intervention in Cluster 3 was implemented from September 2021 to May 2022. 12 month data collection was completed in September 2022.
|
Cluster 4: 24 Months Baseline, Then 12 Months NE Intervention
Cluster 4 was implemented from September 2021 to September 2022. Cluster 4 was implemented simultaneously with Cluster 3. The NE intervention was implemented from September 2021 to May 2022, at the same time as Cluster 3. 12 month collection was completed in September 2022.
|
Cluster 5: 36 Months Baseline, Then 12 Months NE Intervention
Cluster 5 was implemented from September 2022 to September 2023. The NE intervention was implemented from September 2022 to May 2023. 12 month data collection was completed in September 2023.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
115
|
23
|
12
|
12
|
13
|
Baseline Characteristics
We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive Health Intervention for American Indian Youth
Baseline characteristics by cohort
| Measure |
Cluster 1
n=210 Participants
Cluster 1 took place from September 2019 to September 2020. Baseline, mid-intervention, and 3 month post intervention data was collected. The Covid-19 pandemic prevented the collection of of the post intervention data.
|
Cluster 2
n=41 Participants
Cluster 2 took place from January 2021 to September 2021. Baseline, mid-intervention, post-intervention, and 3 month post intervention were collected. However, data collection was truncated due to the school in cluster 2 being closed because of the COVID-19 pandemic. Data was collected from January 2021 to September 2021.
|
Cluster 3
n=23 Participants
Cluster 3 took place from September 2021 to September 2022. Baseline, mid-intervention, post-intervention, and 3 month post intervention were collected as planned.
|
Cluster 4
n=29 Participants
Cluster 4 took place from September 2021 to September 2022 simultaneously with Cluster 3. Baseline, mid-intervention, post-intervention, and 3 month post intervention were collected as planned.
|
Cluster 5
n=150 Participants
Cluster 5 took place from September 2022 to September 2023. Baseline, mid-intervention, post-intervention, and 3 month post intervention were collected as planned.
|
Total
n=453 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
15.7 years
STANDARD_DEVIATION 1.5 • n=24 Participants
|
15.9 years
STANDARD_DEVIATION 1.8 • n=20 Participants
|
15.5 years
STANDARD_DEVIATION 1.4 • n=40 Participants
|
15.0 years
STANDARD_DEVIATION 1.5 • n=565 Participants
|
15.6 years
STANDARD_DEVIATION 1.4 • n=349 Participants
|
15.6 years
STANDARD_DEVIATION 1.5 • n=4 Participants
|
|
Age, Customized
Age of participants
|
15.7 years
STANDARD_DEVIATION 1.5 • n=24 Participants
|
15.9 years
STANDARD_DEVIATION 1.8 • n=20 Participants
|
15.5 years
STANDARD_DEVIATION 1.4 • n=40 Participants
|
15.0 years
STANDARD_DEVIATION 1.5 • n=565 Participants
|
15.6 years
STANDARD_DEVIATION 1.4 • n=349 Participants
|
15.5 years
STANDARD_DEVIATION 1.5 • n=4 Participants
|
|
Sex/Gender, Customized
Student gender (number that are male) by cluster.
|
107 participants
n=24 Participants
|
14 participants
n=20 Participants
|
9 participants
n=40 Participants
|
13 participants
n=565 Participants
|
82 participants
n=349 Participants
|
225 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=24 Participants
|
28 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
16 Participants
n=565 Participants
|
68 Participants
n=349 Participants
|
229 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=24 Participants
|
13 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
13 Participants
n=565 Participants
|
82 Participants
n=349 Participants
|
224 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
210 Participants
n=24 Participants
|
41 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
29 Participants
n=565 Participants
|
150 Participants
n=349 Participants
|
453 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
210 Participants
n=24 Participants
|
41 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
29 Participants
n=565 Participants
|
150 Participants
n=349 Participants
|
453 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
210 Participants
n=24 Participants
|
41 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
29 Participants
n=565 Participants
|
150 Participants
n=349 Participants
|
453 Participants
n=4 Participants
|
|
Number of protected anal or vaginal intercourse acts in past 30 days
|
0.40 proportion of protected sex acts
n=24 Participants
|
0.40 proportion of protected sex acts
n=20 Participants
|
0.40 proportion of protected sex acts
n=40 Participants
|
0.40 proportion of protected sex acts
n=565 Participants
|
0.40 proportion of protected sex acts
n=349 Participants
|
0.40 proportion of protected sex acts
n=4 Participants
|
PRIMARY outcome
Timeframe: Outcome measure time frame was 30 days from survey completion at 3 months post intervention.Population: American Indian youth ages 14 - 18 years who are enrolled in a federally recognized tribe and living on the Fort Peck Reservation in Montana.
Number of protected acts of sex using a condom during vaginal and/or anal sex in the past 30 days is measured as proportion of condom use during vaginal/anal sex using 2 items (number of times condom used relative to number of times had vaginal/anal sex).
Outcome measures
| Measure |
NE Intervention
n=453 Participants
Primary outcome measure is reported for all clusters during the intervention period and was assessed for changes from baseline to 3 month post intervention.
|
|---|---|
|
Change in Number of Protected Acts Using a Condom During Vaginal and/or Anal Sex in the Past 30 Days.
|
0.31 proportion
Interval 0.15 to 0.47
|
SECONDARY outcome
Timeframe: From enrollment (baseline) to 3 months post-intervention (i.e., 12 months after enrollment)Participants reported whether they ever had sex by responding to the question, "Have you ever had sexual intercourse?", with response options of "Yes" or "No". Answers of "Yes" were coded to "1" and answers of "No" were coded to "0".
Outcome measures
| Measure |
NE Intervention
n=453 Participants
Primary outcome measure is reported for all clusters during the intervention period and was assessed for changes from baseline to 3 month post intervention.
|
|---|---|
|
Change in Number of Participants Reporting "Yes" to Having Engaged in Sexual Intercourse
|
179 Participants
|
SECONDARY outcome
Timeframe: From enrollment (baseline) to 3 months post-intervention (i.e., 12 months after enrollment)The mean number of lifetime sex partners (i.e., the total number of people with whom a participant had sex in their lifetime) was assessed by asking participants, "During your life, with how many people have you had sexual intercourse?" with responses of "1 person", "2 people", "3 people", "4 people", "5 people", and "6 or more people". Responses were treated as integer values from 1-6, where the change in mean number of lifetime sex partners was assessed at 3-months post-intervention (12-months post-baseline) compared to baseline.
Outcome measures
| Measure |
NE Intervention
n=453 Participants
Primary outcome measure is reported for all clusters during the intervention period and was assessed for changes from baseline to 3 month post intervention.
|
|---|---|
|
Change in Mean Number of Lifetime Sex Partners.
|
2.66 number of sex partners
Standard Deviation 1.72 • Interval -0.469 to 1.704
|
SECONDARY outcome
Timeframe: From baseline to 3-months post-intervention (i.e., 12 months post-baseline)Participants reported the number of times they had vaginal and/or anal sex in the past 30 days as an integer value (i.e., 0, 1, 2, 3, etc. times), where answers could be at a minimum of 0 times with no maximum limit. The change in mean number of sex acts was calculated from baseline to 3-months post-intervention.
Outcome measures
| Measure |
NE Intervention
n=453 Participants
Primary outcome measure is reported for all clusters during the intervention period and was assessed for changes from baseline to 3 month post intervention.
|
|---|---|
|
Change in Mean Number of Vaginal and/or Anal Sex Acts in the Past 30 Days.
|
2.07 Number of anal/vaginal sex acts
Standard Deviation 3.44 • Interval 1.4 to 13.77
|
SECONDARY outcome
Timeframe: From baseline to 3 months post-intervention (i.e., 12 months post-baseline)The number of times non-condom birth control was used during sex in the past 30 days was assessed by asking participants, "Of the times you had sex over the past month, how many TIMES did you use birth control other than a condom, like birth control pills or having a deprova shot?". Responses ranged from 0 (minimum) to any positive integer value, where the maximum was limited by the number of times they had sex in the past month.
Outcome measures
| Measure |
NE Intervention
n=453 Participants
Primary outcome measure is reported for all clusters during the intervention period and was assessed for changes from baseline to 3 month post intervention.
|
|---|---|
|
Change in Mean Number of Times Non-condom Birth Control Was Used During Sex in the Past 30 Days.
|
0.99 number of times birth control used
Standard Deviation 2.27 • Interval -6.062 to 1.076
|
SECONDARY outcome
Timeframe: Baseline to 3 months post-intervention (i.e., 12 months post-baseline)Number of times participants reported that they had been pregnant or gotten someone pregnant
Outcome measures
| Measure |
NE Intervention
n=453 Participants
Primary outcome measure is reported for all clusters during the intervention period and was assessed for changes from baseline to 3 month post intervention.
|
|---|---|
|
Change in Mean Number of Pregnancies
|
0.09 pregnancies
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Baseline to 3 months post-intervention (i.e., 12 months post-baseline)Participants reported "Yes" or "No" to the question, "Did you drink alcohol or use drugs before you had sexual intercourse the last time?"
Outcome measures
| Measure |
NE Intervention
n=453 Participants
Primary outcome measure is reported for all clusters during the intervention period and was assessed for changes from baseline to 3 month post intervention.
|
|---|---|
|
Change in Number of Participants Reporting "Yes" to Having Used Substances During Sex
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 3 months post-intervention (i.e., 12 months post-baseline)Parent/legal-child communication about sexual and reproductive health topics was measured using a 24-item communication scale. Each item asked participants if they had discussed a certain topic with their parents, with possible responses of "Yes" and "No". Answers of "Yes" were coded to 1 and "No" coded to 0. All 24 answers were summed to create a communication score with a minimum of 0 and a maximum of 24.
Outcome measures
| Measure |
NE Intervention
n=453 Participants
Primary outcome measure is reported for all clusters during the intervention period and was assessed for changes from baseline to 3 month post intervention.
|
|---|---|
|
Change in Mean Score of Parent/Legal Guardian-child Communication About Sexual and Reproductive Health Topics
|
9.42 units on a scale
Standard Deviation 6.47 • Interval 0.27 to 4.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to 3 months post-intervention (i.e., 12 months post-baseline)Use of sexual and reproductive health services from IHS was measured with one question that asked participants, "Have you ever been to Indian Health Services or Fort Peck Tribal Health for things like condoms, birth control, a pregnancy test, or STD test?", where responses were either "Yes" or "No". Responses of "Yes" were coded to 1 and "No" to 0.
Outcome measures
| Measure |
NE Intervention
n=453 Participants
Primary outcome measure is reported for all clusters during the intervention period and was assessed for changes from baseline to 3 month post intervention.
|
|---|---|
|
Change in Number of Participants Reporting "Yes" to Having Used Sexual and Reproductive Health Services From Indian Health Service (IHS)
|
115 Participants
Interval 1.69 to 37.15
|
Adverse Events
Cluster 1
Cluster 2
Cluster 3
Cluster 4
Cluster 5
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place