Trial Outcomes & Findings for We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive Health Intervention for American Indian Youth (NCT NCT03694418)

Last Updated: 2025-08-19

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

453 participants

Primary outcome timeframe

Measure for within the past 30 days from completing survey at 3 months, 9 months, 12 months; data at 12 months reported.

Results posted on

2025-08-19

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

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

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

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=93 Participants	15.9 years STANDARD_DEVIATION 1.8 • n=4 Participants	15.5 years STANDARD_DEVIATION 1.4 • n=27 Participants	15.0 years STANDARD_DEVIATION 1.5 • n=483 Participants	15.6 years STANDARD_DEVIATION 1.4 • n=36 Participants	15.6 years STANDARD_DEVIATION 1.5 • n=10 Participants
Age, Customized Age of participants	15.7 years STANDARD_DEVIATION 1.5 • n=93 Participants	15.9 years STANDARD_DEVIATION 1.8 • n=4 Participants	15.5 years STANDARD_DEVIATION 1.4 • n=27 Participants	15.0 years STANDARD_DEVIATION 1.5 • n=483 Participants	15.6 years STANDARD_DEVIATION 1.4 • n=36 Participants	15.5 years STANDARD_DEVIATION 1.5 • n=10 Participants
Sex/Gender, Customized Student gender (number that are male) by cluster.	107 participants n=93 Participants	14 participants n=4 Participants	9 participants n=27 Participants	13 participants n=483 Participants	82 participants n=36 Participants	225 participants n=10 Participants
Sex: Female, Male Female	103 Participants n=93 Participants	28 Participants n=4 Participants	14 Participants n=27 Participants	16 Participants n=483 Participants	68 Participants n=36 Participants	229 Participants n=10 Participants
Sex: Female, Male Male	107 Participants n=93 Participants	13 Participants n=4 Participants	9 Participants n=27 Participants	13 Participants n=483 Participants	82 Participants n=36 Participants	224 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	210 Participants n=93 Participants	41 Participants n=4 Participants	23 Participants n=27 Participants	29 Participants n=483 Participants	150 Participants n=36 Participants	453 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	210 Participants n=93 Participants	41 Participants n=4 Participants	23 Participants n=27 Participants	29 Participants n=483 Participants	150 Participants n=36 Participants	453 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Region of Enrollment United States	210 Participants n=93 Participants	41 Participants n=4 Participants	23 Participants n=27 Participants	29 Participants n=483 Participants	150 Participants n=36 Participants	453 Participants n=10 Participants
Number of protected anal or vaginal intercourse acts in past 30 days	0.40 proportion of protected sex acts n=93 Participants	0.40 proportion of protected sex acts n=4 Participants	0.40 proportion of protected sex acts n=27 Participants	0.40 proportion of protected sex acts n=483 Participants	0.40 proportion of protected sex acts n=36 Participants	0.40 proportion of protected sex acts n=10 Participants

PRIMARY outcome

Timeframe: Measure for within the past 30 days from completing survey at 3 months, 9 months, 12 months; data at 12 months reported.

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.

Outcome measures

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.
Number of Protected Acts of Vaginal and/or Anal Sex in the Past 30 Days.	0.31 proportion Interval 0.15 to 0.47

SECONDARY outcome

Timeframe: Measured at time of survey

Measured as a binary yes/no variable. 1 = yes, 0 = no.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at time of survey completion.

Number of sex partners in the past 30 days is measured as an integer with no upper limit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time frame is assessed as within the past 30 days from survey completion.

Frequency of vaginal and/or anal sex in the past 30 days is measured as an integer with no upper limit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months, 9 months and 12 months

Change in number of pregnancies will be measure with 1 item (number of pregnancies)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time frame is measured as the past year.

Number of times used birth control during vaginal sex.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time frame is the past 30 days.

Substance use during sex is measured as a binary variable 1 = yes, 0 = no.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months, 9 months and 12 months

Change in increased parent/legal-child communication about sexual and reproductive health topics will be measured using a 24 item Likert scale, higher score = higher communication

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months, 9 months and 12 months

Change in increased usage of sexual and reproductive health services will be measured with 9 items ( frequency, type and follow up of sexual and reproductive health services used)