NCT06485284

Brief Summary

The goal of this randomized controlled trial is to evaluate the impacts of El Camino, a goal-setting sexual health promotion program targeted toward Latino adolescents. The primary research questions are:

  • Research Question 1: Is participation in the El Camino goal setting program associated with greater abstinence (measured as never had sex, no recent sexual activity) relative to a comparison group that did not receive El Camino?
  • Research Question 2: Is participation in El Camino associated with reduced unprotected sex (measured as sex without any method of contraception, sex without a condom) for the intervention group relative to the comparison group? Researchers will compare those who received El Camino to a comparison group who received an alternative program that does not include sexual health components. As part of the study, participants will be asked to:
  • Attend approximately 11 hours of programming completed over 11 weeks
  • Complete baseline, post-intervention, and 12-month follow-up surveys
  • For select participants who received the El Camino program, participate in an optional focus group discussion

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
746

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

2.9 years

First QC Date

June 26, 2024

Last Update Submit

June 26, 2024

Conditions

Sexual BehaviorAdolescent Behavior

Outcome Measures

Primary Outcomes (4)

  • Ever had penis-in-vagina sex

    Ever had penis-in-vagina sex (yes/no). Dichotomous variable coded 1 if yes, 0 if no and missing otherwise

    Immediately following program completion, 12 months after program completion

  • Had penis-in-vagina sex in the last three months

    Had penile-vaginal sex in the past three months, even once (yes/no). Dichotomous variable coded 1 if yes, 0 if no and missing otherwise

    Immediately following program completion, 12 months after program completion

  • Had penis-in-vagina sex in the last three months without any method of contraception

    Survey measure: "In the past 3 months, how often have you or your partner used any method of birth control, including condoms, during penis-in-vagina sex?" 5 response categories: 4-point scale from "All of the time" (4) to "None of the time" (1) and I don't know. Coded as 0 if answer is "All of the time". Otherwise coded as 1

    Immediately following program completion, 12 months after program completion

  • Had penis-in-vagina sex in the last three months without use of a condom

    Survey measure: "In the past 3 months, how often have you or your partner used condoms during penis-in-vagina sex?" 5 response categories: 4-point scale from "All of the time" (4) to "None of the time" (1) and I don't know. Coded as 0 if answer is "All of the time". Otherwise coded 1

    Immediately following program completion, 12 months after program completion

Secondary Outcomes (15)

  • Intend to use condoms

    Immediately following program completion, 12 months after program completion

  • Intend to use contraception

    Immediately following program completion, 12 months after program completion

  • Awareness of birth control methods

    Immediately following program completion, 12 months after program completion

  • Knowledge about condoms

    Immediately following program completion, 12 months after program completion

  • Knowledge about birth control

    Immediately following program completion, 12 months after program completion

  • +10 more secondary outcomes

Study Arms (2)

El Camino

EXPERIMENTAL

Adolescents receiving the intervention/treatment - El Camino.

Behavioral: El Camino

Control

OTHER

Adolescents receiving the control - alternative life skills program.

Behavioral: Life skills program

Interventions

El CaminoBEHAVIORAL

El Camino is a goal-setting sexual health promotion program. El Camino's lessons and activities: * Are anchored in sexual health promotion and goal-setting * Incorporate a goal achievement model throughout the curriculum * Are designed with a focus on the needs of Latino youth * Focus on the most effective forms of contraception, including long-acting reversible contraceptives The El Camino curriculum contains eleven 45-minute lessons and is divided into three sections, or arcs. The three arcs focus on goal setting, sexual and reproductive health, and healthy relationships.

El Camino
Life skills programBEHAVIORAL

Youth enrolled in the control condition will receive one of several curricula focused on life skills or leadership, depending on the site and implementation period. These curricula include PODER, an 11-session curriculum that focuses on youth leadership development; Youth Encuentros, a psychoeducational curriculum focused on mental health; El Joven Noble, a youth leadership curriculum; and Courageous Queens, a socio-emotional and character strengthening curriculum.

Control

Eligibility Criteria

Age14 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • High school student in Montgomery County, MD
  • Have not previously received El Camino during pilot study
  • Have parental consent (if under 18)
  • Agree to be in study

You may not qualify if:

  • Previously participated in pilot study and received El Camino curriculum
  • No parental consent (if under 18)
  • Do not agree to be in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Identity, Inc.

Gaithersburg, Maryland, 20877, United States

Location

Montgomery County Public Schools

Rockville, Maryland, 20850, United States

Location

Related Publications (2)

  • Faccio B, McClay A, McConnell K, Gates C, Finocharo J, Tallant J, Martinez V, Manlove J. Comparing Virtual and In-Person Implementation of a School-Based Sexual Health Promotion Program in High Schools with Large Latino Populations. Prev Sci. 2023 Dec;24(Suppl 2):251-261. doi: 10.1007/s11121-023-01526-0. Epub 2023 Jun 23.

    PMID: 37351668BACKGROUND

  • McConnell K, Ibrahimi S, Yumiseva M, Shan S, Lewin A. Short-Term Impacts of a School-Based Teen Pregnancy Prevention Program for Latino Youth: a Cluster Randomized Trial. Prev Sci. 2025 Jul;26(5):716-726. doi: 10.1007/s11121-025-01805-y. Epub 2025 Apr 14.

    PMID: 40229508DERIVED

MeSH Terms

Conditions

Sexual BehaviorAdolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scholar

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

February 17, 2021

Primary Completion

January 25, 2024

Study Completion

January 25, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)