Clinical Trials Logo

Clinical Trial Summary

The aim of this research protocol is to test the efficacy of a self-care intervention through a randomized controlled trial (RCT), for increasing protective sexual health behaviors among youth in the participating Native American community. The investigators will randomize 450 youth and young adults ages 14-26 to the self-care intervention or a control program. Efficacy data will be collected up to 6 months post-intervention. The primary outcome will be uptake of sexually transmitted infection (STI) screening. Secondary outcomes will include: a) sexual risk and protective behaviors; and b) psychosocial assets and resources. The investigators hypothesize the self-care intervention will increase protective behaviors by: i) helping youth gain knowledge of their own sexual health risks, assets and resources; ii) motivating protection of those assets and resources; and iii) encouraging good health practices and making responsible choices.


Clinical Trial Description

The proposed study is a RCT to test the efficacy of a self-care intervention for sexual health promotion among youth and young adults in a participating Native American community. The goal of the intervention is to increase protective sexual health practices. The investigators will compare outcomes between two groups: the 1) experimental group and the 2) comparison group. Youth will be enrolled in the study and assessed at baseline, 3-months and 6-months post-intervention. Participants ages 14-26 will be enrolled through a non-probability sampling frame at: a) the local Indian Health Service (IHS) facility, including the Emergency Department waiting room; b) local schools; c) during health fairs and other community-based events; and d) other community gathering spots. Eligible individuals will be of Native American ethnicity, 14-26 years of age, and have primary residence and/or employment within the participating tribe's reservation. Research staff will screen potential participants for inclusion/exclusion criteria, explain study goals and procedures, and administer informed consent. After obtaining participant consent, participants will complete a baseline assessment and then be randomized to receive the self-care intervention or a control program. Follow-up assessments will be administered at 3-months and 6-months post-intervention for all study participants. Each assessment is expected to take 20-30 minutes to complete. The baseline assessment will take place at the location of recruitment and consent; follow-up assessments will take place at home or in a private location. All assessments will be self-administered on tablets using REDCap mobile technology. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03895320
Study type Interventional
Source Johns Hopkins Bloomberg School of Public Health
Contact
Status Completed
Phase N/A
Start date March 1, 2019
Completion date March 31, 2022

See also
  Status Clinical Trial Phase
Completed NCT05071989 - The Influence of Sleep Education With Social Media Reminders on the Sleep Quality in Adolescents N/A
Recruiting NCT05064293 - Assisted Identification and Navigation of Early Mental Health Symptoms in Children N/A
Enrolling by invitation NCT05017779 - A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth N/A
Completed NCT03685643 - Study Proposal for Web Based Intervention to Promote the Safe Usage of Dating Applications in Young Adults N/A
Completed NCT03270943 - The S.M.A.R.T. Project: Stress Management and Resilience Training for Teens N/A
Recruiting NCT05525962 - Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
Completed NCT03411577 - Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program N/A
Recruiting NCT05334381 - Navigating Mental Health Treatment for Black Youth N/A
Active, not recruiting NCT05926141 - Advanced Cooking Education Pilot Study N/A
Recruiting NCT04317547 - Translation Study of a Safe Teen Driving Intervention N/A
Recruiting NCT06001892 - Tennessee Youth Prepared for Success N/A
Enrolling by invitation NCT06127277 - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care N/A
Not yet recruiting NCT06310434 - Analysis of COMPASsion and Humanisation of Adolescents Facing the End-of-life Processes.
Not yet recruiting NCT05316948 - Mental Health and Sexuality in Adolescents and Young Adults
Terminated NCT02578147 - JUEGA: A Fun Study for Hispanic/Latino Adolescent Girls N/A
Completed NCT02683811 - Effectiveness of the Updated Version of the School-based Program Diario Della Salute (DDS-2) N/A
Active, not recruiting NCT02329015 - Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools Phase 1
Completed NCT03482687 - It's Your Game: An Innovative Approach to Preventing Teen Dating Violence N/A
Completed NCT01433679 - The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents N/A
Completed NCT00056953 - Peer Mentors for Adolescents in HIV Affected Families Phase 2