Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Adolescent Behavior
  • Chlamydia
  • Gonorrhea
  • Self Evaluation
  • Sexual Behavior
  • Sexually Transmitted Diseases
  • Trichomonas
  • Unprotected Sex
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Basic Science

Participation Requirements

Age
Between 14 years and 26 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT03895320
Collaborators
Not Provided
Investigators
Principal Investigator: Lauren Tingey, PhD Johns Hopkins Bloomberg School of Public Health