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Clinical Trials/NCT01910714
NCT01910714
Completed
Not Applicable

Adapting and Evaluating an Evidence-Based Intervention to Prevent HIV/AIDS Risk Among Apache Youth

Johns Hopkins Bloomberg School of Public Health1 site in 1 country267 target enrollmentSeptember 2010
ConditionsHIV/AIDS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
Johns Hopkins Bloomberg School of Public Health
Enrollment
267
Locations
1
Primary Endpoint
Improved score on condom use self-efficacy scale in treatment vs. control group at 12 months follow-up
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The investigators seek to adapt, implement and evaluate a randomized controlled trial of an evidence based intervention delivered by Apache interventionists to reduce HIV/AIDS risk, targeting Apache adolescents. Specific study objectives include:

  1. To perform formative research through focus groups and individual interviews on attitudes, practices and intervention preferences among Apache adolescents and community stakeholders.
  2. To adapt the Focus on Youth (FOY) evidence-based intervention using findings from the formative research, components of Protection Motivation Theory, and input from a community advisory board.
  3. To enroll 304 White Mountain Apache youth ages 13-19 to participate in a randomized intervention trial measuring behavior change at 6- and 12- months follow-up.
  4. To determine the feasibility of gathering biological specimens via self-administered swabs to track sexually transmitted diseases among 18-19 year olds enrolled in this and future studies.

Detailed Description

The general format of the study consists of a randomized controlled trial delivered through the medium of an 8-day basketball camp. Intervention activities will consist of the daily delivery of a youth HIV/AIDS prevention curriculum over the course of 8 days.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
September 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • American Indian ethnicity and primary residence and/or employment within the White Mountain Apache (Fort Apache) Reservation. Participants must be aged 13-19 years and have parent/guardian consent for youth under 18 years old.

Exclusion Criteria

  • Youth that are unable to fully participate in the evaluation assessments or intervention components will be excluded. In addition, individuals age 16 or older that are listed on either the Federal or Tribal sexual offender registries will be excluded from participation.

Outcomes

Primary Outcomes

Improved score on condom use self-efficacy scale in treatment vs. control group at 12 months follow-up

Time Frame: 12 months follow-up

Secondary Outcomes

  • Improved score on scale of HIV prevention knowledge, intention and perceptions in treatment vs. control group at 12 months follow-up(12 months follow-up)
  • Improved score on scale of partner negotiation skills related to sex and drug use between treatment vs. control group at 12 months follow-up(12 months follow-up)
  • Higher use of condoms at last sex in treatment vs. control group at 12 months follow-up(12 months follow-up)
  • Less frequency of sex with substance use in treatment vs. control group at 12 months follow-up(12 months follow-up)
  • Higher age of sexual initiation in treatment vs. control group at 12 months follow-up(12 months follow-up)

Study Sites (1)

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