Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01910714
First received: July 17, 2013
Last updated: July 25, 2013
Last verified: May 2013
  Purpose

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.

Condition Intervention
HIV/AIDS
Behavioral: Focus On Youth
Behavioral: General health education control condition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Adapting and Evaluating an Evidence-Based Intervention to Prevent HIV/AIDS Risk Among Apache Youth

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Improved score on condom use self-efficacy scale in treatment vs. control group at 12 months follow-up [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved score on scale of HIV prevention knowledge, intention and perceptions in treatment vs. control group at 12 months follow-up [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
  • Improved score on scale of partner negotiation skills related to sex and drug use between treatment vs. control group at 12 months follow-up [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
  • Higher use of condoms at last sex in treatment vs. control group at 12 months follow-up [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
  • Less frequency of sex with substance use in treatment vs. control group at 12 months follow-up [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
  • Higher age of sexual initiation in treatment vs. control group at 12 months follow-up [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 267
Study Start Date: September 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Health Education Control Condition
The health education control condition consists of team-building activities and viewing of educational videos on nutrition and fitness, environmental protection and nature. The control condition program will be delivered according to the same structure as the Focus on Youth intervention; daily for 60-90 minutes over the course of 8 days. Due to local staffing availability and the pilot nature of this research, youth in the control condition will not receive the control program in small-group peer format. Rather, youth will receive the control condition program in groups of approximately 30-50.
Behavioral: General health education control condition
Experimental: Focus on Youth Intervention (FOY)
Focus on Youth is a community-based, eight session group intervention that provides youth with the skills and knowledge they need to protect themselves from HIV and other STDs. Focus on Youth uses fun, interactive activities such as games, role plays and discussions to convey prevention knowledge and skills pertaining to Protection Motivation Theoretical concepts. The intervention consists of 8 group sessions delivered daily over 8 days by two Apache facilitators to same-sex peer groups of 8-12 Apache youth. Each lesson lasts approximately 60-90 minutes. The goal of the sessions will be to teach youth about sexual and reproductive health with a specific focus on safe sex practices and sexual decision making.
Behavioral: Focus On Youth

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.

  Eligibility

Ages Eligible for Study:   13 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01910714

Locations
United States, Maryland
Johns Hopkins Center for American Indian Health
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: Anne Rompalo, MD, ScM Johns Hopkins School of Medicine
  More Information

No publications provided

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01910714     History of Changes
Other Study ID Numbers: NARCH V: U26IHS300286/03
Study First Received: July 17, 2013
Last Updated: July 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
HIV/AIDS
Prevention
American Indian
Substance use
CBPR

ClinicalTrials.gov processed this record on October 22, 2014