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

July 17, 2013
July 25, 2013
September 2010
August 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01910714 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth
Adapting and Evaluating an Evidence-Based Intervention to Prevent HIV/AIDS Risk Among Apache Youth

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV/AIDS
  • Behavioral: Focus On Youth
  • Behavioral: General health education control condition
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Focus On Youth
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
267
October 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
13 Years to 19 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01910714
NARCH V: U26IHS300286/03
No
Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
Not Provided
Principal Investigator: Anne Rompalo, MD, ScM Johns Hopkins School of Medicine
Johns Hopkins Bloomberg School of Public Health
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP