Adapting and Evaluating an EBI 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:
- To perform formative research through focus groups and individual interviews on attitudes, practices and intervention preferences among Apache adolescents and community stakeholders.
- 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.
- 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.
- 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.
Behavioral: Focus On Youth
Behavioral: General health education control condition
|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|
- 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 ]
- 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 ]
|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)|
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01910714
|United States, Maryland|
|Johns Hopkins Center for American Indian Health|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Anne Rompalo, MD, ScM||Johns Hopkins School of Medicine|