Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Johns Hopkins Bloomberg School of Public Health


Information provided by (Responsible Party)
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier
NCT01910714

First received: July 17, 2013
Last updated: April 15, 2015
Last Verified: April 2015
History of Changes
Purpose

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 : Health Education Control Condition

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adapting and Evaluating an Evidence-Based Intervention to Prevent HIV/AIDS Risk Among Apache Youth

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 ]
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 ]
  • 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 ]
  • Higher use of condoms at last sex in treatment vs. control group at 12 months follow-up [ Time Frame: 12 months follow-up ]
  • Less frequency of sex with substance use in treatment vs. control group at 12 months follow-up [ Time Frame: 12 months follow-up ]
  • Higher age of sexual initiation in treatment vs. control group at 12 months follow-up [ Time Frame: 12 months follow-up ]

Enrollment: 267
Study Start Date: September 2010
Study Completion Date: September 2013
Primary Completion Date: September 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: 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.

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

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.

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

Eligibility

Ages Eligible for Study: 13 Years to 19 Years  
Sexes Eligible for Study: All  
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

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

More Information


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: April 15, 2015  

Keywords provided by Johns Hopkins Bloomberg School of Public Health:

HIV/AIDS
Prevention
American Indian
Substance use
CBPR

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.