search
Back to results

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

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focus On Youth
Health Education Control Condition
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring HIV/AIDS, Prevention, American Indian, Substance use, CBPR

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Johns Hopkins Center for American Indian Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Health Education Control Condition

Focus on Youth Intervention (FOY)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Improved score on condom use self-efficacy scale in treatment vs. control group at 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
Improved score on scale of partner negotiation skills related to sex and drug use between treatment vs. control group at 12 months follow-up
Higher use of condoms at last sex in treatment vs. control group at 12 months follow-up
Less frequency of sex with substance use in treatment vs. control group at 12 months follow-up
Higher age of sexual initiation in treatment vs. control group at 12 months follow-up

Full Information

First Posted
July 17, 2013
Last Updated
April 15, 2015
Sponsor
Johns Hopkins Bloomberg School of Public Health
search

1. Study Identification

Unique Protocol Identification Number
NCT01910714
Brief Title
Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth
Official Title
Adapting and Evaluating an Evidence-Based Intervention to Prevent HIV/AIDS Risk Among Apache Youth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV/AIDS, Prevention, American Indian, Substance use, CBPR

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health Education Control Condition
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Focus on Youth Intervention (FOY)
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Focus On Youth
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Health Education Control Condition
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
Higher use of condoms at last sex in treatment vs. control group at 12 months follow-up
Time Frame
12 months follow-up
Title
Less frequency of sex with substance use in treatment vs. control group at 12 months follow-up
Time Frame
12 months follow-up
Title
Higher age of sexual initiation in treatment vs. control group at 12 months follow-up
Time Frame
12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Rompalo, MD, ScM
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Center for American Indian Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs