Expired Study
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Baltimore, Maryland 21205


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

NARCH V: U26IHS300286/03


NCT ID:

NCT01910714


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

13 Years


Maximum Age:

19 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Johns Hopkins Bloomberg School of Public Health


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

267


Enrollment Type:

Actual


Overall Contact Information

Official Name:Anne Rompalo, MD, ScM
Principal Investigator
Johns Hopkins School of Medicine

Study Dates

Start Date:September 2010
Completion Date:September 2013
Completion Type:Actual
Primary Completion Date:September 2013
Primary Completion Type:Actual
Verification Date:April 2015
Last Changed Date:April 15, 2015
First Received Date:July 17, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Higher age of sexual initiation in treatment vs. control group at 12 months follow-up
Time Frame:12 months follow-up
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Less frequency of sex with substance use in treatment vs. control group at 12 months follow-up
Time Frame:12 months follow-up
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Higher use of condoms at last sex in treatment vs. control group at 12 months follow-up
Time Frame:12 months follow-up
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type: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
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Focus On Youth
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 8-1
Arm Name:Focus on Youth Intervention (FOY)
Intervention Type:Behavioral
Name:Health Education Control Condition
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 pee
Arm Name:Health Education Control Condition

Study Arms

Study Arm Type:Experimental
Arm Name:Focus on Youth Intervention (FOY)
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 8-1
Study Arm Type:Active Comparator
Arm Name:Health Education Control Condition
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 pee

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Johns Hopkins Bloomberg School of Public Health

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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