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Completed

NCT Number: NCT01910714

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:

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Center for American Indian Health

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Focus On Youth

Behavioral

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.

Health Education Control Condition

Behavioral

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 outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. Higher use of condoms at last sex in treatment vs. control group at 12 months follow-up

    Time frame: 12 months follow-up

  4. Less frequency of sex with substance use in treatment vs. control group at 12 months follow-up

    Time frame: 12 months follow-up

  5. Higher age of sexual initiation in treatment vs. control group at 12 months follow-up

    Time frame: 12 months follow-up

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Registry information

Official study title

Adapting and Evaluating an Evidence-Based Intervention to Prevent HIV/AIDS Risk Among Apache Youth

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 30, 2013
Registry last updated
Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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