HIV/AIDSNCT01910714
Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth
A study testing Focus On Youth in people with HIV/AIDS, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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: 1. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Focus On Youth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Center for American Indian Health
Baltimore, Maryland, 21205
About this study
Official title: Adapting and Evaluating an Evidence-Based Intervention 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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- Focus On Youth, Health Education Control Condition
- Keywords
- HIV/AIDS, Prevention, American Indian, Substance use, CBPR
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus On YouthBehavioural
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 ConditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Health Education Control Condition | Active comparator | 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. Receives: Behavioral: Health Education Control Condition |
| Focus on Youth Intervention (FOY) | Experimental | 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. Receives: Behavioral: Focus On Youth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved score on condom use self-efficacy scale in treatment vs. control group at 12 months follow-up
Measured: 12 months follow-up
Secondary outcomes (5)
Improved score on scale of HIV prevention knowledge, intention and perceptions in treatment vs. control group at 12 months follow-up
Measured: 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
Measured: 12 months follow-up
Higher use of condoms at last sex in treatment vs. control group at 12 months follow-up
Measured: 12 months follow-up
Less frequency of sex with substance use in treatment vs. control group at 12 months follow-up
Measured: 12 months follow-up
Higher age of sexual initiation in treatment vs. control group at 12 months follow-up
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startSep 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Rompalo, MD, ScM, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910714
- Sponsor's protocol ID
- NARCH V: U26IHS300286/03
- Status last verified
- Apr 2015
- First submitted
- 17 Jul 2013
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Evaluating an Evidence-Based Intervention to Prevent HIV/AIDS Risk Among Apache Youth
- ClinicalTrials.gov ID
- NCT01910714
- Acronym / sponsor ID
- NARCH V: U26IHS300286/03
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, Prevention, American Indian, Substance use, CBPR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Education Control Condition | Active comparator | Behavioral: Health Education Control ConditionThe 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 Intervention (FOY) | Experimental | Behavioral: Focus On YouthFocus 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. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus On YouthFocus 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. | Behavioural | Focus on Youth Intervention (FOY) |
| Health Education Control ConditionThe 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. | Behavioural | Health Education Control Condition |
Primary outcome
Improved score on condom use self-efficacy scale in treatment vs. control group at 12 months follow-up
Time frame: 12 months follow-up
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Rompalo, MD, ScM principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focus On Youth in people with HIV/AIDS, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2015.