HIVPhase 2/3NCT01633879
Addressing Proven Factors in HIV Prevention for Latino Youth
A Phase 2/3 study testing audio-CD parent education and health and success parent and school in people with HIV and Sexually Transmitted Infections, run by Education Development Center, Inc..
Trial summary
This study tests the effectiveness of the bilingual Health and Success program, which aims to support Latino parents and schools in their efforts to promote the academic success and healthy choices of youth, with the goal of reducing barriers that lead to elevated levels of HIV/AIDS in urban Latino communities. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Sexually Transmitted Infections
- What is being tested?
- audio-CD parent education and health and success parent and school
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,400 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Jul 2014
- Phase
- Phase 2/3
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- youth attend school selected as study site
- youth in 6-7th grade
Who cannot join
- parent/youth non-English or Spanish speakers
About this study
Official title: Health and Success: Addressing Proven Factors in HIV Prevention for Latino Youth
This study tests the effectiveness of the bilingual Health and Success program, which aims to support Latino parents and schools in their efforts to promote the academic success and healthy choices of youth, with the goal of reducing barriers that lead to elevated levels of HIV/AIDS in urban Latino communities.
- Conditions
- HIV, Sexually Transmitted Infections
- Being tested
- audio-CD parent education, health and success parent and school
- Keywords
- parenting, prevention, HIV/AIDS, adolescents, Latino
- Medical subject headings
- Sexually Transmitted Diseases, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
audio-CD parent educationBehavioural
Also called health and success
audio CD stories in English and Spanish that support positive parenting practices
health and success parent and schoolBehavioural
Parenting education and school intervention
| Study group | Role | What they receive |
|---|---|---|
| parent education | Experimental | audio-CD parent EDC supporting positive parenting practices Receives: Behavioral: audio-CD parent education |
| parent and school intervention | Experimental | health and success parent and school intervention Receives: Behavioral: health and success parent and school |
| print materials | No intervention | brochures to parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in risk behavior
The study will examine whether there is a reduction in risky sexual behavior among youth exposed to the two treatment conditions compared to the control condition.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startJul 2009
- Primary completionDec 2013 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Education Development Center, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Lydia O'Donnell, Education Development Center, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633879
- Sponsor's protocol ID
- 5R01HD062084
- Status last verified
- Jul 2012
- First submitted
- 29 Jun 2012
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Success: Addressing Proven Factors in HIV Prevention for Latino Youth
- ClinicalTrials.gov ID
- NCT01633879
- Acronym / sponsor ID
- 5R01HD062084
- Conditions
- HIV, Sexually Transmitted Infections
- Keywords
- parenting, prevention, HIV/AIDS, adolescents, Latino
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,400 participants (estimated)
- Lead sponsor
- Education Development Center, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 4 Jul 2012 (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.
This study tests the effectiveness of the bilingual Health and Success program, which aims to support Latino parents and schools in their efforts to promote the academic success and healthy choices of youth, with the goal of reducing barriers that lead to elevated levels of HIV/AIDS in urban Latino communities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| parent education | Experimental | Behavioral: audio-CD parent educationaudio-CD parent EDC supporting positive parenting practices |
| parent and school intervention | Experimental | Behavioral: health and success parent and schoolhealth and success parent and school intervention |
| print materials | No intervention | –brochures to parents |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- youth attend school selected as study site
- youth in 6-7th grade
Key exclusion criteria (1 listed)
- parent/youth non-English or Spanish speakers
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 |
|---|---|---|
| audio-CD parent educationAlso: health and successaudio CD stories in English and Spanish that support positive parenting practices | Behavioural | parent education |
| health and success parent and schoolParenting education and school intervention | Behavioural | parent and school intervention |
Primary outcome
reduction in risk behavior
Time frame: 18 months
The study will examine whether there is a reduction in risky sexual behavior among youth exposed to the two treatment conditions compared to the control condition.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing audio-CD parent education and health and success parent and school in people with HIV and Sexually Transmitted Infections, run by Education Development Center, Inc..
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 2 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: status not confirmed, as of the sponsor's last update on 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
reduction in risk behavior (time frame: 18 months). 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 4 Jul 2012.