HIV InfectionsNCT00963963
Reducing HIV Risks in African American Teens
A study testing Healthy Futures parent education in people with HIV Infections, run by Education Development Center, Inc. at 1 site in United States.
Trial summary
This study is developing and testing an innovative, parent education intervention, Preparing Our Sons and Daughters for Healthy Futures. This intervention aims to reduce HIV risk among African American and other Black youth living in high-poverty urban neighborhoods. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Healthy Futures parent education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to 30 Apr 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 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Attendance at selected schools
- 6th graders and their parents
Who cannot join
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Education Development Center
Newton, Massachusetts, 02458
About this study
Official title: Reducing HIV Risks in African American Teens in High Poverty Urban Settings
This study is developing and testing an innovative, parent education intervention, Preparing Our Sons and Daughters for Healthy Futures. This intervention aims to reduce HIV risk among African American and other Black youth living in high-poverty urban neighborhoods. Investigators, working with a community advisory board and focus groups of youth and parents, will develop a multi-year set of audio-CDs to promote positive parenting practices that support young adolescents in establishing healthy patterns of behavior. This parent education intervention will be tested in a field trial with families of 6th graders recruited from multiple schools in New York City. Baseline and annual follow up surveys will be conducted until youth enter high school. Families receiving the intervention will be compared to those assigned to either an attention-controlled print materials condition or a non-attention controlled condition. It is hypothesized that youth whose parents receive the intervention will delay sexual initiation and report fewer sexual risks, and that their parents will report more positive parenting practices.
- Conditions
- HIV Infections
- Being tested
- Healthy Futures parent education
- Keywords
- sexual health, adolescent health, parent education, HIV Seronegativity, treatment experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Futures parent educationBehavioural
Multi-year audio CD parent education
| Study group | Role | What they receive |
|---|---|---|
| health promotion materials | Active comparator | Parents receive health promotion booklets Receives: Behavioral: Healthy Futures parent education |
| attention-controlled parent print materials | Active comparator | Booklets on adolescent sexuality and health Receives: Behavioral: Healthy Futures parent education |
| audio-CD parent education | Experimental | audio-CDs on parenting practices Receives: Behavioral: Healthy Futures parent education |
What is being measured
The primary outcome is the main question the study is designed to answer.
youth risk behaviors
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study startApr 2006
- Primary completion30 Apr 2013
- Study completion30 Apr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
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
- NCT00963963
- Sponsor's protocol ID
- 5R01HD054297
- Status last verified
- Jan 2018
- First submitted
- 21 Aug 2009
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing HIV Risks in African American Teens in High Poverty Urban Settings
- ClinicalTrials.gov ID
- NCT00963963
- Acronym / sponsor ID
- 5R01HD054297
- Conditions
- HIV Infections
- Keywords
- sexual health, adolescent health, parent education, HIV Seronegativity, treatment experienced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Education Development Center, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2006 (actual)
- Primary completion
- 30 Apr 2013 (actual)
- Study completion
- 30 Apr 2013 (actual)
- First posted
- 24 Aug 2009 (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 is developing and testing an innovative, parent education intervention, Preparing Our Sons and Daughters for Healthy Futures. This intervention aims to reduce HIV risk among African American and other Black youth living in high-poverty urban neighborhoods. Investigators, working with a community advisory board and focus groups of youth and parents, will develop a multi-year set of audio-CDs to promote positive parenting practices that support young adolescents in establishing healthy patterns of behavior. This parent education intervention will be tested in a field trial with families of 6th graders recruited from multiple schools in New York City. Baseline and annual follow up surveys will be conducted until youth enter high school. Families receiving the intervention will be compared to those assigned to either an attention-controlled print materials condition or a non-attention controlled condition. It is hypothesized that youth whose parents receive the intervention will delay sexual initiation and report fewer sexual risks, and that their parents will report more positive parenting practices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| health promotion materials | Active comparator | Behavioral: Healthy Futures parent educationParents receive health promotion booklets |
| attention-controlled parent print materials | Active comparator | Behavioral: Healthy Futures parent educationBooklets on adolescent sexuality and health |
| audio-CD parent education | Experimental | Behavioral: Healthy Futures parent educationaudio-CDs on parenting practices |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Attendance at selected schools
- 6th graders and their parents
Key exclusion criteria (1 listed)
- Non-English speaking
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 |
|---|---|---|
| Healthy Futures parent educationMulti-year audio CD parent education | Behavioural | attention-controlled parent print materials, audio-CD parent education, health promotion materials |
Primary outcome
youth risk behaviors
Time frame: 12 months
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 1 Feb 2018.
Related trials for HIV Infections
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingPhase 2
Multiple Interventions With Distinct Anti-reservoir Activities in People on Antiretroviral Treatment
HIV - Human Immunodeficiency Virus
RecruitingPhase 2
CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma
Recruiting
Improving Engagement in HIV and Cancer Care in Zimbabwe
Cancer, HIV
RecruitingObservational study
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
HIV
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Futures parent education in people with HIV Infections, run by Education Development Center, Inc. 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 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: finished, as of the sponsor's last update on 1 Feb 2018. 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?
youth risk behaviors (time frame: 12 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 1 Feb 2018.