HIVPhase 3NCT00859144
Training Community Members to Deliver HIV Prevention Programs to Urban Youth
A Phase 3 study testing Be Proud! Be Responsible!, Becoming A Responsible Teen (BART) and Reducing the Risk in people with HIV and HIV Infections, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study will examine methods for involving local community members in programs to teach urban youth about how to prevent transmission of HIV. Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, HIV Infections
- What is being tested?
- Be Proud! Be Responsible!, Becoming A Responsible Teen (BART) and Reducing the Risk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 901 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Mar 2012
- Phase
- Phase 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 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adult community HIV educators who are parents of a middle or high school aged child
- Adult participants must be between 25 and 60 years of age
- Youth participants must be between 12 and 15 years of age
- Residents of target communities in Bronx, NY
Who cannot join
- Parent or guardian is excluded if youth participant cannot provide informed consent because of mental health or substance abuse diagnosis
- Significant cognitive impairment that might interfere with understanding of program content or informed consent process
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: Community Partnerships to Prevent Urban Youth Health Risks (CHAMPions)
This study will examine methods for involving local community members in programs to teach urban youth about how to prevent transmission of HIV.
Read the detailed description
HIV is a sexually transmitted virus that damages or destroys a body's immune system. When the infection progresses to its later stages, AIDS can develop. Several programs have been developed for educating adolescents about how to prevent HIV transmission. Preventing infection is particularly important because there is not yet a way to cure HIV. This study will examine the processes needed to train community members to deliver HIV prevention programs to urban youth.
This study has three steps. In Step 1, an existing group of urban community members who have already delivered the Be Proud! Be Responsible! HIV prevention program will be invited to serve as mentors for new HIV educators in the community. Participants in this step will complete self-administered assessments of their willingness to collaborate with university-based researchers, their confidence in skills necessary for collaborative projects, and any foreseeable obstacles to participation. The goal of this step is to examine the response over time to ongoing HIV leadership.
In Step 2, parents from the targeted community will be recruited and trained in HIV prevention programs. They will be randomly assigned to one of three programs: Becoming a Responsible Teen, Be Proud! Be Responsible!, and Reducing the Risk. All three of these programs involve group meetings with adolescents to discuss puberty, sexuality, communication, self-esteem, HIV/AIDS, and setting and achieving goals and dreams. Participants in this phase will undergo the same assessments as those in Step 1.
In Step 3, the parents trained in Step 2 will be randomly assigned to a middle school or high school where they will deliver the program in which they were trained. Randomly selected adolescent participants from these schools will be assigned to whichever program is being offered at their school. All three prevention programs will include four to six sessions over 4 to 6 weeks. Adolescent participants will be required to complete interviews and questionnaires when they enter the study, after 3 months, and after 15 months. These interviews and questionnaires will measure HIV/AIDS knowledge, self-esteem, intention to protect health, and engagement in risk-taking behaviors. Parent participants in Step 3 will repeat the assessments from Steps 1 and 2 before and after delivering their prevention curriculums.
- Conditions
- HIV, HIV Infections
- Being tested
- Be Proud! Be Responsible!, Becoming A Responsible Teen (BART), Reducing the Risk
- Keywords
- HIV Prevention, Youth, Adolescent, Community Collaboration, Community Mentorship, Minority, Urban, Sexual Risk Behaviors, HIV seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Be Proud! Be Responsible!Behavioural
This intervention consists of highly structured modules that involve group discussions, videos, games, brainstorming, experiential exercises, and skill building activities. The program encourages participants to be proud of themselves and their community, to behave responsibly for themselves and their community, and to consider their goals for the future and how risk behaviors may interfere with the attainment of their goals.
Becoming A Responsible Teen (BART)Behavioural
This program consists of highly structured modules administered using intervention manuals in community-based settings. Each intervention session involves group discussion, videos, games, presentations, demonstrations, role plays, and practice. Youth learn problem solving, decision-making, communication, condom negotiation and use skills, and behavioral self-management. Youth also meet with HIV infected peers to promote risk recognition and improve their perception of vulnerability.
Reducing the RiskBehavioural
This program consists of instruction on developing social skills to reduce sexual risk-taking behavior and role plays to practice and model skills. Additional activities-such as teaching decision making and assertive communication skills, offering encouragement to obtain relevant health information from stores and clinics, and asking parents about their views on abstinence and birth control-support the premise that students should avoid unprotected intercourse, either by remaining abstinent or using contraceptives.
| Study group | Role | What they receive |
|---|---|---|
| BART | Experimental | Participants will complete the Becoming a Responsible Teen (BART) program. Receives: Behavioral: Becoming A Responsible Teen (BART) |
| Reducing the Risk | Experimental | Participants will complete the Reducing the Risk program. Receives: Behavioral: Reducing the Risk |
| Be Proud Be Responsible | Active comparator | Participants will complete the Be Proud! Be Responsible! program. Receives: Behavioral: Be Proud! Be Responsible! |
What is being measured
The primary outcome is the main question the study is designed to answer.
Youth sexual risk behaviors
Measured at baseline, after 3 to 4 months, and after 15 months
Measured: Measured at baseline
Youth sexual risk behaviors
Measured at baseline, after 3 to 4 months, and after 15 months
Measured: Measured after 3 to 4 months
Youth sexual risk behaviors
Measured at baseline, after 3 to 4 months, and after 15 months
Measured: Measured after 15 months
HIV educators' intentions to collaborate
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured: Measured at baseline
HIV educators' intentions to collaborate
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured: Measured at post-intervention
HIV educators' intentions to collaborate
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured: Measured at 3-month follow-up
HIV educators' intentions to collaborate
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured: Measured at 15-month follow-up
Collaboration by HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured: Measured at baseline
Collaboration by HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured: Measured at post-intervention
Collaboration by HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured: Measured at 3-month follow-up
Collaboration by HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured: Measured at 15-month follow-up
Youth sexual behavior
Measured at baseline, after 3 to 4 months, and after 15 months
Measured: Measured at baseline
Youth sexual behavior
Measured at baseline, after 3 to 4 months, and after 15 months
Measured: Measured after 3 to 4 months
Youth sexual behavior
Measured at baseline, after 3 to 4 months, and after 15 months
Measured: Measured after 15 months
Youth negotiation of sexual risk situations
Measured at baseline, after 3 to 4 months, and after 15 months
Measured: Measured at baseline
Youth negotiation of sexual risk situations
Measured at baseline, after 3 to 4 months, and after 15 months
Measured: Measured after 3 to 4 months
Youth negotiation of sexual risk situations
Measured at baseline, after 3 to 4 months, and after 15 months
Measured: Measured after 15 months
Secondary outcomes (11)
Leadership skills of HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured: Measured at baseline
Leadership skills of HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured: Measured at post-intervention
Leadership skills of HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured: Measured at 3-month follow-up
Leadership skills of HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured: Measured at 15-month follow-up
HIV/AIDS knowledge and attitudes of educators and youth
Measured at baseline, after 3 to 4 months, and after 15 months
Measured: Measured at baseline
HIV/AIDS knowledge and attitudes of educators and youth
Measured at baseline, after 3 to 4 months, and after 15 months
Measured: Measured after 3 to 4 months
HIV/AIDS knowledge and attitudes of educators and youth
Measured at baseline, after 3 to 4 months, and after 15 months
Measured: Measured after 15 months
Self-esteem and self-efficacy of HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured: Measured at baseline
Self-esteem and self-efficacy of HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured: Measured at post-intervention
Self-esteem and self-efficacy of HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured: Measured at 3-month follow-up
Self-esteem and self-efficacy of HIV educators
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Measured: Measured at 15-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2012
- Study completionMar 2012
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.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Mary M. McKay, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859144
- Sponsor's protocol ID
- GCO 03-0888
- Other IDs
- R01MH069934, DAHBR 9A-ASPA
- Status last verified
- Mar 2012
- First submitted
- 6 Mar 2009
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Partnerships to Prevent Urban Youth Health Risks (CHAMPions)
- ClinicalTrials.gov ID
- NCT00859144
- Acronym / sponsor ID
- GCO 03-0888
- Conditions
- HIV, HIV Infections
- Keywords
- HIV Prevention, Youth, Adolescent, Community Collaboration, Community Mentorship, Minority, Urban, Sexual Risk Behaviors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 901 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 10 Mar 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 will examine methods for involving local community members in programs to teach urban youth about how to prevent transmission of HIV.
Detailed description
HIV is a sexually transmitted virus that damages or destroys a body's immune system. When the infection progresses to its later stages, AIDS can develop. Several programs have been developed for educating adolescents about how to prevent HIV transmission. Preventing infection is particularly important because there is not yet a way to cure HIV. This study will examine the processes needed to train community members to deliver HIV prevention programs to urban youth.
This study has three steps. In Step 1, an existing group of urban community members who have already delivered the Be Proud! Be Responsible! HIV prevention program will be invited to serve as mentors for new HIV educators in the community. Participants in this step will complete self-administered assessments of their willingness to collaborate with university-based researchers, their confidence in skills necessary for collaborative projects, and any foreseeable obstacles to participation. The goal of this step is to examine the response over time to ongoing HIV leadership.
In Step 2, parents from the targeted community will be recruited and trained in HIV prevention programs. They will be randomly assigned to one of three programs: Becoming a Responsible Teen, Be Proud! Be Responsible!, and Reducing the Risk. All three of these programs involve group meetings with adolescents to discuss puberty, sexuality, communication, self-esteem, HIV/AIDS, and setting and achieving goals and dreams. Participants in this phase will undergo the same assessments as those in Step 1.
In Step 3, the parents trained in Step 2 will be randomly assigned to a middle school or high school where they will deliver the program in which they were trained. Randomly selected adolescent participants from these schools will be assigned to whichever program is being offered at their school. All three prevention programs will include four to six sessions over 4 to 6 weeks. Adolescent participants will be required to complete interviews and questionnaires when they enter the study, after 3 months, and after 15 months. These interviews and questionnaires will measure HIV/AIDS knowledge, self-esteem, intention to protect health, and engagement in risk-taking behaviors. Parent participants in Step 3 will repeat the assessments from Steps 1 and 2 before and after delivering their prevention curriculums.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BART | Experimental | Behavioral: Becoming A Responsible Teen (BART)Participants will complete the Becoming a Responsible Teen (BART) program. |
| Reducing the Risk | Experimental | Behavioral: Reducing the RiskParticipants will complete the Reducing the Risk program. |
| Be Proud Be Responsible | Active comparator | Behavioral: Be Proud! Be Responsible!Participants will complete the Be Proud! Be Responsible! program. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adult community HIV educators who are parents of a middle or high school aged child
- Adult participants must be between 25 and 60 years of age
- Youth participants must be between 12 and 15 years of age
- Residents of target communities in Bronx, NY
Key exclusion criteria (2 listed)
- Parent or guardian is excluded if youth participant cannot provide informed consent because of mental health or substance abuse diagnosis
- Significant cognitive impairment that might interfere with understanding of program content or informed consent process
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 |
|---|---|---|
| Be Proud! Be Responsible!This intervention consists of highly structured modules that involve group discussions, videos, games, brainstorming, experiential exercises, and skill building activities. The program encourages participants to be proud of themselves and their community, to behave responsibly for themselves and their community, and to consider their goals for the future and how risk behaviors may interfere with the attainment of their goals. | Behavioural | Be Proud Be Responsible |
| Becoming A Responsible Teen (BART)This program consists of highly structured modules administered using intervention manuals in community-based settings. Each intervention session involves group discussion, videos, games, presentations, demonstrations, role plays, and practice. Youth learn problem solving, decision-making, communication, condom negotiation and use skills, and behavioral self-management. Youth also meet with HIV infected peers to promote risk recognition and improve their perception of vulnerability. | Behavioural | BART |
| Reducing the RiskThis program consists of instruction on developing social skills to reduce sexual risk-taking behavior and role plays to practice and model skills. Additional activities-such as teaching decision making and assertive communication skills, offering encouragement to obtain relevant health information from stores and clinics, and asking parents about their views on abstinence and birth control-support the premise that students should avoid unprotected intercourse, either by remaining abstinent or using contraceptives. | Behavioural | Reducing the Risk |
Primary outcome
Youth sexual risk behaviors
Time frame: Measured at baseline
Measured at baseline, after 3 to 4 months, and after 15 months
Youth sexual risk behaviors
Time frame: Measured after 3 to 4 months
Measured at baseline, after 3 to 4 months, and after 15 months
Youth sexual risk behaviors
Time frame: Measured after 15 months
Measured at baseline, after 3 to 4 months, and after 15 months
HIV educators' intentions to collaborate
Time frame: Measured at baseline
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
HIV educators' intentions to collaborate
Time frame: Measured at post-intervention
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
HIV educators' intentions to collaborate
Time frame: Measured at 3-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
HIV educators' intentions to collaborate
Time frame: Measured at 15-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Collaboration by HIV educators
Time frame: Measured at baseline
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Collaboration by HIV educators
Time frame: Measured at post-intervention
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Collaboration by HIV educators
Time frame: Measured at 3-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Collaboration by HIV educators
Time frame: Measured at 15-month follow-up
Measured at baseline, post-intervention, and at 3- and 15-month follow-ups
Youth sexual behavior
Time frame: Measured at baseline
Measured at baseline, after 3 to 4 months, and after 15 months
Youth sexual behavior
Time frame: Measured after 3 to 4 months
Measured at baseline, after 3 to 4 months, and after 15 months
Youth sexual behavior
Time frame: Measured after 15 months
Measured at baseline, after 3 to 4 months, and after 15 months
Youth negotiation of sexual risk situations
Time frame: Measured at baseline
Measured at baseline, after 3 to 4 months, and after 15 months
Youth negotiation of sexual risk situations
Time frame: Measured after 3 to 4 months
Measured at baseline, after 3 to 4 months, and after 15 months
Youth negotiation of sexual risk situations
Time frame: Measured after 15 months
Measured at baseline, after 3 to 4 months, and after 15 months
11 secondary outcomes
Leadership skills of HIV educators
Time frame: Measured at baseline
Leadership skills of HIV educators
Time frame: Measured at post-intervention
Leadership skills of HIV educators
Time frame: Measured at 3-month follow-up
Leadership skills of HIV educators
Time frame: Measured at 15-month follow-up
HIV/AIDS knowledge and attitudes of educators and youth
Time frame: Measured at baseline
HIV/AIDS knowledge and attitudes of educators and youth
Time frame: Measured after 3 to 4 months
HIV/AIDS knowledge and attitudes of educators and youth
Time frame: Measured after 15 months
Self-esteem and self-efficacy of HIV educators
Time frame: Measured at baseline
Self-esteem and self-efficacy of HIV educators
Time frame: Measured at post-intervention
Self-esteem and self-efficacy of HIV educators
Time frame: Measured at 3-month follow-up
Self-esteem and self-efficacy of HIV educators
Time frame: Measured at 15-month 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 8 Mar 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.
Mary M. McKay, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Be Proud! Be Responsible!, Becoming A Responsible Teen (BART) and Reducing the Risk in people with HIV and HIV Infections, run by Icahn School of Medicine at Mount Sinai 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 4 inclusion and 2 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 8 Mar 2012. 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.
What does this phase mean?
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?
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 sexual risk behaviors (time frame: Measured at baseline). The study lists 17 primary outcomes in all. 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 8 Mar 2012.