Sexual BehaviorPhase 3HARTNCT02674165
Evaluation of Haitian American Responsible Teens
A Phase 3 study testing HART in people with Sexual Behavior, run by Boston Medical Center.
Trial summary
The Haitian American Responsible Teen (HART) afterschool program, a cultural adaptation of the BART curriculum, will provide an HIV/AIDS curriculum adapted to Haitian students that consists of eight sessions lasting approximately two hours each over a twelve- week period. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior
- What is being tested?
- HART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 637 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Sep 2015
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Haitian descent
- 13 to 19 years of age
- 9th and 10th grade
- Having signed assent and parental consent forms
- Willingness to participate in the pretest survey
Who cannot join
- Not of Haitian descent
- Age greater than 19 years
- Under 13 years of age
- Cognitive impairment
- Not having signed assent and parental consent forms
- Not willingness to participate in the pretest survey
About this study
The Haitian American Responsible Teen (HART) afterschool program, a cultural adaptation of the BART curriculum, will provide an HIV/AIDS curriculum adapted to Haitian students that consists of eight sessions lasting approximately two hours each over a twelve- week period. The comparison group will receive a nutrition intervention during the same time period. The primary goals of the evaluation are to determine the effectiveness of the HART program on delaying initiation of sexual intercourse, reducing number of sexual partners, and increasing "abstinent" behavior and contraception use among those who were sexually experienced at baseline.
Over a five semester period, the programs will be implemented in 7 or more schools in the greater Boston area, with offerings in the fall, the spring and summer, among approximately 780 male and female Haitian students. The programs will recruit 9th \& 10th grade Haitian students who will range in age from 13 to 19 years old. We will implement a randomized controlled trial in which each semester, students within schools will be stratified by gender and then randomly assigned to participate in the HART or the nutrition condition. Students will be recruited annually and enrolled until the summer of 2015. During the spring and summer of 2012, 120 youth will be randomly assigned to a treatment condition. During year three, 180 youth will be randomly assigned to condition each semester (360 youth total during Year 3). During year four, 180 youth will be randomly assigned in the first semester, and 120 youth will be randomly assigned in the second semester (300 youth total during Year 4). The number of times student-level randomization will occur and the number of groups formed will vary depending on the size of the 9th and 10th grade Haitian population served in each school.
Read the detailed description
This is an intervention with an evaluation component. In each school, students will have equal chance to participate in the sex education class or in the nutrition education class. Each participating school will have two (2) groups:
- The intervention group which will receive the HART sex education curriculum.
- The comparison group which will receive a nutrition education curriculum. There will be one PTSD awareness session for both groups.. This session will be provided by mental health professionals from the Haitian Mental Health Network. Each group will consist of about 13-15 student participants, with the groups meeting each week on specific week days. In addition to the ten-week curriculum, there will be sessions at the beginning and end of the cycle to administer the pre- and post-test questionnaires. The 12-week cycle will be repeated 2-3 times through the school year.
- Conditions
- Sexual Behavior
- Being tested
- HART
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HARTBehavioural
Skills based sexual education intervention plus PTSD awareness
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The pregnancy prevention intervention to be tested is an adaptation of Becoming a Responsible Teen (BART), an evidence-based (proven to work by research) HIV prevention curriculum designed primarily for African American adolescents, ages 14-18, in community-based settings.
The culturally-adapted version HART consists of nine sessions, lasting about 2 hours each, and includes interactive group discussions and role plays that are -performed by adolescents. Unlike BART, one PTSD awareness session has been added to address what happens to people who have been exposed to mental trauma and natural disasters. Receives: Behavioral: HART |
| Control or nutrition | No intervention | Nutrition/fitness curriculum will teach students about ingredients in food that are good for the body and will keep it in good health |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV knowledge measured by having a statistically significant difference between treatment and control participants, in proportion of true or false statements about HIV transmission, prevention and cure that are accurately identified.
This outcome is collected at one week post intervention using a quantitative self-administered survey. Pre-test measures and key demographic data e.g. age, gender and other covariates of prognostic significance that are found not to have a balanced distribution between the treatment and control are adjusted for using multivariate analysis to increase precision of treatment effect measure
Measured: One week after the intervention ended
Secondary outcomes (3)
Three- cognitive constructs that are causally related with HIV knowledge within the "Information Motivation and Behavioral Skills" framework.. Our study includes : 3 measures of Personal motivation
- A statistically significant posttest difference between treatment and control in proportion of participants reporting definite intent to have sex next year
- A statistically significant posttest difference between treatment and control in proportion of participants reporting a definite intent to use condom if have sex in next year
- A statistically significant posttest difference between treatment and control in proportion of participants reporting definite intent to use birth control if have sex in next year
Measured: One week after the intervention ended
4 measures of Social motivation for preventive behavior
A statistically significant posttest difference between the treatment and control in proportion of participants reporting not being embarrassed to buy, use, talk about condoms b) A statistically significant posttest difference between the treatment and control in Proportion of participant reporting condom effectiveness to prevent HIV c) A statistically significant posttest difference between the treatment and control in proportion reporting condom effectiveness to prevent pregnancy d) A statistically significant posttest difference between the treatment and control in proportion of participants reporting not believing that condom purchase is a regulation for youth under the age of 16.
Measured: One week after the intervention ended
4 measures of Behavioral skills of avoiding risky social situations that could engage in risky sexual behavior.
- A statistically significant posttest difference between the treatment and control in Proportion of participants reporting being alone 3 or more times in the last 3 months with someone very attracted to
- A statistically significant posttest difference between the treatment and control in proportion of participants reporting being alone 3 or more times in the last 3 months kissing and touching someone really liked
- A statistically significant posttest difference between the treatment and control in proportion of participant reporting being alone 3 or more times in the last 3 months with someone really liked and laid down on a couch or bed
- A statistically significant posttest difference between the treatment and control in proportion of participants reporting being alone 3 or more times in the last 3 months, at a party where there were no adults in the house
Measured: One week after the intervention ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startApr 2012
- Primary completionMar 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 637 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Prudent, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674165
- Sponsor's protocol ID
- H30298
- Acronym
- HART
- Status last verified
- Feb 2016
- First submitted
- 27 Jan 2016
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Haitian American Responsible Teens
- ClinicalTrials.gov ID
- NCT02674165
- Acronym / sponsor ID
- HART / H30298
- Conditions
- Sexual Behavior
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 637 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Feb 2016 (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 Haitian American Responsible Teen (HART) afterschool program, a cultural adaptation of the BART curriculum, will provide an HIV/AIDS curriculum adapted to Haitian students that consists of eight sessions lasting approximately two hours each over a twelve- week period. The comparison group will receive a nutrition intervention during the same time period. The primary goals of the evaluation are to determine the effectiveness of the HART program on delaying initiation of sexual intercourse, reducing number of sexual partners, and increasing "abstinent" behavior and contraception use among those who were sexually experienced at baseline.
Over a five semester period, the programs will be implemented in 7 or more schools in the greater Boston area, with offerings in the fall, the spring and summer, among approximately 780 male and female Haitian students. The programs will recruit 9th \& 10th grade Haitian students who will range in age from 13 to 19 years old. We will implement a randomized controlled trial in which each semester, students within schools will be stratified by gender and then randomly assigned to participate in the HART or the nutrition condition. Students will be recruited annually and enrolled until the summer of 2015. During the spring and summer of 2012, 120 youth will be randomly assigned to a treatment condition. During year three, 180 youth will be randomly assigned to condition each semester (360 youth total during Year 3). During year four, 180 youth will be randomly assigned in the first semester, and 120 youth will be randomly assigned in the second semester (300 youth total during Year 4). The number of times student-level randomization will occur and the number of groups formed will vary depending on the size of the 9th and 10th grade Haitian population served in each school.
Detailed description
This is an intervention with an evaluation component. In each school, students will have equal chance to participate in the sex education class or in the nutrition education class. Each participating school will have two (2) groups:
- The intervention group which will receive the HART sex education curriculum.
- The comparison group which will receive a nutrition education curriculum. There will be one PTSD awareness session for both groups.. This session will be provided by mental health professionals from the Haitian Mental Health Network. Each group will consist of about 13-15 student participants, with the groups meeting each week on specific week days. In addition to the ten-week curriculum, there will be sessions at the beginning and end of the cycle to administer the pre- and post-test questionnaires. The 12-week cycle will be repeated 2-3 times through the school year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: HARTThe pregnancy prevention intervention to be tested is an adaptation of Becoming a Responsible Teen (BART), an evidence-based (proven to work by research) HIV prevention curriculum designed primarily for African American adolescents, ages 14-18, in community-based settings. The culturally-adapted version HART consists of nine sessions, lasting about 2 hours each, and includes interactive group discussions and role plays that are -performed by adolescents. Unlike BART, one PTSD awareness session has been added to address what happens to people who have been exposed to mental trauma and natural disasters. |
| Control or nutrition | No intervention | –Nutrition/fitness curriculum will teach students about ingredients in food that are good for the body and will keep it in good health |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Haitian descent
- 13 to 19 years of age
- 9th and 10th grade
- Having signed assent and parental consent forms
- Willingness to participate in the pretest survey
Key exclusion criteria (6 listed)
- Not of Haitian descent
- Age greater than 19 years
- Under 13 years of age
- Cognitive impairment
- Not having signed assent and parental consent forms
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 |
|---|---|---|
| HARTSkills based sexual education intervention plus PTSD awareness | Behavioural | Intervention |
Primary outcome
HIV knowledge measured by having a statistically significant difference between treatment and control participants, in proportion of true or false statements about HIV transmission, prevention and cure that are accurately identified.
Time frame: One week after the intervention ended
This outcome is collected at one week post intervention using a quantitative self-administered survey. Pre-test measures and key demographic data e.g. age, gender and other covariates of prognostic significance that are found not to have a balanced distribution between the treatment and control are adjusted for using multivariate analysis to increase precision of treatment effect measure
3 secondary outcomes
Three- cognitive constructs that are causally related with HIV knowledge within the "Information Motivation and Behavioral Skills" framework.. Our study includes : 3 measures of Personal motivation
Time frame: One week after the intervention ended
4 measures of Social motivation for preventive behavior
Time frame: One week after the intervention ended
4 measures of Behavioral skills of avoiding risky social situations that could engage in risky sexual behavior.
Time frame: One week after the intervention ended
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 4 Feb 2016.
- Individual participant dataSharing planned: No
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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 3 study testing HART in people with Sexual Behavior, run by Boston Medical Center.
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 5 inclusion and 6 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 4 Feb 2016. 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 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?
HIV knowledge measured by having a statistically significant difference between treatment and control participants, in proportion of true or false statements about HIV transmission, prevention and cure that are accurately identified. (time frame: One week after the intervention ended). 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 Feb 2016.