HIV Prevention in Haitian American Adolescents
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00494273 |
Recruitment Status
:
Completed
First Posted
: June 29, 2007
Last Update Posted
: October 29, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Behavioral: Cognitive Behavioral and Standard Care with Healthy Living | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 320 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
Primary Purpose: | Prevention |
Official Title: | HIV Prevention in Haitian Youths (HAP) |
Study Start Date : | December 2002 |
Actual Primary Completion Date : | December 2006 |
Actual Study Completion Date : | December 2006 |

- The BART Condition will reduce HIV transmission risk behavior over time more than the SC. Assessments will be completed prior, after, 4 , 8 and 12 months after the intervention. Measure examples are
- Sexual and Condom Attitudes
- Self-Efficacy Scale
- Behavioral Intentions scale
- Health Protective Sexual Communication Scale
- Comfort talking about Safer Sex measure
- Condom Use Skills
- Risk Behavior Assessment
- Examples are
- The Millon Adolescent Clinical Inventory
- The Adolescent-Family Inventory of Life Events & Changes
- Stephenson Multigroup Acculturation Scale
- Adolescent Health Questionnaire-Adolescent and Parent Version.

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Ages Eligible for Study: | 14 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- The adolescent reports being at high risk for HIV transmission by virtue of having ever engaged in risky sexual behavior.
- The adolescent is available for the full duration of the study with no anticipated circumstances impeding study participation (e.g., jail term, out-of-town, etc.).
- The adolescent is fluent in spoken English required to complete our assessment battery and participate in group interventions. Because all of the adolescent are in or have been in the English speaking Public School system they virtually all are fluent in English.
- The adolescent is willing to assent for participation in the study.
- The adolescent has an identifiable parent or parent-figure (i.e., a number of adolescents will have sisters, aunts, or grandmothers who function as their primary caretaker) who is the legal guardian for the adolescent and who is willing to sign the informed consent. A bilingual assessor who is fluent in Creole will be available to parents that speak limited English and the consent forms for the parents will be in Creole.
- The adolescent is assessed not to be harmful to self or others using the relevant sections of the POSIT-HRS and Millon Adolescent Clinical Inventory (MACI).
- The adolescent has no evidence of psychiatric impairments (e.g., psychosis) that might compromise the participants' ability to comprehend and participate in the assessment and intervention processes.
- The child's guardian will be invited to complete a questionnaire regarding communication with their teenager about sex and their guardian's level of acculturation.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494273
United States, Florida | |
Center for Haitian Studies | |
Miami, Florida, United States, 33138 |
Principal Investigator: | Robert M. Malow, Ph.D. | Florida International University |
ClinicalTrials.gov Identifier: | NCT00494273 History of Changes |
Other Study ID Numbers: |
R01HD038458 ( U.S. NIH Grant/Contract ) |
First Posted: | June 29, 2007 Key Record Dates |
Last Update Posted: | October 29, 2014 |
Last Verified: | September 2014 |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Haitian American Adolescents HIV Prevention Cognitive Behavioral Intervention |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |