Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103532
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2005-02-09
Brief Title:
Healthy Choices to Promote Health and Reduce Risk in HIV-Infected Youth
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Motivational Enhancement to Promote Health and Reduce Risk in HIV-Infected Youth
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Risk behaviors and their associated adverse health outcomes are becoming increasingly problematic among HIV-infected youth This study is being conducted to test whether a brief motivational enhancement ME intervention will help reduce health risk behaviors drug and alcohol use sexual risk behavior poor adherence to medications among HIV youth
Detailed Description:
Healthy Choices is a randomized clinical trial examining the efficacy of motivational enhancement in reducing risk and promoting healthy behaviors This study will use a sample of 225 youth 180 after attrition ages 16-24 of whom 90 will receive the intervention referral and standard care and 90 will receive referral plus standard care The sample will be drawn from five study sites Using parallel screening recruitment will target 100 youth with an adherence problem 100 youth with a substance use problem and 25 youth with a sexual risk problem A repeated measures design will be used for the proposed study Primary outcome measures are drug and alcohol use condom use and HIV medication adherence Youth will complete an initial data collection session baseline during which questionnaire and interview measures will be administered Blood specimens for viral load and CD4 count will also be obtained
Randomization procedures will take place after completion of the baseline assessment Participants who are randomized to the intervention group will participate in four sessions for approximately 3 months and will also receive standard care plus individualized referrals The control group will receive standard care and individualized referrals All five sites offer comprehensive multidisciplinary care including social work and case management services and access to mental health services Participants will receive a three-month post-test designed to coincide with ME completion Subsequent post-tests will occur at 6 9 12 and 15 months after baseline data collection 3 6 9 and 12 months after ME completion
Randomization procedures will take place after completion of the baseline assessment Participants who are randomized to the intervention group will participate in four sessions for approximately 3 months and will also receive standard care plus individualized referrals The control group will receive standard care and individualized referrals All five sites offer comprehensive multidisciplinary care including social work and case management services and access to mental health services Participants will receive a three-month post-test designed to coincide with ME completion Subsequent post-tests will occur at 6 9 12 and 15 months after baseline data collection 3 6 9 and 12 months after ME completion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None