Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227825
Status:
UNKNOWN
Last Update Posted:
2017-01-11
First Post:
2005-09-27
Brief Title:
The Aim of This Study is to Determine the Effectiveness of a Motivational Enhancement Intervention in Reducing Risk Behaviors Drug and Alcohol Use Sexual Risk Behavior Poor Adherence to Medications Among HIV Youth - 1
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Motivational Enhancement Therapy to Reduce Risk Behaviors in HIV Infected Youth
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
NOT_YET_RECRUITING
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:
The purpose of this study is to conduct a pilot study of Motivational Enhancement Therapy MET an empirically validated behavioral change strategy with young adults who are HIV The aim is to determine if MET is effective in increasing general health promotion behaviors adherence to HIV specific medical treatment over and above taking medication and decreasing risky behaviors in young adults who are HIV positive The longer-term objective is to identify and way to decrease HIV transmission rates disease progression illness episodes and hospitalizations in this high-risk population
Hypotheses 1Youth receiving the motivational intervention plus referrals will report greater reductions in risky behaviors than youth in the control group receiving standard care plus referrals at 3-months post-baseline This hypothesis will first be tested in the whole sample using an overall risk index Then the hypothesis will be tested with each behavior reduced drug and alcohol use condom use taking medications within the subgroups reporting problem levels of that behavior 2Youth in the intervention group will demonstrate improved viral loads will report greater improvement in perceived health status depression general psychological distress disclosure to sexual partners and will demonstrate greater attendance of medical and support service appointments than youth in the control group at 3 months post-baseline 3Youth in the intervention group will report greater reductions in temptation to engage in risky behaviors increased self-efficacy and improvements in readiness to change their behavior than youth in the control group at 3 months post-baseline 4The differences between the intervention and control group from pre- to post- intervention will be maintained at 6 9 12 and 15 months post-baseline 3 6 9 and 12 months after intervention completion
Hypotheses 1Youth receiving the motivational intervention plus referrals will report greater reductions in risky behaviors than youth in the control group receiving standard care plus referrals at 3-months post-baseline This hypothesis will first be tested in the whole sample using an overall risk index Then the hypothesis will be tested with each behavior reduced drug and alcohol use condom use taking medications within the subgroups reporting problem levels of that behavior 2Youth in the intervention group will demonstrate improved viral loads will report greater improvement in perceived health status depression general psychological distress disclosure to sexual partners and will demonstrate greater attendance of medical and support service appointments than youth in the control group at 3 months post-baseline 3Youth in the intervention group will report greater reductions in temptation to engage in risky behaviors increased self-efficacy and improvements in readiness to change their behavior than youth in the control group at 3 months post-baseline 4The differences between the intervention and control group from pre- to post- intervention will be maintained at 6 9 12 and 15 months post-baseline 3 6 9 and 12 months after intervention completion
Detailed Description:
The proposed study is a randomized clinical trial with a wait-list control The sample will be 60 HIV young adults between the ages of 16 to 24 years recruited from the DMC Horizons Project and other community based HIV programs Self referred persons meeting the diagnostic criteria of HIV will also be accepted There are no exclusion criteria Subjects will be randomly assigned to one of 2 groups MET NOW or MET LATER MET LATER is the wait list control group The only difference between the groups is the timing of the intervention and data collection All subjects will complete 5 research visits and 4 MET therapy sessions Research visits consists of an interview completion of self-report questionnaires a 20cc blood drawn for complete blood count CBC viral load and CD4 count and adherence rating completed by the physician Established questionnaires are used to measure health behaviors sexual risk behaviors substance use self-efficacy stage of change social support health beliefs and mental health status Research visits take about 1 hours Therapy sessions consist of MET provided by a trained therapist Sessions last about 1 hour and focus on changing behavior to improve health increase medical adherence andor reduce risk Subjects choose the behaviors they want to change There are a total of 4 sessions over 3 months The MET NOW group will begin session immediately after the first baseline research visit and the MET LATER group will begin therapy sessions approximately 9 months after the first research visit All subjects will be paid 2500 for the first research visit with a 5 increase for each subsequent research visit a total of 17500 for the 5 research visits Subjects will receive 10 gift certificate at each therapy session Cab vouchers or parking fees will be provided for each therapy or research session
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21-14710-1 | None | None | None |