Ignite Creation Date:
2024-05-05 @ 11:29 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01347437
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2011-04-04
Brief Title:
Improving Antiretroviral Medication Adherence Among HIV-infected Youth
Sponsor:
Fenway Community Health
Organization:
Fenway Community Health
Study Overview
Official Title:
Improving Antiretroviral Medication Adherence Among HIV-infected Youth Phase II
Status:
COMPLETED
Status Verified Date:
2017-04
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:
HIV is increasing among adolescents and young adults in the US Antiretroviral medications when taken correctly 90 of prescribed doses taken can vastly improve life expectancy However adherence among HIV-infected young people is suboptimal and few interventions are available to help adolescents adhere to treatment
The study is a randomized controlled trial RCT pilot trial of Positive STEPS the adapted form of the Life-Steps behavioral intervention to improve medication adherence among HIV-infected youth The study will allow us to demonstrate participant acceptance ability to recruit feasibility of intervention delivery with study counselors and all study procedures and initial clinically significant improvement in medication adherence via MEMS caps This research will lay the groundwork for a federal grant application for a multi-site randomized controlled intervention trial
The study is a randomized controlled trial RCT pilot trial of Positive STEPS the adapted form of the Life-Steps behavioral intervention to improve medication adherence among HIV-infected youth The study will allow us to demonstrate participant acceptance ability to recruit feasibility of intervention delivery with study counselors and all study procedures and initial clinically significant improvement in medication adherence via MEMS caps This research will lay the groundwork for a federal grant application for a multi-site randomized controlled intervention trial
Detailed Description:
Aims
1 To conduct a randomized controlled pilot test of a behavioral adherence intervention to improve medication adherence among HIV-infected youth aged 13-24 Feasibility of all study procedures and participant acceptability will be assessed
2 To explore whether the intervention leads to improved medication adherence among youth who receive the intervention compared to a control group of youth who do not
40 HIV-infected adolescents will be recruited for a RCT pilot of the Positive STEPS intervention at Fenway Health and Childrens Hospital Boston Participants will be randomized into one of two arms half and half Randomization for all participants will occur after the beginning of the week 2 study visit The duration of the study is 3 months
Randomization
The investigators will conduct block randomization based on two categories of electronic adherence 85 or above versus 85 All participants will have exhibited some non-adherence in order to be eligible for the study although they may vary in the extent of non-adherence Because insufficient information is known about the range of non-adherence in the population to determine the most valid non-adherence cut-off points the investigators may need to reconsider adherence categories over the course of the pilot study The investigators will regularly examine the data to determine whether finer adherence categories are needed and the investigators will adjust the categories if such a determination is made
Intervention arm
Participants will receive one on one Positive STEPS counseling sessions 1 hour sessions per week for 5 weeks
Participants will receive motivational reminders to take medications sent via text message to their cell phones
Participants will receive the Medication Event Monitoring Systems MEMS pill cap monitoring device to measure antiretroviral medication adherence
Comparison condition arm
Participants will receive the Medication Event Monitoring Systems MEMS pill cap monitoring device to measure antiretroviral medication adherence
1 To conduct a randomized controlled pilot test of a behavioral adherence intervention to improve medication adherence among HIV-infected youth aged 13-24 Feasibility of all study procedures and participant acceptability will be assessed
2 To explore whether the intervention leads to improved medication adherence among youth who receive the intervention compared to a control group of youth who do not
40 HIV-infected adolescents will be recruited for a RCT pilot of the Positive STEPS intervention at Fenway Health and Childrens Hospital Boston Participants will be randomized into one of two arms half and half Randomization for all participants will occur after the beginning of the week 2 study visit The duration of the study is 3 months
Randomization
The investigators will conduct block randomization based on two categories of electronic adherence 85 or above versus 85 All participants will have exhibited some non-adherence in order to be eligible for the study although they may vary in the extent of non-adherence Because insufficient information is known about the range of non-adherence in the population to determine the most valid non-adherence cut-off points the investigators may need to reconsider adherence categories over the course of the pilot study The investigators will regularly examine the data to determine whether finer adherence categories are needed and the investigators will adjust the categories if such a determination is made
Intervention arm
Participants will receive one on one Positive STEPS counseling sessions 1 hour sessions per week for 5 weeks
Participants will receive motivational reminders to take medications sent via text message to their cell phones
Participants will receive the Medication Event Monitoring Systems MEMS pill cap monitoring device to measure antiretroviral medication adherence
Comparison condition arm
Participants will receive the Medication Event Monitoring Systems MEMS pill cap monitoring device to measure antiretroviral medication adherence
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