Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259389
Status:
COMPLETED
Last Update Posted:
2012-09-18
First Post:
2005-11-28
Brief Title:
Directly Observed Therapy for HIV Infected Adolescents
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Directly Observed Therapy DOT in HIV-1 Infected Adolescents
Status:
COMPLETED
Status Verified Date:
2012-09
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:
Adherence to a doctor-prescribed anti-HIV drug regimen is crucial in the management of HIV infection In previous studies with tuberculosis patients directly observed therapy DOT a strategy in which patients are observed while taking their medications has been proven useful in increasing patient adherence The purpose of this study is to determine the effectiveness of a new DOT strategy in HIV infected adolescents who have had difficulty adhering to anti-HIV drug regimens or regimens to prevent opportunistic infections OIs in the past
Detailed Description:
For HIV infected people control of HIV infection is best achieved by adhering to the highly active antiretroviral therapy HAART regimen prescribed by their doctors Poor adherence to a HAART regimen leads to clinical failure and the development of resistance Many HIV infected adolescents have difficulty adhering to their prescribed anti-HIV regimens or OI prophylaxis often they cite forgetting to take their medications as the reason for poor adherence This is a pilot study of using DOT and assessing adherence during DOT in HIV infected adolescents who have had difficulty adhering to HAART regimens in the past The purpose of this study is to evaluate the efficacy in increasing patient adherence and the feasibility of using DOT among HIV infected adolescents
This study will last 24 weeks For the first 2 weeks of the study DOT will be provided 7 days a week at the study site participants will visit the study site daily and will be observed taking their medication For the next 6 weeks the frequency of DOT will be reduced from 7 days a week to 5 days a week Based on adherence from Weeks 4 to 8 each participant will be recommended to continue with a DOT strategy as follows
Adherence Level 1 greater than 93 - DOT 3 days a week
Adherence Level 2 86 to 93 - DOT 5 days a week
Adherence Level 3 less than 86 - DOT 7 days a week
Participants will decide whether to accept their DOT assignment and to continue in the study At Week 12 and every 4 weeks thereafter adherence will be assessed and DOT may be adjusted as follows
Adherence Level 1 - Reduce frequency of DOT Those already receiving DOT 3 days a week stop DOT and start self-administered therapy
Adherence Level 2 - Keep same frequency of DOT as the past 4 weeks
Adherence Level 3 - Increase frequency of DOT by one level as described in previous list
HAART will not be provided by this study so participants must have access to their HAART medications coordinated separately through the study site Participants who are taking medication requiring twice-daily dosing will self-administer their second doses
There will be 7 study visits they will occur at study entry and every 4 weeks thereafter Medical history will occur at study entry At every visit participants adherence to their regimens will be assessed and they will also be interviewed by a social worker about their use of support services Participants will undergo several assessments at study entry and Weeks 12 and 24 to determine participant confidence beliefs about medicine severity of depression feelings of hopelessness coping responses and emotional and behavioral problems Blood collection will occur at study entry and Weeks 8 12 and 24 When participants successfully complete their prescribed courses of DOT or elect to discontinue DOT they will again be interviewed by study staff
This study will last 24 weeks For the first 2 weeks of the study DOT will be provided 7 days a week at the study site participants will visit the study site daily and will be observed taking their medication For the next 6 weeks the frequency of DOT will be reduced from 7 days a week to 5 days a week Based on adherence from Weeks 4 to 8 each participant will be recommended to continue with a DOT strategy as follows
Adherence Level 1 greater than 93 - DOT 3 days a week
Adherence Level 2 86 to 93 - DOT 5 days a week
Adherence Level 3 less than 86 - DOT 7 days a week
Participants will decide whether to accept their DOT assignment and to continue in the study At Week 12 and every 4 weeks thereafter adherence will be assessed and DOT may be adjusted as follows
Adherence Level 1 - Reduce frequency of DOT Those already receiving DOT 3 days a week stop DOT and start self-administered therapy
Adherence Level 2 - Keep same frequency of DOT as the past 4 weeks
Adherence Level 3 - Increase frequency of DOT by one level as described in previous list
HAART will not be provided by this study so participants must have access to their HAART medications coordinated separately through the study site Participants who are taking medication requiring twice-daily dosing will self-administer their second doses
There will be 7 study visits they will occur at study entry and every 4 weeks thereafter Medical history will occur at study entry At every visit participants adherence to their regimens will be assessed and they will also be interviewed by a social worker about their use of support services Participants will undergo several assessments at study entry and Weeks 12 and 24 to determine participant confidence beliefs about medicine severity of depression feelings of hopelessness coping responses and emotional and behavioral problems Blood collection will occur at study entry and Weeks 8 12 and 24 When participants successfully complete their prescribed courses of DOT or elect to discontinue DOT they will again be interviewed by study staff
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 |
|---|---|---|---|
| 10044 | REGISTRY | DAIDS-ES | None |