Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272220
Status:
COMPLETED
Last Update Posted:
2007-11-07
First Post:
2005-12-30
Brief Title:
Longitudinal Study of HAART Social Networks Adherence
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Longitudinal Randomized Controlled Study of Modified Directly Observed HAART in Mozambique
Status:
COMPLETED
Status Verified Date:
2007-11
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:
Our study is a randomized controlled trial that aims to evaluate the effectiveness of modified directly observed therapy mDOT to 1 increase both short and long term adherence to HAART treatment and 2 improve clinical outcomes associated with HAART therapy
Our hypothesis is that modified directly observed therapy mDOT during the initial 6 weeks of HAART supervised primarily by HIV-positive lay activists will improve adherence and clinical outcomes compared with those that do not have supervised mDOT We also hypothesize that the benefits of mDOT will be achieved through a variety of mediators that will result from the social interactions the patients will have with the activists These mediators include improved social support improved knowledge about HAART reduced stigma and improved self-efficacy
Our hypothesis is that modified directly observed therapy mDOT during the initial 6 weeks of HAART supervised primarily by HIV-positive lay activists will improve adherence and clinical outcomes compared with those that do not have supervised mDOT We also hypothesize that the benefits of mDOT will be achieved through a variety of mediators that will result from the social interactions the patients will have with the activists These mediators include improved social support improved knowledge about HAART reduced stigma and improved self-efficacy
Detailed Description:
To test this hypothesis we intend to randomize 350 ARV naïve patients starting HAART to either receive mDOT for the initial 6 weeks of treatment or standard adherence support Both intervention and control groups will receive standard HIV care that includes HAART medications free of charge clinical and laboratory follow-up psychosocial adherence support by a trained social worker and referral to community-based peer support groups Patients in the intervention group will in addition to stand care receive their morning weekday dose of a twice-daily HAART regimen under DOT in clinic for 6 weeks Nighttime and weekend doses are self-administered A group of HIV-positive DOT activists who are trained and paid lay-clinic personnel will be primarily responsible for the direct observation of treatment in the mDOT group In addition to observing treatment DOT activists will provide counseling education and emotional support to patients and will also locate patients not presenting for DOT on the same day Although the HIV activists may also provide psychosocial and adherence support to specific patients in the control group this support will only be a daily and formalized part of care in the group randomized to mDOT
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 |
|---|---|---|---|
| TAPHIV-AIDSMS-DPCGACOPI04 | None | None | None |