Modified Directly Observed Antiretroviral Therapy (M-DART)
|ClinicalTrials.gov Identifier: NCT01985269|
Recruitment Status : Unknown
Verified November 2013 by ABRAHAM M. SIIKA, MBChB, MMed, MS, Moi University.
Recruitment status was: Active, not recruiting
First Posted : November 15, 2013
Last Update Posted : November 15, 2013
M-DART Study is a randomized clinical trial comparing the effectiveness of a home-based modified directly observed antiretroviral (ART) treatment strategy to clinic-based standard of care in patients with HIV/AIDS in Port Victoria, Busia, Kitale, Chulaimbo and Khunyangu, Kenya.
Hypothesis 1a: It is feasible to implement M-DART in remote, poverty stricken, high-HIV prevalence rural communities in western Kenya.
Hypothesis 1b: M-DART will be a more effective strategy than standard of care (High-Risk Express Care) in reducing mortality and LTFU in patients at the highest risk of dying following ART initiation.
Hypothesis 2: M-DART will be cost effective over the 48-week study period
Hypothesis 3a: Patients enrolled in M-DART will have higher quality of life scores at 24 and 48 weeks as compared to the control patients.
Hypothesis 3b: Patients enrolled in M-DART will have lower HIV related stigma scores at 24 and 48-weeks as compared to the control patients.
|Condition or disease||Intervention/treatment||Phase|
|HIV||Other: Home visits||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||511 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Modified Directly Observed Antiretroviral Therapy (M-DART): An Intensive, Nurse-directed, Home-centered, Treatment Strategy to Reduce Mortality and Loss to Follow-up in High-risk HIV-infected Patients Initiating Antiretroviral Therapy|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Active Comparator: Home visits
Minimal physical examination at home Drug adherence/pill counts
Other: Home visits
The participants' vital signs (blood pressure, temperature, pulse rate, respiratory rate, and arterial oxygen saturation) will be taken and a limited physical examination (e.g. oral cavity for thrush, Kaposi's lesions, ulcers and dehydration; skin for rash, herpes zoster and dehydration; eyes for jaundice and pallor, gross neurological function such as ability to walk without difficulty, presence of facial droop, one-sided body weakness etc.) conducted. The nurse will then review medications adherence before observing the study participant swallow their pills (antiretrovirals, anti-TB, antibiotics, and analgesics).
No Intervention: Control
Normal standard of care
- Death [ Time Frame: 48 weeks ]Death data will be collected at 48 weeks of the study
- Lost to follow up [ Time Frame: 48 weeks ]Lost to follow up data will be collected at 48 weeks of the study
- plasma viral load (pVL) [ Time Frame: 48 weeks ]Plasma viral load (pVL) changes at 48 weeks will be measured
- CD4 Count (cells/ml) [ Time Frame: 48 weeks ]CD4 count changes at 48 weeks will be measured
- Weight (Kg) [ Time Frame: 48 weeks ]Weight changes at 48 weeks will be measured
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985269
|Moi Teaching and Referral Hospital|
|Eldoret, Rift Valley, Kenya, 30100|
|Principal Investigator:||Abraham M Siika, MBCHB,MMED,MS||Moi University|