Modified Directly Observed Antiretroviral Therapy (M-DART)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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|
- Death [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]Death data will be collected at 48 weeks of the study
- Lost to follow up [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]Lost to follow up data will be collected at 48 weeks of the study
- plasma viral load (pVL) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]Plasma viral load (pVL) changes at 48 weeks will be measured
- CD4 Count (cells/ml) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]CD4 count changes at 48 weeks will be measured
- Weight (Kg) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]Weight changes at 48 weeks will be measured
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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
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|Moi Teaching and Referral Hospital|
|Eldoret, Rift Valley, Kenya, 30100|
|Principal Investigator:||Abraham M Siika, MBCHB,MMED,MS||Moi University|