Modified Directly Observed Antiretroviral Therapy (M-DART)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
ABRAHAM M. SIIKA, MBChB, MMed, MS, Moi University
ClinicalTrials.gov Identifier:
NCT01985269
First received: October 24, 2013
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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 Intervention
HIV
Other: Home visits

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Moi University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 511
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)
Arms Assigned Interventions
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).
Other Names:
  • Treatment arm
  • Intervention arm
No Intervention: Control
Normal standard of care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients who require initiation of ART and fulfill the following AMPATH High-Risk Express Care criteria will be eligible for enrollment into the study.

  1. Newly diagnosed HIV-infected patients
  2. Age >14 years
  3. CD4 count <100 cells/ml
  4. ART naïve

Exclusion Criteria:

  1. Patients declining home visits
  2. Refusal to consent to the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01985269

Locations
Kenya
Moi Teaching and Referral Hospital
Eldoret, Rift Valley, Kenya, 30100
Sponsors and Collaborators
Moi University
United States Agency for International Development (USAID)
Investigators
Principal Investigator: Abraham M Siika, MBCHB,MMED,MS Moi University
  More Information

No publications provided

Responsible Party: ABRAHAM M. SIIKA, MBChB, MMed, MS, Associate Professor of Medicine, Moi University
ClinicalTrials.gov Identifier: NCT01985269     History of Changes
Other Study ID Numbers: AID-623-A-00-08-00003
Study First Received: October 24, 2013
Last Updated: November 8, 2013
Health Authority: Kenya: Institutional Review Board

Keywords provided by Moi University:
High risk
ART naive

ClinicalTrials.gov processed this record on April 17, 2014