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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014