Modified Directly Observed Antiretroviral Therapy

NCT01985269 | Unknown DMC

• 1 other identifier: AID-623-A-00-08-00003
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Keywords

High risk; ART naive

Outcome Measures

Primary Outcomes (2)

• Death

  Death data will be collected at 48 weeks of the study

  48 weeks

• Lost to follow up

  Lost to follow up data will be collected at 48 weeks of the study

  48 weeks

Secondary Outcomes (3)

• plasma viral load (pVL)

  48 weeks

• CD4 Count (cells/ml)

  48 weeks

• Weight (Kg)

  48 weeks

Study Arms (2)

Home visits

ACTIVE COMPARATOR

Minimal physical examination at home Drug adherence/pill counts

Other: Home visits

Control

NO INTERVENTION

Normal standard of care

Interventions

Home visits OTHER

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).

Also known as: Treatment arm, Intervention arm

Home visits

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who require initiation of ART and fulfill the following AMPATH High-Risk Express Care criteria will be eligible for enrollment into the study.
• Newly diagnosed HIV-infected patients
• Age \>14 years
• CD4 count \<100 cells/ml
• ART naïve

You may not qualify if:

• Patients declining home visits
• Refusal to consent to the study

Sponsors & Collaborators

• Moi University: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

Moi Teaching and Referral Hospital

Eldoret, Rift Valley, 30100, Kenya

Location

MeSH Terms

Interventions

House Calls

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Abraham M Siika, MBCHB,MMED,MS

  Moi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 15, 2013
• Study Start: August 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 15, 2013

Record last verified: 2013-11

Locations

KE (1)