Home Assessment and Initiation of Antiretroviral Therapy for HIV in Malawi (CONDA-YAPA)

This study has been completed.
Sponsor:
Collaborators:
University of Malawi College of Medicine
London School of Hygiene and Tropical Medicine
Ministry of Health and Population, Malawi
Information provided by (Responsible Party):
Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01414413
First received: August 10, 2011
Last updated: February 19, 2014
Last verified: February 2014
Results First Received: February 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: HIV
Interventions: Other: Home assessment and initiation of ART
Other: Clinic-based ART assessment and initiation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Home Assessment and Initiation of ART Optional home initiation of HIV care following HIV self-testing
Clinic-based ART Assessment and Initiation Facility-based HIV care following HIV self-testing only

Participant Flow:   Overall Study
    Home Assessment and Initiation of ART     Clinic-based ART Assessment and Initiation  
STARTED     8194 [1]   8466 [1]
COMPLETED     8194 [1]   8466 [1]
NOT COMPLETED     0     0  
[1] Adult population denominator for cluster randomised trial



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   ART Initiation   [ Time Frame: First six months following introduction of home-based HIV testing ]

2.  Secondary:   Uptake of Home-based HIV Testing   [ Time Frame: The first 6-months following home assessment and initiation of ART being made available ]

3.  Secondary:   Reporting of HIV-positive Results   [ Time Frame: The first 6-months following availability of home-based HIV testing ]

4.  Secondary:   Loss to Retention   [ Time Frame: The first 6-months following availability of home-based HIV testing ]

5.  Secondary:   Adherence to ART   [ Time Frame: First 6-months following availability of home-based HIV testing ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Adult Mortality   [ Time Frame: The first 6-months following availability of home-based HIV testing ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Peter MacPherson
Organization: Liverpool School of Tropical Medicine
phone: 0044151 705 3100
e-mail: p.macpherson@liv.ac.uk


No publications provided by Liverpool School of Tropical Medicine

Publications automatically indexed to this study:

Responsible Party: Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier: NCT01414413     History of Changes
Other Study ID Numbers: MLW-089673, WT089673/B/09/Z
Study First Received: August 10, 2011
Results First Received: February 19, 2014
Last Updated: February 19, 2014
Health Authority: Malawi: College of Medicine Research and Ethics Committee