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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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The 14 clusters included in the study had a combined adult population of 16660, with 8194 adults resident in 3213 households in the OHC arm and 8466 adults resident in 3397 households in the FCO arm. Socio-demographic characteristics assessed in the baseline enumeration were well balanced between intervention groups.

Reporting Groups
  Description
Home Assessment and Initiation of ART 8194 adults resident in 3213 households
Clinic-based ART Assessment and Initiation 8466 adults resident in 3397 households
Total Total of all reporting groups

Baseline Measures
    Home Assessment and Initiation of ART     Clinic-based ART Assessment and Initiation     Total  
Number of Participants  
[units: participants]
  8194     8466     16660  
Age  
[units: years]
Mean ± Standard Deviation
  30.4  ± 11.8     30.2  ± 11.4     30.3  ± 11.6  
Gender  
[units: participants]
     
Female     3942     4067     8009  
Male     4252     4399     8651  



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

Measure Type Primary
Measure Title ART Initiation
Measure Description Comparison between study arms of the proportion of all resident adults (per capita, and irrespective of HIV status or participation in home-based HIV testing intervention) who initiate ART during the first 6 months of the home-based HIV-testing intervention.
Time Frame First six months following introduction of home-based HIV testing  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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

Measured Values
    Home Assessment and Initiation of ART     Clinic-based ART Assessment and Initiation  
Number of Participants Analyzed  
[units: participants]
  8194     8466  
ART Initiation  
[units: participants]
  181     63  

No statistical analysis provided for ART Initiation



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

Measure Type Secondary
Measure Title Uptake of Home-based HIV Testing
Measure Description Comparison between study arms of the proportion of all resident adults who request HIV testing (either as standard HTC or as supervised HIV self-testing) from the resident community counsellor during the first year of the study.
Time Frame The first 6-months following home assessment and initiation of ART being made available  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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

Measured Values
    Home Assessment and Initiation of ART     Clinic-based ART Assessment and Initiation  
Number of Participants Analyzed  
[units: participants]
  8194     8466  
Uptake of Home-based HIV Testing  
[units: participants]
  5287     4433  

No statistical analysis provided for Uptake of Home-based HIV Testing



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

Measure Type Secondary
Measure Title Reporting of HIV-positive Results
Measure Description Comparison of the proportion of all cluster adults confiding HIV-positive results to the resident community counsellor between study arms during the 1-year study period
Time Frame The first 6-months following availability of home-based HIV testing  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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

Measured Values
    Home Assessment and Initiation of ART     Clinic-based ART Assessment and Initiation  
Number of Participants Analyzed  
[units: participants]
  8194     8466  
Reporting of HIV-positive Results  
[units: participants]
  490     278  

No statistical analysis provided for Reporting of HIV-positive Results



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

Measure Type Secondary
Measure Title Loss to Retention
Measure Description Comparison between study arms of the proportion of participants who initiate ART during the first 6-months of the HIV-testing intervention who are lost to retention within 6 months after initiating ART 6-months
Time Frame The first 6-months following availability of home-based HIV testing  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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

Measured Values
    Home Assessment and Initiation of ART     Clinic-based ART Assessment and Initiation  
Number of Participants Analyzed  
[units: participants]
  181     63  
Loss to Retention  
[units: participants]
  52     15  

No statistical analysis provided for Loss to Retention



5.  Secondary:   Adherence to ART   [ Time Frame: First 6-months following availability of home-based HIV testing ]
Results not yet reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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