We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01414413
Recruitment Status : Completed
First Posted : August 11, 2011
Results First Posted : April 7, 2014
Last Update Posted : April 7, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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

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

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 
Overall Participants Analyzed 
[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

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 ]
  Hide Outcome Measure 2

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  

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 
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 ]

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 reported.   Anticipated Reporting Date:   No text entered.  

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.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier: NCT01414413     History of Changes
Other Study ID Numbers: MLW-089673
WT089673/B/09/Z ( Other Grant/Funding Number: Wellcome Trust, UK )
First Submitted: August 10, 2011
First Posted: August 11, 2011
Results First Submitted: February 19, 2014
Results First Posted: April 7, 2014
Last Update Posted: April 7, 2014