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Trial record 15 of 110 for:    test | ( Map: Malawi )

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:
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

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
Enrollment 16660
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Home Assessment and Initiation of ART Clinic-based ART Assessment and Initiation
Hide Arm/Group Description Optional home initiation of HIV care following HIV self-testing Facility-based HIV care following HIV self-testing only
Period Title: Overall Study
Started 8194 [1] 8466 [1]
Completed 8194 [1] 8466 [1]
Not Completed 0 0
[1]
Adult population denominator for cluster randomised trial
Arm/Group Title Home Assessment and Initiation of ART Clinic-based ART Assessment and Initiation Total
Hide Arm/Group Description 8194 adults resident in 3213 households 8466 adults resident in 3397 households Total of all reporting groups
Overall Number of Baseline Participants 8194 8466 16660
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8194 participants 8466 participants 16660 participants
30.4  (11.8) 30.2  (11.4) 30.3  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8194 participants 8466 participants 16660 participants
Female
3942
  48.1%
4067
  48.0%
8009
  48.1%
Male
4252
  51.9%
4399
  52.0%
8651
  51.9%
1.Primary Outcome
Title ART Initiation
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Assessment and Initiation of ART Clinic-based ART Assessment and Initiation
Hide Arm/Group Description:
Optional home initiation of HIV care following HIV self-testing
Facility-based HIV care following HIV self-testing only
Overall Number of Participants Analyzed 8194 8466
Measure Type: Number
Unit of Measure: participants
181 63
2.Secondary Outcome
Title Uptake of Home-based HIV Testing
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Assessment and Initiation of ART Clinic-based ART Assessment and Initiation
Hide Arm/Group Description:
Optional home initiation of HIV care following HIV self-testing
Facility-based HIV care following HIV self-testing only
Overall Number of Participants Analyzed 8194 8466
Measure Type: Number
Unit of Measure: participants
5287 4433
3.Secondary Outcome
Title Reporting of HIV-positive Results
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Assessment and Initiation of ART Clinic-based ART Assessment and Initiation
Hide Arm/Group Description:
Optional home initiation of HIV care following HIV self-testing
Facility-based HIV care following HIV self-testing only
Overall Number of Participants Analyzed 8194 8466
Measure Type: Number
Unit of Measure: participants
490 278
4.Secondary Outcome
Title Loss to Retention
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Home Assessment and Initiation of ART Clinic-based ART Assessment and Initiation
Hide Arm/Group Description:
Optional home initiation of HIV care following HIV self-testing
Facility-based HIV care following HIV self-testing only
Overall Number of Participants Analyzed 181 63
Measure Type: Number
Unit of Measure: participants
52 15
5.Secondary Outcome
Title Adherence to ART
Hide Description Comparison between study arms of the proportion of HIV-positive participants who are adherent to ART during the 1-year study period
Time Frame First 6-months following availability of home-based HIV testing
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Adult Mortality
Hide Description Comparison between study arms of non-traumatic and HIV-related adult (15-49) mortality rates during the first 6 months of the HIV-testing intervention
Time Frame The first 6-months following availability of home-based HIV testing
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Home Assessment and Initiation of ART Clinic-based ART Assessment and Initiation
Hide Arm/Group Description Optional home initiation of HIV care following HIV self-testing Facility-based HIV care following HIV self-testing only
All-Cause Mortality
Home Assessment and Initiation of ART Clinic-based ART Assessment and Initiation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Home Assessment and Initiation of ART Clinic-based ART Assessment and Initiation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8194 (0.00%)   0/8466 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Home Assessment and Initiation of ART Clinic-based ART Assessment and Initiation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8194 (0.00%)   0/8466 (0.00%) 
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
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