Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services in Mozambique
Primary Purpose
HIV, Syphilis, Anemia During Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PIMA® for quantitative analysis of CD4-count
Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin
SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis
Sponsored by
About this trial
This is an interventional diagnostic trial for HIV focused on measuring PMTCT, HIV, Syphilis, Anemia during pregnancy, Point of care diagnostics
Eligibility Criteria
Inclusion Criteria:
- First antenatal care visit
- Able to provide informed consent and signed consent form
- Minimum 18 years of age
- Diagnosed HIV positive at antenatal care visit
- Living in the catchment area of the health facility
Exclusion Criteria:
- Age <18 years
- No consent form signed
- Being on ART at time of first antenatal care visit
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Point of Care Testing
Laboratory Testing - Standard of care
Arm Description
The point-of-care devices will be located in the MCH services, where a trained lay counselor will do the tests.
Samples sent to the laboratory for analysis, (standard of care)
Outcomes
Primary Outcome Measures
The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women.
Number of HIV positive pregnant women initiating antiretroviral therapy divided by the number of eligible HIV positive pregnant women
Secondary Outcome Measures
Proportion of women at first ANC visit tested and treated for syphilis
Number of women at first ANC tested and treated for syphilis divided by the number of women attending first ANC visit
The proportion of pregnant women tested and treated for anemia
Number of pregnant women test and treated for anemia divided by the number of pregnant women
Number of HIV infections in infants averted
Number of HIV-positive pregnant women who accessed antiretrovial therapy in a timely manner
Full Information
NCT ID
NCT02191527
First Posted
August 15, 2013
Last Updated
July 21, 2020
Sponsor
Elizabeth Glaser Pediatric AIDS Foundation
Collaborators
Ministry of Health, Mozambique
1. Study Identification
Unique Protocol Identification Number
NCT02191527
Brief Title
Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services in Mozambique
Official Title
Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services and Their Impact on Mother and Child Health Outcomes in Cabo Delgado Province, Mozambique
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elizabeth Glaser Pediatric AIDS Foundation
Collaborators
Ministry of Health, Mozambique
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The general goal of the proposed study is to evaluate the cost-effectiveness of POC technologies for diagnosis of syphilis, quantitative analysis for hemoglobin and CD4 counting performed within MCH services to improve maternal and infant health.
A prospective, quasi-experimental study will be done in Cabo Delgado province, where health facilities will be randomized in an intervention or comparison arm. Outcomes on maternal and infant health will be measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Syphilis, Anemia During Pregnancy
Keywords
PMTCT, HIV, Syphilis, Anemia during pregnancy, Point of care diagnostics
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Before and after intervention study design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1673 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Point of Care Testing
Arm Type
Experimental
Arm Description
The point-of-care devices will be located in the MCH services, where a trained lay counselor will do the tests.
Arm Title
Laboratory Testing - Standard of care
Arm Type
No Intervention
Arm Description
Samples sent to the laboratory for analysis, (standard of care)
Intervention Type
Device
Intervention Name(s)
PIMA® for quantitative analysis of CD4-count
Intervention Type
Device
Intervention Name(s)
Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin
Intervention Type
Device
Intervention Name(s)
SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis
Primary Outcome Measure Information:
Title
The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women.
Description
Number of HIV positive pregnant women initiating antiretroviral therapy divided by the number of eligible HIV positive pregnant women
Time Frame
Within 1 month
Secondary Outcome Measure Information:
Title
Proportion of women at first ANC visit tested and treated for syphilis
Description
Number of women at first ANC tested and treated for syphilis divided by the number of women attending first ANC visit
Time Frame
Within 1 month
Title
The proportion of pregnant women tested and treated for anemia
Description
Number of pregnant women test and treated for anemia divided by the number of pregnant women
Time Frame
Within 1 month
Title
Number of HIV infections in infants averted
Description
Number of HIV-positive pregnant women who accessed antiretrovial therapy in a timely manner
Time Frame
1-3 months of age
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
First antenatal care visit
Able to provide informed consent and signed consent form
Minimum 18 years of age
Diagnosed HIV positive at antenatal care visit
Living in the catchment area of the health facility
Exclusion Criteria:
Age <18 years
No consent form signed
Being on ART at time of first antenatal care visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline DeSchacht, MD, MSc
Organizational Affiliation
Elizabeth Glaser Pediatric AIDS Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ilesh V Jani, MD, PhD
Organizational Affiliation
Instituto Nacional de Saúde, Mozambique
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services in Mozambique
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