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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
Elizabeth Glaser Pediatric AIDS Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    August 15, 2013
    Last Updated
    July 21, 2020
    Sponsor
    Elizabeth Glaser Pediatric AIDS Foundation
    Collaborators
    Ministry of Health, Mozambique
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    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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