Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services in Mozambique

July 21, 2020 updated by: Elizabeth Glaser Pediatric AIDS Foundation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1673

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Point of Care Testing
The point-of-care devices will be located in the MCH services, where a trained lay counselor will do the tests.
Device: PIMA® for quantitative analysis of CD4-count
Device: Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin
Device: SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis
No Intervention: Laboratory Testing - Standard of care
Samples sent to the laboratory for analysis, (standard of care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women.
Time Frame: Within 1 month
Number of HIV positive pregnant women initiating antiretroviral therapy divided by the number of eligible HIV positive pregnant women
Within 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of women at first ANC visit tested and treated for syphilis
Time Frame: Within 1 month
Number of women at first ANC tested and treated for syphilis divided by the number of women attending first ANC visit
Within 1 month
The proportion of pregnant women tested and treated for anemia
Time Frame: Within 1 month
Number of pregnant women test and treated for anemia divided by the number of pregnant women
Within 1 month
Number of HIV infections in infants averted
Time Frame: 1-3 months of age
Number of HIV-positive pregnant women who accessed antiretrovial therapy in a timely manner
1-3 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Collaborators

Ministry of Health, Mozambique

Investigators

  • Principal Investigator: Caroline DeSchacht, MD, MSc, Elizabeth Glaser Pediatric AIDS Foundation
  • Principal Investigator: Ilesh V Jani, MD, PhD, Instituto Nacional de Saúde, Mozambique

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

August 15, 2013

First Submitted That Met QC Criteria

July 15, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGPAF-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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