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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV, Syphilis, Anemia During Pregnancy

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Before and after intervention study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Point of Care Testing<br>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<br> <br> Device: Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin<br> <br> Device: SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis<br> <br> |
| No Intervention: Laboratory Testing - Standard of care<br>Samples sent to the laboratory for analysis, (standard of care) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Within 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Within 1 month | 
| 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 | Within 1 month | 
| Number of HIV infections in infants averted | Number of HIV-positive pregnant women who accessed antiretrovial therapy in a timely manner | 1-3 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia during pregnancy, PMTCT, HIV, Syphilis, Point of care diagnostics