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

Sponsor

Elizabeth Glaser Pediatric AIDS Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT02191527

Collaborator

Ministry of Health, Mozambique (Other)

1,673

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Syphilis Anemia During Pregnancy	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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1673 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Before and after intervention study designBefore and after intervention study design

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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 Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women. [Within 1 month]
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 [Within 1 month]
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 [Within 1 month]
Number of pregnant women test and treated for anemia divided by the number of pregnant women
Number of HIV infections in infants averted [1-3 months of age]
Number of HIV-positive pregnant women who accessed antiretrovial therapy in a timely manner

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Elizabeth Glaser Pediatric AIDS Foundation
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