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

Not Applicable

Completed

• Conditions: HIV; Syphilis; Anemia During Pregnancy
• Interventions: 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

• Registration Number: NCT02191527
• Lead Sponsor: Elizabeth Glaser Pediatric AIDS Foundation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-15
• Study Start: 2013-09
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-16
• Primary Completion: 2014-10
• Study Completion: 2015-02
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1673

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Point of Care Testing	PIMA® for quantitative analysis of CD4-count	The point-of-care devices will be located in the MCH services, where a trained lay counselor will do the tests.
Point of Care Testing	Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin	The point-of-care devices will be located in the MCH services, where a trained lay counselor will do the tests.
Point of Care Testing	SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis	The point-of-care devices will be located in the MCH services, where a trained lay counselor will do the tests.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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