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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1673 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-02-28

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.

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Detailed Description

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Conditions

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HIV Syphilis Anemia During Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Before and after intervention study design

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PIMA® for quantitative analysis of CD4-count

Intervention Type DEVICE

Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin

Intervention Type DEVICE

SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis

Intervention Type DEVICE

Laboratory Testing - Standard of care

Samples sent to the laboratory for analysis, (standard of care)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PIMA® for quantitative analysis of CD4-count

Intervention Type DEVICE

Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin

Intervention Type DEVICE

SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis

Intervention Type DEVICE

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