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

NCT02191527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1673

Last updated 2020-07-23

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Ministry of Health, Mozambique

    collaborator OTHER_GOV

  • Elizabeth Glaser Pediatric AIDS Foundation

    lead OTHER

Principal Investigators

  • Caroline DeSchacht, MD, MSc · Elizabeth Glaser Pediatric AIDS Foundation

  • Ilesh V Jani, MD, PhD · Instituto Nacional de Saúde, Mozambique

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-10-31
Completion
2015-02-28

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02191527 on ClinicalTrials.gov