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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02191527
Enrollment
1673
Registered
2014-07-16
Start date
2013-09-30
Completion date
2015-02-28
Last updated
2020-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia During Pregnancy, HIV, Syphilis

Keywords

PMTCT, HIV, Syphilis, Anemia during pregnancy, Point of care diagnostics

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.

Interventions

DEVICEPIMA® for quantitative analysis of CD4-count
DEVICEHemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin
DEVICESD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis

Sponsors

Ministry of Health, Mozambique
CollaboratorOTHER_GOV
Elizabeth Glaser Pediatric AIDS Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Before and after intervention study design

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women.Within 1 monthNumber of HIV positive pregnant women initiating antiretroviral therapy divided by the number of eligible HIV positive pregnant women

Secondary

MeasureTime frameDescription
Proportion of women at first ANC visit tested and treated for syphilisWithin 1 monthNumber 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 anemiaWithin 1 monthNumber of pregnant women test and treated for anemia divided by the number of pregnant women
Number of HIV infections in infants averted1-3 months of ageNumber of HIV-positive pregnant women who accessed antiretrovial therapy in a timely manner

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026