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

Elizabeth Glaser Pediatric AIDS Foundation

Status: Completed

Conditions: Syphilis; Anemia During Pregnancy; HIV

Treatments: Device: SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis; Device: Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin; Device: PIMA® for quantitative analysis of CD4-count

Study type: Interventional

Funder types: Other

Identifiers

NCT02191527

EGPAF-004

Details and patient eligibility

About

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.

Enrollment: 1,673 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,673 participants in 2 patient groups

Point of Care Testing

Experimental group

Description:

The point-of-care devices will be located in the MCH services, where a trained lay counselor will do the tests.

Treatment:

Device: PIMA® for quantitative analysis of CD4-count

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

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

Laboratory Testing - Standard of care

No Intervention group

Description:

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