Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services in Mozambique
|ClinicalTrials.gov Identifier: NCT02191527|
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : October 16, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Syphilis Anemia During Pregnancy||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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||October 2014|
Experimental: 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.
|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|
|No Intervention: Laboratory Testing - Standard of care|
- The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women. [ Time Frame: Within 1 month ]
- Proportion of women at first ANC visit tested and treated for syphilis [ Time Frame: Within 1 month ]
- The proportion of pregnant women tested and treated for anemia [ Time Frame: Within 1 month ]
- Number of HIV infections in infants averted [ Time Frame: 1-3 months of age ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191527
|Principal Investigator:||Caroline DeSchacht, MD, MSc||Elizabeth Glaser Pediatric AIDS Foundation|
|Principal Investigator:||Ilesh V Jani, MD, PhD||Instituto Nacional de Saúde, Mozambique|