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

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ClinicalTrials.gov Identifier: NCT02191527
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : October 16, 2014
Sponsor:
Collaborator:
MINISTRY OF HEALTH MOZAMBIQUE (INSTITUTO NACIONAL DE SAÚDE, COMITE NACIONAL DE BIOETICA PARA A SAUDE)
Information provided by (Responsible Party):
Elizabeth Glaser Pediatric AIDS Foundation

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.


Condition or disease Intervention/treatment
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Primary Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Syphilis
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women. [ Time Frame: Within 1 month ]

Secondary Outcome Measures :
  1. Proportion of women at first ANC visit tested and treated for syphilis [ Time Frame: Within 1 month ]
  2. The proportion of pregnant women tested and treated for anemia [ Time Frame: Within 1 month ]
  3. Number of HIV infections in infants averted [ Time Frame: 1-3 months of age ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Elizabeth Glaser Pediatric AIDS Foundation
MINISTRY OF HEALTH MOZAMBIQUE (INSTITUTO NACIONAL DE SAÚDE, COMITE NACIONAL DE BIOETICA PARA A SAUDE)
Investigators
Principal Investigator: Caroline DeSchacht, MD, MSc Elizabeth Glaser Pediatric AIDS Foundation
Principal Investigator: Ilesh V Jani, MD, PhD Instituto Nacional de Saúde, Mozambique

Responsible Party: Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier: NCT02191527     History of Changes
Other Study ID Numbers: EGPAF-004
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014

Keywords provided by Elizabeth Glaser Pediatric AIDS Foundation:
PMTCT
HIV
Syphilis
Anemia during pregnancy
Point of care diagnostics

Additional relevant MeSH terms:
Syphilis
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female