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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT02191527
First received: August 15, 2013
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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 Intervention
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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Elizabeth Glaser Pediatric AIDS Foundation:

Primary Outcome Measures:
  • The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women. [ Time Frame: Within 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of women at first ANC visit tested and treated for syphilis [ Time Frame: Within 1 month ] [ Designated as safety issue: No ]
  • The proportion of pregnant women tested and treated for anemia [ Time Frame: Within 1 month ] [ Designated as safety issue: No ]
  • Number of HIV infections in infants averted [ Time Frame: 1-3 months of age ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: September 2013
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier: NCT02191527     History of Changes
Other Study ID Numbers: EGPAF-004
Study First Received: August 15, 2013
Last Updated: October 15, 2014
Health Authority: Mozambqiue: Instituto Nacional de Saúde
United States: Centers for Disease Control and Prevention

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

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

ClinicalTrials.gov processed this record on October 29, 2014