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Completed

NCT Number: NCT02191527

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

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.

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Key information

Conditions

HIV Anemia During Pregnancy Bacterial Infections Bacterial Infections and Mycoses Communicable Diseases Genital Diseases Gram-Negative Bacterial Infections Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Spirochaetales Infections Syphilis Treponemal Infections Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Primary outcomes

  1. The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women.

    Time frame: Within 1 month

    Number of HIV positive pregnant women initiating antiretroviral therapy divided by the number of eligible HIV positive pregnant women

Secondary outcomes

  1. Proportion of women at first ANC visit tested and treated for syphilis

    Time frame: Within 1 month

    Number of women at first ANC tested and treated for syphilis divided by the number of women attending first ANC visit

  2. The proportion of pregnant women tested and treated for anemia

    Time frame: Within 1 month

    Number of pregnant women test and treated for anemia divided by the number of pregnant women

  3. Number of HIV infections in infants averted

    Time frame: 1-3 months of age

    Number of HIV-positive pregnant women who accessed antiretrovial therapy in a timely manner

Sponsors and collaborators

Lead sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Other

Collaborators

  • Ministry of Health, Mozambique

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jul 16, 2014
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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