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

NCT02191527 | Completed

• 1 other identifier: EGPAF-004
• Study Type: interventional
• Target: 1,673
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV; Syphilis; Anemia During Pregnancy

Keywords

PMTCT; HIV; Syphilis; Anemia during pregnancy; Point of care diagnostics

Outcome Measures

Primary Outcomes (1)

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

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

  Within 1 month

Secondary Outcomes (3)

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

  Within 1 month

• The proportion of pregnant women tested and treated for anemia

  Within 1 month

• Number of HIV infections in infants averted

  1-3 months of age

Study Arms (2)

Point of Care Testing

EXPERIMENTAL

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

Laboratory Testing - Standard of care

NO INTERVENTION

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

Interventions

PIMA® for quantitative analysis of CD4-count DEVICE

Point of Care Testing

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

Point of Care Testing

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

Point of Care Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years
• No consent form signed
• Being on ART at time of first antenatal care visit

Sponsors & Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation: lead
• Ministry of Health, Mozambique: collaborator

MeSH Terms

Conditions

Syphilis

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Caroline DeSchacht, MD, MSc

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

• Ilesh V Jani, MD, PhD

  Instituto Nacional de Saúde, Mozambique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Before and after intervention study design

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: July 16, 2014
• Study Start: September 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: February 1, 2015
• Last Updated: July 23, 2020

Record last verified: 2020-07