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

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191527
• Other study ID #: EGPAF-004
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: February 2015

Study information

• Verified date: July 2020
• Source: Elizabeth Glaser Pediatric AIDS Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1673
• Est. completion date: February 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia During Pregnancy
• HIV
• Syphilis

Intervention

Device:
• PIMA® for quantitative analysis of CD4-count

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

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Elizabeth Glaser Pediatric AIDS Foundation	Ministry of Health, Mozambique

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of women at first ANC visit tested and treated for syphilis	Number of women at first ANC tested and treated for syphilis divided by the number of women attending first ANC visit	Within 1 month
Secondary	The proportion of pregnant women tested and treated for anemia	Number of pregnant women test and treated for anemia divided by the number of pregnant women	Within 1 month
Secondary	Number of HIV infections in infants averted	Number of HIV-positive pregnant women who accessed antiretrovial therapy in a timely manner	1-3 months of age