- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02191527
Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services in Mozambique
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
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
|
No Intervention: Laboratory Testing - Standard of care
Samples sent to the laboratory for analysis, (standard of care)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Within 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Within 1 month
|
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
|
Within 1 month
|
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
|
1-3 months of age
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Caroline DeSchacht, MD, MSc, Elizabeth Glaser Pediatric AIDS Foundation
- Principal Investigator: Ilesh V Jani, MD, PhD, Instituto Nacional de Saúde, Mozambique
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Sexually Transmitted Diseases, Bacterial
- Spirochaetales Infections
- Treponemal Infections
- Syphilis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Chrysarobin
Other Study ID Numbers
- EGPAF-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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