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| Name | Class |
|---|---|
| Ministry of Health, Mozambique | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Laboratory Testing - Standard of care | No Intervention | Samples sent to the laboratory for analysis, (standard of care) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIMA® for quantitative analysis of CD4-count | Device |
| ||
| Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The proportion of pregnant women tested and treated for anemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline DeSchacht, MD, MSc | Elizabeth Glaser Pediatric AIDS Foundation | Principal Investigator |
| Ilesh V Jani, MD, PhD | Instituto Nacional de Saúde, Mozambique | Principal Investigator |
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Before and after intervention study design
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| Device |
|
| SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis | Device |
|
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 | Number of HIV-positive pregnant women who accessed antiretrovial therapy in a timely manner | 1-3 months of age |
| ID | Term |
|---|---|
| D013587 | Syphilis |
| ID | Term |
|---|---|
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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