HIVNCT02191527
Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services in Mozambique
A study testing PIMA® for quantitative analysis of CD4-count, Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin and SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis in people with HIV and Syphilis, run by Elizabeth Glaser Pediatric AIDS Foundation.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV, Syphilis, Anemia During Pregnancy
- What is being tested?
- PIMA® for quantitative analysis of CD4-count, Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin and SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,673 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age <18 years
- No consent form signed
- Being on ART at time of first antenatal care visit
About this study
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
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
- Being tested
- 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
- Keywords
- PMTCT, HIV, Syphilis, Anemia during pregnancy, Point of care diagnostics
- Medical subject headings
- Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIMA® for quantitative analysis of CD4-countDevice
Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobinDevice
SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilisDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 1 month
Secondary outcomes (3)
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
Measured: Within 1 month
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
Measured: Within 1 month
Number of HIV infections in infants averted
Number of HIV-positive pregnant women who accessed antiretrovial therapy in a timely manner
Measured: 1-3 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startSep 2013
- Primary completionOct 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Before and after intervention study design
- Masking
- None (open label)
- Enrolment
- 1,673 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Mozambique
- Responsible party
- Sponsor
- Investigators
- Caroline DeSchacht, MD, MSc, Principal investigator, Elizabeth Glaser Pediatric AIDS FoundationIlesh V Jani, MD, PhD, Principal investigator, Instituto Nacional de Saúde, Mozambique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191527
- Sponsor's protocol ID
- EGPAF-004
- Status last verified
- Jul 2020
- First submitted
- 15 Aug 2013
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02191527
- Acronym / sponsor ID
- EGPAF-004
- Conditions
- HIV, Syphilis, Anemia During Pregnancy
- Keywords
- PMTCT, HIV, Syphilis, Anemia during pregnancy, Point of care diagnostics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,673 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Collaborators
- Ministry of Health, Mozambique
- Study start
- Sep 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before and after intervention study design
| Arm | Type | Receives |
|---|---|---|
| Point of Care Testing | Experimental | 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 syphilisThe 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Age <18 years
- No consent form signed
- Being on ART at time of first antenatal care visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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
3 secondary outcomes
Proportion of women at first ANC visit tested and treated for syphilis
Time frame: Within 1 month
The proportion of pregnant women tested and treated for anemia
Time frame: Within 1 month
Number of HIV infections in infants averted
Time frame: 1-3 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline DeSchacht, MD, MSc principal investigator
Elizabeth Glaser Pediatric AIDS Foundation
Ilesh V Jani, MD, PhD principal investigator
Instituto Nacional de Saúde, Mozambique
Questions about this trial
What is this clinical trial studying?
A study testing PIMA® for quantitative analysis of CD4-count, Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin and SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis in people with HIV and Syphilis, run by Elizabeth Glaser Pediatric AIDS Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women. (time frame: Within 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.