DeathNCT00753428
Community-based Evaluation of a Pilot PMTCT Project in Kafue District
An observational study of Death and HIV Infection, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
Trial summary
In this study, the investigators will assess the population effectiveness of using routine HAART as a PMTCT strategy, through a community-based survey. The survey will be done in the catchment areas of four health clinics in rural Zambia both before and after giving routine ART in the clinics, so as to estimate… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Death, HIV Infection
- What is being tested?
- Community-based Survey
- How many people
- 4,129 participants
- Where
- 1 siteZambia
- Study dates
- Nov 2008to Nov 2011
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Households will be eligible for the full survey if they report that a child was born to a household member within the past two years. If the answer to this question is "yes," an attempt will be made to speak with the mother of the child. If the mother of the child is not available, then the primary care-taker of the child will be interviewed at that time.
Who may be able to join
- Household where a child has been born in the past two years.
Who cannot join
- Household where there no child has been born in the past two years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CIDRZ 1236 - Community-based Evaluation of a Pilot PMTCT Project in Kafue District: Impact of HAART to Prevent Pediatric AIDS in Rural Zambia.
In this study, the investigators will assess the population effectiveness of using routine HAART as a PMTCT strategy, through a community-based survey. The survey will be done in the catchment areas of four health clinics in rural Zambia both before and after giving routine ART in the clinics, so as to estimate population HIV-free survival among infants born in each target community.
The investigators hypothesize that incorporation of routine ART into PMTCT will increase the HIV-free survival of exposed infants to 75%.
Read the detailed description
The primary objective is to determine the incremental benefit of a routine ART strategy for PMTCT on a population basis, when compared to short-course Zidovudine and single-dose Nevirapine (the current PMTCT standard of care).
We will take advantage of planned implementation of a pilot project for routine ART across four primary care centres in rural Zambia (Kafue District). Using a community-based survey modeled after the Demographic and Health Survey, we will measure HIV-free survival among children under two years of age in the catchment areas surrounding these pilot sites, both before and after implementation of services. We will use before-after comparisons in each of these four communities to better understand the incremental benefit of providing these services.
- Conditions
- Death, HIV Infection
- Being tested
- Community-based Survey
- Keywords
- HIV-free survival, Community based evaluation, Pregnancy, Under 2 child survival, PMTCT, Pediatric HIV infection, HAART, Routine ART, HIV Seronegativity
- Medical subject headings
- Death, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based SurveyOther
Questionnaires will be used to record detailed information regarding demographic and socioeconomic characteristics, maternal medical history, recent obstetrical history (including access to preventive services for mother-to-child HIV transmission), and infant medical history. Infant deaths will also be recorded as part of the survey. In cases where either the mother or infant has died, we will perform verbal autopsy interviews (Appendix 5) with surviving family members to determine cause of death and gather information regarding HIV infection and/or exposure.
Heel/finger pricks will be taken so as to perform dried blood spot cards, and test for HIV in children and adults.
| Study group | Role | What they receive |
|---|---|---|
| Baseline evaluation | Prior to the implementation of the pilot project of giving routine HAART as a method of PMTCT, a minimum of 387 households with children under the age of two will be sampled within each community, for a total of 1,548 households for the first round. Receives: Other: Community-based Survey | |
| Following implementation | Two years after full implementation of the pilot project of giving routine HAART for PMTCT across all sites, a minimum of 387 households with children under the age of two will be sampled within each community, for a total of 1,548 households. [Note: At time of implementation, we used the same sampling frame for each community. Because of the population increased observed in parts of Kafue, the final number of households significantly exceeded the minimum threshold.] Receives: Other: Community-based Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Population HIV-free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeathStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 4,129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Benjamin Chi, M.D., Principal investigator, Centre for Infectious Disease Research in Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753428
- Sponsor's protocol ID
- 12-0399
- Other IDs
- X080331005
- Status last verified
- Apr 2018
- First submitted
- 15 Sep 2008
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Turnbull E, Lembalemba MK, Guffey MB, Bolton-Moore C, Mubiana-Mbewe M, Chintu N, Giganti MJ, Nalubamba-Phiri M, Stringer EM, Stringer JS, Chi BH. Causes of stillbirth, neonatal death and early childhood death in rural Zambia by verbal autopsy assessments. Trop Med Int Health. 2011 Jul;16(7):894-901. doi: 10.1111/j.1365-3156.2011.02776.x. Epub 2011 Apr 7.
PubMed 21470348
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIDRZ 1236 - Community-based Evaluation of a Pilot PMTCT Project in Kafue District: Impact of HAART to Prevent Pediatric AIDS in Rural Zambia.
- ClinicalTrials.gov ID
- NCT00753428
- Acronym / sponsor ID
- 12-0399
- Conditions
- Death, HIV Infection
- Keywords
- HIV-free survival, Community based evaluation, Pregnancy, Under 2 child survival, PMTCT, Pediatric HIV infection, HAART, Routine ART
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,129 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Study start
- Nov 2008 (actual)
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 Sep 2008 (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.
In this study, the investigators will assess the population effectiveness of using routine HAART as a PMTCT strategy, through a community-based survey. The survey will be done in the catchment areas of four health clinics in rural Zambia both before and after giving routine ART in the clinics, so as to estimate population HIV-free survival among infants born in each target community.
The investigators hypothesize that incorporation of routine ART into PMTCT will increase the HIV-free survival of exposed infants to 75%.
Detailed description
The primary objective is to determine the incremental benefit of a routine ART strategy for PMTCT on a population basis, when compared to short-course Zidovudine and single-dose Nevirapine (the current PMTCT standard of care).
We will take advantage of planned implementation of a pilot project for routine ART across four primary care centres in rural Zambia (Kafue District). Using a community-based survey modeled after the Demographic and Health Survey, we will measure HIV-free survival among children under two years of age in the catchment areas surrounding these pilot sites, both before and after implementation of services. We will use before-after comparisons in each of these four communities to better understand the incremental benefit of providing these services.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline evaluation | – | Other: Community-based SurveyPrior to the implementation of the pilot project of giving routine HAART as a method of PMTCT, a minimum of 387 households with children under the age of two will be sampled within each community, for a total of 1,548 households for the first round. |
| Following implementation | – | Other: Community-based SurveyTwo years after full implementation of the pilot project of giving routine HAART for PMTCT across all sites, a minimum of 387 households with children under the age of two will be sampled within each community, for a total of 1,548 households. [Note: At time of implementation, we used the same sampling frame for each community. Because of the population increased observed in parts of Kafue, the final number of households significantly exceeded the minimum threshold.] |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Households will be eligible for the full survey if they report that a child was born to a household member within the past two years. If the answer to this question is "yes," an attempt will be made to speak with the mother of the child. If the mother of the child is not available, then the primary care-taker of the child will be interviewed at that time.
Key inclusion criteria (1 listed)
- Household where a child has been born in the past two years.
Key exclusion criteria (1 listed)
- Household where there no child has been born in the past two years.
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 |
|---|---|---|
| Community-based SurveyQuestionnaires will be used to record detailed information regarding demographic and socioeconomic characteristics, maternal medical history, recent obstetrical history (including access to preventive services for mother-to-child HIV transmission), and infant medical history. Infant deaths will also be recorded as part of the survey. In cases where either the mother or infant has died, we will perform verbal autopsy interviews (Appendix 5) with surviving family members to determine cause of death and gather information regarding HIV infection and/or exposure. Heel/finger pricks will be taken so as to perform dried blood spot cards, and test for HIV in children and adults. | Other | Baseline evaluation, Following implementation |
Primary outcome
Population HIV-free survival
Time frame: 2 years
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 19 Apr 2018.
- Results publication: PubMed 21470348Turnbull E, Lembalemba MK, Guffey MB, Bolton-Moore C, Mubiana-Mbewe M, Chintu N, Giganti MJ, Nalubamba-Phiri M, Stringer EM, Stringer JS, Chi BH. Causes of stillbirth, neonatal death and early childhood death in rural Zambia by verbal autopsy assessments. Trop Med Int Health. 2011 Jul;16(7):894-901. doi: 10.1111/j.1365-3156.2011.02776.x. Epub 2011 Apr 7.
- Website for organisation implementing research studyLink provided by the sponsor.
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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.
Benjamin Chi, M.D. principal investigator
Centre for Infectious Disease Research in Zambia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Death and HIV Infection, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
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 1 inclusion and 1 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 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Population HIV-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00753428, which also lists 1 linked publication.
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 19 Apr 2018.