Ignite Creation Date:
2024-05-06 @ 1:32 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01836003
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2013-04-10
Brief Title:
An Intervention to Improve Antenatal Access to CD4 Testing and HAART in Botswana
Sponsor:
Harvard School of Public Health HSPH
Organization:
Harvard School of Public Health HSPH
Study Overview
Official Title:
Programmatic CD4 Testing and HAART Initiation Among HIV-Infected Pregnant Women in Gaborone Botswana A Randomized Staged Trial of an Improvement Intervention
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Access to highly active antiretroviral therapy can improve maternal health outcomes for the 4000 HIV- infected women who give birth daily and nearly eliminate transmission of HIV to their infants However system inefficiencies particularly CD4 testing to determine treatment eligibility are barriers The project aims to study the effectiveness of a programmatic intervention at improving antenatal access to treatment
Detailed Description:
Perinatal antiretroviral therapy dramatically reduces the risk of transmission of HIV to the 14 million infants born annually to HIV-infected mothers Single-dose and single-drug strategies lead to important reductions in mother-to-child transmission MTCT However more intense strategies using maternal highly active antiretroviral therapy HAART to suppress viral replication lead to 10-fold greater reductions in the risk of MTCT Wider access to maternal HAART could nearly eliminate the estimated 430000 annual HIV- infections acquired by infants worldwide Additionally prompt initiation of HAART in pregnant women with low CD4 cell counts could improve maternal mortality and prevent the development of resistant maternal and infant HIV infections
However studies from southern Africa including Botswana indicate that less than one-third of treatment-eligible women are able to access antenatal HAART Programmatic inefficiencies in these settings lead to substantial delays in CD4 testing and subsequent treatment initiation Novel implementation strategies are urgently needed to improve access to the established benefits of antenatal HAART In collaboration with colleagues in the Botswana Ministry of Health we have completed an analysis of root causes of the failure to antenatal HAART identifying delayed CD4 testing and result reporting and loss-to-follow-up as the principal barriers
To assess the hypothesis that a low-cost intervention can improve antenatal access to CD4 testing and HAART initiation the Tokafatso project is a staged-wedge cluster-randomized study of a combination programmatic intervention The intervention includes- improved access to CD4 phlebotomy rapid CD4 result return via SMS messaging and active follow-up of treatment eligible women All enrolled clinics will receive the intervention but the order of implementation will be randomized 10 stages of 2 clinics Endpoints will be assessed between clinics receiving and not receiving the intervention while adjusting for temporal factors While clinics will be enrolled and receive the intervention endpoints will be assessed through anonymous maternity record abstraction of women who subsequently deliver at the catchment inpatient maternity ward
While tailored to the situation in Botswana findings are expected to generalizable to implementation of comprehensive prevention of MTCT services throughout the region
However studies from southern Africa including Botswana indicate that less than one-third of treatment-eligible women are able to access antenatal HAART Programmatic inefficiencies in these settings lead to substantial delays in CD4 testing and subsequent treatment initiation Novel implementation strategies are urgently needed to improve access to the established benefits of antenatal HAART In collaboration with colleagues in the Botswana Ministry of Health we have completed an analysis of root causes of the failure to antenatal HAART identifying delayed CD4 testing and result reporting and loss-to-follow-up as the principal barriers
To assess the hypothesis that a low-cost intervention can improve antenatal access to CD4 testing and HAART initiation the Tokafatso project is a staged-wedge cluster-randomized study of a combination programmatic intervention The intervention includes- improved access to CD4 phlebotomy rapid CD4 result return via SMS messaging and active follow-up of treatment eligible women All enrolled clinics will receive the intervention but the order of implementation will be randomized 10 stages of 2 clinics Endpoints will be assessed between clinics receiving and not receiving the intervention while adjusting for temporal factors While clinics will be enrolled and receive the intervention endpoints will be assessed through anonymous maternity record abstraction of women who subsequently deliver at the catchment inpatient maternity ward
While tailored to the situation in Botswana findings are expected to generalizable to implementation of comprehensive prevention of MTCT services throughout the region
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3R01HD044391-06S1 | NIH | None | httpsreporternihgovquickSearch3R01HD044391-06S1 |