Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT01836003
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 1.4 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 430,000 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.
Study:
NCT01836003
Study Brief:
Protocol Section:
NCT01836003