An Intervention to Improve Antenatal Access to CD4 Testing and HAART in Botswana
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Purpose
| Condition | Intervention |
|---|---|
|
HIV Infection Pregnancy |
Other: Tokafatso programmatic intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Programmatic CD4 Testing and HAART Initiation Among HIV-Infected Pregnant Women in Gaborone, Botswana: A Randomized Staged Trial of an Improvement Intervention |
- Proportion of eligible pregnant women with CD4 enumeration prior to 26 weeks gestation [ Time Frame: At delivery ] [ Designated as safety issue: No ]Gestational age at time of CD4 enumeration will be estimated from last normal menstrual period. Dates of CD4 enumeration and last normal menstrual period will be abstracted from medical records at the time of delivery.
- Proportion of eligible women with HAART initiation prior to 30 weeks gestation [ Time Frame: At delivery ] [ Designated as safety issue: No ]Gestational age at time of HAART initiation will be estimated from last normal menstrual period. Dates of HAART initiation and last normal menstrual period will be abstracted from medical records at the time of delivery.
- Proportion of eligible women with CD4 testing prior to delivery [ Time Frame: At delivery ] [ Designated as safety issue: No ]Gestational age at time of CD4 enumeration will be estimated from last normal menstrual period. Dates of CD4 enumeration and last normal menstrual period will be abstracted from medical records at the time of delivery.
- Proportion of eligible women with HAART initiation prior to delivery [ Time Frame: At delivery ] [ Designated as safety issue: No ]Gestational age at time of HAART initiation will be estimated from last normal menstrual period. Dates of HAART initiation and last normal menstrual period will be abstracted from medical records at the time of delivery.
- Gestational age of eligible women at time of CD4 enumeration [ Time Frame: At delivery ] [ Designated as safety issue: No ]Gestational age at time of CD4 enumeration will be estimated from last normal menstrual period. Dates of CD4 enumeration and last normal menstrual period will be abstracted from medical records at the time of delivery.
- Gestational age of eligible women at the time of HAART initiation [ Time Frame: At delivery ] [ Designated as safety issue: No ]Gestational age at time of HAART initiation will be estimated from last normal menstrual period. Dates of HAART initiation and last normal menstrual period will be abstracted from medical records at the time of delivery.
| Enrollment: | 422 |
| Study Start Date: | July 2011 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tokafatso programmatic intervention
Antenatal clinic receives the Tokafatso programmatic intervention, including educational session, SMS-based facilitation of CD4 result delivery, and patient tracing support.
|
Other: Tokafatso programmatic intervention
Tokafatso programmatic intervention:
|
|
No Intervention: Usual Care
Has not yet received Tokafatso combination programmatic intervention
|
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.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Accepts Healthy Volunteers: | No |
Study was conducted and intervention was implemented in antenatal clinics. Criteria for clinic participation:
Inclusion Criteria:
- Clinic providing antenatal services within greater Gaborone, Botswana
- CD4 specimens analyzed at Botswana Harvard HIV Reference Laboratory
- Supervising authority provided written permission for participation
Exclusion Criteria:
- Facilities caring for incarcerated women
- Facilities without a dedicated antenatal program
Endpoints assessed in pregnant women meeting the following criteria:
Inclusion Criteria:
- Delivered at Princess Marina Hospital
- Documented HIV infection
- Botswana citizen
Exclusion Criteria:
- Receiving HAART prior to antenatal clinic registration
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01836003
| Botswana | |
| Botswana Harvard AIDS Institute | |
| Gaborone, Botswana | |
| Principal Investigator: | Scott Dryden-Peterson, MD | Harvard School of Public Health, Botswana Harvard AIDS Institute, Brigham and Women's Hospital |
More Information
| Responsible Party: | Scott Dryden-Peterson, Instructor in Medicine, Harvard Medical School, Harvard School of Public Health |
| ClinicalTrials.gov Identifier: | NCT01836003 History of Changes |
| Other Study ID Numbers: | BHP044 3R01HD044391-06S1 |
| Study First Received: | April 10, 2013 |
| Last Updated: | April 11, 2013 |
| Health Authority: | Botswana: Health Research and Development Committee |
Keywords provided by Harvard School of Public Health:
|
Pregnancy Prevention of Mother to Child Transmission Short Message Service (SMS) |
HIV infection CD4 testing Antiretroviral therapy |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on September 28, 2016