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An Intervention to Improve Antenatal Access to CD4 Testing and HAART in Botswana

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Scott Dryden-Peterson, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01836003
First received: April 10, 2013
Last updated: April 11, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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:

  • SMS-based platform for delivery of CD4 test results
  • Participatory educational session for clinic staff
  • Loan program for HIV and CD4 testing supplies
  • Facilitation of tracing of HAART-eligible pregnant women
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
Accepts Healthy Volunteers:   No
Criteria

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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01836003

Locations
Botswana
Botswana Harvard AIDS Institute
Gaborone, Botswana
Sponsors and Collaborators
Harvard School of Public Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Scott Dryden-Peterson, MD Harvard School of Public Health, Botswana Harvard AIDS Institute, Brigham and Women's Hospital
  More Information

No publications provided

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:
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
 RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on February 26, 2015