Clinical trial NCT01836003: An Intervention to Improve Antenatal Access to CD4 Testing and HAART in Botswana
Official title: Programmatic CD4 Testing and HAART Initiation Among HIV-Infected Pregnant Women in Gaborone, Botswana: A Randomized Staged Trial of an Improvement Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Pregnancy
Keywords: Pregnancy
Prevention of Mother to Child Transmission
Short Message Service (SMS)
HIV infection
CD4 testing
Antiretroviral therapy
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-04-19
Enrollment: 422
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Proportion of eligible pregnant women with CD4 enumeration prior to 26 weeks gestation
timeFrame: At delivery
measure: Proportion of eligible women with HAART initiation prior to 30 weeks gestation
timeFrame: At delivery
Secondary outcomes:
measure: Proportion of eligible women with CD4 testing prior to delivery
timeFrame: At delivery
measure: Proportion of eligible women with HAART initiation prior to delivery
timeFrame: At delivery
measure: Gestational age of eligible women at time of CD4 enumeration
timeFrame: At delivery
measure: Gestational age of eligible women at the time of HAART initiation
timeFrame: At delivery
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Botswana Harvard AIDS Institute
Study officials:
affiliation: Harvard School of Public Health, Botswana Harvard AIDS Institute, Brigham and Women's Hospital
name: Scott Dryden-Peterson, MD
role: PRINCIPAL_INVESTIGATOR
References: