HIV InfectionNCT01836003
An Intervention to Improve Antenatal Access to CD4 Testing and HAART in Botswana
A study testing Tokafatso programmatic intervention in people with HIV Infection and Pregnancy, run by Harvard School of Public Health (HSPH) at 1 site in Botswana.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- HIV Infection, Pregnancy
- What is being tested?
- Tokafatso programmatic intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 422 participants
- Where
- 1 siteBotswana
- Study dates
- Jul 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinic providing antenatal services within greater Gaborone, Botswana
- CD4 specimens analyzed at Botswana Harvard HIV Reference Laboratory
- Supervising authority provided written permission for participation
- Delivered at Princess Marina Hospital
- Documented HIV infection
- Botswana citizen
Who cannot join
- Facilities caring for incarcerated women
- Facilities without a dedicated antenatal program
- Endpoints assessed in pregnant women meeting the following criteria:
- Receiving HAART prior to antenatal clinic registration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Programmatic CD4 Testing and HAART Initiation Among HIV-Infected Pregnant Women in Gaborone, Botswana: A Randomized Staged Trial of an Improvement Intervention
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.
Read the 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.
- Conditions
- HIV Infection, Pregnancy
- Being tested
- Tokafatso programmatic intervention
- Keywords
- Pregnancy, Prevention of Mother to Child Transmission, Short Message Service (SMS), HIV infection, CD4 testing, Antiretroviral therapy
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tokafatso programmatic interventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Tokafatso programmatic intervention | Experimental | Antenatal clinic receives the Tokafatso programmatic intervention, including educational session, SMS-based facilitation of CD4 result delivery, and patient tracing support. Receives: Other: Tokafatso programmatic intervention |
| Usual Care | No intervention | Has not yet received Tokafatso combination programmatic intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible pregnant women with CD4 enumeration prior to 26 weeks gestation
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.
Measured: At delivery
Proportion of eligible women with HAART initiation prior to 30 weeks gestation
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.
Measured: At delivery
Secondary outcomes (4)
Proportion of eligible women with CD4 testing prior to delivery
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.
Measured: At delivery
Proportion of eligible women with HAART initiation prior to delivery
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.
Measured: At delivery
Gestational age of eligible women at time of CD4 enumeration
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.
Measured: At delivery
Gestational age of eligible women at the time of HAART initiation
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.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startJul 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Scott Dryden-Peterson, Harvard School of Public Health (HSPH)
- Investigators
- Scott Dryden-Peterson, MD, Principal investigator, Harvard School of Public Health, Botswana Harvard AIDS Institute, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836003
- Sponsor's protocol ID
- BHP044
- Other IDs
- 3R01HD044391-06S1
- Status last verified
- Jan 2024
- First submitted
- 10 Apr 2013
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programmatic CD4 Testing and HAART Initiation Among HIV-Infected Pregnant Women in Gaborone, Botswana: A Randomized Staged Trial of an Improvement Intervention
- ClinicalTrials.gov ID
- NCT01836003
- Acronym / sponsor ID
- BHP044
- Conditions
- HIV Infection, Pregnancy
- Keywords
- Pregnancy, Prevention of Mother to Child Transmission, Short Message Service (SMS), HIV infection, CD4 testing, Antiretroviral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 19 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tokafatso programmatic intervention | Experimental | Other: Tokafatso programmatic interventionAntenatal clinic receives the Tokafatso programmatic intervention, including educational session, SMS-based facilitation of CD4 result delivery, and patient tracing support. |
| Usual Care | No intervention | –Has not yet received Tokafatso combination programmatic intervention |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Clinic providing antenatal services within greater Gaborone, Botswana
- CD4 specimens analyzed at Botswana Harvard HIV Reference Laboratory
- Supervising authority provided written permission for participation
- Delivered at Princess Marina Hospital
- Documented HIV infection
Key exclusion criteria (4 listed)
- Facilities caring for incarcerated women
- Facilities without a dedicated antenatal program
- Receiving HAART prior to antenatal clinic registration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tokafatso programmatic interventionTokafatso 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 | Other | Tokafatso programmatic intervention |
Primary outcome
Proportion of eligible pregnant women with CD4 enumeration prior to 26 weeks gestation
Time frame: At delivery
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
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.
4 secondary outcomes
Proportion of eligible women with CD4 testing prior to delivery
Time frame: At delivery
Proportion of eligible women with HAART initiation prior to delivery
Time frame: At delivery
Gestational age of eligible women at time of CD4 enumeration
Time frame: At delivery
Gestational age of eligible women at the time of HAART initiation
Time frame: At delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Dryden-Peterson, MD principal investigator
Harvard School of Public Health, Botswana Harvard AIDS Institute, Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tokafatso programmatic intervention in people with HIV Infection and Pregnancy, run by Harvard School of Public Health (HSPH) at 1 site in Botswana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible pregnant women with CD4 enumeration prior to 26 weeks gestation (time frame: At delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.