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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
422

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

April 10, 2013

Last Update Submit

January 3, 2024

Conditions

HIV InfectionPregnancy

Keywords

PregnancyPrevention of Mother to Child TransmissionShort Message Service (SMS)HIV infectionCD4 testingAntiretroviral therapy

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    At delivery

Secondary Outcomes (4)

  • Proportion of eligible women with CD4 testing prior to delivery

    At delivery

  • Proportion of eligible women with HAART initiation prior to delivery

    At delivery

  • Gestational age of eligible women at time of CD4 enumeration

    At delivery

  • Gestational age of eligible women at the time of HAART initiation

    At delivery

Study Arms (2)

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.

Other: Tokafatso programmatic intervention

Usual Care

NO INTERVENTION

Has not yet received Tokafatso combination programmatic intervention

Interventions

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

Tokafatso programmatic intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinic providing antenatal services within greater Gaborone, Botswana
  • CD4 specimens analyzed at Botswana Harvard HIV Reference Laboratory
  • Supervising authority provided written permission for participation

You may not qualify if:

  • Facilities caring for incarcerated women
  • Facilities without a dedicated antenatal program
  • Endpoints assessed in pregnant women meeting the following criteria:
  • Delivered at Princess Marina Hospital
  • Documented HIV infection
  • Botswana citizen
  • Receiving HAART prior to antenatal clinic registration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Botswana Harvard AIDS Institute

Gaborone, Botswana

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Scott Dryden-Peterson, MD

    Harvard School of Public Health, Botswana Harvard AIDS Institute, Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Medicine, Harvard Medical School

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 19, 2013

Study Start

July 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations

BO(1)