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Situkulwane Lesiphephile-Safe Generations

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Columbia University
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Ministry of Health, Swaziland
University of Cape Town
Elizabeth Glaser Pediatric AIDS Foundation
National Emergency Response Council on HIV and AIDS (NERCHA)
Information provided by (Responsible Party):
Elaine J. Abrams, MD, Columbia University
ClinicalTrials.gov Identifier:
NCT01891799
First received: June 28, 2013
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to understand how best to provide care and treatment services to human immunodeficiency virus (HIV) positive pregnant women and their babies in Swaziland. The study is designed to evaluate a new approach for Preventing Mother-to-Child Transmission (PMTCT)where all HIV positive pregnant women initiate lifelong triple ARV therapy regardless of their disease stage. The goal is to prevent delays in women accessing treatment for their own health and ensure that women and their children remain in care. This study will compare this new approach to PMTCT, known as Option B+, to Option A, which is the current standard of care for PMTCT in Swaziland. The study will be conducted at 10 health facilities in the Manzini and Lubombo regions in Swaziland. The study has three components: the main component is a PMTCT Options Evaluation where data from medical records will be abstracted on all HIV positive pregnant women attending antenatal services at the 10 selected study facilities; data will be abstracted on their HIV exposed infants as well. Other components of the study include a PMTCT Options Acceptability Evaluation using semi-structured questionnaires with PMTCT clients and health care workers (HCWs) as well as a cost effectiveness evaluation comparing costs under conditions of Option A and Option B+.


Condition Intervention
HIV/AIDS
Other: Option B+

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Situkulwane Lesiphephile-Safe Generations: Improving Approaches to Antiretroviral Therapy for HIV-Positive Pregnant Women

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Number of (1) infant HIV positive PCR at six months postpartum OR (2) mother lost to follow-up from at six months postpartum [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Combined maternal-child endpoint: The primary outcome will be measured on all HIV+ pregnant women not on ART at their first ANC visit at a participating study site, approximately 2600 women(becoming mother-infant pairs postpartum). This includes women entering PMTCT with known HIV+ status, not on ART, and women testing HIV+ on entry into ANC.


Secondary Outcome Measures:
  • Proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    ART Initiation During Pregnancy: Proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy

  • Proportion of women and children retained in HIV care at 12 and 18 months postpartum [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Maternal/Infant Retention in Care: Proportion of women and children retained in HIV care at 12 and 18 months postpartum

  • Duration of ART/ARV received prior to delivery [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    ART/ARV Duration: Duration of ART/ARV received prior to delivery


Biospecimen Retention:   None Retained

50 microliters of capillary blood will be drawn via heelstick or finger prick phlebotomy from infants using filter paper. Blood will be collected from infants at 6mos of age to conduct DNA PCR HIV testing, specifically for this study.


Estimated Enrollment: 2600
Study Start Date: August 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PMTCT Options Evaluation
All HIV positive pregnant women not on ART engaging in PMTCT services at the study sites will be included. This will include HIV+ women not on ART enrolling in PMTCT services and pregnant women newly testing HIV+ in the ANC.
Other: Option B+
  • Using one low toxicity triple ARV regimen [(tenofovir (TDF) + lamivudine/emtricitabine (3TC/FTC) + efavirenz (EFV)] for all women, rather than adapting regimens by CD4+
  • Engaging all pregnant and postpartum women and their infants in the structured appointment and follow-up system currently only available to women receiving ART
  • Providing a simplified standardized public health approach both antenatally and postnatally, with adherence and retention support tailored to the particular health and social needs of peripartum women

  Hide Detailed Description

Detailed Description:

Purpose:

"Situkulwane Lesiphephile—Safe Generations" is an implementation science research study designed to evaluate an innovative PMTCT strategy that includes a modified Option B approach, where all HIV positive pregnant women initiate lifelong triple antiretroviral (ARV) therapy independent of CD4+ count (Option B+) and all HIV positive pregnant and postpartum women and their infants are engaged in the same structured appointment and follow-up protocols currently available only to women receiving antiretroviral therapy (ART). The study hypothesizes that this single, uniform and streamlined treatment and retention approach for all HIV positive pregnant women will eliminate delays, prevent losses and will: (1) result in a higher proportion of mothers and infants successfully completing the PMTCT cascade and fewer new pediatric infections; (2) lead to a higher proportion of ART-eligible women initiating triple ART earlier in pregnancy; (3) will be more feasible to implement; 4) have greater acceptability among staff and patients; and 5) will be more cost-effective compared to Option A.

Design:

Stepped wedge design at 10 health facilities with one facility transitioning from Option A to the Option B+ approach every month over 12 months. Outcome measures will be compared under Option A and Option B+ conditions for all sites as well as before and after the transition at each site. Routinely collected data from facility registers and medical records will be abstracted to determine study outcomes. In addition, two purposely selected cohorts of (1)120 PMTCT clients and; (2) approximately 50 health care workers will complete questionnaires at repeated time points to assess acceptability of Option A and Option B+ approaches.

Study Population:

All HIV positive pregnant women not on ART engaging in PMTCT services at the study sites will be part of the PMTCT Options Evaluation. This will include HIV+ women not on ART enrolling in PMTCT services and pregnant women newly testing HIV+ in the absolute neutrophil count (ANC). A subset of HIV+ pregnant women not on ART engaging in PMTCT services and health care workers providing PMTCT services at the study sites will be enrolled in an acceptability evaluation.

Study Size:

A total of approximately 2,600 HIV positive pregnant women enrolled in PMTCT services at ten Ministry of Health (MOH) facilities.

Primary Objective:

To compare the impact of implementing Option A and Option B+ on the composite endpoint of infant HIV-positive polymerase chain reaction (PCR) at 6 months postpartum or maternal loss to follow-up at 6 months postpartum.

Secondary Objectives:

  1. To compare Option A and Option B+ on proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy and on duration of ART received prior to delivery for ART-eligible pregnant women
  2. To compare Option A and Option B+ on the proportion of women and children retained in HIV care at 12, and 18 months postpartum
  3. To examine patient and provider level acceptability of Option A and Option B+
  4. To compare the cost-effectiveness of Option A and Option B+

Tertiary Objectives:

  1. To determine pregnancy and infant outcomes (including fetal losses, neonatal death, birth weight and gestational age) among HIV+ pregnant women receiving PMTCT and compare outcomes by maternal ARV regimens.
  2. To compare Option A and Option B+ on maternal and child adherence as measured by prescriptions dispensed for maternal and infant antiretroviral medications.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

For the PMTCT Options Evaluation component, the target population is all HIV+ pregnant women not on ART at their first ANC visit at the 10 study facilities. A total of approximately 2600 mother-infant pairs (2600 HIV positive women + 2600 of their HIV exposed babies) will be observed.

Criteria

Inclusion:

  • HIV+ pregnant women
  • Currently not on ART
  • Presents at one the study facilities for PMTCT services
  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: NCT01891799

Contacts
Contact: Harriet Nuwagaba-Biribonwoha, MD/PhD +26824045797 hn2158@columbia.edu

Locations
Swaziland
Good Shepherd Hospital Recruiting
Siteki, Lubombo, Swaziland
Siphofaneni Recruiting
Siteki, Lubombo, Swaziland
Siteki PHU Recruiting
Siteki, Lubombo, Swaziland
Mbabane Government Hospital Recruiting
Manzini, Swaziland
King Soghuza II PHU Recruiting
Manzini, Swaziland
Lamvelase Clinic Recruiting
Manzini, Swaziland
Luyengo Clinic Recruiting
Manzini, Swaziland
Mankayane PHU Recruiting
Manzini, Swaziland
Raleigh Fitkin Memorial Hospital Recruiting
Manzini, Swaziland
Mbikhwakhe Clinic Recruiting
Manzini, Swaziland
MSF Matsapha Recruiting
Manzini, Swaziland
Family Life Association Clinic Recruiting
Manzini, Swaziland
Sponsors and Collaborators
Columbia University
United States Agency for International Development (USAID)
Ministry of Health, Swaziland
University of Cape Town
Elizabeth Glaser Pediatric AIDS Foundation
National Emergency Response Council on HIV and AIDS (NERCHA)
Investigators
Principal Investigator: Elaine J Abrams, MD Columbia University
  More Information

No publications provided

Responsible Party: Elaine J. Abrams, MD, Professor of Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT01891799     History of Changes
Other Study ID Numbers: AAAL0661, AID-OAA-A-12-000020
Study First Received: June 28, 2013
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
HIV/AIDS
PMTCT
Option B+
Swaziland

ClinicalTrials.gov processed this record on November 25, 2014