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

June 28, 2013
June 12, 2014
August 2013
September 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01891799 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Situkulwane Lesiphephile-Safe Generations
Situkulwane Lesiphephile-Safe Generations: Improving Approaches to Antiretroviral Therapy for HIV-Positive Pregnant Women

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+.

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.
Observational
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

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.

Non-Probability Sample

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.

HIV/AIDS
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
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.
Intervention: Other: Option B+
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2600
September 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion:

  • HIV+ pregnant women
  • Currently not on ART
  • Presents at one the study facilities for PMTCT services
Female
18 Years and older
No
Contact: Harriet Nuwagaba-Biribonwoha, MD/PhD +26824045797 hn2158@columbia.edu
Swaziland
 
NCT01891799
AAAL0661, AID-OAA-A-12-000020
No
Elaine J. Abrams, MD, Columbia University
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)
Principal Investigator: Elaine J Abrams, MD Columbia University
Columbia University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP