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Swaziland Safe Generations

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ClinicalTrials.gov Identifier: NCT01891799
Recruitment Status : Unknown
Verified January 2016 by Elaine J. Abrams, MD, Columbia University.
Recruitment status was:  Active, not recruiting
First Posted : July 3, 2013
Last Update Posted : January 29, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 antiretroviral (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 or disease Intervention/treatment
HIV/AIDS Other: Option B+

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 4200 participants
Time Perspective: Prospective
Official Title: Situkulwane Lesiphephile-Safe Generations: Improving Approaches to Antiretroviral Therapy for HIV-Positive Pregnant Women
Study Start Date : August 2013
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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. All women will eventually receive the intervention of Option B+ as each clinic transitions from Option A to B+.
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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy [ Time Frame: Up to 24 months ]
    ART Initiation During Pregnancy: Proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy

  2. Proportion of women and children retained in HIV care at 12 and 18 months postpartum [ Time Frame: Up to 24 months ]
    Maternal/Infant Retention in Care: Proportion of women and children retained in HIV care at 12 and 18 months postpartum

  3. Duration of ART/ARV received prior to delivery [ Time Frame: Up to 24 months ]
    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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population for the PMTCT Options Evaluation 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.

Inclusion Criteria:

  • Women at least 18 years of age
  • Documented pregnancy (per routine ANC protocol in this setting)
  • Documented HIV-infection (per routine ANC protocol in this setting)
  • Infants born to eligible and enrolled women

Exclusion Criteria:

• Women already on ART when entering ANC

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891799

Good Shepherd Hospital
Siteki, Lubombo, Swaziland
Siteki, Lubombo, Swaziland
Siteki PHU
Siteki, Lubombo, Swaziland
Family Life Association Clinic
Manzini, Swaziland
King Soghuza II PHU
Manzini, Swaziland
Lamvelase Clinic
Manzini, Swaziland
Luyengo Clinic
Manzini, Swaziland
Mankayane PHU
Manzini, Swaziland
Mbabane Government Hospital
Manzini, Swaziland
Mbikhwakhe Clinic
Manzini, Swaziland
MSF Matsapha
Manzini, Swaziland
Raleigh Fitkin Memorial Hospital
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)
Principal Investigator: Elaine J Abrams, MD Columbia University
More Information

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 ( Other Grant/Funding Number: USAID )
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016

Keywords provided by Elaine J. Abrams, MD, Columbia University:
Option B+