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Swaziland Safe Generations

NCT01891799 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2518

Last updated 2018-02-12

No results posted yet for this study

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+.

Conditions

Interventions

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

Sponsors & Collaborators

  • United States Agency for International Development (USAID)

    collaborator FED

  • Ministry of Health, Swaziland

    collaborator OTHER_GOV

  • University of Cape Town

    collaborator OTHER

  • Elizabeth Glaser Pediatric AIDS Foundation

    collaborator OTHER

  • National Emergency Response Council on HIV and AIDS (NERCHA)

    collaborator UNKNOWN

  • Columbia University

    lead OTHER

Principal Investigators

  • Elaine J Abrams, MD · Columbia University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-10-30
Completion
2016-10-30

Countries

  • Eswatini

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01891799 on ClinicalTrials.gov