Safe Generations Plus: Swaziland PMTCT LTF Study (SG+)

Safe Generations Plus: Mother Infant Retention Across the Option B-plus Cascade

This study is to understand how to improve retention in care and treatment services to HIV positive pregnant women and their babies in Swaziland. The investigators will evaluate outcomes of patients who are lost-to-follow-up (LTF) under a new approach for prevention of mother-to-child (PMTCT) called Option B+, where all HIV positive pregnant women initiate lifelong antiretroviral therapy (ART) regardless of their disease stage. The goal is to understand the outcomes of patients who are LTF from care, and the reasons for disengagement from care in the context of PMTCT in order to inform efforts to improve retention in care among patients under Option B+.

Study Overview

• Status: Completed
• Conditions: HIV (Human Immunodeficiency Virus)

Detailed Description

The study will be conducted among approximately 1,600 women and their infants who received Option B+ PMTCT services at ten facilities in Swaziland. These facilities were included in another study on Option B+ called Safe Generations in which routinely collected patient-level data was abstracted from medical registers. This study has three parts: the first is a review of alternative patient medical records among women and their infants who were documented as LTF in the Safe Generations study. The second component consists of tracing women who are LTF on the phone or in the community to administer a questionnaire. Lastly, an in-depth interview will be conducted among a sub-group of women to explore patterns of care.

• Study Type: Observational
• Enrollment (Actual): 616

Contacts and Locations

Study Locations

• Swaziland
  • Swaziland, Swaziland
    • Luyengo Clinic
  • Swaziland, Swaziland
    • Raleigh Fitkin Memorial Hospital
  • Swaziland, Swaziland
    • Siphofaneni Clinc
  • Swaziland, Swaziland
    • Family Life Association Swaziland (FLAS) Manzini
  • Swaziland, Swaziland
    • King Sobhuza II Hospital
  • Swaziland, Swaziland
    • Mankayane PHU
  • Swaziland, Swaziland
    • Mbikwakhe Clinic
  • Swaziland, Swaziland
    • Médecins sans Frontières (MSF) Matsapha
  • Swaziland, Swaziland
    • Siteki PHU
  • Zombodze, Swaziland
    • Lamvelase

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV-infected pregnant mothers enrolled in PMTCT care under Option B+ as part of the Safe Generations study between September 16, 2013 and August 31, 2014

Description

Inclusion Criteria:

• Mothers and their infants who were enrolled in PMTCT at Safe Generations study sites after the sites transitioned to Option B+.
• Determined to be LTF per the Safe Generations study protocol (i.e., have not attended a clinic visit in the 90 days prior to their 6-month postpartum appointment and are not known to be dead or transferred out, according to clinical visit data abstracted to the Safe Generations study database).

Exclusion Criteria:

• Mothers that are not a PMTCT client.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who are retained in care	Confirmation of retained status among all Option B+ mothers and their infants who are identified as LTF per the Safe Generations study through review of facility-based records - to determine maternal reasons for leaving care.	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who have died	Confirmation patients being retained in care among all Option B+ mothers and their infants who are identified as LTF per the Safe Generations study through review of facility-based records - to capture events such as fetal loss and maternal/infant deaths that are not well documented.	Up to 24 months
Proportion of patients who are in care at another facility	Mothers and/or infants who are LTF will be traced via telephone by facility-based healthcare workers or via questionnaire/interview conducted in the community - to determine if they have transferred care to another facility (via a self-transfer of care) and therefore remain engaged in care.	Up to 24 months
Proportion of patients who have disengaged from care entirely	Confirmation of LTF status among all Option B+ mothers and their infants who are identified as LTF per the Safe Generations study through review of facility-based records - to capture events such as fetal loss and maternal/infant deaths that are not well documented.	Up to 24 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Ministry of Health, Swaziland
• Investigators: Principal Investigator: William Reidy, PhD, ICAP at Columbia University; Study Director: Elaine Abrams, PhD, ICAP at Columbia University; Study Director: Averie Gachuhi, MSc, ICAP at Columbia University; Study Director: Harriet Nuwagaba-Biribonwoha, MBChB, PhD, ICAP at Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimate): November 21, 2016

Study Record Updates

• Last Update Posted (Actual): January 24, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: HIV (Human Immunodeficiency Virus); ART (antiretroviral therapy); PMTCT (Prevention of Mother-to-Child Transmission); Loss to follow-up (LTF); Option B+ (B+)
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: AAAP5700

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO