Safe Generations Plus: Swaziland PMTCT LTF Study

NCT02969161 | Completed

• 1 other identifier: AAAP5700
• Study Type: observational
• Target: 616
• Locations: 1 country
• Sites: 10

Brief Summary

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+.

Conditions

HIV (Human Immunodeficiency Virus)

Keywords

PMTCT (Prevention of Mother-to-Child Transmission); HIV (Human Immunodeficiency Virus); Loss to follow-up (LTF); Option B+ (B+); ART (antiretroviral therapy)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion of patients who have died

  Up to 24 months

• Proportion of patients who are in care at another facility

  Up to 24 months

• Proportion of patients who have disengaged from care entirely

  Up to 24 months

Eligibility Criteria

• Age: 1 Year - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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).

You may not qualify if:

• Mothers that are not a PMTCT client.

Sponsors & Collaborators

• Columbia University: lead
• Ministry of Health, Swaziland: collaborator

Study Sites (10)

Family Life Association Swaziland (FLAS) Manzini

Swaziland, Eswatini

Location

King Sobhuza II Hospital

Swaziland, Eswatini

Location

Luyengo Clinic

Swaziland, Eswatini

Location

Mankayane PHU

Swaziland, Eswatini

Location

Mbikwakhe Clinic

Swaziland, Eswatini

Location

Médecins sans Frontières (MSF) Matsapha

Swaziland, Eswatini

Location

Raleigh Fitkin Memorial Hospital

Swaziland, Eswatini

Location

Siphofaneni Clinc

Swaziland, Eswatini

Location

Siteki PHU

Swaziland, Eswatini

Location

Lamvelase

Zombodze, Eswatini

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• William Reidy, PhD

  ICAP at Columbia University

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist, ICAP

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 21, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: September 1, 2017
• Last Updated: January 24, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)