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

23. Januar 2018 aktualisiert von: William Reidy, Columbia University

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+.

Studienübersicht

Status

Abgeschlossen

Bedingungen

HIV (Humanes Immunschwächevirus)

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

616

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

1 Jahr bis 50 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Proportion of patients who are retained in care Zeitfenster: Up to 24 months	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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Proportion of patients who have died Zeitfenster: Up to 24 months	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 Zeitfenster: Up to 24 months	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 Zeitfenster: Up to 24 months	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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Columbia University

Mitarbeiter

Ministry of Health, Swaziland

Ermittler

Hauptermittler: William Reidy, PhD, ICAP at Columbia University
Studienleiter: Elaine Abrams, PhD, ICAP at Columbia University
Studienleiter: Averie Gachuhi, MSc, ICAP at Columbia University
Studienleiter: Harriet Nuwagaba-Biribonwoha, MBChB, PhD, ICAP at Columbia University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. März 2016

Primärer Abschluss (Tatsächlich)

1. Mai 2017

Studienabschluss (Tatsächlich)

1. September 2017

Studienanmeldedaten

Zuerst eingereicht

17. November 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat