Safe Generations Plus: Swaziland PMTCT LTF Study

HIV (Human Immunodeficiency Virus) Clinical Trial

— SG+  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02969161
• Other study ID #: AAAP5700
• Status: Completed
• Phase: N/A
• First received: November 17, 2016
• Last updated: January 23, 2018
• Start date: March 2016
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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+.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 616
• Est. completion date: September 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV (Human Immunodeficiency Virus)
• HIV Infections
• Immunologic Deficiency Syndromes

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Ministry of Health, Swaziland

Country where clinical trial is conducted

Swaziland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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