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

Columbia University

Status: Completed

Conditions: HIV (Human Immunodeficiency Virus)

Study type: Observational

Funder types: Other

Identifiers

NCT02969161

AAAP5700

Details and patient eligibility

About

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+.

Full 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.

Enrollment: 616 patients

Sex: All

Ages: 1 to 50 years old

Volunteers: No Healthy Volunteers

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.