NCT02969161

Safe Generations Plus: Swaziland PMTCT LTF Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 616 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 1 Year – 50 Years
• Healthy volunteers: Not accepted

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+.

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.

Conditions

• HIV (Human Immunodeficiency Virus)

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-05-01
• Completion: 2017-09-01
• First posted: 2016-11-21
• Last updated: 2018-01-24

Locations

10 sites across 1 country: Eswatini