Clinical trial NCT02969161: Safe Generations Plus: Swaziland PMTCT LTF Study
Official title: Safe Generations Plus: Mother Infant Retention Across the Option B-plus Cascade
Study type: OBSERVATIONAL
Overall status: COMPLETED
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)
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Swaziland
First posted: 2016-11-21
Enrollment: 616
Sex: ALL
Minimum age (years): 1
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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+.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients who are retained in care
timeFrame: Up to 24 months
Secondary outcomes:
measure: Proportion of patients who have died
timeFrame: Up to 24 months
measure: Proportion of patients who are in care at another facility
timeFrame: Up to 24 months
measure: Proportion of patients who have disengaged from care entirely
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Swaziland
country: Swaziland
facility: Family Life Association Swaziland (FLAS) Manzini
city: Swaziland
country: Swaziland
facility: King Sobhuza II Hospital
city: Swaziland
country: Swaziland
facility: Luyengo Clinic
city: Swaziland
country: Swaziland
facility: Mankayane PHU
city: Swaziland
country: Swaziland
facility: Mbikwakhe Clinic
city: Swaziland
country: Swaziland
facility: Médecins sans Frontières (MSF) Matsapha
city: Swaziland
country: Swaziland
facility: Raleigh Fitkin Memorial Hospital
city: Swaziland
country: Swaziland
facility: Siphofaneni Clinc
city: Swaziland
country: Swaziland
facility: Siteki PHU
city: Zombodze
country: Swaziland
facility: Lamvelase
Study officials:
affiliation: ICAP at Columbia University
name: William Reidy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ICAP at Columbia University
name: Elaine Abrams, PhD
role: STUDY_DIRECTOR
affiliation: ICAP at Columbia University
name: Averie Gachuhi, MSc
role: STUDY_DIRECTOR
affiliation: ICAP at Columbia University
name: Harriet Nuwagaba-Biribonwoha, MBChB, PhD
role: STUDY_DIRECTOR
References: