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Clinical Trials/NCT02552693
NCT02552693
Completed
Not Applicable

Enhancing Retention in Care for HIV-positive Mothers and Their Infants by Improving Facility Tracking and Community Health Worker Tracing in Zimbabwe

Elizabeth Glaser Pediatric AIDS Foundation1 site in 1 country946 target enrollmentMarch 2015
ConditionsHIV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
Elizabeth Glaser Pediatric AIDS Foundation
Enrollment
946
Locations
1
Primary Endpoint
Proportion of HIV positive women traced
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

This study evaluates the effectiveness of an enhanced package of support for activities described in the "Standard Operating Procedures (SOP) for Patient Tracing in Health Facilities in Zimbabwe". This package is intended to increase the effectiveness of active patient tracing activities by developing tools, providing mentorship and implementing systematic review of processes to improve communication, coordination, and supervision between community health workers and facility-based staff.

Detailed Description

This study consists of a pre-/post- intervention rapid assessment of SOP implementation in study health facilities. The rapid assessment includes a facility audit, and the cross-verification of Mother-baby pair service records, and scheduled appointments. Following the baseline rapid assessment, the research team implements the proposed intervention package in health facilities randomly assigned to the intervention arm of the study. Data collectors conduct monthly visits to study facilities in order to extract appointment attendance information from PMTCT, ART, pharmacy, HIV exposed infants (HEI), and early infant diagnoses (EID) service registers.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
September 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Godfrey Woelk

Director of Global Implementation Research

Elizabeth Glaser Pediatric AIDS Foundation

Eligibility Criteria

Inclusion Criteria

  • Mother-baby pair (MBP):
  • Mother is HIV-positive
  • Infant was born between October 1st, 2013 and March 30th, 2015, or initiates HIV exposed infant services within the first seven months of the data collection period
  • Mothers and infants are assigned unique facility-issued ID numbers that can be used to pair their records, and link service attendance between clinical units, and over time
  • Enrolled in post-natal PMTCT, ART, or EID services at a study health facility
  • Based on guidelines in the SOP, MBP cannot be classified as lost to follow-up at beginning of data collection period
  • Community Health Workers (CHW):
  • CHW or facility-based staff working at selected study sites
  • Participated in the implementation of MBP tracking and tracing activities for a minimum of three months
  • Participant in district-level or selected facility-level CHW meetings

Exclusion Criteria

  • If inclusion criteria not met

Outcomes

Primary Outcomes

Proportion of HIV positive women traced

Time Frame: 6 months

To determine whether the strategies proposed to enhance support for the implementation of Zimbabwe's patient tracing SOP affect rates of MBP retention in PMTCT programs, and infant HIV testing.

Secondary Outcomes

  • Proportion of HIV exposed infants tested for HIV(6 months)

Study Sites (1)

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