The TracTOR (Tracking and Tracing Operations Research) Study -- Zimbabwe

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Other: Enhanced training, supervision and support


Participation Criteria
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Eligibility Criteria
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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 Above age of consent (18 years or above) Able and willing to provide informed consent to participate in the study Exclusion Criteria: If inclusion criteria not met
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Facility<br>Enhanced training, supervision and support for MOHCC Standard Operating Procedure (SOP) implementation of identifying, tracing and returning to care (tracking and tracing) defaulting mother/infant pairs. Facilities in the experimental group will receive additional training, supervision and support in identifying, tracing and returning to care defaulting mother/infant pairs. | Other: Enhanced training, supervision and support<br>* The intervention includes the following activities: Conduct of pre-intervention facility audits; Cross-verification of appointment diaries with facility attendance records; Development and implementation of job aids and tools; Provides supplemental training and technical support to focal facility point (FFP) and other staff, and community health workers (CHWs); Improves coordination, supervision and reporting systems at the health facilities.<br>|
| No Intervention: Control Facility<br>Facilities in the control group will be operating as described in the MOHCC SOP. (Standard practice in tracking and tracing of defaulting mother/infant pairs) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of HIV positive women traced | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of HIV exposed infants tested for HIV | To document the implementation of mother-baby-pair tracking and tracing activities; and assess their fidelity to the SOP. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enhancing retention