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

Elizabeth Glaser Pediatric AIDS Foundation946 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

946

Conditions

HIV

Interventions

Enhanced training, supervision and supportOTHER

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: Mother-baby pair (MBP): 1. Mother is HIV-positive 2. 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 3. 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 4. Enrolled in post-natal PMTCT, ART, or EID services at a study health facility 5. 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): 1. CHW or facility-based staff working at selected study sites 2. Participated in the implementation of MBP tracking and tracing activities for a minimum of three months 3. Participant in district-level or selected facility-level CHW meetings 4. Above age of consent (18 years or above) 5. Able and willing to provide informed consent to participate in the study Exclusion Criteria: * If inclusion criteria not met

Locations (1)

EGPAF Zimbabwe

Harare, Zimbabwe

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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