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

NCT ID: NCT02552693

Last Updated: 2017-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 946 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-09-30

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Experimental Facility

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.

Group Type: EXPERIMENTAL

Enhanced training, supervision and support

Intervention Type: OTHER

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.

Control Facility

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Enhanced training, supervision and support

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Population Council

OTHER

Sponsor Role: collaborator

Elizabeth Glaser Pediatric AIDS Foundation

OTHER

Sponsor Role: lead

Responsible Party

Godfrey Woelk

Director of Global Implementation Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Godfrey B Woelk, PhD

Role: PRINCIPAL_INVESTIGATOR

Elizabeth Glaser Pediatric AIDS Foundation

Locations

EGPAF Zimbabwe

Harare, , Zimbabwe

Countries

Zimbabwe

Other Identifiers

EG0137

Identifier Type: -

Identifier Source: org_study_id