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

NCT02552693 | Completed

• 1 other identifier: EG0137
• Study Type: interventional
• Target: 946
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Enhancing retention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of HIV exposed infants tested for HIV

  6 months

Study Arms (2)

Experimental Facility

EXPERIMENTAL

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

Control Facility

NO INTERVENTION

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)

Interventions

Enhanced training, supervision and support 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.

Experimental Facility

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation: lead
• Population Council: collaborator

Study Sites (1)

EGPAF Zimbabwe

Harare, Zimbabwe

Location

MeSH Terms

Interventions

Organization and Administration; Palliative Care

Intervention Hierarchy (Ancestors)

Health Services Administration; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Godfrey B Woelk, PhD

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Global Implementation Research

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 17, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 16, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

ZI (1)