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

Not Applicable

Completed

• Conditions: HIV
• Interventions: Other: Enhanced training, supervision and support

• Registration Number: NCT02552693
• Lead Sponsor: Elizabeth Glaser Pediatric AIDS Foundation

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-09-15
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-17
• Primary Completion: 2016-03
• Study Completion: 2016-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 946

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Facility	Enhanced training, supervision and support	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.

Primary Outcome Measures

Name	Time	Method
Proportion of HIV positive women traced	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 Outcome Measures

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

Trial Locations

Locations (1)

EGPAF Zimbabwe; 🇿🇼 Harare, Zimbabwe