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Completed

NCT Number: NCT02552693

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

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.

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Key information

Conditions

HIV

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EGPAF Zimbabwe

Harare, Zimbabwe

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Proportion of HIV positive women traced

    Time frame: 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 outcomes

  1. Proportion of HIV exposed infants tested for HIV

    Time frame: 6 months

    To document the implementation of mother-baby-pair tracking and tracing activities; and assess their fidelity to the SOP.

Sponsors and collaborators

Lead sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Other

Collaborators

  • Population Council

Registry information

Official study title

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

Acronym: TracTOR

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 17, 2015
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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