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

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ClinicalTrials.gov Identifier: NCT02552693
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : January 16, 2017
Sponsor:
Collaborator:
Population Council
Information provided by (Responsible Party):
Godfrey Woelk, 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.

Condition or disease Intervention/treatment Phase
HIV Other: Enhanced training, supervision and support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 946 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Enhancing Retention in Care for HIV-positive Mothers and Their Infants by Improving Facility Tracking and Community Health Worker Tracing in Zimbabwe
Study Start Date : March 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 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.

Other: 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.


No Intervention: 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)



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Exclusion Criteria:

  • If inclusion criteria not met

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552693


Locations
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Zimbabwe
EGPAF Zimbabwe
Harare, Zimbabwe
Sponsors and Collaborators
Elizabeth Glaser Pediatric AIDS Foundation
Population Council
Investigators
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Principal Investigator: Godfrey B Woelk, PhD Elizabeth Glaser Pediatric AIDS Foundation

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Responsible Party: Godfrey Woelk, Director of Global Implementation Research, Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier: NCT02552693     History of Changes
Other Study ID Numbers: EG0137
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Dataset has been shared with the USAID study sponsor who will make data available in 2018
Keywords provided by Godfrey Woelk, Elizabeth Glaser Pediatric AIDS Foundation:
Enhancing retention