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

HIV Clinical Trial

— TracTOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552693
• Other study ID #: EG0137
• Status: Completed
• Phase: N/A
• First received: September 15, 2015
• Last updated: January 12, 2017
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: Elizabeth Glaser Pediatric AIDS Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 946
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
Zimbabwe	EGPAF Zimbabwe	Harare

Sponsors (2)

Lead Sponsor	Collaborator
Elizabeth Glaser Pediatric AIDS Foundation	Population Council

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of HIV exposed infants tested for HIV	To document the implementation of mother-baby-pair tracking and tracing activities; and assess their fidelity to the SOP.	6 months