Clinical trial NCT02552693: The TracTOR (Tracking and Tracing Operations Research) Study -- Zimbabwe
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Enhancing retention
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: Population Council
First posted: 2015-09-17
Enrollment: 946
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Proportion of HIV positive women traced
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of HIV exposed infants tested for HIV
timeFrame: 6 months
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: EGPAF Zimbabwe
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Godfrey B Woelk, PhD
role: PRINCIPAL_INVESTIGATOR
References: