The TracTOR (Tracking and Tracing Operations Research) Study -- Zimbabwe (TracTOR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02552693|
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : January 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV||Other: Enhanced training, supervision and support||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||946 participants|
|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|
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)
- 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.
- 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.
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
|Principal Investigator:||Godfrey B Woelk, PhD||Elizabeth Glaser Pediatric AIDS Foundation|