- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02479659
Measuring the Impact of Integrating Maternal and Newborn HIV Testing With Childhood Immunization Services
June 30, 2015 updated by: IDinsight
A Cluster Randomised Trial on the Impact of Integrating Early Infant HIV Diagnosis With the Expanded Programme on Immunization on Immunization and HIV Testing Rates in Rural Zambian Health Facilities
This randomized evaluation measured the impact of two levels of support for the integration of infant and postpartum maternal HIV testing with routine immunization services in Southern Zambia on the number of postpartum maternal HIV tests, infant HIV tests, and 1st dose diphtheria, pertussis, and tetanus (DPT1) vaccines.
Study Overview
Status
Completed
Conditions
Detailed Description
This evaluation assessed two levels of support for the integration of early infant and maternal HIV testing with existing routine immunization services in rural health facilities in Southern Zambia with the aim of determining whether infant and postpartum maternal HIV testing rates would increase without harming immunization uptake.
The evaluation randomized 60 health facilities to one of three study arms: 1) Control (status quo); 2) Simple Intervention; and 3) Comprehensive Intervention.
The Simple Intervention included restocking of HIV test kits and reminding health facilities of existing HIV testing guidelines by government health officials.
The Comprehensive Intervention included the Simple Intervention components, as well as community sensitization, hands-on operational support to integrate services and improve patient flow, and opt-out HIV testing for mothers and infants according to existing guidelines.
The change in the average number of monthly HIV tests and immunizations (DPT1) between the intervention period and baseline were compared between treatment and control facilities.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Note that this evaluation used administrative data - no participants were enrolled for the main part of this study. Participants were enrolled for the qualitative portions of the study.
Inclusion Criteria:
- Mothers who had an infant within the past 18 months during the intervention period (Oct 2013 - Mar 2014)
- Infants who were at least six weeks of age and under six months of age during the intervention period (Oct 2013 - Mar 2014)
- Qualitative activities included facility staff and mothers and caregivers whose infants were due for their 6 week immunization during the intervention period.
Exclusion Criteria:
- Mothers who did not have an infant within the past 18 months during the intervention period
- Infants who were less than six weeks of age during the intervention period or greater than six months of age throughout out the intervention period.
- Adults who were not mothers or caregivers with an infant due for his/her 6 week immunization during the intervention period were excluded from the qualitative activities.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Facilities in this arm maintained status quo HIV testing and routine childhood immunization services
|
|
Experimental: Simple Intervention
This included: 1) HIV testing commodity reinforcement and 2) a policy reinforcement meeting
|
HIV testing commodities were replenished directly (outside of the government supply) in the event of a stock-out by study staff.
Treatment facilities were visited monthly to assess stock levels, and facility staff could contact study staff when stock levels were low.
District health officials met with facility staff to remind them of the current HIV testing policies for mothers and newborns in Zambia.
Current policy states mothers with unknown or previously negative status should be tested every 3 months until the infant is 18 months of age.
HIV-exposed newborns should be tested at 6 weeks and 6 months.
|
Experimental: Comprehensive Intervention
This arm included: 1) HIV testing commodity reinforcement, 2) a policy reinforcement meeting, 3) community sensitization, 4) Opt-out HIV testing for mothers and newborns, and 5) Operational support for service integration
|
HIV testing commodities were replenished directly (outside of the government supply) in the event of a stock-out by study staff.
Treatment facilities were visited monthly to assess stock levels, and facility staff could contact study staff when stock levels were low.
District health officials met with facility staff to remind them of the current HIV testing policies for mothers and newborns in Zambia.
Current policy states mothers with unknown or previously negative status should be tested every 3 months until the infant is 18 months of age.
HIV-exposed newborns should be tested at 6 weeks and 6 months.
Facility staff were instructed to examine the maternal HIV status on the under-five (U-5) or antenatal care (ANC) card for all infants attending their first U-5 visit and do the following:
The evaluation team worked with facility staff to identify efficient allocations of staff and tailor the order of services.
A key component of the operational optimization was a new patient triaging approach that sorted patient U-5 cards into bins and used separate queues for three types of patients: 1) first visit infants (six weeks), 2) second visit or later infants who required immunizations and 3) infants who were scheduled to only receive growth monitoring.
Health facility staff were instructed to communicate all aspects of the Comprehensive Intervention during ANC appointments, in-facility child birth deliveries, and postnatal care (PNC) visits.
Additionally, at six week immunization visits, mothers and caregivers received group counseling on opt-out HIV screening service and the importance of regular HIV screening for mother and child health.
Finally, the research team engaged Safe Motherhood Action Groups (SMAGs), community health workers (CHWs), and active neighborhood health committee members to further increase awareness in facility catchment areas.
These community members completed low-touch community sensitization over changes that would be made to U-5 services.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in average monthly number of infant DBS HIV tests
Time Frame: Baseline and 6 mos (endline)
|
Using a difference-in-differences analytic approach, the investigators analyzed counts of the number of infant dried blood spot (DBS) HIV tests administered per month at each of the 60 study facilities between Oct 2013 and Mar 2014 (intervention period), and compared it to retrospective baseline data from Jan 2012 - Sept 2013
|
Baseline and 6 mos (endline)
|
Change in average monthly number of maternal postpartum HIV tests
Time Frame: Baseline and 6 mos (endline)
|
Using a difference-in-differences analytic approach, the investigators analyzed counts of the number of maternal postpartum HIV tests administered per month at each of the 60 study facilities between Oct 2013 and Mar 2014 (intervention period), and compared it to retrospective baseline data from Jan 2013 - Sept 2013
|
Baseline and 6 mos (endline)
|
Change in average monthly number of DPT1 doses administered
Time Frame: Baseline and 6 mos (endline)
|
Using a difference-in-differences analytic approach, the investigators analyzed counts of the number of first dose diphtheria, pertussis, and tetanus vaccine (DPT1) administered per month at each of the 60 study facilities between Oct 2013 and Mar 2014 (intervention period), and compared it to retrospective baseline data from Jan 2012 - Sept 2013
|
Baseline and 6 mos (endline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
June 14, 2015
First Submitted That Met QC Criteria
June 19, 2015
First Posted (Estimate)
June 24, 2015
Study Record Updates
Last Update Posted (Estimate)
July 1, 2015
Last Update Submitted That Met QC Criteria
June 30, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 001 (NavyGHB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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