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Study Overview

Title:
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
Study is 3ie funded:
No
Study ID:
RIDIE-STUDY-ID-5592e12fb104d
Initial Registration Date:
06/30/2015
Last Update Date:
06/11/2015
Study Status:
Completed
Location(s):
Zambia
Abstract:
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.
Registration Citation:
Categories:
Health, Nutrition, and Population
Additional Keywords:
Immunization, early infant diagnosis of HIV, service integration
Secondary ID Number(s):

Principal Investigator(s)

Name of First PI:
Paul Wang
Affiliation:
IDinsight
Name of Second PI:
Affiliation:

Study Sponsor

Name:
DFID
Study Sponsor Location:
United Kingdom

Research Partner

Name of Partner Institution:
Type of Organization:
Location:
Intervention

Intervention Overview

Intervention:
Integration of services was tested at two levels of support. For the Simple Intervention: 1) The study team topped up HIV test kits when the stock at a clinic ran low. 2) District health officials visited each facility to remind staff of current MoH guidelines for infant and maternal postpartum HIV testing. The Comprehensive Intervention included: 1) The two components of the Simple Intervention (test kit stock reinforcement and reminder of testing guidelines). 2) Community sensitization on HIV and immunization service integration for mothers and caregivers. 3) Hands-on operational support to integrate services by optimizing patient management and flow at under-five clinic. 4) Opt-out HIV testing for all mothers and infants according to existing guidelines.
Private Intervention Details:
Theory of Change:
Multiple Treatment Arms Evaluated?
Yes

Implementing Agency

Name of Organization:
Government of Zambia - Ministry of Health (MOH) and Ministry of Community Development, Mother and Child Health (MCDMCH)
Type of Organization:
Public Sector, e.g. Government Agency or Ministry

Program Funder

Name of Organization:
DFID
Type of Organization:
Foreign or Multilateral Aid Agency

Intervention Timing

Intervention or Program Started at time of Registration?
Yes
Start Date:
10/01/2013
End Date:
03/31/2014
Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:
Randomized control trial
Other (not Listed) Method:
Additional Evaluation Method (If Any):
Other (not Listed) Method:

Method Details

Details of Evaluation Approach:
After stratifying for location, this evaluation used a constrained randomized approach to allocate health facilities to one of the three study arms. Administrative data, including health facility registers and laboratory data, were used to collect the number of infant HIV tests (by dried blood spot method), maternal postpartum HIV tests, and DPT1 doses administered monthly at each evaluation facility. A difference-in-differences analytical approach was used to compare the change in the monthly average number of infant HIV tests, maternal HIV tests, and DPT1 doses per facility over the baseline period (Jan 2012 - Sept 2013 for infant dried blood spot tests and DPT1 doses; Jan 2013 - Sept 2013 for maternal postpartum HIV tests) to the monthly averages per facility during the intervention period (Oct 2013 - Mar 2014) between each treatment arm and the control arm.
Private Details of Evaluation Approach:
Outcomes (Endpoints):
Difference in the monthly average number of infant dried blood spot HIV tests administered per facility between baseline and the intervention period Difference in the monthly average number of maternal postpartum HIV tests administered per facility between baseline and the intervention period Difference in the monthly average number of DPT1 doses administered per facility between baseline and the intervention period
Unit of Analysis:
Health facility
Hypotheses:
1a. The change in the monthly average number of infant dried blood spot HIV tests between baseline and the intervention period will be greater in the Simple Intervention facilities than in the Control facilities. 1b. The change in the monthly average number of infant dried blood spot HIV tests between baseline and the intervention period will be greater in the Comprehensive Intervention facilities than in the Control facilities. 2a. The change in the monthly average number of postpartum maternal HIV tests between baseline and the intervention period will be greater in the Simple Intervention facilities than in the Control facilities. 2b. The change in the monthly average number of postpartum maternal HIV tests between baseline and the intervention period will be greater in the Comprehensive Intervention facilities than in the Control facilities. 3. The change in the monthly average number of DPT1 doses between baseline and the intervention period among the treatment facilities (combined Simple + Comprehensive Interventions) will be the same as the change experienced among the Control facilities. Secondary hypothesis is to test this outcome for each of the Intervention arms.
Unit of Intervention or Assignment:
Health facilities
Number of Clusters in Sample:
Number of Individuals in Sample:
60 health facilities
Size of Treatment, Control, or Comparison Subsamples:
Control: 20 Health Facilities; Simple Intervention: 20 Health Facilities; Comprehensive Intervention: 20 Health Facilities

Supplementary Files

Analysis Plan:
Other Documents:
Data

Outcomes Data

Description:
Research team members conducted monthly visits to all 60 study facilities to collect data from facility registers, HIV Activity Sheets, and under-five clinic tally sheets. The number of infant HIV tests was measured with data from the University Teaching Hospital database; the number of maternal postpartum HIV tests was measured with data from the Boston University PMTCT Integration Programme monthly report; and the number of DPT1 doses was measured with routine facility-level data.
Data Already Collected?
Yes
Data Previously Used?
Not sure
Data Access:
Restricted -- Access requires a formal approval process
Data Obtained by the Study Researchers?
Data Approval Process:
We submitted formal requests to both the Ministry of Health and the Ministry of Community Development, Mother and Child Health to access all administrative data.
Approval Status:
Yes-obtained approval and have received the data

Treatment Assignment Data

Participation or Assignment Information:
No
Description:
The evaluation team allocated the facilities to a treatment group.
Data Obtained by the Study Researchers?
Yes
Data Previously Used?
No
Data Access:
Not restricted - access with no requirements or minimal requirements (e.g. web registration)
Data Obtained by the Study Researchers?
Yes
Data Approval Process:
Approval Status:

Data Analysis

Data Analysis Status:
Yes

Study Materials

Upload Study Materials:

Registration Category

Registration Category:
Non-Prospective, Category 4: Data for measuring impacts have been obtained/collected by the research team and analysis for this evaluation has started
Completion

Completion Overview

Intervention Completion Date:
Data Collection Completion Date:
Unit of Analysis:
Clusters in Final Sample:
Total Observations in Final Sample:
Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:
Preliminary Report URL:
Summary of Findings:
Paper:
Paper Summary:
Paper Citation:

Data Availability

Data Availability (Primary Data):
Date of Data Availability:
Data URL or Contact:
Access procedure:

Other Materials

Survey:
Survey Instrument Links or Contact:
Program Files:
Program Files Links or Contact:
External Link:
External Link Description:
Description of Changes:

Study Stopped

Date:
Reason: