Clinical trial NCT02479659: Measuring the Impact of Integrating Maternal and Newborn HIV Testing With Childhood Immunization Services
Official 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Immunizations
Lead sponsor: IDinsight
Sponsor class: OTHER
Collaborators: name: Zambia Center for Applied Health Research and Development
name: Ministry of Health, Zambia
name: Minister of Community Development, Mother and Child Health, Zambia
name: Clinton Health Access Initiative Inc.
First posted: 2015-06-24
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in average monthly number of infant DBS HIV tests
timeFrame: Baseline and 6 mos (endline)
measure: Change in average monthly number of maternal postpartum HIV tests
timeFrame: Baseline and 6 mos (endline)
measure: Change in average monthly number of DPT1 doses administered
timeFrame: Baseline and 6 mos (endline)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: IDinsight
name: Paul Wang, MPAID/MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang PC, Mwango A, Moberley S, Brockman BJ, Connor AL, Kalesha-Masumbu P, Mutembo S, Bweupe M, Chanda-Kapata P, Biemba G, Hamer DH, Chibuye B, McCarthy E. 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 Health Facilities in Southern Zambia. PLoS One. 2015 Oct 29;10(10):e0141455. doi: 10.1371/journal.pone.0141455. eCollection 2015.