Measuring the Impact of Integrating Maternal and Newborn HIV Testing With Childhood Immunization Services

NCT02479659 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-07-01

No results posted yet for this study

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.

Conditions

Interventions

OTHER

HIV testing commodity reinforcement

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.

OTHER

Policy reinforcement meeting

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.

OTHER

Opt-out HIV testing for mothers and newborns

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: * If marked Confirmed Exposed (CE), the health care worker conducted the DBS test on the infant only. * If marked, Mother Status Unknown (MSU) or Confirmed Not Exposed (CNE) the mother or caregiver was asked if the mother had ever tested HIV-positive. If yes, a DBS was done on the infant only. If no, the mother was offered an HIV antibody test in an opt-out manner.

OTHER

Operational support for service integration

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.

OTHER

Community sensitization

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.

Sponsors & Collaborators

  • Zambia Center for Applied Health Research and Development

    collaborator OTHER
  • Ministry of Health, Zambia

    collaborator OTHER_GOV
  • Minister of Community Development, Mother and Child Health, Zambia

    collaborator OTHER
  • Clinton Health Access Initiative Inc.

    collaborator OTHER
  • IDinsight

    lead OTHER

Principal Investigators

  • Paul Wang, MPAID/MBA · IDinsight

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-03-31
Completion
2014-05-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02479659 on ClinicalTrials.gov