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

NCT02479659 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV

Keywords

Immunizations

Outcome Measures

Primary Outcomes (3)

• Change in average monthly number of infant DBS HIV tests

  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

  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

  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)

Study Arms (3)

Control

NO INTERVENTION

Facilities in this arm maintained status quo HIV testing and routine childhood immunization services

Simple Intervention

EXPERIMENTAL

This included: 1) HIV testing commodity reinforcement and 2) a policy reinforcement meeting

Other: HIV testing commodity reinforcement; Other: Policy reinforcement meeting

Comprehensive Intervention

EXPERIMENTAL

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

Other: HIV testing commodity reinforcement; Other: Policy reinforcement meeting; Other: Opt-out HIV testing for mothers and newborns; Other: Operational support for service integration; Other: Community sensitization

Interventions

HIV testing commodity reinforcement OTHER

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.

Comprehensive Intervention; Simple Intervention

Policy reinforcement meeting OTHER

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.

Comprehensive Intervention; Simple Intervention

Opt-out HIV testing for mothers and newborns OTHER

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.

Comprehensive Intervention

Operational support for service integration OTHER

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.

Comprehensive Intervention

Community sensitization OTHER

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.

Comprehensive Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IDinsight: lead
• Zambia Center for Applied Health Research and Development: collaborator
• Ministry of Health, Zambia: collaborator
• Minister of Community Development, Mother and Child Health, Zambia: collaborator
• Clinton Health Access Initiative Inc.: collaborator

Related Publications (1)

• 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.

  PMID: 26513240 DERIVED

Study Officials

• Paul Wang, MPAID/MBA

  IDinsight

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2015
• First Posted: June 24, 2015
• Study Start: October 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 1, 2015

Record last verified: 2015-06