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

NCT ID: NCT02479659

Last Updated: 2015-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-05-31

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Simple Intervention

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

Group Type: EXPERIMENTAL

HIV testing commodity reinforcement

Intervention Type: 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.

Policy reinforcement meeting

Intervention Type: 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

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

Group Type: EXPERIMENTAL

HIV testing commodity reinforcement

Intervention Type: 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.

Policy reinforcement meeting

Intervention Type: 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.

Opt-out HIV testing for mothers and newborns

Intervention Type: 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.

Operational support for service integration

Intervention Type: 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.

Community sensitization

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zambia Center for Applied Health Research and Development

OTHER

Sponsor Role: collaborator

Ministry of Health, Zambia

OTHER_GOV

Sponsor Role: collaborator

Minister of Community Development, Mother and Child Health, Zambia

OTHER

Sponsor Role: collaborator

Clinton Health Access Initiative Inc.

OTHER

Sponsor Role: collaborator

IDinsight

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Wang, MPAID/MBA

Role: PRINCIPAL_INVESTIGATOR

IDinsight

References

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.

Reference Type: DERIVED

PMID: 26513240 (View on PubMed)

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id