HIVNCT02479659
Measuring the Impact of Integrating Maternal and Newborn HIV Testing With Childhood Immunization Services
A study testing HIV testing commodity reinforcement, Policy reinforcement meeting and Opt-out HIV testing for mothers and newborns in people with HIV, run by IDinsight.
Trial 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)… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- HIV testing commodity reinforcement, Policy reinforcement meeting and Opt-out HIV testing for mothers and newborns
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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
- Being tested
- HIV testing commodity reinforcement, Policy reinforcement meeting, Opt-out HIV testing for mothers and newborns, Operational support for service integration, Community sensitization
- Keywords
- Immunizations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV testing commodity reinforcementOther
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 meetingOther
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 newbornsOther
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 integrationOther
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 sensitizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline and 6 mos (endline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startOct 2013
- Primary completionMar 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IDinsight
- Sponsor type
- University, hospital or other
- Collaborators
- Zambia Center for Applied Health Research and Development, Ministry of Health, Zambia, Minister of Community Development, Mother and Child Health, Zambia, Clinton Health Access Initiative Inc.
- Responsible party
- Sponsor
- Investigators
- Paul Wang, MPAID/MBA, Principal investigator, IDinsight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479659
- Sponsor's protocol ID
- 001
- Status last verified
- Jun 2015
- First submitted
- 14 Jun 2015
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26513240
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02479659
- Acronym / sponsor ID
- 001
- Conditions
- HIV
- Keywords
- Immunizations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IDinsightUniversity, hospital or other
- Collaborators
- Zambia Center for Applied Health Research and Development, Ministry of Health, Zambia, Minister of Community Development, Mother and Child Health, Zambia, Clinton Health Access Initiative Inc.
- Study start
- Oct 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Facilities in this arm maintained status quo HIV testing and routine childhood immunization services |
| Simple Intervention | Experimental | Other: HIV testing commodity reinforcement, Other: Policy reinforcement meetingThis included: 1) HIV testing commodity reinforcement and 2) a policy reinforcement meeting |
| Comprehensive Intervention | Experimental | 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 sensitizationThis 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV testing commodity reinforcementHIV 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 | Comprehensive Intervention, Simple Intervention |
| Policy reinforcement meetingDistrict 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 | Comprehensive Intervention, Simple Intervention |
| Opt-out HIV testing for mothers and newbornsFacility 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 | Comprehensive Intervention |
| Operational support for service integrationThe 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 | Comprehensive Intervention |
| Community sensitizationHealth 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. | Other | Comprehensive Intervention |
Primary outcome
Change in average monthly number of infant DBS HIV tests
Time frame: Baseline and 6 mos (endline)
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
Change in average monthly number of maternal postpartum HIV tests
Time frame: Baseline and 6 mos (endline)
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
Change in average monthly number of DPT1 doses administered
Time frame: Baseline and 6 mos (endline)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
- Derived from this study: PubMed 26513240Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Wang, MPAID/MBA principal investigator
IDinsight
Questions about this trial
What is this clinical trial studying?
A study testing HIV testing commodity reinforcement, Policy reinforcement meeting and Opt-out HIV testing for mothers and newborns in people with HIV, run by IDinsight.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average monthly number of infant DBS HIV tests (time frame: Baseline and 6 mos (endline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02479659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2015.