Ignite Creation Date:
2024-05-06 @ 3:08 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02214875
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2014-07-16
Brief Title:
Lafiyan Jikin Mata Excellent Health for Mothers
Sponsor:
Centre for Integrated Health Programs Nigeria
Organization:
Centre for Integrated Health Programs Nigeria
Study Overview
Official Title:
Increasing Retention-in-care of HIV Positive Women in PMTCT Services Through Continuous Quality Improvement -Break Through Series in Primary Secondary Health Care Facilities in Nigeria A Cluster Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LJM
Brief Summary:
This study aims to address the research question Will continuous quality improvement using a Break Through Series approach increase uptake of PMTCT services and retention-in-care of HIV-infected pregnant women and mothers at six and 12 months postpartum
Continuous Quality Improvement CQI is a health systems intervention to assist programs to systematically improve services and health outcomes The Break Through Series BTS is a specific CQI approach is a short-term 6- to 15-month learning system that brings together teams from several hospitals or clinics collaboratives to seek improvement in a focused topic area through a common process of data sharing and review Primary Objective To assess whether retention-in-care of HIV-infected women at six 6 months postpartum is higher at health facilities implementing CQI-BTS approaches than at health facilities not implementing CQI-BTS approaches
Secondary Objectives
To assess whether implementation of CQI-BTS initiatives at health facilities increases
1 Uptake of PMTCT services by HIV-infected pregnant women
2 Retention-in-care of HIV-infected women at twelve 12 months postpartum
3 Retention-in-care of HIV-exposed babies at six 6 and twelve 12 months of age
4 Uptake of a pre-defined minimum set of integrated RHPMTCT services by HIV-infected women in health facilities
Continuous Quality Improvement CQI is a health systems intervention to assist programs to systematically improve services and health outcomes The Break Through Series BTS is a specific CQI approach is a short-term 6- to 15-month learning system that brings together teams from several hospitals or clinics collaboratives to seek improvement in a focused topic area through a common process of data sharing and review Primary Objective To assess whether retention-in-care of HIV-infected women at six 6 months postpartum is higher at health facilities implementing CQI-BTS approaches than at health facilities not implementing CQI-BTS approaches
Secondary Objectives
To assess whether implementation of CQI-BTS initiatives at health facilities increases
1 Uptake of PMTCT services by HIV-infected pregnant women
2 Retention-in-care of HIV-infected women at twelve 12 months postpartum
3 Retention-in-care of HIV-exposed babies at six 6 and twelve 12 months of age
4 Uptake of a pre-defined minimum set of integrated RHPMTCT services by HIV-infected women in health facilities
Detailed Description:
Methods Study design Population Interventions Study Design A cluster randomized controlled trial in which 32 public primary and secondary health care facilities are randomized into 16 intervention and 16 control sites The control sites will receive routine CIHP support while the intervention sites will receive structured CQI-BTS interventions
Study sites Based on pre-set site selection criteria 32 sites were selected from a total of 241 eligible sites supported by the Centre for Integrated Healthcare Programs CIHP to provide comprehensive HIV care and treatment programs These sites are at higher levels of standardized care compared to Government of Nigeria sites where there is minimal standardization of care The following criteria were used to select health facilities for the study
Facility supports ANCPMTCT services and has capacity to provide ART until 12-18 months post-partum
Onsite delivery of HIV women by the facility
Provision of postpartum care follow-up for HIV women
ANC attendance with at least 2 HIV women per month for general hospitals and at least 1 per month for primary health care PHCs
Availability of at least two trained community health extension workers
Facilities providing PMTCT services for more than six months prior to onset of study
Study Participants
Participants are HIV-infected pregnant women presenting at study sites for 1st booking at antenatal clinics with gestational age of 34 weeks or less ART naive accept ARV and agree to remain in care for at least six months post-partum
Control and Intervention arms
Individual pregnant women and mothers attending facilities in the control and intervention arms receive the same routine care that includes a test and treat protocol ie same day HIV testing and initiation of triple ARVs option B of HIV pregnant women Clients eligible for lifelong ART based on CD4 count andor WHO staging continue ARVs indefinitely for their own health while those not eligible continue ARV prophylaxis according to the National guidelines For the purpose of this study antenatal clients are seen for their ARV drug refills until delivery according to the National ANC schedule of appointments Postpartum visits follow the immunization schedule ie 6 weeks 10 weeks and 14 weeks and thereafter 2 monthly until 12 months Facilities in the control arm continue to receive routine health system support from CIHP
Intervention package
CQI interventions employ rapid cycles of data collection testing of solutions and review of changes will be implemented At each site a Quality Improvement Team QIT will be established from among the local staff Local Government and State level QI teams will also be set up to provide oversight function of the health facilities QI initiatives The BTS is a collaborative learning approach conducted quarterly in each study state at a central location with participants from the intervention sites The sessions provide opportunity for teams to learn from each other and to adapt and implement changes using the Plan-Do-Study-Act PDSA model Driver diagrams will be developed to understand the primary and secondary drivers for low retention of HIV positive mothers and formulate action plans and indicator sets to address these Between the collaborative sessions specific designated improvement coaches will follow up site teams at regular intervals via physical site visits and telephone calls to guide implementation of change ideas Different site teams will also be encouraged to communicate with each other through telephone calls and cross-site visits to strengthen learning and exchange of ideas
Sample size estimation
Sample size was calculated using the windows programme for epidemiologists The CQI-BTS approach tested within the study would be deemed worthwhile if there is a 20 absolute increase in retention of mothers at 6 months eg expected retention rate in the control arm 40 expected retention rate in the control arm 60 First the minimum sample size needed under individual randomization was calculated to detect the desirable difference of proportions with a level of significance set at 95 two-sided and at 80 power We found that 94 mother-infant pairs would be needed in each arm under individual randomization Second bearing in mind that this trial will randomize the intervention package under several clusters the sample size from a non-cluster randomized trial was inflated by an Inflation Factor IF The IF is calculated as follows IF 1 m - 1 ro where m is the size of each cluster and ro the internal variability which represents how strongly individuals within clusters are related to each other In our case it is difficult to estimate a priori this internal variability due to lack of primary data it is possible that the standardized structure of the intervention tested within the trial will lead to a relatively low cluster internal variability alternatively because the intervention package depends on the individual capacitywill of health-care personnel this may increase the internal variability across clusters Hence we believe it is reasonable to assume a ro value of 010 as recommended by most authors We set the size of cluster at 20 which gave an inflation factor of 29 Additionally since this research is being carried out in an operational context we allowed for up to 20 of routine data to be incomplete or maternal mortality in pregnancy and therefore data on retention in care not available for analysis As a conclusion a total of 327 mother-infant pairs are needed in each arm There will be 16 clusters in each arm with a minimum number of 20 HIV-infected pregnant women per site A total of 640 pregnant HIV-infected women will be recruited
Data management plan
Primary outcome data is sourced from the local health registers -Data collection and entry occur weekly in both study arms by research assistants A monthly review of these data is conducted by the LJM study team In addition process measures are routinely collected to assess the integrity of implementation of the CQI-BTS intervention
Primary Outcome Proportion of HIV pregnant women in care 6 months postpartum Source Document PMTCT ARV register
Secondary Outcome 1 Proportion of HIV pregnant women initiating ARV prophylaxis or treatment within 2 weeks of enrolment Source Document PMTCT HCT register PMTCT ARV register and Mother Child Care Form
Secondary Outcome 2 Proportion of HIV pregnant women care 12 months postpartum Source Document PMTCT ARV register Mother and Child Care Form
Secondary Outcome 3 Proportion of HIV exposed infants with Dry Blood Spot DBS samples taken at 8 weeks of life Source Document Child follow up register and Mother Child Care Form
Analysis plan
Descriptive analyses will be conducted to outline participants and clusters baseline characteristics and outcomes by study arms using frequency tabulations and summary statistics Bi-variate analysis will be done to identify potential prognostic factors confounding the distribution of baseline characteristics among the arms that require adjustment
Study sites Based on pre-set site selection criteria 32 sites were selected from a total of 241 eligible sites supported by the Centre for Integrated Healthcare Programs CIHP to provide comprehensive HIV care and treatment programs These sites are at higher levels of standardized care compared to Government of Nigeria sites where there is minimal standardization of care The following criteria were used to select health facilities for the study
Facility supports ANCPMTCT services and has capacity to provide ART until 12-18 months post-partum
Onsite delivery of HIV women by the facility
Provision of postpartum care follow-up for HIV women
ANC attendance with at least 2 HIV women per month for general hospitals and at least 1 per month for primary health care PHCs
Availability of at least two trained community health extension workers
Facilities providing PMTCT services for more than six months prior to onset of study
Study Participants
Participants are HIV-infected pregnant women presenting at study sites for 1st booking at antenatal clinics with gestational age of 34 weeks or less ART naive accept ARV and agree to remain in care for at least six months post-partum
Control and Intervention arms
Individual pregnant women and mothers attending facilities in the control and intervention arms receive the same routine care that includes a test and treat protocol ie same day HIV testing and initiation of triple ARVs option B of HIV pregnant women Clients eligible for lifelong ART based on CD4 count andor WHO staging continue ARVs indefinitely for their own health while those not eligible continue ARV prophylaxis according to the National guidelines For the purpose of this study antenatal clients are seen for their ARV drug refills until delivery according to the National ANC schedule of appointments Postpartum visits follow the immunization schedule ie 6 weeks 10 weeks and 14 weeks and thereafter 2 monthly until 12 months Facilities in the control arm continue to receive routine health system support from CIHP
Intervention package
CQI interventions employ rapid cycles of data collection testing of solutions and review of changes will be implemented At each site a Quality Improvement Team QIT will be established from among the local staff Local Government and State level QI teams will also be set up to provide oversight function of the health facilities QI initiatives The BTS is a collaborative learning approach conducted quarterly in each study state at a central location with participants from the intervention sites The sessions provide opportunity for teams to learn from each other and to adapt and implement changes using the Plan-Do-Study-Act PDSA model Driver diagrams will be developed to understand the primary and secondary drivers for low retention of HIV positive mothers and formulate action plans and indicator sets to address these Between the collaborative sessions specific designated improvement coaches will follow up site teams at regular intervals via physical site visits and telephone calls to guide implementation of change ideas Different site teams will also be encouraged to communicate with each other through telephone calls and cross-site visits to strengthen learning and exchange of ideas
Sample size estimation
Sample size was calculated using the windows programme for epidemiologists The CQI-BTS approach tested within the study would be deemed worthwhile if there is a 20 absolute increase in retention of mothers at 6 months eg expected retention rate in the control arm 40 expected retention rate in the control arm 60 First the minimum sample size needed under individual randomization was calculated to detect the desirable difference of proportions with a level of significance set at 95 two-sided and at 80 power We found that 94 mother-infant pairs would be needed in each arm under individual randomization Second bearing in mind that this trial will randomize the intervention package under several clusters the sample size from a non-cluster randomized trial was inflated by an Inflation Factor IF The IF is calculated as follows IF 1 m - 1 ro where m is the size of each cluster and ro the internal variability which represents how strongly individuals within clusters are related to each other In our case it is difficult to estimate a priori this internal variability due to lack of primary data it is possible that the standardized structure of the intervention tested within the trial will lead to a relatively low cluster internal variability alternatively because the intervention package depends on the individual capacitywill of health-care personnel this may increase the internal variability across clusters Hence we believe it is reasonable to assume a ro value of 010 as recommended by most authors We set the size of cluster at 20 which gave an inflation factor of 29 Additionally since this research is being carried out in an operational context we allowed for up to 20 of routine data to be incomplete or maternal mortality in pregnancy and therefore data on retention in care not available for analysis As a conclusion a total of 327 mother-infant pairs are needed in each arm There will be 16 clusters in each arm with a minimum number of 20 HIV-infected pregnant women per site A total of 640 pregnant HIV-infected women will be recruited
Data management plan
Primary outcome data is sourced from the local health registers -Data collection and entry occur weekly in both study arms by research assistants A monthly review of these data is conducted by the LJM study team In addition process measures are routinely collected to assess the integrity of implementation of the CQI-BTS intervention
Primary Outcome Proportion of HIV pregnant women in care 6 months postpartum Source Document PMTCT ARV register
Secondary Outcome 1 Proportion of HIV pregnant women initiating ARV prophylaxis or treatment within 2 weeks of enrolment Source Document PMTCT HCT register PMTCT ARV register and Mother Child Care Form
Secondary Outcome 2 Proportion of HIV pregnant women care 12 months postpartum Source Document PMTCT ARV register Mother and Child Care Form
Secondary Outcome 3 Proportion of HIV exposed infants with Dry Blood Spot DBS samples taken at 8 weeks of life Source Document Child follow up register and Mother Child Care Form
Analysis plan
Descriptive analyses will be conducted to outline participants and clusters baseline characteristics and outcomes by study arms using frequency tabulations and summary statistics Bi-variate analysis will be done to identify potential prognostic factors confounding the distribution of baseline characteristics among the arms that require adjustment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None