Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04598958
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2020-10-05
Brief Title:
A Multidisciplinary Integrated Management Team to Improve Maternal-Child Outcomes IMPROVE Intervention to Improve Maternal and Child Outcomes in Lesotho
Sponsor:
Elizabeth Glaser Pediatric AIDS Foundation
Organization:
Elizabeth Glaser Pediatric AIDS Foundation
Study Overview
Official Title:
A Multidisciplinary Integrated Management Team to Improve Maternal-Child Outcomes IMPROVE Intervention to Improve Maternal and Child Outcomes and HIV Service and Antiretroviral Therapy Uptake and Retention in Lesotho
Status:
COMPLETED
Status Verified Date:
2020-10
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:
IMPROVE
Brief Summary:
This study aims to improve maternal and child health MCH outcomes by implementing and evaluating a multidisciplinary Integrated Management Team to Improve Maternal-Child Outcomes IMPROVE intervention to increase MCH antiretroviral therapy ART and HIV services uptake and retention in Lesotho The proposed intervention will focus efforts to improve the effectiveness of existing village health workers VHW and HIV support organizations Lesotho Network of AIDS Service Organizations LENASO and Mothers2Mothers M2M based at the facility and coordination between the facility and community The IMPROVE intervention includes 1 Multidisciplinary integrated management teams to coordinate patient-focused and outcome-oriented PMTCT and MCH services 2 Enhanced Positive Health Dignity and Prevention PHDP-focused counseling and skills-building training and job aids and 3 Increased early community-based counseling and support for first antenatal care clinic ANC attendees with particular attention to HIV-positive women to minimize loss to follow-up
The study will be a cluster randomized design with facilities randomized to receive the IMPROVE intervention or routine services offering the national standard of care A cohort of HIV-positive and HIV-negative pregnant women will be enrolled and prospectively followed every three months through pregnancy and until the participants child reaches 24 months of age The primary HIV objectives will be to evaluate the effect of the intervention on retention in HIV care viral suppression adherence to ART in HIV-positive women and HIV retesting in HIV-negative women The investigators will also assess the effect of the IMPROVE intervention on general MCH indices including antenatal care ANC attendance facility delivery family planning and immunization coverage Secondary objectives include evaluation of adherence self-efficacy HIV positive or prevention self-efficacy HIV negative depression and stigma as well as disclosure knowledge of partner status and identification of discordant couples in intervention versus control facilities Analysis of the cost-effectiveness of the IMPROVE intervention will also be conducted In addition qualitative interviews and focus group discussions will be conducted with study women health care workers HCW LENASO and VHWs to evaluate the feasibility and acceptability of integrating this intervention into routine care
The study will be a cluster randomized design with facilities randomized to receive the IMPROVE intervention or routine services offering the national standard of care A cohort of HIV-positive and HIV-negative pregnant women will be enrolled and prospectively followed every three months through pregnancy and until the participants child reaches 24 months of age The primary HIV objectives will be to evaluate the effect of the intervention on retention in HIV care viral suppression adherence to ART in HIV-positive women and HIV retesting in HIV-negative women The investigators will also assess the effect of the IMPROVE intervention on general MCH indices including antenatal care ANC attendance facility delivery family planning and immunization coverage Secondary objectives include evaluation of adherence self-efficacy HIV positive or prevention self-efficacy HIV negative depression and stigma as well as disclosure knowledge of partner status and identification of discordant couples in intervention versus control facilities Analysis of the cost-effectiveness of the IMPROVE intervention will also be conducted In addition qualitative interviews and focus group discussions will be conducted with study women health care workers HCW LENASO and VHWs to evaluate the feasibility and acceptability of integrating this intervention into routine care
Detailed Description:
Lesotho is among countries with the highest HIV prevalence worldwide with an estimated prevalence of HIV among pregnant women of 258 in 2013 In April 2013 Lesotho transitioned from the WHO Option A strategy to implementation of Option B lifelong ART for all HIV-positive women strategy for PMTCT in the context of a program that is integrated into MCH services Through this study the investigators propose to evaluate a package of interventions to provide enhanced individualized counseling and community support within a coordinated system of training and accountability to optimize the delivery of patient-focused services using PHDP principles within the routine PMTCTMCH program in Lesotho
The study will be conducted in 12 health facilities in Maseru district
The proposed intervention will focus efforts to improve the effectiveness of existing VHW and HIV support organizations LENASO M2M based at the facility and coordination between the facility and community The package includes
1 MCH staff counselors M2MLENASO and VHWs meeting regularly to coordinate patient-focused and outcome-oriented PMTCT and MCH services to all women with immediate follow-up of defaulters
2 Enhanced Positive Health Dignity and Prevention PHDP-focused counseling and skills-building training and job aids to improve the quality and consistency of counseling provided by all IMPROVE team members Such individualized support will facilitate self-efficacy support partner disclosure provide screening and referral for depression and provide linkages to community-based services
3 Increased early community-based counseling and support for all ANC attendees that will include 1 to 2 additional home or community visits at 2-7 days andor 9-14 days after first ANC visit with particular attention to HIV-positive women to minimize immediate and early loss to follow-up LTFU
Aim and Objectives The overall aim of this study is to improve maternal and child health outcomes by implementing and evaluating a multidisciplinary Integrated Management Team to Improve Maternal-Child Outcomes IMPROVE intervention to increase overall MCH ART and HIV service uptake and retention
Primary Objectives
1 To evaluate the effect of the IMPROVE intervention on retention in HIV care viral suppression and adherence to ART at 24 months postpartum in a prospective cohort of HIV-positive pregnantpostpartum women and their infants compared to a cohort of HIV-positive women receiving routine care alone
2 To evaluate the effect of the IMPROVE intervention on repeat HIV testing by 24 months postpartum in a prospective cohort of HIV-negative pregnantpostpartum women compared to a cohort of HIV-negative women receiving routine care alone
3 To evaluate the effect of the IMPROVE intervention on targeted MCH health seeking behaviors eg facility delivery child immunization in both HIV-positive and HIV-negative women compared to women receiving routine care alone
4 To determine the costs associated with the IMPROVE package of interventions for both HIV-positive and HIV-negative women compared to HIV-positive and HIV-negative women receiving routine care without the IMPROVE intervention
Secondary Objectives
1 To assess additional MCH outcomes eg ANC attendance infant mortality maternal mortality other HIV prevention indices eg disclosure knowledge of partner status identification of discordant couples unintended pregnancy prevention indices eg use of modern contraceptives repeat pregnancy fertility intentions and other indices of HIV care eg timing of infant diagnosis number of infected infants among HIV-positive and HIV-negative women receiving the IMPROVE intervention versus those receiving routine care alone
2 To compare depression experienced stigma and self-efficacy among both HIV-positive treatment self-efficacy and HIV-negative women HIV prevention self-efficacy in the intervention and control facilities
3 To compare pregnantpostpartum womens attitudes toward lifelong ART HIV-positive only acceptability of the IMPROVE intervention intervention facilities only and satisfaction with PMTCTMCH services among both HIV-positive and HIV-negative women in intervention and control facilities
4 To assess HCW counselor and VHW attitudes toward the feasibility and acceptability of integrating the IMPROVE package in routine services
5 To evaluate the cost-effectiveness of the IMPROVE intervention on retention in HIV care viral suppression and adherence to ART HIV retesting and uptake of family planning and child immunizations at 24 months postpartum in a prospective cohort of pregnantpostpartum women and their infants compared to a similar cohort of women and infants receiving routine care without the IMPROVE intervention
Hypotheses
1 HIV-positive women in facilities with IMPROVE versus routine care will have higher adherence and retention in HIV care
2 HIV-negative women in facilities receiving the IMPROVE intervention will have an increase in HIV re-testing in the postpartum period
3 HIV-positive and HIV-negative women in facilities with IMPROVE versus routine care will show improvement in health seeking behavior leading to improved maternal and infant outcomes
4 The IMPROVE intervention is a cost-effective approach to improve health outcomes among HIV-positive and HIV -negative pregnantpostpartum women and their infants
Data gathering activities The study will be conducted in Maseru district which is large and representative of a variety of settings within Lesotho Maseru has one of the highest HIV prevalence rates and the lowest PMTCT and MCH indicator coverage rates in Lesotho Twelve health facilities serving between 150-900 pregnant women annually from Maseru district were purposefully selected to reflect a common range of ANC volumes while allowing for timely recruitment of the sample size of HIV-positive women needed during the enrollment period Pregnant women attending their first ANC visit at a study health facility will be eligible for enrollment in a prospective cohort and followed until 24 months post-partum Because the study intervention begins at the first ANC visit with enhanced counseling and close follow-up at home within the next week the study will only enroll women who are attending ANC for their first visit The investigators will enroll 310 HIV-positive and 200 HIV-negative women in each arm over 10-15 months for a total of 1020 participants
After obtaining written informed consent pregnant women will be enrolled in the study into either the IMPROVE intervention arm or control arm depending on the facility the woman attends At enrollment women will undergo an interview to collect demographic pregnancy medical and HIV related information Clinical and laboratory data will be abstracted from clinic medical records After the enrollment visit womeninfants will be seen by study staff for study specific visits during ANC at the next ANC visit after enrollment or sooner if late in gestation timing depends on gestational age at first visit around the time of delivery 6 and 14 weeks and 6 9 12 18 and 24 months postpartum Study visits will be scheduled to coincide with routine health service visits to the clinic for the mother or child as much as possible At each study visit a participant interview and abstraction of clinical and laboratory data from medical records will be conducted
Study nurses will be present in each study facility and will be responsible for the collection and maintenance of study records and data Informed consent documents study screeningenrollment logs and participant locator forms that include identifiable information will be completed at enrollment and stored in a locked secure location in the health facility with access limited to study staff Multivariate random-effects 2-stage model level-1 individual level-2 cluster logistic regression will be used to compare proportional outcomes between intervention and control groups Time to event outcomes will be analyzed using survival analysis approaches An intent to treat analysis will be used Descriptive analyses will be used for the assessment of the fidelity to the IMPROVE intervention implementation over time and secondary outcomes that are likely to be infrequent and thus with limited power to detect differences such as mortality HIV infection rates in children seroincidence repeat pregnancies etc The evaluation results will be presented as either odds ratios or hazard ratios for the time-to-event analysis and 95 confidence intervals
Risks and Benefits to Participants There may or may not be direct benefits to study participants However possible benefits to the participants include close monitoring that may identify problems sooner screening and referral for depression additional viral load monitoring for HIV-positive women and potential receipt of improved service delivery for women in IMPROVE intervention facilities
The study poses minimal safety risks to the study participants The services are being conducted in the framework of routine MCH services The intervention addresses mainly service delivery changes that do not subject study participants to risks outside of what would be expected within routine services Potential risks include the potential for unintended disclosure of mother and infants HIV status All efforts will be made to conduct interviews in private to protect participant confidentiality
Women enrolled in the IMPROVE study will be identified by their unique study identifier and data collection and forms will be linked to the patient using this unique identifier only Study participants will not receive any compensation or incentive for participating in the study
Qualitative data collection A subset of women participating in the study 40 in each arm will be asked to undergo semi-structured interviews for a total of about 80 semi-structured interviews These will include approximately 20 HIV-positive and 20-HIV negative women in each of the intervention and control arms Women attending their 18 or 24 month visit during the time that the qualitative component is underway will be randomly selected to participate in a semi-structured interview Focus Group Discussions FGDs will be used to gather information about the HCW and VHWLENASOM2M experiences with separate FGD for the two cadres Sources of qualitative data will be the open-ended responses from interviews and FGDs All qualitative data will be entered into Microsoft Word as data files and analyzed using MAXqda or another similar qualitative data analysis program Prior to beginning study procedures for this component of the study verbal informed consent will be documented for all individuals participating in interviews by study staff trained in protocol and ethical procedures
Costing data collection The cost-effectiveness component of the study will measure the cost-effectiveness of the IMPROVE intervention in achieving positive health outcomes among pregnantpostpartum women and their infants The endpoints of the study relevant to the cost-effectiveness analysis are 1 retention through 24 months postpartum 2 ART adherence among HIV-positive women 3 viral load suppression among HIV-positive women 4 rate of HIV re-testing among HIV-negative women 5 rate of family planning uptake 6 rate of immunization uptake These will be among the inputs used to compute Quality of Life Years QALYs gained per woman
The outcomes will be measured in terms of incremental cost per QALY gained per HIV-positive woman cost per infection averted per HIV-exposed infant cost per QALY gained per HIV exposed infant cost per adult HIV infection averted cost per birth averted and cost per child death averted
The outcomes will be computed using the OneHealth Tool and data compiled from the primary endpoints The cost estimation will include a summation of the IMPROVE intervention package plus the sum of costs incurred by participants pregnant and postpartum women and infants for service provision less any cost savings achieved through 1 productivity losses averted and 2 costs averted per treatment or prevention of disease
The study will be conducted in 12 health facilities in Maseru district
The proposed intervention will focus efforts to improve the effectiveness of existing VHW and HIV support organizations LENASO M2M based at the facility and coordination between the facility and community The package includes
1 MCH staff counselors M2MLENASO and VHWs meeting regularly to coordinate patient-focused and outcome-oriented PMTCT and MCH services to all women with immediate follow-up of defaulters
2 Enhanced Positive Health Dignity and Prevention PHDP-focused counseling and skills-building training and job aids to improve the quality and consistency of counseling provided by all IMPROVE team members Such individualized support will facilitate self-efficacy support partner disclosure provide screening and referral for depression and provide linkages to community-based services
3 Increased early community-based counseling and support for all ANC attendees that will include 1 to 2 additional home or community visits at 2-7 days andor 9-14 days after first ANC visit with particular attention to HIV-positive women to minimize immediate and early loss to follow-up LTFU
Aim and Objectives The overall aim of this study is to improve maternal and child health outcomes by implementing and evaluating a multidisciplinary Integrated Management Team to Improve Maternal-Child Outcomes IMPROVE intervention to increase overall MCH ART and HIV service uptake and retention
Primary Objectives
1 To evaluate the effect of the IMPROVE intervention on retention in HIV care viral suppression and adherence to ART at 24 months postpartum in a prospective cohort of HIV-positive pregnantpostpartum women and their infants compared to a cohort of HIV-positive women receiving routine care alone
2 To evaluate the effect of the IMPROVE intervention on repeat HIV testing by 24 months postpartum in a prospective cohort of HIV-negative pregnantpostpartum women compared to a cohort of HIV-negative women receiving routine care alone
3 To evaluate the effect of the IMPROVE intervention on targeted MCH health seeking behaviors eg facility delivery child immunization in both HIV-positive and HIV-negative women compared to women receiving routine care alone
4 To determine the costs associated with the IMPROVE package of interventions for both HIV-positive and HIV-negative women compared to HIV-positive and HIV-negative women receiving routine care without the IMPROVE intervention
Secondary Objectives
1 To assess additional MCH outcomes eg ANC attendance infant mortality maternal mortality other HIV prevention indices eg disclosure knowledge of partner status identification of discordant couples unintended pregnancy prevention indices eg use of modern contraceptives repeat pregnancy fertility intentions and other indices of HIV care eg timing of infant diagnosis number of infected infants among HIV-positive and HIV-negative women receiving the IMPROVE intervention versus those receiving routine care alone
2 To compare depression experienced stigma and self-efficacy among both HIV-positive treatment self-efficacy and HIV-negative women HIV prevention self-efficacy in the intervention and control facilities
3 To compare pregnantpostpartum womens attitudes toward lifelong ART HIV-positive only acceptability of the IMPROVE intervention intervention facilities only and satisfaction with PMTCTMCH services among both HIV-positive and HIV-negative women in intervention and control facilities
4 To assess HCW counselor and VHW attitudes toward the feasibility and acceptability of integrating the IMPROVE package in routine services
5 To evaluate the cost-effectiveness of the IMPROVE intervention on retention in HIV care viral suppression and adherence to ART HIV retesting and uptake of family planning and child immunizations at 24 months postpartum in a prospective cohort of pregnantpostpartum women and their infants compared to a similar cohort of women and infants receiving routine care without the IMPROVE intervention
Hypotheses
1 HIV-positive women in facilities with IMPROVE versus routine care will have higher adherence and retention in HIV care
2 HIV-negative women in facilities receiving the IMPROVE intervention will have an increase in HIV re-testing in the postpartum period
3 HIV-positive and HIV-negative women in facilities with IMPROVE versus routine care will show improvement in health seeking behavior leading to improved maternal and infant outcomes
4 The IMPROVE intervention is a cost-effective approach to improve health outcomes among HIV-positive and HIV -negative pregnantpostpartum women and their infants
Data gathering activities The study will be conducted in Maseru district which is large and representative of a variety of settings within Lesotho Maseru has one of the highest HIV prevalence rates and the lowest PMTCT and MCH indicator coverage rates in Lesotho Twelve health facilities serving between 150-900 pregnant women annually from Maseru district were purposefully selected to reflect a common range of ANC volumes while allowing for timely recruitment of the sample size of HIV-positive women needed during the enrollment period Pregnant women attending their first ANC visit at a study health facility will be eligible for enrollment in a prospective cohort and followed until 24 months post-partum Because the study intervention begins at the first ANC visit with enhanced counseling and close follow-up at home within the next week the study will only enroll women who are attending ANC for their first visit The investigators will enroll 310 HIV-positive and 200 HIV-negative women in each arm over 10-15 months for a total of 1020 participants
After obtaining written informed consent pregnant women will be enrolled in the study into either the IMPROVE intervention arm or control arm depending on the facility the woman attends At enrollment women will undergo an interview to collect demographic pregnancy medical and HIV related information Clinical and laboratory data will be abstracted from clinic medical records After the enrollment visit womeninfants will be seen by study staff for study specific visits during ANC at the next ANC visit after enrollment or sooner if late in gestation timing depends on gestational age at first visit around the time of delivery 6 and 14 weeks and 6 9 12 18 and 24 months postpartum Study visits will be scheduled to coincide with routine health service visits to the clinic for the mother or child as much as possible At each study visit a participant interview and abstraction of clinical and laboratory data from medical records will be conducted
Study nurses will be present in each study facility and will be responsible for the collection and maintenance of study records and data Informed consent documents study screeningenrollment logs and participant locator forms that include identifiable information will be completed at enrollment and stored in a locked secure location in the health facility with access limited to study staff Multivariate random-effects 2-stage model level-1 individual level-2 cluster logistic regression will be used to compare proportional outcomes between intervention and control groups Time to event outcomes will be analyzed using survival analysis approaches An intent to treat analysis will be used Descriptive analyses will be used for the assessment of the fidelity to the IMPROVE intervention implementation over time and secondary outcomes that are likely to be infrequent and thus with limited power to detect differences such as mortality HIV infection rates in children seroincidence repeat pregnancies etc The evaluation results will be presented as either odds ratios or hazard ratios for the time-to-event analysis and 95 confidence intervals
Risks and Benefits to Participants There may or may not be direct benefits to study participants However possible benefits to the participants include close monitoring that may identify problems sooner screening and referral for depression additional viral load monitoring for HIV-positive women and potential receipt of improved service delivery for women in IMPROVE intervention facilities
The study poses minimal safety risks to the study participants The services are being conducted in the framework of routine MCH services The intervention addresses mainly service delivery changes that do not subject study participants to risks outside of what would be expected within routine services Potential risks include the potential for unintended disclosure of mother and infants HIV status All efforts will be made to conduct interviews in private to protect participant confidentiality
Women enrolled in the IMPROVE study will be identified by their unique study identifier and data collection and forms will be linked to the patient using this unique identifier only Study participants will not receive any compensation or incentive for participating in the study
Qualitative data collection A subset of women participating in the study 40 in each arm will be asked to undergo semi-structured interviews for a total of about 80 semi-structured interviews These will include approximately 20 HIV-positive and 20-HIV negative women in each of the intervention and control arms Women attending their 18 or 24 month visit during the time that the qualitative component is underway will be randomly selected to participate in a semi-structured interview Focus Group Discussions FGDs will be used to gather information about the HCW and VHWLENASOM2M experiences with separate FGD for the two cadres Sources of qualitative data will be the open-ended responses from interviews and FGDs All qualitative data will be entered into Microsoft Word as data files and analyzed using MAXqda or another similar qualitative data analysis program Prior to beginning study procedures for this component of the study verbal informed consent will be documented for all individuals participating in interviews by study staff trained in protocol and ethical procedures
Costing data collection The cost-effectiveness component of the study will measure the cost-effectiveness of the IMPROVE intervention in achieving positive health outcomes among pregnantpostpartum women and their infants The endpoints of the study relevant to the cost-effectiveness analysis are 1 retention through 24 months postpartum 2 ART adherence among HIV-positive women 3 viral load suppression among HIV-positive women 4 rate of HIV re-testing among HIV-negative women 5 rate of family planning uptake 6 rate of immunization uptake These will be among the inputs used to compute Quality of Life Years QALYs gained per woman
The outcomes will be measured in terms of incremental cost per QALY gained per HIV-positive woman cost per infection averted per HIV-exposed infant cost per QALY gained per HIV exposed infant cost per adult HIV infection averted cost per birth averted and cost per child death averted
The outcomes will be computed using the OneHealth Tool and data compiled from the primary endpoints The cost estimation will include a summation of the IMPROVE intervention package plus the sum of costs incurred by participants pregnant and postpartum women and infants for service provision less any cost savings achieved through 1 productivity losses averted and 2 costs averted per treatment or prevention of disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None