Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04598958 |
| Other study ID # |
EG0142 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 27, 2016 |
| Est. completion date |
September 30, 2020 |
Study information
| Verified date |
October 2020 |
| Source |
Elizabeth Glaser Pediatric AIDS Foundation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 participant's 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.
Description:
Lesotho is among countries with the highest HIV prevalence worldwide, with an estimated
prevalence of HIV among pregnant women of 25.8% 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 PMTCT/MCH 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, M2M/LENASO 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 and/or 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 pregnant/postpartum 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 pregnant/postpartum 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 (e.g., 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 (e.g., ANC attendance, infant mortality, maternal
mortality); other HIV prevention indices (e.g., disclosure, knowledge of partner status,
identification of discordant couples); unintended pregnancy prevention indices (e.g.,
use of modern contraceptives, repeat pregnancy, fertility intentions); and other indices
of HIV care (e.g., 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 pregnant/postpartum women's attitudes toward lifelong ART (HIV-positive
only), acceptability of the IMPROVE intervention (intervention facilities only), and
satisfaction with PMTCT/MCH 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
pregnant/postpartum 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 pregnant/postpartum 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, women/infants 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
screening/enrollment 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 infant's 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 VHW/LENASO/M2M 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
pregnant/postpartum 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.
