Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03021070 |
| Other study ID # |
AFYA 41361 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
January 9, 2017 |
| Last updated |
January 12, 2017 |
| Start date |
January 2017 |
| Est. completion date |
December 2019 |
Study information
| Verified date |
January 2017 |
| Source |
Stockholm Environment Institute |
| Contact |
Onyango Sangoro, PhD |
| Phone |
+254 721 816 804 |
| Email |
onyango.sangoro[@]sei-international.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Antenatal care (ANC), facility delivery and postnatal care (PNC) are proven strategies that
can tackle the high burden of maternal and child mortality and morbidity currently witnessed
in sub-Saharan Africa. However very few pregnant women utilize these services. This study
aims to assess the impact, cost-effectiveness, and scalability of conditional cash transfers
(CCTs) to promote increased and uninterrupted contact between pregnant women and the formal
healthcare system in Siaya County, Kenya.
The study is a cluster randomized controlled trial with the intervention being a conditional
cash transfer to women each time they honour their health appointments for ANC, facility
birth and PNC visits until their new-borns reach 1 year of age. Study participants are
pregnant women identified during their first ANC visit (n = 7200), and their subsequent
new-borns. Mothers and their children are followed up throughout their health visits and at
3 additional time points. Trial clusters are 48 public primary health facilities, (24 in the
intervention arm and 24 in the control arm).
The primary outcomes are: a) proportion of all eligible ANC visits made during pregnancy; b)
delivery at health facility; c) proportion of all eligible PNC visits honoured; d)
proportion of referrals honoured during pregnancy and postnatal period; e) proportion of
child immunizations received. Secondary outcomes include; health screening and infection
control, live birth, maternal and child survival 48 hours after delivery, exclusive
breastfeeding, birth spacing and self-rated wellness of mother and new-born at respective
time points.
Primary outcomes will be measured through abstraction of health records at the health
facilities attended by the women during the trial period and supplemented by data collection
using an electronic based system that comprises of a card and reader system installed at
recruited study facilities. Secondary data will be abstracted from the women's medical
records at the health facilities and supplemented by telephone surveys administered at three
time-points over the course of the study. Additional quantitative and qualitative data will
be collected through questionnaires and phone interviews for process and economic
evaluations.
This trial will contribute to evidence on effectiveness and cost-effectiveness of
conditional cash transfers in facilitating health visits and promoting maternal and child
health in Kenya and other similar contexts.
Description:
1. BACKGROUND
A "Continuum of Care" for reproductive, maternal, new-born and child health (RMNCH)
includes integrated service delivery for mothers and children from pre-pregnancy to
delivery, the immediate postnatal period, and childhood (1). Assuring continuity of
care has become a key programme strategy for improving the health of mothers and
new-borns, and is an important measure of service quality for outcomes such as
prevention of mother-to-child transmission of HIV (PMTCT) (2). Yet in many countries
there remains major gaps in seeking care along this continuum. Retaining women in this
continuum even during pregnancy has not been possible to achieve in sub-Saharan Africa
(SSA), with only 44% of women making the recommended 4 minimum ANC visits (focused ANC)
(3). Focused ANC is a scheduled service, and when clients do not adhere to the
recommended timing and repeat visits as required, the very purpose of the service is
challenged. A number of treatments provided during ANC have to be delivered in sequence
for them to be effective. Post-natal services are equally essential, as half of all
postnatal maternal deaths occur during the first week after the baby is born, and one
in four child deaths occur during the first month of life (5). In SSA, postnatal care
programmes are among the weakest of all reproductive and child health programmes (6).
Follow-up treatments and services such as PMTCT; counselling on family planning,
breastfeeding and infant feeding practices; and childhood immunizations cannot be
achieved if many women are lost to care immediately after delivery, as is the current
trend.
A major opportunity for altering the low care seeking behavior in SSA exists however,
since over two thirds of women come into contact with the formal healthcare system at
least once during pregnancy (3). A strategy that can retain these women in care, from
their first contact during pregnancy through to birth and childhood period could thus
alter considerably the negative trends in maternal and child health in Africa.
Personal financial incentives (PFIs) can offer a broad based solution that is needed to
tackle the challenge of low care seeking and retention of women in the care continuum.
It can tackle both the financial barriers to care seeking, as well as the motivational
barriers. A number of studies (30, 31, 32, 33) have demonstrated personal financial
incentives (PFIs) can help to increase adherence to lengthy treatment schedules.
Empirical evidence supports this rationale; although it is still an emerging field. In
developed countries, paying people to change their behaviour has been demonstrated as
effective with behavioural problems (10). Notable successes in developing countries are
in TB treatment programmes (11) (12). In sub-Saharan Africa, this is still a very new
concept.
2. METHODS
2.1 Study setting
The study will be conducted in Siaya County, which is located on the shores of Lake Victoria
in Western Kenya. The County is made up of 6 sub counties which are mostly rural, and has a
population of 8.3 million people (13).
2.2 Sample size determination
A sample size of 7200 women provides 80% power to detect a difference in the co-primary
outcomes if the intra-cluster correlation coefficient (ICC) is either low (0.005) or
moderate (0.025), taking the standard 5% significance level. The expected prevalence of
these indicators in the control arm ranges between 30 and 80%. The average cluster size (48
clusters) is 150 participants.
2.3. Data collection methods
2.3.1 Abstraction of health records
The primary mode for data collection will be the health records of women held at the
facilities they visit during the study period. With the consent of the study participants
and approval of the ethics committee, health data that is relevant for answering both the
primary and secondary research questions and adjusting for confounders will be abstracted on
a monthly basis from participating facilities and on a quarterly basis from
non-participating facilities.
2.3.3 Electronic capture of health visits
A secondary method for collecting data on the primary health outcomes is an electronic based
system that will be utilized primarily for cash transfers to participants, but with
additional capabilities of remotely tracking health visits made by the study participants.
The system is capable of capturing data on health visits remotely and in real-time each time
a nurse touches the Afya Card on the NCF terminal reader as a means of validating a health
visit. The card readers will be installed in all participating health facilities (24
intervention and 24 controls), as well as all hospitals in the County where most referrals
take place.
2.3.4 Enrollment
During enrollment, after informed written consent has been obtained, the nurse at the
enrolling facility will enter the details of the participant into the card reader.
2.3.5 Telephone Surveys
A telephone survey will be administered to all participants to generate data on outcomes
that cannot be obtained for women who do not make health facility visits.
The second part of the survey will assess health care seeking between the time of enrollment
and the time of the interview and will be used to assess quality of care.
. 2.3.6 Data collection in sub-group of participants
Additional telephone surveys
For a random sub-sample of participants (50%), there will be two additional phone surveys to
gather more data on the primary and secondary outcomes, as well as establish baseline and
end line data needed for cost-effectiveness analyses.
2 weeks after enrollment
The first contact between the research team and a sub-group of the enrolled women will take
place two weeks after enrollment, which is the first follow-up period. A short questionnaire
will be administered to assess cost of health facility visit.
12 months after the Actual Delivery Date
There will be a final exit survey with the same sub-group of participants to follow-up on
health visits and health status of the particpants, and to gather feedback on the experience
with the cash transfer project.
High risk groups
High risk groups in this study include mothers with infections that can be transmitted from
mother to child, or that could cause severe complications in the mother that makes it
impossible to infer any positive benefit of our intervention on their health.
In addition to the methods already outlined for tracking health records of participants,
health visits of study participants who have permanently shifted to health facilities
outside the evaluation zone will also be tracked. This will be done through extra phone
calls to the participants (outside the regular phone surveys) to elicit information on
health facilities the study participants are currently receiving care in, and visits made to
those facilities to obtain records on a quarterly basis.
2.3.7 Economic evaluation
Cost effectiveness analysis
Economics data will be collected that serves two purposes: a) Enable for an adjustment of
service provision when evaluating the impact of the intervention on the outcomes, and b) For
cost-effectiveness analyses.
Data will also be collected on health worker's motivation (22) in both arms of the trial.
3. ETHICAL CONSIDERATIONS
The ethical approval for this study will be obtained from the Maseno University Ethics
Review Committee (MUERC) and UCL Ethics committee, before data collection commences. The
MUERC approved the pilot phase of the trial in which the aims of this main trial were
clearly outlined.
3.1 DATA MANAGEMENT AND ANALYSIS PLAN
3.1.1 Blinding
Due to the nature of the intervention, the participants will not be blinded to their study
allocation. The research team will however generally be blinded to the intervention
allocation status of participants.
The primary outcomes data will be gathered using an electronic system designed by a third
party and the research team will remain completely blind to the intervention allocation
status of participants and their health visit outcomes until the end of the trial.
The system will randomly select participants in the intervention and control groups for
phone interviews. The exception are specific cash transfer questions and usages. Data on the
cash transfer would be separated from the rest of the data, and only merged after the rest
of the data has been analyzed.
Secondary data will be abstracted by a project implementing partner. The abstracted records
will not identify intervention allocation status of the woman. The cards will be mixed so
that they do not follow any sequence, to make it impossible to link the ID to an enrolling
facility. The trial statisticians will conduct interim and final analyses blind to
allocation.
3.1.2 Interim analysis and monitoring by DMC
The investigators do not expect any adverse effects of the intervention but plan to carry
out two interim analyses in 2018 and 2019, which will be reported to an independent Data
Management Committee (DMC) to be convened according to the DAMOCLES charter (27). For these
meetings, the DMC will be provided with a report on the two key safety measures for the
trial, presented separately by trial arm, which are infant and maternal mortality. The DMC
will decide at each meeting whether to request further analyses, which may include analysis
of the study primary outcomes, and will ultimately on each occasion recommend that the study
continues or stops.
3.1.3 Final analysis
Final analyses will be by intention-to-treat and include all mothers who were pregnant
during the recruitment period (January 2017 - September 2017) and their children, regardless
of whether they received the intervention or not. The investigators will test for
differences between intervention and control areas in the primary outcomes using logistic
regression for the binary outcome, and ordinal logistic regression for the ordinal outcomes,
adjusting for clustering using random effect models.
The investigators will also carry out sub-group analyses to examine whether the effect of
the intervention differs by wealth/multi-dimensional poverty quintile to understand the
equity impact of the intervention.
The final analysis will be presented according to the CONSORT requirements for cRCTs (28,
29). Both the interim and final analyses will be conducted by the trial statisticians.
A detailed statistical analysis plan will be prepared before analysis begins.
3.4 Process evaluation
In order to enable replication and scale up of the intervention, a mixed method process
evaluation will be conducted to document the design, implementation and mechanisms of the
intervention. Five main sources of data will be used: (a) project planning and monitoring
documents; (b) forms to capture attendance, problems and strategies identified by the women
and health facility staff; (c) phone surveys data; e) facility costs data and (e) field
notes from intervention team members to be reviewed through monthly debriefings will
document intervention events.
4. CHALLENGES AND LIMITATIONS
4.1 Data and measurements related challenges
- Certain health outcomes will be difficult to assess in the project; such as
prematurity, since the last monthly period (LMP) used to estimate the expected delivery
date (EDD) is recall based and may not be accurate. To mitigate this, telephone surveys
will be used to obtain the actual birth date, and subsequent follow-ups will be based
on actual delivery date.
- There could be infections such as Malaria that occurred before the intervention, but
which have important consequences on the secondary outcomes of the study. It will not
be possible to make a retrospective identification of these type of health conditions
if they have not been captured in health records.
- It will not possible to get detailed data on birth health outcomes for women that
deliver at home, who are more likely to be in the control than intervention groups. The
investigators will therefore utilize the phone surveys as a secondary method of
gathering data on these outcomes.
