Antenatal Care Clinical Trial
Official title:
Strategies to Increase Antenatal Iron and Folic Acid Supplementation and Malaria Prophylaxis in Rural South-central Côte d'Ivoire: Study Protocol of a Cluster Randomised Controlled Trial
Pregnancy increases the risk of malaria and nutritional deficiency. Despite some progress in ANC access over the past years, coverage of antenatal iron and folic acid supplementation (AIFAS) and intermittent preventive treatment of malaria in pregnancy (IPTp) remains low in many countries. The main objective of this research project is to identify the most effective ways to increase AIFAS and IPTp in low-income settings. We will assess the relative effectiveness of two strategies: the provision of information on the importance of AIFAS and IPTp for pregnant women (Intervention Arm I - demand side intervention), and the direct delivering of supplements and malaria drugs to women's homes (Intervention Arm 2 - supply side intervention). The two strategies will be tested through a small-randomized experiment with 720 pregnant women in the Taabo Health and Demographic Surveillance Site located in South-central Côte d'Ivoire. The primary outcome variable for the pilot study will be post-partum anemia and malaria infections. Secondary outcomes will be AIFAS and IPTp coverage as well as miscarriages, stillbirths and low birth weight deliveries as adverse birth outcomes.
Background Despite major progress in antennal care (ANC) access over the past years, coverage
of essential antenatal interventions remains limited in many low- and middle-income
countries. At the same time, rates of maternal anemia and exposure to malaria in pregnancy
remain high. In Côte d'Ivoire, 59% of pregnant women are estimated to be anemic (Hb< 110g/L),
and only a minority of women receive antenatal iron supplementation consistently throughout
their pregnancy and less than one third of women received intermittent preventive treatment
of malaria in pregnancy (IPTp). Both interventions have been shown to be highly effective for
reducing the risk of stillbirth, prematurity and low birth weight, and have been highlighted
as essential for reducing the burden of malnutrition in the 2013 Lancet series. Low coverage
rates of essential ANC interventions have been attributed to lacking demand from
beneficiaries (e.g. low ANC attendance), weak early health system contact with women, limited
funding, stock outages and ineffective management of supplies.
In general, limited coverage of essential health services as well as limited adherence to
national protocol have been attributed to multiple challenges in the health system. These
challenges include the lack of knowledge on importance of medication, interrupted supply and
stock outs, high cost of care, lack of availability of services, and demand-side barriers
such as distance, education, opportunity cost, and cultural and social barriers. To address
these challenges successfully, a large number of community-based studies assessed a range of
interventions including community-based distribution of drugs, vaccines, or other public
health services. In 2018, a systematic review of strategies identified 28 studies evaluating
the treatment coverage in community-based public health programs. These studies covered a
range of different strategies, including community-based treatment, distributor incentives,
distribution along kinship networks, intensified information, education, and communication
activities, fixed-point delivery, conversion from school- to community-based delivery, and
management by a non-governmental organization. Services delivered included community-based
public child health programs such as vitamin A supplementation, child immunizations, and mass
drug administration campaigns targeting neglected tropical diseases. The largest positive
influence on treatment coverage was found for 4 strategies: community-directed distribution,
incentives to increase distributor motivation, distribution along kinship networks and
implementation of intensified IEC activities. A 2016 Cochrane review evaluated the
effectiveness of community-based health education and household monetary incentives in child
immunization coverage in low and middle-income countries (LMICs). Overall, health education
at village meetings or at home, as well as household monetary incentives had only
moderate-certainty evidence and little or no effect respectively on full immunization
coverage. Vouchers have been widely used also to promote maternal and newborn health in low-
and middle-income countries: a systematic review consolidated evidence from seven published
systematic reviews on the effects of different types of cash transfers and vouchers on the
use and quality of maternity care services. Positive findings were found, indicating that
reproductive health voucher programs increased utilization of reproductive health services,
improved quality of care, and improved population health outcomes. In another Cochrane review
focusing directly on antenatal care, 34 randomized controlled trials testing community-based
interventions to improve uptake of antenatal care (media campaigns, education or financial
incentives for pregnant women), and health systems interventions (home visits for pregnant
women or equipment for clinics) were identified. The review highlighted several potentially
effective interventions, and suggested a combination of interventions for stronger impact.
Overall, evidence on the most effective ways to increase both IPTp and AIFAS remains mixed
overall, with very few studies directly identifying cost-effective ways to increase coverage
of both interventions. The objective of the proposed research is to assess both the cost,
impact and relative cost-effectiveness of two of the most commonly used strategies in a rural
low-income setting compared to the default system. This will help to identify the most
effective ways to increase antenatal iron and folic acid supplementation (AIFAS) and IPT-p
coverage among pregnant women in rural Cote d'Ivoire and similar settings.
Methods Study design The study will be designed as a cluster-randomized experiment with three
arms: a control arm, an information or demand generation arm, and a direct distribution arm.
The investigators expected to recruit approximately 240 pregnant women for each arm, for a
total sample size of 720 women. This study will be carried out in the HDSS of Taabo in
south-central Côte d'Ivoire. The Taabo HDSS has continuously monitored a population of
approximately 45,000 since 2009. The pilot study will target 720 pregnant women across the
132 clusters constituting the HDSS monitoring area. The 132 clusters will be split into three
groups: a control group (44 clusters), an information group (44 clusters), and a distribution
of free supplements group (44 clusters).
Setting The proposed research will be implemented in the Taabo health and demographic
surveillance site (HDSS), located some 160 km north-west of Abidjan, the economic capital of
Côte d'Ivoire. The study area is mainly rural and covers a surface area of about 980 km2, but
already displays clear signs of the epidemiological transition. The Taabo HDSS is situated in
the health district of Tiassalé, which has an estimated population of 200,000 people. The
HDSS area includes an urban setting (Taabo-Cité), 13 villages, and more than 100 small
hamlets. Demographic data (i.e. pregnancy, birth, death, and in- and out-migration) are
collected longitudinally at the individual and household level, usually in three data
collection rounds per year. Deaths are reported by key informants and verbal autopsies are
conducted using standard protocols to determine causes of death.
Main causes of death include malaria, HIV/AIDS, and tuberculosis. The HDSS population
(approximately 45,000 individuals from 8,000 households) is predominantly Ivorian, with Akan
as the main ethnic group. There are ten health facilities in the Taabo HDSS area: a 12-bed
hospital in Taabo-Cité and nine health centers.
Selection of study participants Recruitment Pregnant women in the first trimester of their
pregnancy, living in the HDSS with an age ≥15 and ≤ 49 years will be eligible to participate
in this study. They should be registered as a member in the HDSS of Taabo and willing to
provide one drop of blood for hemoglobin assessment and the rapid diagnostic malaria test.
Key informants will be recruited by the study team in all areas to report pregnancies as
early as possible to the study staff. Key informants will be given a reward of 1,000 CFA (USD
2) for each pregnancy reported. Once the study coordinator will be informed about a new
pregnancy, he will then send out an interviewer to invite pregnant women to participate in
the study. Conditional on women's consent, they will be enrolled in the study and a short
baseline questionnaire will be conducted. Participants may decide not to continue
participating in the study at any time for any reason if they wish to do so without any
particular involvement. The investigator may decide to remove a participant from the study
for reasons of ethical concerns or insufficient participant recruitment.
Participant Information and consent The investigators will use a separate informed consent
form for this study. A general study participation consent form that will primarily cover the
baseline and endline surveys, and consent forms for the two interventions. Mothers in the
information (intervention) arm will be informed about the objective of this intervention.
Mothers in the supplements arm will be informed about the objective of the arm as well as the
package of this intervention. These intervention consent forms will be short and administered
by study staff at the beginning of their first visit.
Pregnant women below 18 years old could be treated differently and depending on the
situation. For non-emancipated mothers under 18, permission to participate in the study will
be sought from a legal representative in the household. For illiterate mothers, the
investigators will use a thumbprint instead of a signature on the consent form.
Intervention As part of this study, the investigators will conduct two interventions: a
supply side intervention ("home delivery of iron and folic acid supplements and
Sulfadoxine-pyrimethamine") and a demand side intervention ("providing information on the
importance of IFAS and IPTp"). In the supply side intervention women will receive a monthly
home visit by study staff. During this visit study staff will inform women about recommended
ANC attendance and supplementation and inquire about supplements received. All women not
having received supplements from their ANC visits will be provided with a monthly dose of
iron and folic acid. Similarly, all women not having received SP will be directly provided SP
together with additional information and instructions on how to take the medication. At the
end of each visit, study staff will remind women about their next ANC appointment and remind
them to take supplements daily. On the other hand, the demand side intervention focuses on
empowering pregnant mothers to adopt appropriate health practices and health behavior. Health
staff (midwives and nurses) will be trained to inform women on the importance of AIFAS as
well as IPTp, and then visit all women in this arm at the beginning of their pregnancy.
During this visit, the nurse will talk with participating women about the benefits,
side-effects, and when, why, and how to take iron and folic acid supplements and SP. The
nurse will also provide pregnant women with a phone number they can call in case they have
questions related to ANC, supplements or IPTp.
Data collection
Data will be collected by a trained researcher team. In addition to the baseline collection,
the investigators will collect detailed monitoring data on home visits as well as cost data
for the two arms. To assess the relative effectiveness of each strategy, the investigators
will conduct an endline survey within the first two weeks after delivery. The form to be used
to conduct the endline survey among women will combine both information on prenatal
supplementation and IPTp-SP (supplements, doses, period, frequency, and date, anemia and
malaria status), socio-demographic characteristics (maternal age, education attainment,
household assets), and pregnancy outcome (live birth, still birth, preterm birth, birth
weight,). Given that the investigators expect women's self-report on AIFAS supplementation
not be very accurate, the investigators will collect hemoglobin level and malaria infection
rates as primary study outcome measures at endline. Hemoglobin levels will be assessed using
HEMOCUE devices; malaria infection will be tested using standard Rapid Diagnostic Tests
(RDTs). All endline surveys will be conducted by study nurses who are familiar with both test
procedures.
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