Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04148690 |
| Other study ID # |
7226 GANC-TZ |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 15, 2019 |
| Est. completion date |
July 10, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
Centers for Disease Control and Prevention |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Group antenatal care (GANC) is a service delivery model where women with pregnancies of
similar gestational age are brought together for antenatal care (ANC), incorporating
information sharing and peer support. This model provides selected aspects of clinical care
to women in the group at the same time during group visits, as well as creating a support
group of women at a similar stage in pregnancy, to improve the quality of care and engagement
of women in the ANC process, ultimately leading to better retention in care. Initial studies
have suggested that this improves uptake of intermittent preventive treatment in pregnancy
(IPTp) among women who participate, but have not evaluated the effect at community level. The
investigators propose to assess whether use of the GANC model in Tanzania can improve the
quality of ANC as compared to standard individual ANC, by measuring uptake of recommended
interventions, primarily IPTp.
Recent data from Tanzania and Kenya suggest that malaria parasitemia prevalence among
pregnant women correlates with the prevalence among children under five, and could be used to
track trends over time.3-5 The very high coverage of ANC (>80% attending at least one ANC
contact), suggests that pregnant women could be a good sentinel population that could be
readily tracked over time. However, pregnant women represent only about 5% of the overall
population, thus, it is important to demonstrate that the trends in malaria prevalence and
household level coverage of interventions reported by pregnant women attending ANC is
representative of coverage among the general population. If validated, these data could be
used to augment or even replace the data on coverage of interventions collected through the
use of malaria indicator surveys, which are expensive and infrequently conducted, and
generally only powered to the regional level.
Description:
Project Background Group antenatal care (GANC) is a service delivery model where women with
pregnancies of similar gestational age are brought together for antenatal care (ANC),
incorporating information sharing and peer support. This model provides selected aspects of
clinical care to women in the group at the same time during group visits, as well as creating
a support group of women at a similar stage in pregnancy, to improve the quality of care and
engagement of women in the ANC process, ultimately leading to better retention in care.
Initial studies have suggested that this improves uptake of intermittent preventive treatment
in pregnancy (IPTp) among women who participate, but have not evaluated the effect at
community level. The investigators propose to assess whether use of the GANC model in
Tanzania can improve the quality of ANC as compared to standard individual ANC, by measuring
uptake of recommended interventions, primarily IPTp. Tanzania have been selected as coverage
of early ANC is high, with 98% of women receiving ANC from a trained provider in Tanzania and
83% in Benin,1 with a median age of initiation of five and four months, respectively.
Coverage of 4 ANC visits, however, is sub-optimal: just 36% in Geita region of Tanzania.
Despite the relatively early initiation of ANC, in Tanzania only 56% and 26% of women
received two and three doses of IPTp.
Recent data from Tanzania and Kenya suggest that malaria parasitemia prevalence among
pregnant women correlates with the prevalence among children under five, and could be used to
track trends over time.3-5 The very high coverage of ANC (>80% attending at least one ANC
contact), suggests that pregnant women could be a good sentinel population that could be
readily tracked over time. However, pregnant women represent only about 5% of the overall
population, thus, it is important to demonstrate that the trends in malaria prevalence and
household level coverage of interventions reported by pregnant women attending ANC is
representative of coverage among the general population. If validated, these data could be
used to augment or even replace the data on coverage of interventions collected through the
use of malaria indicator surveys, which are expensive and infrequently conducted, and
generally only powered to the regional level.
Study Aims
Primary Objectives:
1. GANC: Assess whether GANC is associated with to improved uptake of IPTp; specifically,
to assess whether the proportion of pregnant women receiving 3 or more doses of IPTp is
higher in the catchment areas of facilities implementing the GANC intervention as
compared to the catchment areas of control facilities without GANC.
2. ANC data for surveillance: Pilot data collection from women at 1st ANC and validate
whether the results obtained from this population are representative of the population
as a whole.
Secondary Objectives:
GANC
1. To assess whether implementation of GANC is associated with to a greater proportion of
women completing the recommended number of ANC visits compared to control facilities
without GANC.
2. To assess whether the implementation of GANC leads to earlier initiation of ANC compared
to control facilities without GANC, as women can only participate in GANC if they
present <24 weeks.
3. To assess whether GANC is associated with increased utilization of facility-based
delivery
4. To assess whether GANC is associated with improved quality of care (defined as the
coverage of key ANC interventions- blood pressure, urine test, blood test, tetanus,
iron-folic acid (IFA), albendazole, insecticide treated bednet (ITN), IPTp)
5. To assess the feasibility and acceptability of increasing the coverage of GANC
6. To assess the costs and cost effectiveness of GANC versus individual ANC (standard of
care)
ANC data for Surveillance
7. To understand the acceptability to pregnant women and healthcare workers of being
asked/asking these additional questions during ANC contacts.
8. To quantify the time per woman required to collect data on coverage of malaria control
interventions into ANC
9. To assess the correlation between the prevalence of malaria by rapid diagnostic test
(RDT) among pregnant women attending 1st ANC and among children under 5 measured in
cross sectional household surveys
10. To explore optimal data collection strategies and determine how best to operationalize
them (i.e., should data be collected and recorded by ANC providers or another cadre;
e.g., a community health worker stationed at the clinic).
Methodology Study design: This will be a cluster randomized controlled trial conducted over
an 18-month period. Facilities will be randomized 1:1 to control and intervention arms. In
the control arm, ANC care will be delivered as per standard practice. In the intervention
sites, women presenting for first ANC prior to 24 weeks will be offered the opportunity to
join group care (as long as there is still space in an appropriate group) starting with the
2nd visit; women presenting after 24 weeks or declining to join a group will receive standard
ANC care.
Baseline and end line cross sectional household surveys will be conducted 18 months apart to
measure the proportion of women living in the facility catchment areas who have completed a
pregnancy (ie. given birth) within the past 12 months in each community who received 1, 2, 3,
4, and 5+ doses of IPTp, the timing of initiation of ANC, number of total ANC visits,
facility-based delivery, birth outcomes, as well as validate the representativeness of data
on parasite prevalence, insecticide treated net (ITN) ownership and use, and care seeking.
The sample size in each country will be sufficient to allow for an estimate of the effect of
GANC for each country, as the effectiveness of this model is dependent on the proportion of
women who attend ANC early, which is somewhat higher in Benin than in Tanzania.
Implications The results will be used by the Ministries of Health (MOH) in Tanzania to
decide: whether to expand the use of GANC as a strategy to improve quality of care and
increase utilization of ANC; and whether pregnant women attending first ANC can be used as a
sentinel population to improve surveillance of malaria control interventions.
Expected findings and dissemination The investigators will share the results of this study
with the MoHs and the partners working in malaria and maternal and child health through:
country-based technical working groups in malaria and maternal and newborn health; community
leaders; and women's associations-as well as dissemination events and print materials. The
findings will contribute to the evidence to determine whether GANC is associated with
improved ANC attendance, IPTp uptake, and quality of care (as defined as the delivery of
specific interventions), and whether it should be scaled-up in other suitable malaria endemic
regions. The findings on ANC surveillance will contribute to the evidence about whether this
method of surveillance is effective and should be scaled up. The results will also be
presented in both local and international scientific meetings and published in a
peer-reviewed journal.
