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MalariaGANC-TZNCT04148690

Assessing the Impact of Group Antenatal Care on IPTp Uptake in Tanzania

A study testing Group antenatal care (GANC) and Standard antenatal care in people with Malaria and Malaria in Pregnancy, run by Centers for Disease Control and Prevention at 1 site in Tanzania.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 15 to 45 years, women only
Conditions the study is for
Malaria, Malaria in Pregnancy
What is being tested?
Group antenatal care (GANC) and Standard antenatal care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,515 participants
Where
1 siteTanzania
Study dates
15 Nov 2019to 10 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 45 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Pregnant women residing in the facility catchment area, who present for initial ANC visit prior to 24 weeks are eligible to participate in GANC provided that they intend to remain in the area for the duration of the pregnancy, and agree to participate in GANC. All women attending first ANC at participating facilities will be asked to respond to a short list of questions regarding the coverage of malaria control interventions in their household.
  • ANC provider who has had at least six months of work experience
  • Health facility in-charge
  • Health management information system (HMIS) focal person
  • In depth interviews may be conducted with program managers (malaria, reproductive health, and statistics/ data collection officers) at the district, regional and national levels

Who cannot join

  • Pregnant women: Women will be excluded from participation in GANC if they initiate ANC care >24 weeks gestation, if there are no available groups that they can join, if they do not intend to remain in the facility catchment area for the duration of the study, or if they are not available during the times the group intends to meet. Women will also be excluded if they do not speak Swahili, as group discussions will be conducted in Swahili.
  • Recently pregnant women (for cross sectional household surveys) Inclusion Criteria • To be included in the women's question portion of the baseline and end line household (HH) surveys, women must be between the ages of 15-49 years, have been pregnant/delivered in the previous 12 months, consent to participation, and will be eligible for inclusion in surveys regardless of where the woman gave birth (i.e., whether at home or in facility). All pregnant/recently pregnant women will be included in the cross sectional survey, but the sample size is calculated in order to identify those who have completed pregnancies in the past 12 months. There will be a short subset of demographic and knowledge questions which will be asked of all households (either female or male respondents) during the baseline and end line surveys, regardless of whether there are any recently pregnant women in the household.
  • Exclusion criteria • Women who gave birth in the past 12 months, but are <15 or >49 years will be excluded. Those who last delivered a child over twelve months ago will be excluded from survey questions specific to recently pregnant women, but may answer questions related to community perception or general demographics. For qualitative research, the same criteria will be used.
  • Children (for blood sampling during the cross sectional household surveys) Inclusion Criteria
  • Children between the ages of 6-59 months will be included provided that they are living in households interviewed during the baseline or end line cross sectional survey and a parent or legal guardian provides consent for their participation
  • Exclusion criteria • Children will be excluded if they are <6 months or >59 months, or if their parent/guardian is not present or does not provide consent
Show all 10Show fewer
  • Providers:
  • Those who have been working in the health facility for less than six months will not be interviewed due to low levels of relevant experience or exposure to the intervention.
  • Policy makers:
  • None

Trial locations and contacts

1 site in 1 country.

Tanzania1 site
  • Chato District Hospital

    Chato

Other trials in Tanzania

About this study

Official title: Assessing the Impact of IPTp Uptake Among Pregnant Women Attending Antenatal Clinic and Feasibility of Malaria Surveillance to Community Based Surveillance in Tanzania

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.

Read the detailed 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.

Being tested
Group antenatal care (GANC), Standard antenatal care
Keywords
Group antenatal care, Surveillance, Tanzania, Malaria in Pregnancy
Medical subject headings
Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group antenatal care (GANC)Other

    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.

  • Standard antenatal careOther

    Routine antenatal care as recommended by th Ministry of Health of Tanzania

Study groups in NCT04148690
Study groupRoleWhat they receive
Group ANC InterventionExperimentalClinics in the group ANC intervention arm offer group Antenatal Care to women who present for their initial visit prior to 24 weeks provided that they intend to remain in the area for the duration of the pregnancy, and agree to participate in GANC. Women not enrolled in group ANC will receive standard ANC per ministry of health protocols.
Receives: Other: Group antenatal care (GANC)
Routine ANCActive comparatorClinics will offer only standard ANC per ministry of health protocols.
Receives: Other: Standard antenatal care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in proportion of recently pregnant women receiving IPTp3

    Proportion of recently pregnant women receiving IPTp3 as measured by cross sectional household surveys

    Measured: Change between 0 and 18 months of implementation

  2. Correlation between ANC data and population data

    Correlation between ANC data and population data collected during cross sectional survey on ITN ownership and care seeking behavior among children

    Measured: Through study completion, an average of 1 year

Secondary outcomes (7)
  1. Change in ANC coverage

    Proportion of recently pregnant women completing the four, six, and eight ANC visits as measured by cross sectional household survey

    Measured: Change between 0 and 18 months of implementation

  2. Change in Gestational age at initiation of ANC

    Mean gestational age at initiation of ANC measured by cross sectional household survey

    Measured: Change between 0 and 18 months of implementation

  3. Change in Proportion of women who recently gave birth who received blood pressure, urine test, blood test, tetanus, IFA, albendazole, ITN, and IPTp

    Change in Proportion of women who recently gave birth who received blood pressure, urine test, blood test, tetanus, IFA, albendazole, ITN, and IPTp as measured by cross sectional household surveys

    Measured: Change between 0 and 18 months of implementation

  4. Change in Proportion of women who recently gave birth who had a facility-based delivery as measured by cross sectional household surveys

    Measured: Change between 0 and 18 months of implementation

  5. Prevalence of malaria by RDT among pregnant women attending 1st ANC

    Measured: throughout study period; average of once per month

  6. Prevalence of malaria by RDT among among children under 5

    Measured: throughout study period; average of once per year

  7. Difference in provider time required to deliver GANC versus individual ANC

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2019
  2. Study start15 Nov 2019
  3. Primary completion10 Jul 2021
  4. Study completion10 Jul 2021

Why it stopped: Group intervention suspended due to COVID-19 risk

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4,515 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04148690
Sponsor's protocol ID
7226 GANC-TZ
Acronym
GANC-TZ
Status last verified
Jul 2021
First submitted
25 Oct 2019
Last updated
29 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data may only be made available upon specific request after appropriate approvals for data sharing have been granted by Tanzanian authorities

Questions about this trial

What is this clinical trial studying?

A study testing Group antenatal care (GANC) and Standard antenatal care in people with Malaria and Malaria in Pregnancy, run by Centers for Disease Control and Prevention at 1 site in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Group intervention suspended due to COVID-19 risk). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in proportion of recently pregnant women receiving IPTp3 (time frame: Change between 0 and 18 months of implementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.

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