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

NCT04148690 | Terminated

• 1 other identifier: 7226 GANC-TZ
• Study Type: interventional
• Target: 4,515
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malaria; Malaria in Pregnancy

Keywords

Group antenatal care; Surveillance; Tanzania; Malaria in Pregnancy

Outcome Measures

Primary Outcomes (2)

• Change in proportion of recently pregnant women receiving IPTp3

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

  Change between 0 and 18 months of implementation

• 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

  Through study completion, an average of 1 year

Secondary Outcomes (7)

• Change in ANC coverage

  Change between 0 and 18 months of implementation

• Change in Gestational age at initiation of ANC

  Change between 0 and 18 months of implementation

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

  Change between 0 and 18 months of implementation

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

  Change between 0 and 18 months of implementation

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

  throughout study period; average of once per month

Study Arms (2)

Group ANC Intervention

EXPERIMENTAL

Clinics 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.

Other: Group antenatal care (GANC)

Routine ANC

ACTIVE COMPARATOR

Clinics will offer only standard ANC per ministry of health protocols.

Other: Standard antenatal care

Interventions

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.

Group ANC Intervention

Standard antenatal care OTHER

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

Routine ANC

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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
• Providers:
• ANC provider who has had at least six months of work experience
• Health facility in-charge
• Health management information system (HMIS) focal person
• 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:
• In depth interviews may be conducted with program managers (malaria, reproductive health, and statistics/ data collection officers) at the district, regional and national levels
• None

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Jhpiego: collaborator
• Ministry of Health, Tanzania: collaborator

Study Sites (1)

Chato District Hospital

Chato, Tanzania

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Ruth Lemwayi, MD

  Jhpiego

  PRINCIPAL INVESTIGATOR

• Julie R Gutman, MD MSc

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Mary Drake

  Jhpiego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the outcomes will be assessed through conduct of a cross sectional survey; those conducting the survey will not be informed as to which arm the women were in
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Officer, Strategic and Applied Science Unit, Malaria Branch

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 1, 2019
• Study Start: November 15, 2019
• Primary Completion: July 10, 2021
• Study Completion: July 10, 2021
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)