Assessing the Impact of IPTp Uptake Among Pregnant Women Attending Antenatal Clinic and Feasibility of Malaria Surveillance to Community Based Surveillance in Tanzania
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 4,515
- Locations
- 1
- Primary Endpoint
- Change in proportion of recently pregnant women receiving IPTp3
Study Overview
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.
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:
- 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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Masking Description
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
Eligibility Criteria
- Ages
- 15 Years to 45 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pregnant women for GANC and ANC surveillance:
- •Inclusion Criteria
- •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.
Exclusion Criteria
- •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
- •Inclusion Criteria
- •ANC provider who has had at least six months of work experience
- •Health facility in-charge
- •Health management information system (HMIS) focal person
- •Exclusion criteria
- •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:
- •Inclusion Criteria
- •In depth interviews may be conducted with program managers (malaria, reproductive health, and statistics/ data collection officers) at the district, regional and national levels
- •Exclusion criteria
Arms & Interventions
Group ANC Intervention
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.
Intervention: Group antenatal care (GANC) (Other)
Routine ANC
Clinics will offer only standard ANC per ministry of health protocols.
Intervention: Standard antenatal care (Other)
Outcomes
Primary Outcomes
Change in proportion of recently pregnant women receiving IPTp3
Time Frame: Change between 0 and 18 months of implementation
Proportion of recently pregnant women receiving IPTp3 as measured by cross sectional household surveys
Correlation between ANC data and population data
Time Frame: Through study completion, an average of 1 year
Correlation between ANC data and population data collected during cross sectional survey on ITN ownership and care seeking behavior among children
Secondary Outcomes
- 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)
- Change in ANC coverage(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)
- Prevalence of malaria by RDT among among children under 5(throughout study period; average of once per year)
- Difference in provider time required to deliver GANC versus individual ANC(12 months)
Investigators
Julie Gutman
Medical Officer, Strategic and Applied Science Unit, Malaria Branch
Centers for Disease Control and Prevention