Clinical trial NCT03673709: Group Antenatal Care: Effectiveness and Contextual Factors Linked to Implementation Success in Malawi
Official title: Group Antenatal Care: Effectiveness for Maternal/Infant and HIV Prevention Outcomes and Contextual Factors Linked to Implementation Success in Malawi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: University of Malawi
name: National Institute of Nursing Research (NINR)
First posted: 2018-09-17
Enrollment: 1887
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this study, we test the effectiveness of an evidence-based model of group antenatal care by comparing it to individual (usual) antenatal care. We simultaneously identify the degree of implementation success and the contextual factors associated with success across 6 antenatal clinics in Blantyre District, Malawi. If results are negative, governments will avoid spending on ineffective care. Positive maternal, neonatal and HIV-related outcomes of group antenatal care will save lives, impact the cost and quality of antenatal care, and influence health policy as governments adopt this innovative model of care nationally.

Detailed description: Sub-Saharan Africa has the world's highest rates of maternal and perinatal mortality and accounts for 2/3 of new HIV infections and 1/4 of preterm births. Antenatal (prenatal) care is the entry point into the health system for many women and offers a unique opportunity to provide life-saving monitoring. However, provider shortages, low quality of care and failure to attend all recommended visits mean that the potential benefits of antenatal care are not realized. There is an urgent need to test novel interventions to reduce health risks for mother and child. Group antenatal care is a transformative model of care that provides a positive pregnancy experience, uses provider time efficiently, and improves perinatal and HIV-related outcomes. Women in group antenatal care have 2-hour visits with the same provider in a group of 8-12 women at a similar stage of pregnancy. Women conduct self-assessments, briefly consult the midwife, and meet for 80-90 minutes of interactive health promotion enlivened by games and role-plays. Women form relationships with midwives and each other. In a US randomized clinical trial (RCT), group care improved prematurity rates, antenatal care attendance, satisfaction with care, breastfeeding practices, safer sex behaviors, and uptake of family planning. Our randomized pilot in Malawi and Tanzania had promising outcomes. More women in group care than in usual care completed ≥4 antenatal visits (94% vs 58%). Their partners were more likely to be tested for HIV during pregnancy (51% vs. 27%). We established that group antenatal care can be offered in a rigorous RCT with high fidelity despite provider shortages. The next step is an adequately powered effectiveness trial. Malawi is an especially appropriate site because it has the world's highest prematurity rate (18%) and high HIV prevalence (10% nationally, 16% at the study site). We use a hybrid design to simultaneously conduct an effectiveness RCT with individual-level randomization and examine implementation processes at 6 clinics in Blantyre District, Malawi. Aim 1 is to evaluate the effectiveness of group antenatal care through 6 months postpartum. We hypothesize that compared to usual care, women in group care and their infants will have less morbidity and mortality and more positive HIV prevention outcomes. We test Aim 1 hypotheses using multi-level hierarchical models using data from repeated surveys and health records. Aim 2 is to identify clinic-level degree of implementation success and contextual factors associated with success for each clinic and across clinics. Analyses use within and across-case matrices. This high-impact study addresses three global health priorities, maternal and infant mortality and HIV prevention, that affect all women of childbearing age in Malawi. The Ministry of Health strongly supports this project; results will help them decide whether to scale-up this innovative model of group care. Negative results will avoid spending on ineffective care. Positive results will provide evidence needed to adopt group antenatal care nationally and in other low-resource countries.

Eligibility criteria: Inclusion Criteria:

* Pregnant, 24 weeks gestation or less, no marked cognitive impairment, speaks and understands Chichewa (the national language)

Exclusion Criteria:

* Not pregnant, more than 24 weeks gestation, marked cognitive impairment, does not speak or understand Chichewa (the national language)

Primary outcomes:
measure: Preterm birth
timeFrame: 8 weeks postpartum
measure: Partner HIV Test
timeFrame: Enrollment, 36-42 weeks gestation
Secondary outcomes:
measure: Spontaneous abortion
timeFrame: 36-42 weeks gestation
measure: Stillbirth
timeFrame: 8 weeks postpartum
measure: Low birthweight
timeFrame: 8 weeks postpartum
measure: Neonatal death
timeFrame: 8 weeks postpartum
measure: Maternal death
timeFrame: 8 weeks postpartum, 6 months postpartum
measure: Woman HIV test
timeFrame: Enrollment, 36-42 weeks gestation
measure: Anemia
timeFrame: Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
measure: Family planning
timeFrame: 8 weeks postpartum; 6 months postpartum
measure: Exclusive breastfeeding
timeFrame: 8 weeks postpartum; 6 months postpartum
measure: Early repeat pregnancy
timeFrame: 8 weeks postpartum; 6 months postpartum
measure: ART medication (woman)
timeFrame: Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
measure: HIV test infant
timeFrame: Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
measure: Self Reporting Questionnaire (SRQ)
timeFrame: Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
measure: Satisfaction with care
timeFrame: 36-42 weeks gestation
measure: Healthcare utilization
timeFrame: 36-42 weeks gestation; 8 weeks postpartum
measure: Adequate HIV knowledge
timeFrame: Enrollment, 36-42 weeks gestation
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Bangwe HC
city: Blantyre
country: Malawi
facility: Chileka HC
city: Blantyre
country: Malawi
facility: Chilomoni HC
city: Blantyre
country: Malawi
facility: Limbe HC
city: Blantyre
country: Malawi
facility: Lirangwe HC
city: Blantyre
country: Malawi
facility: Madziabango HC
Study officials:
affiliation: University of Illinois at Chicago
name: Crystal L Patil, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liese KL, Kapito E, Chirwa E, Liu L, Mei X, Norr KF, Patil CL. Impact of group prenatal care on key prenatal services and educational topics in Malawi and Tanzania. Int J Gynaecol Obstet. 2021 Apr;153(1):154-159. doi: 10.1002/ijgo.13432. Epub 2020 Dec 2.
citation: Chirwa E, Kapito E, Jere DL, Kafulafula U, Chodzaza E, Chorwe-Sungani G, Gresh A, Liu L, Abrams ET, Klima CS, McCreary LL, Norr KF, Patil CL. An effectiveness-implementation hybrid type 1 trial assessing the impact of group versus individual antenatal care on maternal and infant outcomes in Malawi. BMC Public Health. 2020 Feb 10;20(1):205. doi: 10.1186/s12889-020-8276-x.