Group Antenatal Care: Effectiveness and Contextual Factors Linked to Implementation Success in Malawi

Premature Birth Clinical Trial

Official title:

Group Antenatal Care: Effectiveness for Maternal/Infant and HIV Prevention Outcomes and Contextual Factors Linked to Implementation Success in Malawi

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03673709
• Other study ID #: 2018-0845
• Secondary ID: R01NR018115
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 5, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1776
• Est. completion date: May 31, 2024
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Premature Birth

Intervention

Behavioral:
• Antenatal Care
Women in group care bypass the waiting room and have a 2-hour visit with the same provider with a group of 8-12 women at a similar stage of pregnancy. Women assess their own blood pressure and weight, briefly consult the midwife in a corner of the room, and meet for 80-90 minutes of interactive health promotion, enlivened by games and role-plays.

Locations

Country	Name	City	State
Malawi	Bangwe HC	Blantyre
Malawi	Chileka HC	Blantyre
Malawi	Chilomoni HC	Blantyre
Malawi	Limbe HC	Blantyre
Malawi	Lirangwe HC	Blantyre
Malawi	Madziabango HC	Blantyre

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute of Nursing Research (NINR), University of Malawi

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm birth	Newborn born early	8 weeks postpartum
Primary	Partner HIV Test	Proportion of partners tested during this pregnancy	Enrollment, 36-42 weeks gestation
Secondary	Spontaneous abortion	Pregnancy loss less than 20 weeks	36-42 weeks gestation
Secondary	Stillbirth	Baby born with no signs of life at or after 28 weeks gestational age	8 weeks postpartum
Secondary	Low birthweight	Newborn weighing less than 2.5 kg or 2500 grams, measured within 24 hours of birth	8 weeks postpartum
Secondary	Neonatal death	Newborn dies between 0-28 days after birth	8 weeks postpartum
Secondary	Maternal death	Woman dies in pregnancy or within 42 days of the end of pregnancy	8 weeks postpartum, 6 months postpartum
Secondary	Woman HIV test	Initial HIV test, if seronegative then repeated in 3rd trimester of pregnancy	Enrollment, 36-42 weeks gestation
Secondary	Anemia	Hemoglobin	Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Secondary	Family planning	Using a family planning method (yes/no)	8 weeks postpartum; 6 months postpartum
Secondary	Exclusive breastfeeding	Duration in days	8 weeks postpartum; 6 months postpartum
Secondary	Early repeat pregnancy	Negative pregnancy test and no reported pregnancy loss	8 weeks postpartum; 6 months postpartum
Secondary	ART medication (woman)	Received medication from intake through six months postpartum	Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Secondary	HIV test infant	Infant tested for HIV and results received	Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Secondary	Self Reporting Questionnaire (SRQ)	The Self Reporting Questionnaire (SRQ) is a brief measure of psychiatric symptomatology designed by the WHO to be used to screen for common mental disorders. It consists of 20 questions with yes/no answers exploring symptoms of depression, anxiety, and somatic complaints such as headache and non-specific gastrointestinal symptoms. SRQ has been translated and validated in several African countries. A recent study conducted in Rwanda reported the a = 0.85 for refugee women. It consists of 20 Yes/No Items, with a total score range from 0-20; a = 0.789. Higher scores indicate more distress.	Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Secondary	Satisfaction with care	10-item satisfaction with antenatal care index; 5 point Likert scale [1 (poor) and to 5 (excellent)], range 10-50, a =0.980	36-42 weeks gestation
Secondary	Healthcare utilization	Pre- and postnatal care attendance; health facility birth (yes/no), services received (21 items); content covered (18 items)	36-42 weeks gestation; 8 weeks postpartum
Secondary	Adequate HIV knowledge	Total HIV Knowledge is the number of questions answered correctly for five HIV-prevention items defined by UNAIDS as essential plus an additional four items from the Malawi Demographic and Health Survey assessing prevention of maternal-to-child transmission. Higher scores indicate more knowledge about how HIV is transmitted.	Enrollment, 36-42 weeks gestation