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

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

In this study, we test the effectiveness of an evidence-based model of group antenatal care by comparing it to individual (usual) antenatal care (Aim 1) across 7 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.

Study Overview

• Status: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Behavioral: Antenatal Care

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 conducted an effectiveness RCT with individual-level randomization. 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. 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.

• Study Type: Interventional
• Enrollment (Actual): 1887
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Blantyre, Malawi
    • Bangwe HC
  • Blantyre, Malawi
    • Chileka HC
  • Blantyre, Malawi
    • Chilomoni HC
  • Blantyre, Malawi
    • Limbe HC
  • Blantyre, Malawi
    • Lirangwe HC
  • Blantyre, Malawi
    • Madziabango HC
  • Blantyre, Malawi
    • Ndirande HC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Antenatal Care (intervention); Women have the same number of visits as those in individual care. Their first antenatal care (intake) and first postnatal visit is done individually (identical to individual care). Women in group care bypass the waiting area and have a 2-hour visit with the same provider in a group of 8-12 women at a similar stage of pregnancy. Women assess their 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.	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.
No Intervention: Individual Antenatal Care (usual care); Women are provided antenatal care services on a first come, first serve basis and listen to a health lecture. They meet individually with a midwife for a physical assessment. Women complete laboratory tests (including HIV testing) at their first visit. Congruent with the new World Health Organization (WHO) recommendations, individual antenatal care consists of 8 antenatal care visits and 2 postnatal visits at 1 week and 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Born Weighing Less Than 2500 g	Whether a newborn weighed <2,500 grams at birth (yes/no) is used as a proxy for preterm birth due to the lack of accurate gestational age data.	8 weeks postpartum
Partner HIV Test	Proportion of partners tested during this pregnancy	36-42 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stillbirth	Baby born with no signs of life at or after 28 weeks gestational age	8 weeks postpartum
Spontaneous Abortion	Pregnancy loss less than 20 weeks	36-42 weeks gestation
Infant Death	Infant death before the end of the study	6 months postpartum
Maternal Death	Maternal death before the end of the study	6 months postpartum
Anemia	Hemoglobin level of <11 g/dl	36-42 weeks gestation
Family Planning	Reported use of family planning at late postpartum, approximately 6 months after delivery	6 months postpartum
Exclusive Breastfeeding	Exclusive breastfeeding for six months (yes)	6 months postpartum
Self Reporting Questionnaire (SRQ)	Self-Reporting Questionnaire has 20 yes/no items that screen for symptoms of anxiety, depression, psychosomatic symptoms, reduced vital energy, and depressive thoughts. Score range is a minimum of 0 and a maximum of 20 for a total score; a higher score indicates higher distress.	8 weeks postpartum
Satisfaction With Antenatal Care (ANC)	A 10-item scale rating satisfaction with the overall quality of the care, the procedures, providers' level of respect and listening skills, with response options of a 5-point Likert scale ("1= Poor; 2= Fair; 3= Good; 4= Very good; 5= Excellent). The range is 10-50, with higher scores indicating greater satisfaction with care.	36-42 weeks gestation
Joint United Nations Programme on HIV/AIDS (UNAIDS) Comprehensive Knowledge, All Correct	Joint United Nations Programme on HIV/AIDS (UNAIDS) comprehensive HIV prevention knowledge measured as whether the person answered all five questions correctly: if a healthy-looking person can have HIV, whether condom use and having only one uninfected partner reduce the likelihood of getting HIV transmission and two of the most common local misconceptions about HIV transmission (casual contact and mosquito bites).	36-42 weeks gestation
Mean Antenatal Care (ANC) Contacts	Mean number of antenatal care (ANC) contacts. Minimum is 1 since all participants were recruited at their first contact, and maximum is unlimited, but 8 was the ecommended number of contacts	8 weeks postpartum
Pregnancy-related Empowerment Scale (PRES)	The 16-item Likert-type scale with 1 (strongly disagree) to 4 (strongly agree) capturing a sense of control over pregnancy health and healthcare across four domains: provider connectedness, skillful decision-making, peer connectedness, and gaining voice; range 16-64 with a higher score indicating feeling more empowerment.	36 to 42 weeks gestation
Wait Time	Waited less than one hour for antenatal care (ANC) services (% yes)	36-42 weeks gestation
Prefer Group Antenatal Care (ANC) in the Future	In late pregnancy, participants were asked if they would prefer individual or group antenatal care (ANC) if pregnant in the future (% preferring group ANC).	36-42 weeks gestation

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute of Nursing Research (NINR); University of Malawi
• Investigators: Principal Investigator: Crystal L Patil, PhD, University of Illinois at Chicago

Publications and helpful links

General Publications

• 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.
• 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.
• Patil CL, Norr KF, Kapito E, Liu LC, Mei X, Chodzaza E, Chorwe-Sungani G, Kafulafula U, Abrams ET, Desloge A, Gresh A, Jeremiah RD, Patel DR, Batchelder A, Wang H, Faydenko J, Rising SS, Chirwa E. Group antenatal care positively transforms the care experience: Results of an effectiveness trial in Malawi. PLoS One. 2025 Jun 18;20(6):e0317171. doi: 10.1371/journal.pone.0317171. eCollection 2025.

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2019
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Maternal Health Services; Prenatal Care
• Other Study ID Numbers: 2018-0845; R01NR018115 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified data will be made available to other researchers for secondary analyses after the primary outcome publications have been accepted for publication, approximately 3 years after the grant ends.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No