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

November 27, 2023 updated by: Crystal L. Patil, PhD, University of Illinois at Chicago

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. 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1776

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 WHO recommendations, individual antenatal care consists of 8 antenatal care visits and 2 postnatal visits at 1 week and 6 weeks.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Partner HIV Test
Time Frame: Enrollment, 36-42 weeks gestation
Proportion of partners tested during this pregnancy
Enrollment, 36-42 weeks gestation
Preterm birth
Time Frame: 8 weeks postpartum
Newborn born early
8 weeks postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spontaneous abortion
Time Frame: 36-42 weeks gestation
Pregnancy loss less than 20 weeks
36-42 weeks gestation
Stillbirth
Time Frame: 8 weeks postpartum
Baby born with no signs of life at or after 28 weeks gestational age
8 weeks postpartum
Low birthweight
Time Frame: 8 weeks postpartum
Newborn weighing less than 2.5 kg or 2500 grams, measured within 24 hours of birth
8 weeks postpartum
Neonatal death
Time Frame: 8 weeks postpartum
Newborn dies between 0-28 days after birth
8 weeks postpartum
Maternal death
Time Frame: 8 weeks postpartum, 6 months postpartum
Woman dies in pregnancy or within 42 days of the end of pregnancy
8 weeks postpartum, 6 months postpartum
Woman HIV test
Time Frame: Enrollment, 36-42 weeks gestation
Initial HIV test, if seronegative then repeated in 3rd trimester of pregnancy
Enrollment, 36-42 weeks gestation
Anemia
Time Frame: Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Hemoglobin
Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Family planning
Time Frame: 8 weeks postpartum; 6 months postpartum
Using a family planning method (yes/no)
8 weeks postpartum; 6 months postpartum
Exclusive breastfeeding
Time Frame: 8 weeks postpartum; 6 months postpartum
Duration in days
8 weeks postpartum; 6 months postpartum
Early repeat pregnancy
Time Frame: 8 weeks postpartum; 6 months postpartum
Negative pregnancy test and no reported pregnancy loss
8 weeks postpartum; 6 months postpartum
ART medication (woman)
Time Frame: Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Received medication from intake through six months postpartum
Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
HIV test infant
Time Frame: Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Infant tested for HIV and results received
Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Self Reporting Questionnaire (SRQ)
Time Frame: Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
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 α = 0.85 for refugee women. It consists of 20 Yes/No Items, with a total score range from 0-20; α = 0.789. Higher scores indicate more distress.
Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Satisfaction with care
Time Frame: 36-42 weeks gestation
10-item satisfaction with antenatal care index; 5 point Likert scale [1 (poor) and to 5 (excellent)], range 10-50, α =0.980
36-42 weeks gestation
Healthcare utilization
Time Frame: 36-42 weeks gestation; 8 weeks postpartum
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
Adequate HIV knowledge
Time Frame: Enrollment, 36-42 weeks gestation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Crystal L Patil, PhD, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2019

Primary Completion (Estimated)

January 15, 2024

Study Completion (Estimated)

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)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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