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

Study Overview
=================
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.

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

Conditions
-----------------
Premature Birth

Intervention / Treatment
-----------------
* Behavioral: Antenatal Care


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Individual Antenatal Care (usual care)<br>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)<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous abortion | Pregnancy loss less than 20 weeks | 36-42 weeks gestation | 
| Stillbirth | Baby born with no signs of life at or after 28 weeks gestational age | 8 weeks postpartum | 
| Low birthweight | Newborn weighing less than 2.5 kg or 2500 grams, measured within 24 hours of birth | 8 weeks postpartum | 
| Neonatal death | Newborn dies between 0-28 days after birth | 8 weeks postpartum | 
| Maternal death | Woman dies in pregnancy or within 42 days of the end of pregnancy | 8 weeks postpartum, 6 months postpartum | 
| Woman HIV test | Initial HIV test, if seronegative then repeated in 3rd trimester of pregnancy | Enrollment, 36-42 weeks gestation | 
| Anemia | Hemoglobin | Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum | 
| Family planning | Using a family planning method (yes/no) | 8 weeks postpartum; 6 months postpartum | 
| Exclusive breastfeeding | Duration in days | 8 weeks postpartum; 6 months postpartum | 
| Early repeat pregnancy | Negative pregnancy test and no reported pregnancy loss | 8 weeks postpartum; 6 months postpartum | 
| ART medication (woman) | Received medication from intake through six months postpartum | Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum | 
| HIV test infant | Infant tested for HIV and results received | Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum | 
| 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 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 | 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 | 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 | 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 |