Prenatal CareNCT02999334
HIV With Innovative Group Antenatal Care in Two African Countries
A study testing Group Antenatal Care in people with Prenatal Care, run by University of Illinois Chicago.
Trial summary
The quality of antenatal care (ANC) in much of sub-Saharan Africa is constrained by severe resource and staffing shortages. The investigators adapted and piloted an evidence-based model of group antenatal care as an innovative way to improve ANC service delivery and increase health promotion. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Prenatal Care
- What is being tested?
- Group Antenatal Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Physically and mentally competent pregnant women over the age of 16 attending antenatal care
Who cannot join
- Less than 16 years of age
About this study
The quality of antenatal care (ANC) in much of sub-Saharan Africa is constrained by severe resource and staffing shortages. The investigators adapted and piloted an evidence-based model of group antenatal care as an innovative way to improve ANC service delivery and increase health promotion. This pilot will be conducted in Malawi and Tanzania and will provide data to prepare for a large randomized controlled trial to document the impacts that group antenatal has on perinatal health outcomes. This study will ultimately inform policy and practice aimed at improving quality of antenatal care through respectful and woman-centered care to pregnant women.
Read the detailed description
More than 90% of women in sub-Saharan Africa use antenatal care (ANC) at least once in pregnancy. To leverage high attendance rates, most facilities bundle HIV prevention and prevention of maternal-to-child transmission (PMTCT) with ANC. Unfortunately, the quality of ANC in sub-Saharan Africa is sharply constrained by severe resource and staffing shortages, as reflected in numerous "missed opportunities" for PMTCT, clinical service delivery, and health education. Moreover, job satisfaction among the overburdened providers is low. To improve ANC quality, the investigators will adapt and pilot an innovative, evidence-based model of group ANC, an approach that restructures provider time, allowing health facilities to offer respectful, woman-centered and high quality ANC given the limitations.
In CenteringPregnancy (CP), the only evidence-based model of group ANC, 12 women meet jointly for two hour antenatal visits, assessing their own weights and blood pressures, meeting briefly with the provider for individual consultations, and engaging in facilitated health discussions. Randomized controlled trial (RCT) data from ethnically and socioeconomically diverse populations in the US demonstrated that CP is highly effective at improving ANC adherence, provider and client satisfaction, and maternal and child outcomes. In the US, the successful integration of HIV prevention into the CP model reduced sexually transmitted infections and increased condom use.
CP has not been implemented with fidelity and tested for efficacy in a low-resource country. With funding from the Chicago Developmental Center for AIDS Research, the investigators conducted preliminary work in Malawi and Tanzania which suggested that a CP-based model of group ANC was feasible and acceptable; both women and providers were excited and energized by the model. The purpose of this study is to build on this work and: 1) conduct the developmental work to collaboratively adapt CP materials for use in both countries (sessions, training guides, and implementation and evaluation strategies); 2) train providers and pretest activities; and 3) conduct a full-scale randomized pilot. Investigators will work directly with the Centering Healthcare Institute to implement this CP-based model of group ANC with fidelity. This study will result in a feasible, acceptable, and sustainable CP-based model of group ANC adapted for the constraints posed by poorly resourced health systems and those of the clients they serve. These pilot data will be used to generate retention rates and effect sizes for an RCT to test the efficacy of a CP-based group ANC model.
Group antenatal care is an innovative paradigm shift in ANC, and this rigorous evaluation of its impact will expand the limited scientific assessments of reconfigured ANC models and mother and infant health outcomes in low-resource countries in sub-Saharan Africa. Because this model was developed and tested in target countries with high HIV prevalence and poor maternal and neonatal outcomes, it has the potential for broad impacts on maternal and child health, including PMTCT, in other low resource settings.
- Conditions
- Prenatal Care
- Being tested
- Group Antenatal Care
- Keywords
- Group healthcare models, Antenatal care, Prenatal care, Perinatal health, CenteringPregnancy, sub-Saharan Africa, Malawi, Tanzania, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Antenatal CareBehavioural
To examine the effect of type of care on completion of the recommended antenatal and postnatal visits as well as perinatal health outcomes, including knowledge, behaviors, psychosocial well-being, pregnancy-related empowerment, satisfaction with ANC care.
| Study group | Role | What they receive |
|---|---|---|
| Individual ANC (standard care) | No intervention | Individual ANC is the standard of care. Women arrive at the clinic and and are provided ANC services on a first come, first serve basis. While waiting women who are present listen to a health lecture. Women then complete laboratory tests, including HIV testing (at the first visit), then meet individually with a midwife for a brief one-on-one physical assessment. Four ANC visits are recommended. |
| Group ANC (intervention) | Experimental | Women in CP-based group antenatal care (intervention) arrive at clinic at the scheduled appointment time and go directly to the group space. The same group of 12 women and the midwife and co-facilitator are present at each session. Women measure and record their own vital signs and weight. Each then has a brief one-on-one assessment with the midwife in the group space room. Instead of health lectures, the group engages in facilitated and interactive discussions using activities. Four ANC visits are recommended. Receives: Behavioral: Group Antenatal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Care
Two Indicators: Attended 4 (or more) antenatal care visits (yes, no) and the 6-week postnatal visit (yes, no)
Measured: 6-8 weeks postpartum
Secondary outcomes (8)
Healthy Pregnancy Knowledge Index
14-item true/false questions measured two times in pregnancy and scored as percent correct (range 0-100%)
Measured: Enrollment, 32-40 weeks gestation
Healthy Pregnancy Behaviors
Substance use behaviors in the last two months for: tobacco products, alcohol, and marijuana. Two nutritional behaviors were asked about. One was whether or not she ate fruits or vegetables at least 3 times a day for 5 or more days in the past week. The second focused on eating protein at least once a day for 5 or more days in the past week. Measured two times in pregnancy. Three or less of these five behaviors scored as 0 and four or more healthy behaviors were categorized as a 1 (Dichotomous)
Measured: Enrollment, 32-40 weeks gestation
Prevention of Mother-to-Child (PMTCT) Knowledge
4-item PMTCT knowledge index measured two times in pregnancy and scored as 1 if all four were correct and 0 if one or more item was incorrect (Dichotomous)
Measured: Enrollment, 32-40 weeks gestation
Comprehensive HIV Prevention Knowledge
5-item comprehensive HIV knowledge index measured twice in pregnancy. Scored as 1 if all five items were correctly and 0 if one or more item was incorrect (Dichotomous)
Measured: Enrollment, 32-40 weeks gestation
Mental Distress
20-item yes/no Self Reporting Questionnaire (SRQ-20) to assess mental distress was measured two times in pregnancy. Validated in multiple countries including Malawi and Tanzania (Range 0-20, baseline α = 0.789; late pregnancy α = 0.848). We dichotomized scores to low (<8 symptoms) and high (≥8), a level used in clinics for referral. (Dichotomous)
Measured: Enrollment, 32-40 weeks gestation
Pregnancy-Related Empowerment Scale (PRES)
The pregnancy-related empowerment scale (PRES) is a 16-item Likert-type scale with items ranging from 1 (strongly disagree) to 4 (strongly agree) that is intended to assess a woman's sense of control over their pregnancy health and health care. Measured once in late pregnancy (Range 16-64, Continuous)
Measured: 32-40 weeks gestation
Satisfaction with Care
10-item satisfaction with antenatal care index; Measured once in late pregnancy with 5 response options between 1 (poor) and to 5 (excellent) (Range 13-50, Continuous)
Measured: 32-40 weeks gestation
Any Adverse Perinatal Event
Fetal demise, stillbirth, neonatal death, preterm birth, low birth weight, or maternal death. None experienced = 0; one or more = 1 (Dichotomous)
Measured: 6-8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startSep 2013
- Primary completionMay 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prenatal CareStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crystal L. Patil, PhD, University of Illinois Chicago
- Investigators
- Crystal L Patil, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999334
- Sponsor's protocol ID
- NR14413-01
- Status last verified
- Dec 2016
- First submitted
- 11 Dec 2016
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Patil CL, Abrams ET, Klima C, Kaponda CP, Leshabari SC, Vonderheid SC, Kamanga M, Norr KF. CenteringPregnancy-Africa: a pilot of group antenatal care to address Millennium Development Goals. Midwifery. 2013 Oct;29(10):1190-8. doi: 10.1016/j.midw.2013.05.008. Epub 2013 Jul 19.
PubMed 23871278Liese 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.
PubMed 33098114Patil CL, Klima CS, Steffen AD, Leshabari SC, Pauls H, Norr KF. Implementation challenges and outcomes of a randomized controlled pilot study of a group prenatal care model in Malawi and Tanzania. Int J Gynaecol Obstet. 2017 Dec;139(3):290-296. doi: 10.1002/ijgo.12324. Epub 2017 Oct 10.
PubMed 28905377
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV With Innovative Group Antenatal Care in Two African Countries
- ClinicalTrials.gov ID
- NCT02999334
- Acronym / sponsor ID
- NR14413-01
- Conditions
- Prenatal Care
- Keywords
- Group healthcare models, Antenatal care, Prenatal care, Perinatal health, CenteringPregnancy, sub-Saharan Africa, Malawi, Tanzania
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The quality of antenatal care (ANC) in much of sub-Saharan Africa is constrained by severe resource and staffing shortages. The investigators adapted and piloted an evidence-based model of group antenatal care as an innovative way to improve ANC service delivery and increase health promotion. This pilot will be conducted in Malawi and Tanzania and will provide data to prepare for a large randomized controlled trial to document the impacts that group antenatal has on perinatal health outcomes. This study will ultimately inform policy and practice aimed at improving quality of antenatal care through respectful and woman-centered care to pregnant women.
Detailed description
More than 90% of women in sub-Saharan Africa use antenatal care (ANC) at least once in pregnancy. To leverage high attendance rates, most facilities bundle HIV prevention and prevention of maternal-to-child transmission (PMTCT) with ANC. Unfortunately, the quality of ANC in sub-Saharan Africa is sharply constrained by severe resource and staffing shortages, as reflected in numerous "missed opportunities" for PMTCT, clinical service delivery, and health education. Moreover, job satisfaction among the overburdened providers is low. To improve ANC quality, the investigators will adapt and pilot an innovative, evidence-based model of group ANC, an approach that restructures provider time, allowing health facilities to offer respectful, woman-centered and high quality ANC given the limitations.
In CenteringPregnancy (CP), the only evidence-based model of group ANC, 12 women meet jointly for two hour antenatal visits, assessing their own weights and blood pressures, meeting briefly with the provider for individual consultations, and engaging in facilitated health discussions. Randomized controlled trial (RCT) data from ethnically and socioeconomically diverse populations in the US demonstrated that CP is highly effective at improving ANC adherence, provider and client satisfaction, and maternal and child outcomes. In the US, the successful integration of HIV prevention into the CP model reduced sexually transmitted infections and increased condom use.
CP has not been implemented with fidelity and tested for efficacy in a low-resource country. With funding from the Chicago Developmental Center for AIDS Research, the investigators conducted preliminary work in Malawi and Tanzania which suggested that a CP-based model of group ANC was feasible and acceptable; both women and providers were excited and energized by the model. The purpose of this study is to build on this work and: 1) conduct the developmental work to collaboratively adapt CP materials for use in both countries (sessions, training guides, and implementation and evaluation strategies); 2) train providers and pretest activities; and 3) conduct a full-scale randomized pilot. Investigators will work directly with the Centering Healthcare Institute to implement this CP-based model of group ANC with fidelity. This study will result in a feasible, acceptable, and sustainable CP-based model of group ANC adapted for the constraints posed by poorly resourced health systems and those of the clients they serve. These pilot data will be used to generate retention rates and effect sizes for an RCT to test the efficacy of a CP-based group ANC model.
Group antenatal care is an innovative paradigm shift in ANC, and this rigorous evaluation of its impact will expand the limited scientific assessments of reconfigured ANC models and mother and infant health outcomes in low-resource countries in sub-Saharan Africa. Because this model was developed and tested in target countries with high HIV prevalence and poor maternal and neonatal outcomes, it has the potential for broad impacts on maternal and child health, including PMTCT, in other low resource settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual ANC (standard care) | No intervention | –Individual ANC is the standard of care. Women arrive at the clinic and and are provided ANC services on a first come, first serve basis. While waiting women who are present listen to a health lecture. Women then complete laboratory tests, including HIV testing (at the first visit), then meet individually with a midwife for a brief one-on-one physical assessment. Four ANC visits are recommended. |
| Group ANC (intervention) | Experimental | Behavioral: Group Antenatal CareWomen in CP-based group antenatal care (intervention) arrive at clinic at the scheduled appointment time and go directly to the group space. The same group of 12 women and the midwife and co-facilitator are present at each session. Women measure and record their own vital signs and weight. Each then has a brief one-on-one assessment with the midwife in the group space room. Instead of health lectures, the group engages in facilitated and interactive discussions using activities. Four ANC visits are recommended. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Physically and mentally competent pregnant women over the age of 16 attending antenatal care
Key exclusion criteria (1 listed)
- Less than 16 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Antenatal CareTo examine the effect of type of care on completion of the recommended antenatal and postnatal visits as well as perinatal health outcomes, including knowledge, behaviors, psychosocial well-being, pregnancy-related empowerment, satisfaction with ANC care. | Behavioural | Group ANC (intervention) |
Primary outcome
Adherence to Care
Time frame: 6-8 weeks postpartum
Two Indicators: Attended 4 (or more) antenatal care visits (yes, no) and the 6-week postnatal visit (yes, no)
8 secondary outcomes
Healthy Pregnancy Knowledge Index
Time frame: Enrollment, 32-40 weeks gestation
Healthy Pregnancy Behaviors
Time frame: Enrollment, 32-40 weeks gestation
Prevention of Mother-to-Child (PMTCT) Knowledge
Time frame: Enrollment, 32-40 weeks gestation
Comprehensive HIV Prevention Knowledge
Time frame: Enrollment, 32-40 weeks gestation
Mental Distress
Time frame: Enrollment, 32-40 weeks gestation
Pregnancy-Related Empowerment Scale (PRES)
Time frame: 32-40 weeks gestation
Satisfaction with Care
Time frame: 32-40 weeks gestation
Any Adverse Perinatal Event
Time frame: 6-8 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
- Results publication: PubMed 23871278Patil CL, Abrams ET, Klima C, Kaponda CP, Leshabari SC, Vonderheid SC, Kamanga M, Norr KF. CenteringPregnancy-Africa: a pilot of group antenatal care to address Millennium Development Goals. Midwifery. 2013 Oct;29(10):1190-8. doi: 10.1016/j.midw.2013.05.008. Epub 2013 Jul 19.
- Derived from this study: PubMed 33098114Liese 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.
- Derived from this study: PubMed 28905377Patil CL, Klima CS, Steffen AD, Leshabari SC, Pauls H, Norr KF. Implementation challenges and outcomes of a randomized controlled pilot study of a group prenatal care model in Malawi and Tanzania. Int J Gynaecol Obstet. 2017 Dec;139(3):290-296. doi: 10.1002/ijgo.12324. Epub 2017 Oct 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crystal L Patil, PhD principal investigator
University of Illinois Chicago
Questions about this trial
What is this clinical trial studying?
A study testing Group Antenatal Care in people with Prenatal Care, run by University of Illinois Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Care (time frame: 6-8 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02999334, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2016.