HIV With Innovative Group Antenatal Care in Two African Countries

December 16, 2016 updated by: Crystal L. Patil, PhD, University of Illinois at Chicago
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

218

Phase

  • Not Applicable

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

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Physically and mentally competent pregnant women over the age of 16 attending antenatal care

Exclusion Criteria:

  • Less than 16 years of age

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Individual ANC (standard care)
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.
EXPERIMENTAL: Group ANC (intervention)
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.
Behavioral: Group Antenatal Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6-8 weeks postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthy Pregnancy Knowledge Index
Time Frame: Enrollment, 32-40 weeks gestation
14-item true/false questions measured two times in pregnancy and scored as percent correct (range 0-100%)
Enrollment, 32-40 weeks gestation
Healthy Pregnancy Behaviors
Time Frame: Enrollment, 32-40 weeks gestation
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)
Enrollment, 32-40 weeks gestation
Prevention of Mother-to-Child (PMTCT) Knowledge
Time Frame: Enrollment, 32-40 weeks gestation
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)
Enrollment, 32-40 weeks gestation
Comprehensive HIV Prevention Knowledge
Time Frame: Enrollment, 32-40 weeks gestation
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)
Enrollment, 32-40 weeks gestation
Mental Distress
Time Frame: Enrollment, 32-40 weeks gestation
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)
Enrollment, 32-40 weeks gestation
Pregnancy-Related Empowerment Scale (PRES)
Time Frame: 32-40 weeks gestation
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)
32-40 weeks gestation
Satisfaction with Care
Time Frame: 32-40 weeks gestation
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)
32-40 weeks gestation
Any Adverse Perinatal Event
Time Frame: 6-8 weeks postpartum
Fetal demise, stillbirth, neonatal death, preterm birth, low birth weight, or maternal death. None experienced = 0; one or more = 1 (Dichotomous)
6-8 weeks postpartum

Collaborators and Investigators

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

Sponsor

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.

General Publications

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

September 1, 2013

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

December 11, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (ESTIMATE)

December 21, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 21, 2016

Last Update Submitted That Met QC Criteria

December 16, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NR14413-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Prenatal Care

Clinical Trials on Group Antenatal Care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe