HIV With Innovative Group Antenatal Care in Two African Countries

Prenatal Care Clinical Trial

Official title:

HIV With Innovative Group Antenatal Care in Two African Countries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02999334
• Other study ID #: NR14413-01
• Status: Completed
• Phase: N/A
• First received: December 11, 2016
• Last updated: December 16, 2016
• Start date: September 2013
• Est. completion date: August 2016

Study information

• Verified date: December 2016
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: National Health Sciences Research CommitteeTanzania: National Institute for Medical Research
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: August 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Prenatal Care

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

References & Publications (1)

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.2013.05.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to Care	Two Indicators: Attended 4 (or more) antenatal care visits (yes, no) and the 6-week postnatal visit (yes, no)	6-8 weeks postpartum	No
Secondary	Healthy Pregnancy Knowledge Index	14-item true/false questions measured two times in pregnancy and scored as percent correct (range 0-100%)	Enrollment, 32-40 weeks gestation	No
Secondary	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)	Enrollment, 32-40 weeks gestation	No
Secondary	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)	Enrollment, 32-40 weeks gestation	No
Secondary	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)	Enrollment, 32-40 weeks gestation	No
Secondary	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 a = 0.789; late pregnancy a = 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	No
Secondary	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)	32-40 weeks gestation	No
Secondary	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)	32-40 weeks gestation	No
Secondary	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)	6-8 weeks postpartum	No