The US President's Emergency Plan for AIDS Relief (PEPFAR) goal of an AIDS-free generation, re-emphasized in PEPFAR 3.0, will not be achieved without substantial improvement in the adherence to the HIV care continuum among women in maternal and child health clinics (MCH) in resource-limited settings. In a recent meta-analysis of loss to follow-up (LTFU) across the prevention of mother-to-child transmission of HIV (PMTCT) cascade, about 50% of HIV+ pregnant women are already LTFU by delivery; within 3 months of delivery 33.9% of mother-infant pairs are also LTFU. Consequently, half of pediatric infections are currently estimated to occur in the postpartum period during breastfeeding and fewer than 40% of HEI are tested for HIV at 2-3 months. Determinants of this poor performance occur at multiple levels: healthcare delivery systems, providers, and beneficiaries (HIV- infected mothers). Current evidence suggest that beyond individual-level factors, healthcare delivery system level factors are paramount. Quality Improvement (QI) Collaborative is one of the most popular methods for organizing sustained improvement efforts at hospitals and ambulatory practices worldwide. In the Breakthrough Series approach also refer to as continuous quality improvement (CQI),10 QI teams from multiple sites across a region or country are brought together to focus on a common problem. Over one or two years, experts in clinical and performance improvement provide the group with periodic instructions and encourage the teams to share lessons learned and best practices. However, its popularity, CQI effectiveness has never been demonstrated in a randomized trial or a well-designed comparative study.
The aims of the proposed study are: 1) to evaluate the effectiveness of CQI interventions in improving long-term retention in care and virological suppression in women who start lifelong ART in MCH clinics and 2) to identify modifiable health delivery system factors associated with retention in care and sustained virological suppression in women who start lifelong ART in MCH clinics. The study will be implemented in Kinshasa, Democratic Republic of Congo (DRC): an extremely resource-limited country that has struggled to emerge from decades of gross mismanagement, rampant corruption, and wars that have left its health infrastructures in shambles. We will conduct a cluster-randomized trial with health districts as the randomization unit. MCH clinics in the intervention group, will undergo CQI initiatives using participatory data- driven approaches and on-site monitoring and supervisory support. We will use surveys of health facilities, including selected staff, and service beneficiaries (HIV infected mothers) to collect data on key characteristics of the service delivery's organization and providers' and patients' perspective of the HIV care delivery performance. The main outcomes will be LTFU/retention in care, virological suppression and MTCT rates evaluated at 24 months postpartum.

Public Health Relevance

If the CQI interventions are proven to be effective in improving long-term outcomes of therapy in MCH clinics, it will provide PEPFAR and other critical stakeholders with a scalable strategy to strengthen the quality of HIV continuum of care that can be implemented in combination with sustained efforts to expand coverage. Identification of health system delivery characteristics associated with improved long-term outcomes will help determine where and how the CQI interventions can be effectively scaled up to support PEPFAR goal of an AIDS-free generation.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD087993-04
Application #
9705996
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Chakhtoura, Nahida Abdo
Project Start
2016-06-01
Project End
2019-06-30
Budget Start
2019-06-01
Budget End
2019-06-30
Support Year
4
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Ohio State University
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
832127323
City
Columbus
State
OH
Country
United States
Zip Code
43210
Ross, Jonathan; Edmonds, Andrew; Hoover, Donald R et al. (2018) Association between pregnancy at enrollment into HIV care and loss to care among women in the Democratic Republic of Congo, 2006-2013. PLoS One 13:e0195231
GBD 2016 Disease and Injury Incidence and Prevalence Collaborators (2017) Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet 390:1211-1259
Yotebieng, Kelly A; Fokong, Kunuwo; Yotebieng, Marcel (2017) Depression, retention in care, and uptake of PMTCT service in Kinshasa, the Democratic Republic of Congo: a prospective cohort. AIDS Care 29:285-289
GBD 2016 Mortality Collaborators (2017) Global, regional, and national under-5 mortality, adult mortality, age-specific mortality, and life expectancy, 1970-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet 390:1084-1150
GBD 2016 Causes of Death Collaborators (2017) Global, regional, and national age-sex specific mortality for 264 causes of death, 1980-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet 390:1151-1210
Zivich, Paul N; Kiketa, Landry; Kawende, Bienvenu et al. (2017) Vaccination Coverage and Timelines Among Children 0-6 Months in Kinshasa, the Democratic Republic of Congo: A Prospective Cohort Study. Matern Child Health J 21:1055-1064
Yotebieng, Marcel; Behets, Frieda; Kawende, Bienvenu et al. (2017) Continuous quality improvement interventions to improve long-term outcomes of antiretroviral therapy in women who initiated therapy during pregnancy or breastfeeding in the Democratic Republic of Congo: design of an open-label, parallel, group randomized BMC Health Serv Res 17:306
GBD 2016 SDG Collaborators (2017) Measuring progress and projecting attainment on the basis of past trends of the health-related Sustainable Development Goals in 188 countries: an analysis from the Global Burden of Disease Study 2016. Lancet 390:1423-1459
GBD 2016 DALYs and HALE Collaborators (2017) Global, regional, and national disability-adjusted life-years (DALYs) for 333 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet 390:1260-1344
Yotebieng, Marcel; Moracco, Kathryn E; Thirumurthy, Harsha et al. (2017) Conditional Cash Transfers Improve Retention in PMTCT Services by Mitigating the Negative Effect of Not Having Money to Come to the Clinic. J Acquir Immune Defic Syndr 74:150-157