Cohort profile: the Kilombero and Ulanga Antiretroviral Cohort (KIULARCO): a prospective HIV cohort in rural Tanzania

The Kilombero and Ulanga Antiretroviral Cohort (KIULARCO) is a single-site, open and ongoing prospective cohort of people living with human immunodeficiency virus (PLWHIV) established in 2005 at the Chronic Diseases Clinic of Ifakara (CDCI), within the Saint Francis Referral Hospital (SFRH) in Ifakara, Tanzania. The objectives of KIULARCO are to (i) provide patient and cohort-level information on the outcomes of HIV treatment; (ii) provide cohort-level information on opportunistic infections and comorbidities; (iii) evaluate aspects of human immunodeficiency virus (HIV) care and treatment that have national or international policy relevance; (iv) provide a platform for studies on improving HIV care and treatment in sub-Saharan Africa; and (v) contribute to generating local capacity to deal with the challenges posed by the HIV/AIDS pandemic in this region. Moreover, KIULARCO may serve as a model for other healthcare settings in rural sub-Saharan Africa. Since 2005, all patients diagnosed with HIV at the Saint Francis Referral Hospital are invited to participate in the cohort, including non-pregnant adults, pregnant women, adolescents, children and infants. The information collected includes demographics, baseline and follow-up clinical data, laboratory data, medication history, drug toxicities, diagnoses and outcomes. Real-time data are captured during the patient encounter through an electronic medical record system that allowed transition to a paperless clinic in 2013. In addition, KIULARCO is associated with a biobank of cryopreserved plasma samples and cell pellets collected from all participants before and at different time-points during antiretroviral treatment. Up to the end of 2016, 12 185 PLWHIV have been seen at the CDCI; 9218 (76%) of whom have been enrolled into KIULARCO and 6965 (76%) of these have received ART from the clinic. Patients on ART attend at least every 3 months, with laboratory monitoring every 6 months. KIULARCO data have been used to generate relevant information regarding ART outcomes, opportunistic infections, non-AIDS comorbidities, prevention of mother-to-child transmission of HIV, paediatric HIV, and mortality and retention in care. Requests for collaborations on analyses can be submitted to the KIULARCO scientific committee. KIULARCO provides a framework for improving the quality of care of people living with HIV in sub-Saharan Africa, to generate relevant information to evaluate ART programmes and to build local capacity to deal with HIV/AIDS. The comprehensiveness of the data collected, together with the biobank spanning over ten years has created a unique research platform in rural sub-Saharan Africa

Characteristics of the 135 HIV-exposed infants born from mothers diagnosed before pregnancy or during pregnancy, labour and delivery.

<p>Characteristics of the 135 HIV-exposed infants born from mothers diagnosed before pregnancy or during pregnancy, labour and delivery.</p

Retention through the PMTCT cascade for women newly diagnosed with HIV during the current pregnancy (3A) and women who became pregnant while being under HIV care (3B).

<p>* Women known to be HIV-infected (n = 7) have not been included. ** Women retained in care at the One Stop Clinic and women transferred to another facility were considered to be under active follow-up. PMTCT: prevention of mother-to-child transmission of HIV; ANC: antenatal care clinic; ART: antiretroviral treatment; VCT: voluntary HIV counselling and testing.</p

Current prevention of mother-to-child transmission of HIV care pathway at Saint Francis Referral Hospital.

<p>ART: antiretroviral treatment.</p

Changes in the uptake of the prevention of mother-to-child transmission of HIV recommendations before and after Option B+ implementation.

<p>Changes in the uptake of the prevention of mother-to-child transmission of HIV recommendations before and after Option B+ implementation.</p

The One Stop Clinic of Ifakara integrates health services for HIV-infected pregnant women, children, HIV-exposed infants and their families in a rural Tanzanian hospital.

<p>PITC: Provider Initiated HIV Testing and Counseling.</p

Characteristics of HIV-infected women enrolled in HIV care during pregnancy and women enrolled before pregnancy.

<p>Characteristics of HIV-infected women enrolled in HIV care during pregnancy and women enrolled before pregnancy.</p

ePOCT+ and the medAL-suite: Development of an electronic clinical decision support algorithm and digital platform for pediatric outpatients in low- and middle-income countries.

Electronic clinical decision support algorithms (CDSAs) have been developed to address high childhood mortality and inappropriate antibiotic prescription by helping clinicians adhere to guidelines. Previously identified challenges of CDSAs include their limited scope, usability, and outdated clinical content. To address these challenges we developed ePOCT+, a CDSA for the care of pediatric outpatients in low- and middle-income settings, and the medical algorithm suite (medAL-suite), a software for the creation and execution of CDSAs. Following the principles of digital development, we aim to describe the process and lessons learnt from the development of ePOCT+ and the medAL-suite. In particular, this work outlines the systematic integrative development process in the design and implementation of these tools required to meet the needs of clinicians to improve uptake and quality of care. We considered the feasibility, acceptability and reliability of clinical signs and symptoms, as well as the diagnostic and prognostic performance of predictors. To assure clinical validity, and appropriateness for the country of implementation the algorithm underwent numerous reviews by clinical experts and health authorities from the implementing countries. The digitalization process involved the creation of medAL-creator, a digital platform which allows clinicians without IT programming skills to easily create the algorithms, and medAL-reader the mobile health (mHealth) application used by clinicians during the consultation. Extensive feasibility tests were done with feedback from end-users of multiple countries to improve the clinical algorithm and medAL-reader software. We hope that the development framework used for developing ePOCT+ will help support the development of other CDSAs, and that the open-source medAL-suite will enable others to easily and independently implement them. Further clinical validation studies are underway in Tanzania, Rwanda, Kenya, Senegal, and India