Ethics approval and consent to participate
The ethics committees approving the parent study ADReSS were the Biomedical Research Ethics Committee of the University of KwaZulu-Natal, Durban, South Africa, the Partners Institutional Review Board, Boston, Massachusetts, USA and the Emory University Institutional Review Board, Atlanta, Georgia, USA. The reference number is BE 180/13. All participants in the parent study ADReSS provided written informed consent. The intervention and clinic monitoring were determined to be quality improvement projects, and therefore, informed consent was waived.
Consent for publication
Not applicable
Availability of data and materials
Not applicable
Competing interests
No competing interests were declared among the authors of this paper. D.R.K. has received consulting honoraria and/or research support from AbbVie, Gilead, GlaxoSmithKline, Janssen, Merck and ViiV. V.C.M. has received consulting honoraria and/or research support from Lilly, ViiV, Gilead and Bayer.
Funding
The parent study was supported by the Emory University Centre for AIDS Research (CFAR) for salary support (V.C.M., P30AI050409) and NIH/NIAID for salary support and funding the parent study ADReSS (V.C.M. and D.R.K R01 AI098558).
Author contributions
BJ was the principal investigator in the study and contributed to study implementation, data collection, data analysis and writing up all versions of the manuscript.
ZY has contributed to data analysis and interpretation
EJ 1) was the initial point person for the cleaning of collected data in preparation for analyses. 2) was the initial point person for exploratory analyses of the data. 3) contributed to the structure, format, and design of the figures presented in the final manuscript. 4) Additionally, I was a contributor to the interpretation of final analyses appearing in the manuscript. 5) co-wrote and edited all versions of this manuscript and the supplemental section.
JBA helped with the data analysis, data interpretation, writing, tables and figures.
MP Collaborator on study and involved in drafting, reviewing and editing manuscript.
PK Made physical site visits for quality improvement processes and Contributed in data compilation, data analysis and data interpretation.
PS contributed toward study design, implementation, data collection and manuscript review.
CKG Intellectual contribution to discussions during early study design/implementation and subsequent
analysis and interpretation of data
SH Design of the study protocol and tools Regular input into the quality and manner of its implementation
Critical Review of the script.
KAR contributed to study design, data interpretation, acquiring funding for the project and editorial review of the manuscript.
MMYS study design, data interpretation, writing and reviewing manuscript
MVC Grant support, study design and implementation, data analysis and interpretation, figures/tables, manuscript drafting and review.
All authors have read and approved the manuscript.
Acknowledgements
We would like to express our deepest admiration and appreciation for the patients who participated in the parent study and the work of the Bethesda District Hospital Clinic, Jozini Clinic, and Mkuze Clinic in the uMkhanyakude Health District, KZN, South Africa for their commitment to improve patient care and support research. The tremendous contributions on the part of the medical records staff, nurses, and medical officers have been essential to the success of this study. Maneesha Chitnavis, Dr. Kelly Gates, Dr Cyril Nkabinde, Dr Nompumelelo Gloria Nkabinde, Dr Jacinth Mudaly, Ansuri Singh, Sajiv Pertab, Buhle Zuma, Nomzamo Mbatha, Nomathemba B Zungu, Sithembile Mafuleka and Sifiso Shange provided vital assistance for the intervention and data collection.
Ethical standards
The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008.