Abstract
As Antiretroviral Therapy (ART) is scaled up in low- and middle-income countries, it is important to understand Quality of Life (QOL) correlates including disease severity and person characteristics and to determine the extent of between-country differences among those with HIV. QOL and medical data were collected from 1,563 of the 1,571 participants at entry into a randomized clinical trial of ART conducted in the U.S. (n = 203) and 8 resource-limited countries (n = 1,360) in the Caribbean, South America, Asia, and Africa. Participants were interviewed prior to initiation of ART using a modified version of the ACTG SF-21, a health-related QOL measure including 8 subscales: general health perception, physical functioning, role functioning, social functioning, cognitive functioning, pain, mental health, and energy/fatigue. Other measures included demographics, CD4+ lymphocyte count, plasma HIV-1 RNA viral load. Higher quality of life in each of the 8 QOL subscales was associated with higher CD4+ lymphocyte category. General health perception, physical functioning, role functioning, and energy/fatigue varied by plasma HIV-1 RNA viral load categories. Each QOL subscale included significant variation by country. Only the social functioning subscale varied by sex, with men having greater impairments than women, and only the physical functioning subscale varied by age category. This was the first large-scale international ART trial to conduct a standardized assessment of QOL in diverse international settings, thus demonstrating that implementation of the behavioral assessment was feasible. QOL indicators at study entry varied with disease severity, demographics, and country. The relationship of these measures to treatment outcomes can and should be examined in clinical trials of ART in resource-limited settings using similar methodologies.
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Acknowledgments
The authors thank the PEARLS study participants who volunteered their time and efforts. We thank Bristol Myers Squibb for providing atazanavir and efavirenz (with consent of Merck); Gilead for providing emtricitabine, tenofovir, emtricitabine/tenofovir and financial support; GlaxoSmithKline for providing lamivudine, zidovudine and lamivudine/zidovudine; and Boehringer Ingelheim Pharmaceuticals, Inc. for providing nevirapine. The authors acknowledge the contributions of the following PEARLS investigators: Edith Swann, Ph.D., HIV Research Branch, TRP, DAIDS, NIAD, NIH, Bethesda; Ronald L. Barnett, Ph.D., ACTG Operations Centre, Social and Scientific Systems, Inc. Silver Spring; Barbara Brizz, B.S.N., M.H.S.Ed., ACTG Operations Center, Social and Scientific Systems, Inc. Silver Spring; Yvette Delph, M.D., ACTG Operations Center, Social and Scientific Systems, Inc. Silver Spring; Nikki Gettinger, M.P.H., ACTG Operations Center, Social and Scientific Systems Inc. Silver Spring; Ann Walawander, M.A., Frontier Science and Technology Research Foundation, Amherst, NY; Apsara Nair, M.S., Frontier Science and Technology Research Foundation, Amherst, NY; Ronald T. Mitsuyasu, M.D., UCLA CARE Center, Los Angeles; Susan A. Fiscus, Ph.D., Department of Microbiology and Immunology, University of North Carolina, School of Medicine, Chapel Hill, NC; Adriana Andrade, M.D., M.P.H., Division of Infectious Diseases, John Hopkins University, Baltimore; David W. Haas, M.D., Infectious Diseases, Vanderbilt University, Nashville; Farida Amod, MB CHB, FCPath, FCP, Department of Medicine, Nelson R Mandela School of Medicine, Durban; Vladimir Berthaud, M.D., Infectious Disease, Vanderbilt University Medical Centre, Nashville; Robert C. Bollinger, M.D., Division of Infectious Diseases, John Hopkins University, Baltimore; Yvonne Bryson, M.D., Pediatric Infectious Disease Dept., UCLA School of Medicine, Los Angeles; David Celentano, Sc.D., M.H.S., Department of Epidemiology, Johns Hopkins School of Hygiene and Public Health, Baltimore; David Chilongozi, C.O., M.P.H., UNC HIVNET, UNC Project, Lilongwe, Malawi; Myron Cohen, M.D., University of North Carolina, Chapel Hill; Ann C. Collier, M.D., University of Washington, ACTU, Harborview Medical Centre, Seattle; Judith Silverstein Currier, M.D., M.Sc, University of Carolina, Los Angeles; Susan Cu-Uvin, M.D., The Miriam Hospital, Brown University, Immunology Centre, Providence; Joseph Eron, M.D., Division of Infectious Diseases, Dept. of Medicine, University of N Carolina; Charles Flexner, M.D., Johns Hopkins University Hospital, Baltimore; Joel E. Gallant, M.D., M.P.H., Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore; Roy M. Gulick, M.D., M.P.H., The Cornell Clinical Trials Unit, New York; Scott M. Hammer, M.D., Division of Infectious Diseases, Columbia Presbyterian Medical Centre, NY; Irving Hoffman, P.A., M.P.H., University of North Carolina, Chapel Hill; Peter Kazembe, MBCHB FRCP(C), Baylor College of Medicine-Abbott Fund Children’s Clinical Centre of Excellence, Lilongwe, Malawi; Newton Kumwenda, M.P.H., Ph.D., Johns Hopkins Project, Malawi; Javier R. Lama, M.D., M.P.H., Investigaciones Medicas en Salud (INMENSA), Lima, Peru; Jody Lawrence, M.D., University of California, San Francisco, Adult AIDS Clinical Trials Unit; Chiedza Maponga, Pharm. D., DaTIS, Medical University of Zimbabwe, Zimbabwe; Francis Martinson, M.D., UNC Project, Lilongwe; Kenneth Mayer, M.D., Division of Infectious Diseases, Brown University School of Medicine, Memorial Hospital of Rhode Island, Pawtucket; Karin Nielsen, M.D., UCLA School of Medicine, Los Angeles; Richard B. Pendame M.D., M.P.H., Malawi; Bharat Ramratnam, M.D. Laboratory of Retrovirology, Division of Infectious Diseases, Brown University Medical School, Providence; Ian Sanne, University of Witwatersrand, Johannesburg, South Africa; Patrice Severe, M.D. Internal Medical, Infectious Diseases, Institute de Laboratories et de Recherches, Haiti; Thira Sirisanthana, M.D., Research Institute for Health Sciences, Chiang Mai University, Thailand; Suniti Solomon, M.D., YRG Centre for AIDS Research and Education, India; Steve Tabet, M.D., University of Washington, Harborview Medical Centre, Seattle; Taha Taha, M.D., Johns Hopkins University, School of Hygiene and Public Health, Baltimore; Charles van der Horst, M.D., Department of Medicine, University of N. Carolina, Chapel Hill; Christine Wanke, M.D., Tufts University School of Medicine, Boston; Joan Gormley, B.S.N., The Miriam Hospital, Immunology Centre, Providence; Cheryl J. Marcus, R.N., B.S.N., University of N. Carolina, Chapel Hill; Beverly Putnam, R.N., M.S.N., University of Colorado Health Sciences, Denver; Smanga Ntshele, Community Advisory Board Member, Durban; Edde Loeliger, M.D., Clinical Development and Medical Affairs, Greenford, Middlesex; Keith A. Pappa, Pharm, D., GlaxoSmithKline, Infectious Diseases Medicine, Triangle Park, NC; Nancy Webb, M.S., Frontier Science and Technology Research Foundation, Inc., Amherst; David L. Shugarts, M.A., University of Colorado Health Sciences, Denver; Mark A. Winters, M.S., Stanford University Medical Center, Division of Infectious Disease, Stanford.; Renard S. Descallar, Joseph Steele, and Howard Jaffe, M.D., Gilead Sciences, Foster City, CA.
The project described was supported by Award Number U01AI068636 from the National Institute of Allergy and Infectious Diseases and supported by National Institute of Mental Health (NIMH), National Institute of Dental and Craniofacial Research (NIDCR).
The project was also supported in part by the General Clinical Research Center Units funded by the National Center for Research Resources.
Also supported in part by the AIDS Clinical Trials Group (ACTG), funded by the National Institute of Allergy and Infectious Diseases, National Institutes of Health: grants AI68636, AI68634, AI69450 and the following grants to individual Clinical Trials Units (CTU): YRG CARE Medical Ctr., VHS CRS (Site 11701) CTU Grant # U01A1069432; Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz CRS (Site 12101) CTU Grant # U01AI069476; College of Med. JHU CRS (Site 30301) CTU Grant # 1U01AI069518-01; Durban Adult HIV CRS (Site 11201) CTU Grant # 1U01AI069426-01; UNC Project, Lilongwe (Site 12001) CTU Grant # 5 U01 AI069518-04; UZ-Parienyatwa CRS (Site 30313) CTU Grant # 1U01AI069436-01; Clinical HIV Research Unit University of Witwatersrand (Site 11101) CTU Grant # AI069463; Chiang Mai Univ. ACTG CRS (Site 11501) CTU Grant # 5 U01 AI069399-04; Hospital Conceicao, Porto Alegre (Site 12201) CTU Grant # 5U01AI069401; Les Centres GHESKIO (Site 30022) CTU Grant # U01 AI069421-05; National AIDS Research Institute (Site 11601); NARI Clinic at Gadikhana Dr. Kotnis Municipal Disp (Site 11602); NARI Clinic at NIV CRS (Site 11603) CTU Grant # 5U01AI069417-04; Asociacion Civil Impacta Salud y Educacion—Miraflores, CRS (Site 11301); Investigaciones Medicas en Salud—INMENSA. Lince CRS (Site 11302) CTU Grant # 5U01AI069438; UT Southwestern Medical Center at Dallas (Site 3751) CTU Grant # 3U01AI046376-05S4; University of Cincinnati (Site 2401) CTU Grant # 1U01AI069513-01; UC Davis School of Medicine (Site 3851, 3852) CTU Grant # AI38858-09S1; University of Colorado Hospital (Site 6101) CTU Grant # AI69450; RR025780; The Ohio State University (Site 2301) CTU Grant # AI069474; Northwestern University CRS (Site 2701); Rush University Medical Center (Site 2702) CTU Grant # AI069471; University of Minnesota (Site 1501) CTU Grant # AI27661; Washington University (Site 2101) CTU Grant # U01AI069495; Duke University Medical Center (Site 1601) CTU Grant # 5U01 AI069 484-02; Beth Israel Medical Center (Site 2851) CTU Grant # AI46370; The Miriam Hospital (Site 2951) CTU Grant # AI069472; University of Southern California (Site 1201) CTU Grant # AI069428; UCLA CARE Center (Site 601); Harbor-UCLA (Site 603) CTU Grant # AI069424; Grant # MOI-RR00865; GCRC Grant # RR00424; University of North Carolina (Site 3201, 3206) CTU Grant # AI069423-03; CFAR Grant # AI050410; CTSA Grant # UL 1RR 025747; Vanderbilt Therapeutics (Site 3652) CTU Grant # AI-069439; Hosp. of the Univ. of Pennsylvania (Site 6201) CTU Grant # 001-AI069467-04; CFAR Grant # P30-AI045008-11; Columbia University—HIV Prevention and Treatment CRS (Site 30329) CTU Grant # AI069470; CTSA Grant # UL1RR024156; New York University/NYC HHC at Bellevue Hospital Center (Site 401) CTU Grant # AI-27665 and AI069532; The University of Texas Medical Branch, Galveston (Site 6301) CTU Grant # AI032782; University of Rochester (Site 1101); AIDS Care (Site 1108) CTU Grant # U01AI069511-02; Cook County Hospital Core Center (Site 2705) CTU Grant # AI25915; University of Hawaii at Manoa (Site 5201) CTU Grant # AI34853; Cornell CRS (Site 7804) CTU Grant # AI-69419; Grant # RR024996.
Data analysis was performed by the ACTG Statistical Data Management Center with the support of grant U01AI68634.
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health.
Clinical trials registry: ClinicalTrials.gov NCT00084136.
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This study was conducted for the PEARLS Study Team.
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Safren, S.A., Hendriksen, E.S., Smeaton, L. et al. Quality of Life Among Individuals with HIV Starting Antiretroviral Therapy in Diverse Resource-Limited Areas of the World. AIDS Behav 16, 266–277 (2012). https://doi.org/10.1007/s10461-011-9947-5
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DOI: https://doi.org/10.1007/s10461-011-9947-5