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Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: The AACTG Adherence Instruments
Abstract
This paper describes the AACTG Adherence Instruments, which are comprised of two self-report questionnaires for use in clinical trials conducted by the Adult AIDS Clinical Trials Group (AACTG). The questionnaires were administered to 75 patients at ten AACTG sites in the USA. All patients were taking combination antiretroviral therapy (ART), including at least one protease inhibitor. Eleven per cent of patients reported missing at least one dose the day before the interview, and 17% reported missing at least one dose during the two days prior. The most common reasons for missing medications included 'simply forgot' (66%) and a number of factors often associated with improved health, including being busy (53%), away from home (57%) and changes in routine (51%). Less adherent patients reported lower adherence self-efficacy (p = 0.006) and were less sure of the link between non-adherence and the development of drug resistance (p = 0.009). They were also more likely to consume alcohol, to be employed outside the home for pay and to have enrolled in clinical trials to gain access to drugs (all p < 0.05). Twenty-two per cent of patients taking drugs requiring special instructions were unaware of these instructions. Each questionnaire took approximately ten minutes to complete. Responses to the questionnaires were favourable. These questionnaires have been included in six AACTG clinical trials to date and have been widely disseminated to investigators both in the USA and abroad.
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“The VIRAHEP-C self-efficacy measure was a 24-item self-report measure adapted from previously validated self-efficacy measures created for the Adult AIDS Clinical Trials Group (see Appendix A for the original VIRAHEP-C measure) (19;39) (personal communication, S. Smith, Nov. 11, 2010).”
From Reliability and validity of a self‐efficacy instrument for hepatitis C antiviral treatment regimens (2012) · cites this paper as [39]
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InfluentialMedication adherence in HIV-infected adults
Hinkin, C. H., Hardy, D. J., Mason, K. I., Castellon, S. A., Durvasula, R., Lam, M. N., & Stefaniak, M. (2004) · AIDS · doi:10.1097/00002030-200418001-00004 · Cited by 583
“Chesney and colleagues [9] examined self-reported factors influencing adherence among participants in HIV clinical trials, and found that 66% of those surveyed endorsed ‘simply forgot’ as a”
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Self-citationArnsten, J. H., Demas, P., Grant, R. W., Gourevitch, M. N., Farzadegan, H., Howard, A. A., & Schoenbaum, E. E. (2002) · Journal of General Internal Medicine · doi:10.1046/j.1525-1497.2002.10644.x · Cited by 501
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Self-citationIs Patient Activation Associated With Outcomes of Care for Adults With Chronic Conditions?
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“We adapted this measure from an item developed by Chesney and colleagues as part of the Outcomes Committee of the Adults AIDS Clinical Trials (AACTG; Chesney et al., 2000; Wagner et al., 2001).”
MethodSethi, A. K., Celentano, D. D., Gange, S. J., Moore, R. D., & Gallant, J. E. (2003) · Clinical Infectious Diseases · doi:10.1086/378301 · Cited by 475
“The ART adherence instrument was modeled after the Adult AIDS Clinical Trials Group questionnaire [7] and supplemented with pictures of specific antiretrovirals [8].”
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“[42] developed a self-report instrument for use with Adult AIDS Clinical Trials.”
MethodBeach, M. C., Keruly, J. C., & Moore, R. D. (2006) · Journal of General Internal Medicine · doi:10.1111/j.1525-1497.2006.00399.x · Cited by 460
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Hinkin, C. H., Castellon, S. A., Durvasula, R., Hardy, D. J., Lam, M. N., Mason, K. I., Thrasher, D., Goetz, M. B., & Stefaniak, M. (2002) · Neurology · doi:10.1212/01.wnl.0000038347.48137.67 · Cited by 455
Ferradini, L., Jeannin, A., Pinoges, L., Izopet, J., Odhiambo, D., Mankhambo, L., Karungi, G., Szumilin, E., Balandine, S., Fedida, G., et al. (2006) · The Lancet · doi:10.1016/s0140-6736(06)68580-2 · Cited by 450
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Langebeek, N., Gisolf, E. H., Reiss, P., Vervoort, S. C. J. M., Hafsteinsdøttir, T. B., Richter, C., Sprangers, M. A. G., & Nieuwkerk, P. T. (2014) · BMC Medicine · doi:10.1186/preaccept-1453408941291432 · Cited by 481
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“In total, 207 studies were included in our analysis, reporting on 103,836 patients [16-222].”
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“Substance abuse can predict nonadherence, 64–67 but good adherence is still achievable if the provider addresses medication, regimen, and side effect concerns.”
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Swindells, S., Ramchandani, R., Gupta, A., Benson, C. A., Leon-Cruz, J., Mwelase, N., Juste, M. A. J., Lama, J. R., Valencia, J., Omoz-Oarhe, A., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1806808 · Cited by 366
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Gonzalez, J. S., Penedo, F. J., Antoni, M. H., Durán, R. E., McPherson-Baker, S., Ironson, G. H., Fernandez, M. I., Klimas, N. G., FLETCHER, M. A., & Schneiderman, N. (2004) · Health Psychology · doi:10.1037/0278-6133.23.4.413 · Cited by 308
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“The original Adult AIDS Clinical Trials Group (AACTG) instrument [92] (designed to measure adherence to HIV medication) contains an item related to accurate timing; hence these papers had to be excluded.”
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“A substantial amount of research has identified correlates of adherence to ART specifically (Bartlett, 2002; Bozette, 1995; Chesney et al., 2000; Eldred, Wu, Chaisson, & Moore, 1998; Erickson, Ascione, Kirking, & Johnson, 1998; Friedland & Williams, 1999; Gifford et al., 2000; Ickovics & Meisler,…”
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Molina, J., Andrade-Villanueva, J. F., Echevarría, J., Chetchotisakd, P., Corral, J. A., David, N., Moyle, G. J., Mancini, M., Percival, L., Yang, R., et al. (2010) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/qai.0b013e3181c990bf · Cited by 253
“Discontinued 9 (16) 13 (16) 16 (33) 15 (23)”
Mellins, C. A., Brackis‐Cott, E., Dolezal, C. L., & Abrams, E. J. (2004) · The Pediatric Infectious Disease Journal · doi:10.1097/01.inf.0000143646.15240.ac · Cited by 246
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Suppression of Human Immunodeficiency Virus Type 1 Viral Load With Selenium Supplementation
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Samet, J. H., Cheng, D. M., Libman, H., Nunes, D., Alperen, J. K., & Saitz, R. (2007) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/qai.0b013e318142aabb · Cited by 227
“HIV-ALC only 195 (33) 125 (35) 17 (28) 53 (29)”
Shafer, R. W., Smeaton, L. M., Robbins, G. K., Gruttola, V. D., Snyder, S. W., D’Aquila, R. T., Johnson, V. A., Morse, G. D., Nokta, M. A., Martínez, A. I., et al. (2003) · New England Journal of Medicine · doi:10.1056/nejmoa030265 · Cited by 228
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Malta, M., Magnanini, M. M. F., Strathdee, S. A., & Bastos, F. I. (2008) · AIDS and Behavior · doi:10.1007/s10461-008-9489-7 · Cited by 225
Maggiolo, F., Ravasio, L., Ripamonti, D., Gregis, G., Quinzan, G., Arici, C., Airoldi, M., & Suter, F. (2004) · Clinical Infectious Diseases · doi:10.1086/426595 · Cited by 225
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“First, the AACTG 4-day adherence measure was to assess the number of HIV medication doses participants had missed in the preceding 4 days.(37,38) Those who reported missing any doses were coded as nonadherent.”
Mugavero, M. J., Ostermann, J., Whetten, K., Leserman, J., Swartz, M. S., Stangl, D. K., & Thielman, N. M. (2006) · AIDS Patient Care and STDs · doi:10.1089/apc.2006.20.418 · Cited by 220
“18 For the purposes of this analysis, patients were considered nonadher-ent if they reported missing any doses of their HIV medication during the past 7 days.”
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Antiretroviral treatment adherence among HIV patients in KwaZulu-Natal, South Africa
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Chesney, M. A. (2006) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/01.qai.0000243112.91293.26 · Cited by 216
“If details were needed regarding specific adherence to the various medications within the trial, the self-report assessment would need to assess adherence to each medication.(11) Alternatively, if details about the individual medications were not needed, simpler self-report measures would suffice, such as a singleitem…”
BackgroundSelf-citationEllis, R. J., Childers, M. E., Cherner, M., Lazzaretto, D., Letendre, S. L., & Grant, I. (2003) · The Journal of Infectious Diseases · doi:10.1086/379894 · Cited by 216
Effect of adherence to newly initiated antiretroviral therapy on plasma viral load
Gross, R. A., Bilker, W. B., Friedman, H. M., & Strom, B. L. (2001) · AIDS · doi:10.1097/00002030-200111090-00006 · Cited by 215
“Finally, although several groups are currently undertaking research into identi®able and potentially modi®able behavioral factors associated with adherence to HAART [10,11,33,34], more work needs to be done to further elucidate the degree of adherence that should be considered `optimal' to serve as the outcome in stud…”
BackgroundInfluentialHorne, R., Cooper, V., Gellaitry, G., Date, H. L., & Fisher, M. (2007) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/qai.0b013e31806910e3 · Cited by 212
Gender differences in factors associated with adherence to antiretroviral therapy
Berg, K. M., Demas, P., Howard, A. A., Schoenbaum, E. E., Gourevitch, M. N., & Arnsten, J. H. (2004) · Journal of General Internal Medicine · doi:10.1111/j.1525-1497.2004.30445.x · Cited by 213
“Gender Women 49 (43) Men 64 (57) Mean age, y 44 ± 7 Race Hispanic 74 (66) African American 25 (22) White 13 (12) Marital status Married/living with spouse 49 (43) Separated/divorced 13 (12) Widowed 16 (14) Single 33 (29) Housing status Living in own apartment 91 (81) Living in other apartment 15 (14) Temporary housing…”
BackgroundRemien, R. H., Hirky, A. E., Johnson, M. O., Weinhardt, L. S., Whittier, D. N., & Giang, L. M. (2003) · AIDS and Behavior · doi:10.1023/a:1022513507669 · Cited by 206
“Factors associated with better adherence include positive social support, strong beliefs about the necessity of medication, self-efficacy for adherence, and a good understanding of the purpose of treatment ( Chesney et al., 2000a; Horne, 2000; Malow et al., 1998; Wagner et al., 2002).”
BackgroundReynolds, N. R., Testa, M. A., Marc, L. G., Chesney, M. A., Neidig, J. L., Smith, S. R., Vella, S., Robbins, G. K., & Protocol Teams of ACTG 384, A. 7. (2004) · AIDS and Behavior · doi:10.1023/b:aibe.0000030245.52406.bb · Cited by 204
“The ACTG Baseline Adherence Questionnaire (Chesney et al., 2000b) provided a selfreport measure of personal and situational variables including (1) beliefs about the effectiveness of antiretroviral medication and confidence in one’s ability to adhere to antiretroviral medications as directed (ART…”
BackgroundMethodInfluentialSelf-citationParedes, R., Lalama, C. M., Ribaudo, H. J., Schackman, B. R., Shikuma, C. M., Giguel, F. F., Meyer, W. A., Johnson, V. A., Fiscus, S. A., D’Aquila, R. T., et al. (2010) · The Journal of Infectious Diseases · doi:10.1086/650543 · Cited by 204
“and 24 and then every 24 weeks with use of a self-administered adherence questionnaire [26].”
Barriers to HAART Adherence Among Human Immunodeficiency Virus–Infected Adolescents
Murphy, D. A. (2003) · Archives of Pediatrics and Adolescent Medicine · doi:10.1001/archpedi.157.3.249 · Cited by 203
Dowshen, N., Kuhns, L. M., Johnson, A. K., Holoyda, B. J., & Garofalo, R. (2012) · Journal of Medical Internet Research · doi:10.2196/jmir.2015 · Cited by 208
“However, forgetting is the most commonly cited reason for missing doses [12].”
BackgroundHIV Stigma and Missed Medications in HIV-Positive People in Five African Countries
Dlamini, P. S., Wantland, D. J., Makoae, L. N., Chirwa, M. L., Kohi, T. W., Greeff, M., Naidoo, J. R., Mullan, J., Uys, L. R., & Holzemer, W. L. (2009) · AIDS Patient Care and STDs · doi:10.1089/apc.2008.0164 · Cited by 198
A Proposal for Quality Standards for Measuring Medication Adherence in Research
Williams, A. B., Amico, K. R., Bova, C., & Womack, J. A. (2012) · AIDS and Behavior · doi:10.1007/s10461-012-0172-7 · Cited by 196
“Count based recall measures, such as the frequently used recall portion of the AIDS Clinical Trials Group questionnaire [24], ask subjects to report on their ARV regimen in full (medications prescribed, when they are prescribed to be taken, and how many to be taken at each dose time)”
Patient-reported barriers and facilitators to antiretroviral adherence in sub-Saharan Africa
Croome, N., Ahluwalia, M., Hughes, L. D., & Abas, M. (2017) · AIDS · doi:10.1097/qad.0000000000001416 · Cited by 215
“Barrier measures or adapted versions [175,177,186-189] were utilised in some surveys which may have caused certain barriers to be reported more frequently; however, other important barriers may”
BackgroundMethodAsboe, D., Aitken, C., Boffito, M., Booth, C. L., Cane, P., Fakoya, A. O., Geretti, A. M., Kelleher, P., Mackie, N., Muir, D., et al. (2011) · HIV Medicine · doi:10.1111/j.1468-1293.2011.00971.x · Cited by 197
McHorney, C. A. (2008) · Current Medical Research and Opinion · doi:10.1185/03007990802619425 · Cited by 199
A Structural Equation Model of HIV-Related Stigma, Depressive Symptoms, and Medication Adherence
Rao, D., Feldman, B. J., Fredericksen, R. J., Crane, P. K., Simoni, J. M., Kitahata, M. M., & Crane, H. M. (2011) · AIDS and Behavior · doi:10.1007/s10461-011-9915-0 · Cited by 204
“Three items were modified from the Adult AIDS Clinical Trial Group (AACTG) adherence assessment [22, 23], including the number of doses missed 712 AIDS Behav (2012) 16:711–716”
MethodKalichman, S. C., Amaral, C. M., Swetzes, C., Jones, M., Macy, R., Kalichman, M. O., & Cherry, C. (2009) · Journal of the International Association of Physicians in AIDS Care · doi:10.1177/1545109709352884 · Cited by 193
“The most widely used self-report adherence measure was developed by the AIDS Clinical Trials Group (ACTG) network.(7,8) The ACTG interview asks patients to recall how many doses of their medications they missed in the past week using day-by-day retrospective recall.”
MethodSchmittdiel, J. A., Mosen, D. M., Glasgow, R. E., Hibbard, J. H., Remmers, C., & Bellows, J. (2007) · Journal of General Internal Medicine · doi:10.1007/s11606-007-0452-5 · Cited by 191
“Finally, we used an item adapted from Chesney to assess medication adherence.(13,14) Participants were asked how many days of medication doses were missed in the past 7 days.”
MethodCarrieri, P., Cailleton, V., Moing, V. L., Spire, B., Dellamonica, P., Bouvet, É., Raffi, F., Journot, V., & Moatti, J. (2001) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/00042560-200111010-00005 · Cited by 190
Shi, L., Liu, J., Koleva, Y. N., Fonseca, V. A., Kalsekar, A., & Pawaskar, M. D. (2010) · PharmacoEconomics · doi:10.2165/11537400-000000000-00000 · Cited by 190
“The AACTG/PACTG questionnaires, while developed for use in the HIV population,([60]) have shown moderate correlation with MEMS [20] and have also shown well established reliability and internal consistency.”
MethodGrossberg, R. M., Zhang, Y., & Gross, R. (2004) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2004.04.002 · Cited by 189
Johnson, M. O., Catz, S. L., Remien, R. H., Rotheram‐Borus, M. J., Morin, S. F., Charlebois, E. D., Gore-Felton, C. E., Goldsten, R. B., Wolfe, H. E., Lightfoot, M. A., et al. (2003) · AIDS Patient Care and STDs · doi:10.1089/108729103771928708 · Cited by 189
Self-citationFactors Influencing Adherence to Antiretroviral Treatment in Nepal: A Mixed-Methods Study
Wasti, S. P., Simkhada, P. P., Randall, J., Freeman, J. V., & van Teijlingen, E. (2012) · PLoS ONE · doi:10.1371/journal.pone.0035547 · Cited by 183
“Adherence was assessed by using a self-reported Adult AIDS Clinical Trial Groups (AACTG) adherence instrument [15], originally developed in the United States and now widely adopted in many countries [16,17].”
MethodHealth-Related Correlates of Perceived Discrimination in HIV Care
Bird, S. T., Bogart, L. M., & Delahanty, D. L. (2004) · AIDS Patient Care and STDs · doi:10.1089/108729104322740884 · Cited by 183
Preventing HIV Antiretroviral Resistance through Better Monitoring of Treatment Adherence
Bangsberg, D. R. (2008) · The Journal of Infectious Diseases · doi:10.1086/533415 · Cited by 183
Brandt, C. P., Zvolensky, M. J., Woods, S. P., Gonzalez, A., Safren, S. A., & O’Cleirigh, C. M. (2016) · Clinical Psychology Review · doi:10.1016/j.cpr.2016.11.005 · Cited by 192
Kim, M. H., Mazenga, A. C., Yu, X., Ahmed, S., Paul, M. E., Kazembe, P. N., & Abrams, E. J. (2017) · Journal of the International AIDS Society · doi:10.7448/ias.20.1.21437 · Cited by 182
Boarts, J. M., Sledjeski, E. M., Bogart, L. M., & Delahanty, D. L. (2006) · AIDS and Behavior · doi:10.1007/s10461-006-9069-7 · Cited by 175
“Adherence to medications was assessed using a self-report interview adapted from the Adult AIDS Clinical Trials Group (ACTG; Chesney et al., 2000).”
MethodShi, L., Liu, J., Fonseca, V., Walker, P., Kalsekar, A., & Pawaskar, M. (2010) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-8-99 · Cited by 177
Vyavaharkar, M. V., Moneyham, L. L., Tavakoli, A. S., Phillips, K. D., Murdaugh, C. L., Jackson, K. L., & Meding, G. (2007) · AIDS Patient Care and STDs · doi:10.1089/apc.2006.0131 · Cited by 176
Improved Adherence with Contingency Management
Rosen, M. I., Dieckhaus, K. D., McMahon, T. J., Valdes, B., Petry, N. M., Cramer, J. A., & Rounsaville, B. J. (2007) · AIDS Patient Care and STDs · doi:10.1089/apc.2006.0028 · Cited by 176
“Adherence was assessed by MEMS, self-reported adherence during the preceding 3 days using a timeline follow-back approach, 28 and visual analogue scale ratings of the percentage of doses taken in the preceding month.”
Health literacy and anticoagulation-related outcomes among patients taking warfarin
Fang, M. C., Machtinger, E. L., Wang, F. M., & Schillinger, D. (2006) · Journal of General Internal Medicine · doi:10.1111/j.1525-1497.2006.00537.x · Cited by 175
Visual Analog Scale of ART Adherence
Amico, K. R., Fisher, W. A., Cornman, D. H., Shuper, P. A., Redding, C. G., Konkle‐Parker, D. J., Barta, W. D., & Fisher, J. D. (2006) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/01.qai.0000225020.73760.c2 · Cited by 177
“Selfreported adherence from the AACTG was computed as number of doses taken in full as prescribed over number prescribed for each ART medication, and as a total adherence score obtained by collapsing across all ART medications in the patient’s regimen and computing total doses taken in full as prescribed during the 3-…”
Method
Metadata
- Authors
- Chesney, M. A., Ickovics, J. R., Chambers, D. B., Gifford, A. L., Neidig, J., Zwickl, B., Wu, A. W., & PATIENT CARE COMMITTEE & ADHERENCE
- Affiliations
- University of California, San Francisco (US)
- Yale University (US)
- University of California San Diego (US)
- The Ohio State University (US)
- Indiana University Indianapolis (US)
- Johns Hopkins University (US)
- Venue
- AIDS Care
- Publisher
- Informa UK Limited
- Published
- 2000-06
- Volume
- 12
- Issue
- 3
- Pages
- 255-266
- ISSN
- 0954-0121 (ISSN-L)
- 1360-0451
- OpenAlex
- W2088423598
- Cited by
- 1,428
- References
- 12
- Citations by year
- 2026: 14 · 2025: 28 · 2024: 29 · 2023: 29 · 2022: 40 · 2021: 53 · 2020: 51 · 2019: 55 · 2018: 61 · 2017: 66 · 2016: 67 · 2015: 76 · 2014: 81 · 2013: 84 · 2012: 74
- FWCI
- 27.22
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- AIDS Care (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute of Mental Health (P50-MH42459, P30MH059037, P50MH042459, P30-MH 59037)
- National Institute of Allergy and Infectious Diseases (U01AI-38858, U01AI038858)
- Topics
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
- Keywords
- antiretroviral therapy adherence, HIV, self-report questionnaire, medication non-adherence, adherence self-efficacy, alcohol consumption, protease inhibitors, clinical trial participants, questionnaire development
- MeSH terms
- Adult, Alcohol Drinking, Clinical Trials as Topic, Cross-Sectional Studies, Female, Humans, Male, Middle Aged, Patient Compliance, Pilot Projects, Surveys and Questionnaires, Risk Factors, Socioeconomic Factors, HIV Infections, Anti-HIV Agents, Substance-Related Disorders
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