Summary Measures of Adherence Using Pill Counts in Two HIV Prevention Trials: the Need for Standardisation in Reporting

Overview

Journal AIDS Behav

Specialty Infectious Diseases

Date 2013 Jun 27

PMID 23801018

Citations 5

Authors

Kathy Baisley

Jared M Baeten

James P Hughes

Deborah J Donnell

Jing Wang

Richard Hayes

Deborah Watson Jones

Connie Celum

Affiliations

Soon will be listed here.

Abstract

For trials of user-dependent HIV prevention products, accurate adherence measurements are essential to interpret and compare results across trials. We used pill count data from two recent HIV prevention trials of herpes simplex virus type 2 (HSV-2) suppression, to show that estimates of adherence vary substantially depending on assumptions that are made in analysing pill count data. We associate calculated adherence with biological markers of anti-HSV-2 activity. In both trials, calculated adherence varied considerably, depending on the summary measure used, and the handling of intervals with apparent 'over-adherence' (fewer pills returned than expected), and unreturned pills. Intervals of apparent over-adherence were associated with reduced antiviral effects on biological markers of herpes reactivation, indicating these are likely to represent periods of non-adherence. Our results demonstrate the clear need for standardisation in reporting of adherence data that are based on pill counts.

Citing Articles

Adherence to additional medication for management of HIV-associated comorbidities among older children and adolescents taking antiretroviral therapy.

Rehman A, Simms V, McHugh G, Mujuru H, Ngwira L, Semphere R PLoS One. 2022; 17(6):e0269229.

PMID: 35704559 PMC: 9200347. DOI: 10.1371/journal.pone.0269229.

Comparing the cost, glycaemic control and medication adherence of utilizing patients' own medicines (POMs) versus usual dispensing among diabetic patients in an outpatient setting.

Lim P, Chung Y, Tan S, Wong T, Permalu D, Cheah T Daru. 2021; 29(1):125-132.

PMID: 33538999 PMC: 8149523. DOI: 10.1007/s40199-021-00389-6.

Food Insecurity Is Associated With Lower Levels of Antiretroviral Drug Concentrations in Hair Among a Cohort of Women Living With Human Immunodeficiency Virus in the United States.

Leddy A, Sheira L, Tamraz B, Sykes C, Kashuba A, Wilson T Clin Infect Dis. 2019; 71(6):1517-1523.

PMID: 31608363 PMC: 7486839. DOI: 10.1093/cid/ciz1007.

Comparing pharmacologic measures of tenofovir exposure in a U.S. pre-exposure prophylaxis randomized trial.

Baxi S, Vittinghoff E, Bacchetti P, Huang Y, Chillag K, Wiegand R PLoS One. 2018; 13(1):e0190118.

PMID: 29315307 PMC: 5760024. DOI: 10.1371/journal.pone.0190118.

HIV protective efficacy and correlates of tenofovir blood concentrations in a clinical trial of PrEP for HIV prevention.

Donnell D, Baeten J, Bumpus N, Brantley J, Bangsberg D, Haberer J J Acquir Immune Defic Syndr. 2014; 66(3):340-8.

PMID: 24784763 PMC: 4059553. DOI: 10.1097/QAI.0000000000000172.

References

Vrijens B, Urquhart J . Patient adherence to prescribed antimicrobial drug dosing regimens. J Antimicrob Chemother. 2005; 55(5):616-27. DOI: 10.1093/jac/dki066. View

Blaschke T, Osterberg L, Vrijens B, Urquhart J . Adherence to medications: insights arising from studies on the unreliable link between prescribed and actual drug dosing histories. Annu Rev Pharmacol Toxicol. 2011; 52:275-301. DOI: 10.1146/annurev-pharmtox-011711-113247. View

Muchomba F, Gearing R, Simoni J, El-Bassel N . State of the science of adherence in pre-exposure prophylaxis and microbicide trials. J Acquir Immune Defic Syndr. 2012; 61(4):490-8. PMC: 4068619. DOI: 10.1097/QAI.0b013e31826f9962. View

Pocock S, Abdalla M . The hope and the hazards of using compliance data in randomized controlled trials. Stat Med. 1998; 17(3):303-17. DOI: 10.1002/(sici)1097-0258(19980215)17:3<303::aid-sim764>3.0.co;2-0. View

Pool R, Montgomery C, Morar N, Mweemba O, Ssali A, Gafos M . A mixed methods and triangulation model for increasing the accuracy of adherence and sexual behaviour data: the Microbicides Development Programme. PLoS One. 2010; 5(7):e11600. PMC: 2908129. DOI: 10.1371/journal.pone.0011600. View

Gupta R, Wald A . Genital herpes: antiviral therapy for symptom relief and prevention of transmission. Expert Opin Pharmacother. 2006; 7(6):665-75. DOI: 10.1517/14656566.7.6.665. View

Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I . Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996; 276(8):637-9. DOI: 10.1001/jama.276.8.637. View

Jacob S, Baeten J, Hughes J, Peinado J, Wang J, Sanchez J . A post-trial assessment of factors influencing study drug adherence in a randomized biomedical HIV-1 prevention trial. AIDS Behav. 2010; 15(5):897-904. PMC: 3076532. DOI: 10.1007/s10461-010-9853-2. View

Thigpen M, Kebaabetswe P, Paxton L, Smith D, Rose C, Segolodi T . Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012; 367(5):423-34. DOI: 10.1056/NEJMoa1110711. View

10.

Celum C, Wald A, Hughes J, Sanchez J, Reid S, Delany-Moretlwe S . Effect of aciclovir on HIV-1 acquisition in herpes simplex virus 2 seropositive women and men who have sex with men: a randomised, double-blind, placebo-controlled trial. Lancet. 2008; 371(9630):2109-19. PMC: 2650104. DOI: 10.1016/S0140-6736(08)60920-4. View

11.

Jasti S, Siega-Riz A, Cogswell M, Hartzema A . Correction for errors in measuring adherence to prenatal multivitamin/mineral supplement use among low-income women. J Nutr. 2006; 136(2):479-83. DOI: 10.1093/jn/136.2.479. View

12.

Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S . Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012; 367(5):411-22. PMC: 3687217. DOI: 10.1056/NEJMoa1202614. View

13.

Grant R, Lama J, Anderson P, McMahan V, Liu A, Vargas L . Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010; 363(27):2587-99. PMC: 3079639. DOI: 10.1056/NEJMoa1011205. View

14.

Watson-Jones D, Weiss H, Rusizoka M, Changalucha J, Baisley K, Mugeye K . Effect of herpes simplex suppression on incidence of HIV among women in Tanzania. N Engl J Med. 2008; 358(15):1560-71. PMC: 2643126. DOI: 10.1056/NEJMoa0800260. View

15.

Schulz K, Altman D, Moher D . CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010; 340:c332. PMC: 2844940. DOI: 10.1136/bmj.c332. View

16.

Lu M, Safren S, Skolnik P, Rogers W, Coady W, Hardy H . Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2007; 12(1):86-94. DOI: 10.1007/s10461-007-9261-4. View

17.

Liu H, Golin C, Miller L, Hays R, Beck C, Sanandaji S . A comparison study of multiple measures of adherence to HIV protease inhibitors. Ann Intern Med. 2001; 134(10):968-77. DOI: 10.7326/0003-4819-134-10-200105150-00011. View

18.

Amico K . Adherence to preexposure chemoprophylaxis: the behavioral bridge from efficacy to effectiveness. Curr Opin HIV AIDS. 2012; 7(6):542-8. DOI: 10.1097/COH.0b013e3283582d4a. View

19.

Donnell D, Baeten J, Hong T, Lingappa J, Mujugira A, Nakku-Joloba E . Correlation between pill counts and biologic effects in an HIV-1 prevention clinical trial: implications for measuring adherence. AIDS Behav. 2012; 17(2):632-9. PMC: 3721974. DOI: 10.1007/s10461-012-0268-0. View

20.

Mugwanya K, Baeten J, Mugo N, Irungu E, Ngure K, Celum C . High-dose valacyclovir HSV-2 suppression results in greater reduction in plasma HIV-1 levels compared with standard dose acyclovir among HIV-1/HSV-2 coinfected persons: a randomized, crossover trial. J Infect Dis. 2011; 204(12):1912-7. PMC: 3247811. DOI: 10.1093/infdis/jir649. View