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Client-Centered Adherence Counseling with Adherence Measurement Feedback to Support Use of the Dapivirine Ring in MTN-025 (The HOPE Study)

Abstract

Fostering adherence and open communication about adherence challenges is key to harnessing the potential of biomedical HIV prevention products. We describe the counseling intervention and objective adherence measure feedback process implemented to support adherence to the dapivirine vaginal ring among participants in four sub-Saharan countries and present findings on the counselors’ likeability and acceptability of the intervention. Most counselors (N = 42; 86%) liked Options counseling “very much” and during in-depth interviews (N = 22), reported that the intervention reshaped their adherence counselling approach by emphasizing understanding participants’ experiences using the ring, which facilitated open discussion of adherence challenges. Counselors found that reframing residual drug level (RDL) discussions from the “adherence” to “protection” perspective encouraged adherence among consistent users and facilitated decisions to switch to a different HIV prevention approach among infrequent users. Among counselors, 24% said participants “liked it very much” while 26% said that participants “liked it a little” possibly due to two main complaints: perceived repetitiousness of sessions and variability in the RDL assay, which at times resulted in unexpected low RDLs.

Resumen

Fomentar la adherencia y la comunicación abierta sobre los desafíos con la adherencia es clave para aprovechar el potencial de los productos biomédicos de prevención del VIH. Describimos la intervención de consejería y el proceso de compartir los resultados de medidas objetivas de adherencia con participantes en cuatro países subsaharianos para apoyar la adherencia al anillo vaginal de dapivirine y presentamos los resultados sobre la agradabilidad y la aceptabilidad de la intervención a los consejeros. A la mayoría de los consejeros (N=42; 86%) “les gustó mucho” la consejería quienes, durante entrevistas en profundidad (N=22) y reportaron que la intervención cambió su aproximación a la consejería sobre la adherencia. Se enfocaban más en comprender la experiencia de uso del anillo entre las participantes, lo cual facilitaba una conversación abierta sobre posibles desafíos a la adherencia. Los consejeros encontraron que cambiar el enfoque de “adherencia” a “protección” en las conversaciones sobre los niveles residuos de drogas fomentaba la adherencia entre las mujeres que usaban el anillo consistentemente y facilitaba la decisión de cambiar a otro método de prevención del VIH entre las mujeres que lo usaban con poca frecuencia. Entre los consejeros, 24% dijeron que a las participantes “les gustó mucho” la consejería y 26% que a las participantes “les gustó un poco”. Es posible que esto se deba a dos quejas principales: la percepción de que las sesiones sean repetitivas y la variabilidad en el ensayo de los niveles residuos de drogas, lo cual a veces resultaba en niveles bajos inesperados.

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References

  1. Marrazzo JM, Ramjee G, Richardson BA, Gomez K, Mgodi N, Nair G, et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015;372(6):509–18.

    Article  Google Scholar 

  2. Liu A, Glidden DV, Anderson PL, Amico KR, McMahan V, Mehrotra M, et al. Patterns and correlates of PrEP drug detection among MSM and transgender women in the Global iPrEx Study. J Acquir Immune Defic Syndr. 2014;67(5):528–37.

    CAS  Article  Google Scholar 

  3. Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363(27):2587–99.

    CAS  Article  Google Scholar 

  4. Baeten JM, Palanee-Phillips T, Brown ER, Schwartz K, Soto-Torres LE, Govender V, et al. Use of a vaginal ring containing dapivirine for HIV-1 prevention in women. N Engl J Med. 2016. https://doi.org/10.1056/NEJMoa1506110.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Corneli AL, Deese J, Wang M, Taylor D, Ahmed K, Agot K, et al. FEM-PrEP: adherence patterns and factors associated with adherence to a daily oral study product for pre-exposure prophylaxis. J Acquir Immune Defic Syndr. 2014;66(3):324–31.

    CAS  Article  Google Scholar 

  6. Corneli A, Perry B, McKenna K, Agot K, Ahmed K, Taylor J, et al. Participants' explanations for nonadherence in the FEM-PrEP clinical trial. J Acquir Immune Defic Syndr. 2016;71(4):452–61.

    Article  Google Scholar 

  7. Amico KR, Marcus JL, McMahan V, Liu A, Koester KA, Goicochea P, et al. Study product adherence measurement in the iPrEx placebo-controlled trial: concordance with drug detection. J Acquir Immune Defic Syndr. 2014;66(5):530.

    CAS  Article  Google Scholar 

  8. van der Straten A, Montgomery ET, Musara P, Etima J, Naidoo S, Laborde N, et al. Disclosure of pharmacokinetic drug results to understand nonadherence. AIDS. 2015;29(16):2161–71.

    Article  Google Scholar 

  9. Amico KR, McMahan V, Goicochea P, Vargas L, Marcus JL, Grant RM, Liu A. Supporting study product use and accuracy in self-report in the iPrEx study: next step counseling and neutral assessment. AIDS Behav. 2012;16(5):1243–59.

    Article  Google Scholar 

  10. Amico KR, Mansoor LE, Corneli A, Torjesen K, van der Straten A. Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials. AIDS Behav. 2013;17(6):2143–55.

    Article  Google Scholar 

  11. Amico KR, Miller J, Balthazar C, Serrano PA, Brothers J, Zollweg S, Hosek S. Integrated next step counseling (iNSC) for sexual health and PrEP use among young men who have sex with men: Implementation and observations from ATN110/113. AIDS Behav. 2019;23(7):1812–23.

    Article  Google Scholar 

  12. Musara P, Montgomery ET, Mgodi NM, Woeber K, Akello CA, Hartmann M, Cheng H, Levy L, Katz A, Grossman CI, Chirenje ZM. How presentation of drug detection results changed reports of product adherence in South Africa, Uganda and Zimbabwe. AIDS Behav. 2018;22(3):877–86.

    Article  Google Scholar 

  13. Davis A, Sarsembayeva L, Gulyaev V, Primbetova S, Terlikbayeva A, Mergenova G, Remien RH. If you build it, will they use it? Preferences for antiretroviral therapy (ART) adherence monitoring among people who inject drugs (PWID) in Kazakhstan. AIDS Behav. 2019;23(12):3294–305.

    Article  Google Scholar 

  14. Sabin LL, DeSilva MB, Hamer DH, Xu K, Zhang J, Li T, Wilson IB, Gill CJ. Using electronic drug monitor feedback to improve adherence to antiretroviral therapy among HIV-positive patients in China. AIDS Behav. 2010;14(3):580–9.

    Article  Google Scholar 

  15. Hunt T, Lalley-Chareczko L, Daughtridge G, Swyryn M, Koenig H. Challenges to PrEP use and perceptions of urine tenofovir adherence monitoring reported by individuals on PrEP. AIDS Care. 2019;31(10):1203–6.

    Article  Google Scholar 

  16. Landovitz RJ, Beymer M, Kofron R, Amico KR, Psaros C, Bushman L, Anderson PL, Flynn R, Lee DP, Bolan RK, Jordan WC. Plasma tenofovir-levels to support adherence to TDF/FTC pre-exposure prophylaxis for HIV prevention in MSM in Los Angeles, California. J Acquir Immune Defic Syndr. 2017;76(5):501.

    CAS  Article  Google Scholar 

  17. Koester KA, Liu A, Eden C, Amico KR, McMahan V, Goicochea P, Hosek S, Mayer KH, Grant RM. Acceptability of drug detection monitoring among participants in an open-label pre-exposure prophylaxis study. AIDS Care. 2015;27(10):1199–204.

    Article  Google Scholar 

  18. Montgomery ET, Mensch B, Musara P, Hartmann M, Woeber K, Etima J, van der Straten A. Misreporting of product adherence in the MTN-003/VOICE trial for HIV prevention in Africa: participants’ explanations for dishonesty. AIDS Behav. 2017;21(2):481–91.

    Article  Google Scholar 

  19. Palacio A, Garay D, Langer B, Taylor J, Wood BA, Tamariz L. Motivational interviewing improves medication adherence: a systematic review and meta-analysis. J Gen Intern Med. 2016;31(8):929–40.

    Article  Google Scholar 

  20. Miller WR, Rollnick S. Motivational interviewing: helping people change. 3rd ed. New York: Guilford Press; 2013.

    Google Scholar 

  21. Miller WR, Sovereign RG, Krege B. Motivational interviewing with problem drinkers: II. The drinker's check-up as a preventive intervention. Behav Psychother. 1988;16:251–68.

    Article  Google Scholar 

  22. Stephens R, Roffman R, Fearer S, Williams C, Burke R. The marijuana check-up: promoting change in ambivalent marijuana users. Addiction. 2007;102:947–57.

    Article  Google Scholar 

  23. Walker DD, Roffman RA, Picciano JF, Stephens RS. The check-up: in-person, computerized, and telephone adaptations of motivational enhancement therapy to elicit voluntary participation by the contemplator. Subst Abuse Treat Prev Policy. 2007;2:2.

    Article  Google Scholar 

  24. Miller WR, Benefield RG, Tonigan JS. Enhancing motivation for change in problem drinking: a controlled comparison of two therapist styles. J Consult Clin Psychol. 1993;61(3):455–61.

    CAS  Article  Google Scholar 

  25. Balán IC, Lentz C, Giguere R, Mayo AJ, Tagliaferri Rael C, Soto-Torres L, Palanee-Phillips T, Mgodi NM, Hillier S, Baeten JM, on behalf of the MTN-025/HOPE Study Team. Implementation of a fidelity monitoring process to assess delivery of an evidence-based adherence intervention in a multisite PrEP study. AIDS Care. 2020;1–10.

  26. Moyers TB, Martin T, Houck JM, Christopher PJ, Tonigan JS. From in-session behaviors to drinking outcomes: a causal chain for motivational interviewing. J Consult Clin Psychol. 2009;77(6):1113–24.

    Article  Google Scholar 

  27. Vader AM, Walters ST, Prabhu GC, Houck JM, Field CA. The language of motivational interviewing and feedback: counselor language, client language, and client drinking outcomes. Psychol Addict Behav. 2010;24(2):190–7.

    Article  Google Scholar 

  28. Apodaca TR, Longabaugh R. Mechanisms of change in motivational interviewing: a review and preliminary evaluation of the evidence. Addiction. 2009;104(5):705–15.

    Article  Google Scholar 

  29. Magill M, Gaume J, Apodaca TR, Walthers J, Mastroleo NR, Borsari B, et al. The technical hypothesis of motivational interviewing: a meta-analysis of MI’s key causal model. J Consult Clin Psychol. 2014;82(6):973–83.

    Article  Google Scholar 

  30. Moyers TB, Martin T. Therapist influence on client language during motivational interviewing sessions. J Subst Abuse Treat. 2006;30(3):245–51.

    Article  Google Scholar 

  31. Magill M, Apodaca T. The route to change: within-session predictors of change plan completion in a motivational interview. Alcohol Clin Exp Res. 2009;33:112A.

    Google Scholar 

  32. Spence P, Nel A, van Niekerk N, Derrick T, Wilder S, Devlin B. Post-use assay of vaginal rings (VRs) as a potential measure of clinical trial adherence. J Pharmaceut Biomed. 2016;125:94–100.

    CAS  Article  Google Scholar 

  33. Raboud JM, Haley L, Montaner JS, Murphy C, Januszewska M, Schechter MT. Quantification of the variation due to laboratory and physiologic sources in CD4 lymphocyte counts of clinically stable HIV-infected individuals. J Acqir Immun Defic Syndr. 1995;10:S67–73.

    Google Scholar 

  34. Daniel Francois Venter W, Chersich MF, Majam M, Akpomiemie G, Arulappan N, Moorhouse M, Mashabane N, Glencross DK. CD4 cell count variability with repeat testing in South Africa: should reporting include both absolute counts and ranges of plausible values? Int J STD AIDS. 2018;29(11):1048–56.

    Article  Google Scholar 

  35. Balán IC, Giguere R, Brown W, Carballo-Diéguez A, Horn S, Hendrix CW, et al. Brief participant-centered convergence interviews integrate self-reports, product returns, and pharmacokinetic results to improve adherence measurement in MTN-017. AIDS Behav. 2018;22(3):986–95.

    Article  Google Scholar 

  36. Levy AG, Scherer AM, Zikmund-Fisher BJ, Larkin K, Barnes GD, Fagerlin A. Prevalence of and factors associated with patient nondisclosure of medically relevant information to clinicians. JAMA Netw Open. 2018;1(7):e185293–e185293185293.

    Article  Google Scholar 

  37. Davis EL, Oh B, Butow PN, Mullan BA, Clarke S. Cancer patient disclosure and patient-doctor communication of complementary and alternative medicine use: a systematic review. Oncologist. 2012;17(11):1475–81.

    Article  Google Scholar 

  38. van der Straten A, Katz AWK, Balán IC, Reddy K, Etima J, Woeber K, et al. A qualitative evaluation of women’s experience receiving drug feedback in MTN-025/HOPE—an HIV prevention open-label trial of the dapivirine vaginal ring. In: Poster presented at the 22nd International AIDS Conference, 23–27 July 2018, Amsterdam, Netherlands.

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Acknowledgements

The authors declare no conflicts of interest. The authors wish to thank the entire HOPE study team, especially the HOPE study counselors and participants. This study was designed and implemented by the Microbicide Trials Network (MTN), funded by the National Institute of Allergy and Infectious Diseases through individual grants (UM1AI068633, UM1AI068615 and UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health (NIH). The HIV Center for Clinical and Behavioral Studies was funded by the National Institute of Mental Health through a center grant (P30-MH43520, PI: Remien). The vaginal rings used in this study were developed and supplied by the International Partnership for Microbicides (IPM). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Correspondence to Iván C. Balán.

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The study presented received approval from ethics committees at all of the research sites. All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Balán, I.C., Giguere, R., Lentz, C. et al. Client-Centered Adherence Counseling with Adherence Measurement Feedback to Support Use of the Dapivirine Ring in MTN-025 (The HOPE Study). AIDS Behav 25, 447–458 (2021). https://doi.org/10.1007/s10461-020-03011-z

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Keywords

  • Adherence biomarker
  • Counseling
  • HIV prevention
  • Adherence
  • Non-confrontational