Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials

K Rivet Amico, Leila E Mansoor, Amy Corneli, Kristine Torjesen, Ariane van der Straten, K Rivet Amico, Leila E Mansoor, Amy Corneli, Kristine Torjesen, Ariane van der Straten

Abstract

Adherence is a critical component of the success of antiretroviral-based pre-exposure prophylaxis (PrEP) in averting new HIV-infections. Ensuring drug availability at the time of potential HIV exposure relies on self-directed product use. A deeper understanding of how to best support sustained PrEP adherence remains critical to current and future PrEP efforts. This paper provides a succinct synthesis of the adherence support experiences from four pivotal PrEP trials--Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004, FEM-PrEP, Iniciativa Prophylaxis (iPrEx), and Vaginal and Oral Interventions to Control the Epidemic (VOICE). Notwithstanding variability in the design, population/cohort, formulation, drug, dosing strategy, and operationalization of adherence approaches utilized in each trial, the theoretical basis and experiences in implementation and monitoring of the approaches used by these trials provide key lessons for optimizing adherence in future research and programmatic scale-up of PrEP. Recommendations from across these trials include participant-centered approaches, separating measurement of adherence from adherence counseling, incorporating tailored strategies that go beyond education, fostering motivation, and addressing the specific context in which an individual incorporates and negotiates PrEP use.

Trial registration: ClinicalTrials.gov NCT00458393.

Figures

Fig. 1
Fig. 1
Steps and framing of the ASP
Fig. 2
Fig. 2
Steps and framing of NSC
Fig. 3
Fig. 3
Steps and framing of VASP

References

    1. Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329(5996):1168–74.
    1. Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C, the Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399–410.
    1. 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.
    1. Thigpen MC, Kebaabetswa PM, Paxton L, Smith DK, Rose CE, Segolodi TM, Henderson FL, Pathak SR, Soud FA, Chillag K, Mutanhaurwa R, Chirwa LI, Kasonde M, Abebe D, Buliva E, Gvetadze R, Johnson S, Sukalac T, Thomas VT, Hart C, Johnson JA, Malotte CK, Hendrix CW, Brooks JT, for the TDF2 Study Group. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012. doi:10.1056/NEJMoa1110711.
    1. Van Damme L, Corneli A, Ahmed K, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012;367(5):411–22.
    1. Microbicide Trials Network (MTN). MTN statement on decision to discontinue use of Tenofovir gel in VOICE, a major HIV prevention study in women. 2011. Available at: . Accessed Sept 25 2011.
    1. Microbicide Trials Network. MTN statement on decision to discontinue use of oral Tenofovir tablets in VOICE, a major HIV prevention study in women. 2011. Available at: . Accessed Sept 25 2011.
    1. Kashuba AD, Patterson KB, Dumond JB, Cohen MS. Pre-exposure prophylaxis for HIV prevention: how to predict success. Lancet. 2012;379(9835):2409–2411. doi: 10.1016/S0140-6736(11)61852-7.
    1. Stirratt MJ, Gordon CM. Adherence to biomedical HIV prevention methods: considerations drawn from HIV treatment adherence research. Curr HIV/AIDS Rep. 2008;5(4):186–192. doi: 10.1007/s11904-008-0027-z.
    1. Karim S, Karim QA. Antiretroviral prophylaxis: a defining moment in HIV control. Lancet. 2011;378(9809):e23–e25. doi: 10.1016/S0140-6736(11)61136-7.
    1. Amico KR. Adherence to preexposure chemoprophylaxis: the behavioral bridge from efficacy to effectiveness. Curr Opin HIV AIDS. 2012;7(6):542–548. doi: 10.1097/COH.0b013e3283582d4a.
    1. Muchomba FM, Gearing RE, Simoni JM, El-Bassel N. State of the science of adherence to pre-exposure prophylaxis and microbicide trials. J Acquir Immune Defic Syndr. 2012;61(4):490–498. doi: 10.1097/QAI.0b013e31826f9962.
    1. Centers for Disease Control and Prevention. Morbidity and mortality weekly report (MMWR), Interim guidance: Preexposure prophylaxis for the prevention of HIV infection in men who have sex with men. 2011;60(03):65–68. Available at: . Accessed Sept 25 2011.
    1. Centers for Disease Control and Prevention. Morbidity and mortality weekly report (MMWR), Interim guidance for clinicians considering the use of preexposure prophylaxis for the prevention of HIV infection in heterosexually active adults. 2012. Available at: . 9 Aug 2012.
    1. World Health Organization. Guidance on oral pre-exposure prophylaxis (prep) for serodiscordant couples, men and transgender women who have sex with men at high risk of HIV: recommendations for use in the context of demonstration projects. 2012. Available at: . Accessed 9 Sept 2012.
    1. Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992;111(3):455. doi: 10.1037/0033-2909.111.3.455.
    1. Karim QA, Kharsany AB, Naidoo K, Yende N, Gengiah T, Omar Z, Arulappan N, Mlisana KP, Luthuli LR, Karim SS. Co-enrollment in multiple HIV prevention trials - experiences from the CAPRISA 004 tenofovir gel trial. Contemp Clin Trials. 2011;32(3):333–338. doi: 10.1016/j.cct.2011.01.005.
    1. Fisher JD, Cornman DH, Osborn CY, Amico KR, Fisher WA, Friedland GA. Clinician-initiated HIV risk reduction intervention for HIV-positive persons: formative research, acceptability, and fidelity of the Options Project. J Acquir Immune Defic Syndr. 2004;37(Suppl 2):S78–S87. doi: 10.1097/01.qai.0000140605.51640.5c.
    1. Rollnick S, Miller WR. What is motivational interviewing? Behav Cogn Psychother. 1995;23(4):325–334. doi: 10.1017/S135246580001643X.
    1. Emmons KM, Rollnick S. Motivational interviewing in health care settings: opportunities and limitations. Am J Prev Med. 2001;20(1):68–74. doi: 10.1016/S0749-3797(00)00254-3.
    1. Mansoor LE. Enhancing adherence to study product through motivational interviewing: Experiences from CAPRISA 004. Miami: Presented at the 6th International Conference on Treatment and Prevention Adherence; 2011.
    1. Corneli AL, Mack N, Kirkendale S, editors. Socio-behavioral and community activities for an oral HIV prevention prep clinical trial: a multi-disciplinary approach. New Delhi: International Microbicides Conference; 2008.
    1. FHI 360. Joint statement on savvy phase 3 trial in Ghana to test the effectiveness of savvy gel in preventing HIV. 2005. Available at . Accessed 9 Sept 2012.
    1. VCT Toolkit: HIV voluntary counseling and testing: a reference guide for counselors and trainers. Arlington: Family Health International; 2004.
    1. Adherence support worker training facilitator’s guide. Arlington: Family Health International; 2007.
    1. Nursing care of patients with HIV/AIDS: facilitator’s guide. Arlington: Family Health International; 2008.
    1. Halpern V, Lopez LM, Grimes DA, Gallo MF. Strategies to improve adherence and acceptability of hormonal methods of con-traception. status and date. Cochrane Database Syst Rev. 2011
    1. Blouse A, WAgner E. Counseling and testing for HIV: reference manual. Baltimore: JHPEIGO; 2004.
    1. Munro S, Lewin S, Swart T, Volmink J. A review of health behaviour theories: how useful are these for developing interventions to promote long-term medication adherence for TB and HIV/AIDS? BMC Public Health. 2007;7(1):104. doi: 10.1186/1471-2458-7-104.
    1. Kidd R, Clay S. Understanding and challenging HIV stigma: toolkit for action. New York: CHANGE Project (AED) International Center for Research on Women. 2003. Available at . Accessed 17 Sept 2004.
    1. Grant R, McMahan A, Liu J, et al. Completed observation of the randomized placebo-controlled phase of iPrEx: daily oral FTC/TDF pre-exposure HIV prophylaxis among men and trans women who have sex with men. Sixth IAS Conference on HIV Pathogenesis, Tratement and PRevention, 2011 [abstract WELBC04]. Available at . Accessed on 25 Sept 2012.
    1. Grant R, Lama J, Glidden D, iPrEx Study Team. Pre-exposure chemprophylaxis for prevention of HIV among trans-women and MSM: iPREx study. Boston: 18th Conference on Retroviruses and Opportunistic Infections (CROI); 2011.
    1. Bartholomew LK, Parcel GS, Kok G, Gottlieb NH. Planning health promotion programs: an intervention mapping approach. 2. San Francisco: Jossey-Bass; 2006.
    1. Kok G, Schaalma H, Ruiter RA, Van Empelen P, Brug J. Intervention mapping: protocol for applying health psychology theory to prevention programmes. J health Psychol. 2004;9(1):85–98. doi: 10.1177/1359105304038379.
    1. Amico KR, McMahan V, Goicochea P, Vargas L, Marcus JL, Grant RM, et al. Supporting study product use and accuracy in self-report in the iPrEx study: next step counseling and neutral assessment. AIDS Behav. 2012;16(5):1243–1259. doi: 10.1007/s10461-012-0182-5.
    1. Fisher JD, Amico KR, Fisher WA, Harman JJ. The Information-Motivation-Behavioral Skills model of antiretroviral adherence and its applications. Curr HIV/AIDS Rep. 2008;5(4):193–203. doi: 10.1007/s11904-008-0028-y.
    1. Kamb ML, Fishbein M, Douglas JM, Jr, Rhodes F, Rogers J, Bolan G, et al. Efficacy of risk-reducing counseling to prevent human immunodefiency virus and sexually transmitted diseases. JAMA. 1998;280(13):1161–1167. doi: 10.1001/jama.280.13.1161.
    1. Rollnick S, Miller WR, Butler CC. Motivational interviewing in health care: helping patients change behavior. New York: Guilford Press; 2008.
    1. Norton WE, Amico KR, Cornman DH, Fisher WA, Fisher JD. An agenda for advancing the science of implementation of evidence-based HIV prevention interventions. AIDS Behav. 2009;13(3):424–429. doi: 10.1007/s10461-009-9556-8.
    1. Harberer J, Baeten J, Celum C, Katibira E, Ronald, et al. High adherence among HIV-1 serodiscordant couples in the Partners PrEP ancillary adherence study. Miami: International Association for Physicians in AIDS Care. 2012. Available at: . Accessed on 9 Sept 2012.
    1. Psaros C. evaluation and process outcomes from an adherence intervention to support HIV pre-exposure prophylaxis (PrEP) adherence in HIV-serodiscordant couples in Uganda. Miami: Oral presentation at the 7th Annual HIV Treatment and Prevention Adherence Conference of the International Association of Providers in AIDS Care. 2012. Available at . Accessed on 20 Sept 2012.
    1. Ware NC, Wyatt MA, Haberer JE, Baeten JM, Kintu A, Psaros C, Safren S, Tumwesigye E, Celum CL, Bangsberg DR. What’s love got to do with it? Explaining adherence to oral antiretroviral pre-exposure prophylaxis for HIV-serodiscordant couples. J Acquir Immune Defic Syndr. 2012;59(5):463–468. doi: 10.1097/QAI.0b013e31824a060b.
    1. US Food and Drug Administration. FDA approves first drug for reducing the risk of sexually acquired HIV infection. 2012. Available at: . Accessed on 9 September 2012.

Source: PubMed

3
購読する