Adherence and acceptability in MTN 001: A randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women

AIDS and Behavior

Volumn 17, Issue 2, 2013, Pages 737-747

  Minnis, Alexandra M ^a,b   Gandham, Sharavi ^c   Richardson, Barbra A ^d   Guddera, Vijayanand ^e   Chen, Beatrice A ^f   Salata, Robert ^g   Nakabiito, Clemensia ^h   Hoesley, Craig ⁱ   Justman, Jessica ^j   Soto Torres, Lydia ^k   Patterson, Karen ^d   Gomez, Kailazarid ^l   Hendrix, Craig W ^m  

^a RTI INTERNATIONAL   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c SCHARP   (United States)

^d UNIVERSITY OF WASHINGTON   (United States)

^e SOUTH AFRICAN MEDICAL RESEARCH COUNCIL   (South Africa)

^f UNIVERSITY OF PITTSBURGH   (United States)

^g CASE WESTERN RESERVE UNIVERSITY   (United States)

^h MU JHU Research Collaboration   (Uganda)

ⁱ UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^j Department of Medicine   (United States)

^k NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^l FHI 360   (United States)

^m JOHNS HOPKINS UNIVERSITY   (United States)

more..

Author keywords

Administration; Anti infective agents; Foams and jellies; HIV; Microbicide; Oral; Patient compliance; PrEP; Sexual behavior; Vaginal creams

Indexed keywords

ADENINE; AGENTS USED INTRAVAGINALLY; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; DRUG DERIVATIVE; PHOSPHONIC ACID DERIVATIVE; TENOFOVIR;

ADOLESCENT; ADULT; ARTICLE; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MEDICATION COMPLIANCE; MIDDLE AGED; ORAL DRUG ADMINISTRATION; PATIENT ATTITUDE; PATIENT PREFERENCE; PHASE 2 CLINICAL TRIAL; PSYCHOLOGICAL ASPECT; RANDOMIZED CONTROLLED TRIAL; SEXUALITY; SOUTH AFRICA; STATISTICS; TOPICAL DRUG ADMINISTRATION; UGANDA; UNITED STATES;

ADENINE; ADMINISTRATION, ORAL; ADMINISTRATION, TOPICAL; ADOLESCENT; ADULT; ANTI-HIV AGENTS; CROSS-OVER STUDIES; FEMALE; HIV INFECTIONS; HUMANS; MEDICATION ADHERENCE; MIDDLE AGED; ORGANOPHOSPHONATES; PATIENT ACCEPTANCE OF HEALTH CARE; PATIENT PREFERENCE; SEXUAL PARTNERS; SOUTH AFRICA; UGANDA; UNITED STATES; VAGINAL CREAMS, FOAMS, AND JELLIES;

MLCS; MLOWN;

EID: 84880192830     PISSN: 10907165     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10461-012-0333-8     Document Type: Article

References (28)

1. van der Straten A, Van Damme L, Haberer JE, Bangsberg DR. Unraveling the divergent results of pre-exposure prophylaxis trials for HIV prevention. AIDS. 2012; 26(7):F13-9. Epub 2012/02/16.
2. Kashuba AD, Patterson KB, Dumond JB, Cohen MS. Pre-exposure prophylaxis for HIV prevention: how to predict success. Lancet. 2012; 379(9835):2409-11. Epub 2011/12/14.
3. Cohen M, Baden L. Preexposure prophylaxis for HIV-where do we go from here? N Engl J Med. 2012;367(5):459-61.
4. Grady D. FDA advisory panel backs preventive use of HIV drug. New York Times. May 10, 2012; D5.
5. Abdool Karim Q, Abdool Karim SS, Frohlich JA, 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. Epub 2010/07/21.
6. Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010; 363(27):2587-99. Epub 2010/11/26.
7. Baeten J, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012; 367(5):399-410. Epub 2012 Jul 11.
8. Centers for Disease Control and Prevention. CDC trial and another major study find PrEP can reduce risk of HIV infection among heterosexuals. July 13, 2011.
9. Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, et al. The FEM-PrEP Trial of Emtricitabine/Tenofovir Disoproxil Fumarate (Truvada) among African Women. In: Conference on Retroviruses and Opportunistic Infections; Seattle, WA, 2012.
10. MTN Statement on Decision to Discontinue Use of Tenofovir Gel in VOICE, a Major HIV Prevention Study in Women. November 25, 2011. http://www.mtnstopshiv. org/node/3909. Accessed 06 Jun 2012.
11. Donnnel D, Baeten J, Hendrix C, et al. Tenofovir disoproxil fumarate drug levels indicate PrEP use is strongly correlated with HIV-1 protective effects: Kenya and Uganda. In: Conference on retroviruses and opportunistic infections, Seattle, WA, 2012.
12. Norris Turner A, De Kock AE, Meehan-Ritter A, et al. Many vaginal microbicide trial participants acknowledged they had misreported sensitive sexual behavior in face-to-face interviews. J Clin Epidemiol. 2009; 62(7):759-65.
13. Mensch BS, Hewett PC, Abbott S, et al. Assessing the reporting of adherence and sexual activity in a simulated microbicide trial in South Africa: an interview mode experiment using a placebo gel. AIDS Behav. 2011; 15(2):407-21. Epub 2010/10/05.
14. Thomsen S, Gallo M, Ombidi W, et al. Randomised controlled trial on whether advance knowledge of prostate-specific antigen testing improves participant reporting of unprotected sex. Sex Transm Infect. 2007;83(5):419-20.
15. Carraguard Phase II South Africa Study Team. Expanded safety and acceptability of the candidate vaginal microbicide Carraguard(R) in South Africa. Contraception. 2010; 82(6):563-71. Epub 2010/11/16.
16. Greene E, Batona G, Hallad J, Johnson S, Neema S, Tolley EE. Acceptability and adherence of a candidate microbicide gel among high-risk women in Africa and India. Cult Health Sex. 2010; 12(7):739-54. Epub 2010/04/17.
17. Coly A, Gorbach PM. Microbicide acceptability research: recent findings and evolution across phases of product development. Curr Opin HIV AIDS. 2008; 3(5):581-6. Epub 2009/04/18.
18. Severy LJ, Tolley E, Woodsong C, Guest G. A framework for examining the sustained acceptability of microbicides. AIDS Behav. 2005; 9(1):121-31. Epub 2005/04/07.
19. Minnis AM, Shiboski SC, Padian NS. Barrier contraceptive method acceptability and choice are not reliable indicators of use. Sex Transm Dis. 2003; 30(7):556-61. Epub 2003/07/03.
20. Hendrix C, Minnis A, Guddera V, Riddler S, Salata R, Nakabiito C, et al. MTN-001: A phase 2 cross-over study of daily oral and vaginal TFV in healthy, sexually active women results in significantly different product acceptability and vaginal tissue drug concentrations. In: Conference on retroviruses and opportunistic infections; Boston, MA, 2011.
21. Beigi R, Noguchi L, Parsons T, Macio I, Kunjara Na, Ayudhya R, Chen J, et al. Pharmacokinetics and placental transfer of single-dose tenofovir 1 % vaginal gel in term pregnancy. J Infect Dis. 2011;204(10):1527-31.
22. Donnell D, Baeten J, Hendrix C, Bumpus N, Bangsberg D, Haberer J, et al. Tenofovir drug levels indicate PrEP use is strongly correlated with HIV-1 protective effects. In: 19th conference on retroviruses and opportunistic infections; Seattle, WA, 2012.
23. Gafos M, Mzimela M, Sukazi S, Pool R, Montgomery C, Elford J. Intravaginal insertion in KwaZulu-Natal: sexual practices and preferences in the context of microbicide gel use. Cult Health Sex. 2010; 12(8):929-42. Epub 2010/08/26.
24. Montgomery CM, Gafos M, Lees S, Morar NS, Mweemba O, Ssali A, et al. Re-framing microbicide acceptability: findings from the MDP301 trial. Cult Health Sex. 2010; 12(6):649-62. Epub 2010/04/17.
25. MacPhail C, Terris-Prestholt F, Kumaranayake L, Ngoako P, Watts C, Rees H. Managing men: women's dilemmas about overt and covert use of barrier methods for HIV prevention. Cult Health Sex. 2009; 11(5):485-97. Epub 2009/05/30.
26. Baumgartner JN, Lugina H, Johnson L, Nyamhanga T. "Being faithful" in a sexual relationship: perceptions of Tanzanian adolescents in the context of HIV and pregnancy prevention. AIDS Care. 2010; 22(9):1153-8. Epub 2010/09/09.
27. Minnis AM, Steiner MJ, Gallo MF, Warner L, Hobbs MM, van der Straten A, et al. Biomarker validation of reports of recent sexual activity: results of a randomized controlled study in Zimbabwe. Am J Epidemiol. 2009; 170(7):918-24. Epub 2009/09/11.
28. Rotheram-Borus MJ, Swendeman D, Chovnick G. The past, present, and future of HIV prevention: integrating behavioral, biomedical, and structural intervention strategies for the next generation of HIV prevention. Annu Rev Clin Psychol. 2009; 5:143-67. Epub 2009/03/31.