Microbicide acceptability research: Recent findings and evolution across phases of product development

Current Opinion in HIV and AIDS

Volumn 3, Issue 5, 2008, Pages 581-586

  Coly, Astou ^a   Gorbach, Pamina M ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Acceptability; HIV; Microbicide

Indexed keywords

CARBOPOL 974P; CARRAGEENAN; LUBRICATING AGENT; MICROBICIDE; PRO 2000; SPERMICIDAL AGENT; TENOFOVIR;

AFRICA; BURNING SENSATION; CENTRAL AMERICA; CHINA; CLINICAL TRIAL; DRUG FORMULATION; DRUG RESEARCH; DRUG SAFETY; HETEROSEXUAL MALE; HIGH RISK POPULATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INDIA; LIBIDO; MALE HOMOSEXUAL; PATIENT COMPLIANCE; PREVALENCE; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; QUALITATIVE ANALYSIS; QUANTITATIVE ANALYSIS; REVIEW; SEX DIFFERENCE; SEXUAL BEHAVIOR; SEXUAL INTERCOURSE; SKIN PRURITUS; SKIN TINGLING; STANDARDIZATION; THAILAND; VAGINAL LAVAGE;

EID: 67649853292     PISSN: 1746630X     EISSN: 17466318     Source Type: Journal    
DOI: 10.1097/COH.0b013e32830aba00     Document Type: Review

References (32)

1. UNAIDS/WHO. 2007 AIDS epidemic update. Geneva: UNAIDS/WHO; 2007.
2. Severy L, Newcomer S. Critical issues in contraceptive and STI acceptability research. J Soc Issues 2005; 61:45-65.
3. Severy LJ, Tolley E, Woodsong C, Guest G. A framework for examining the sustained accpetability of microbicides. AIDS Behav 2005; 9:121-131.
4. Mantell JE, Myer L, Carballo-Dieguez A, et al. Microbicide acceptability research: current approaches and future directions. Soc Sci Med 2005; 60:319-330.
5. Carballo-Diéguez A, Exner T, Dolezal C, et al. Rectal microbicide acceptability: results of a volume escalation trial. Sex Transm Dis 2007; 34:224-229. This study was innovative in that it attempted to quantify the volume of rectal microbicide that would be acceptibility during receptive anal intercourse among MSM. The findings emphasized the importance of assessing acceptable volumes during sexual intercourse. Volumes that were deemed acceptable without intercourse were no longer acceptable during anal intercourse.
6. Rosen RK, Morrow KM, Carballo-Diéguez A, et al. Acceptability of Tenofovir Gel as a Vaginal Microbicide Among Women in a Phase I Trial: a mixed-methods study. J Womens Health 2008; 17:383-392. In this phase I clinical trial, both quantitative and qualitative data were collected to assess acceptability of tenofovir gel. The authors advocate the use of both methods in future trials as qualitative interviews can help explain acceptability data collected in structured questionnaires.
7. Ballagh SA, Brache V, Mauck C, et al. A phase I study of the functional performance, safety and acceptability of the BufferGel Duet. Contraception 2008; 77:130-137.
8. Williams DL, Newman DR, Ballagh SA, et al. Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY jelly used with a diaphragm. Sex Transm Dis 2007; 34:977-984.
9. Ramjee G, Morar NS, Braunstein S, et al. Acceptability of Carraguard, a candidate microbicide and methyl cellulose placebo vaginal gels among HIV-positive women and men in Durban, South Africa. AIDS Res Ther 2007; 4:20. Acceptability of Carraguard was assessed among HIV-infected men and women in this phase I clinical trial using both structured and semi-structured in-depth interviews. This paper is among the few that examine the acceptability of a candidate microbicide among HIV-positive individuals as part of a clinical trial. As emphasized by the authors, there is a need to study acceptability among HIV-infected individuals as once microbicides are on the market they are likely to be used by individuals who do not know their HIV status.
10. Carballo-Diéguez A, Balán IC, Morrow K, et al. Acceptability of tenofovir gel as a vaginal microbicide by US male participants in a phase I clinical trial (HPTN 050). AIDS Care 2007; 19:1026-1031.
11. Doh AS, Ngoh N, Roddy R, et al. Safety and acceptability of 6% cellulose sulfate vaginal gel applied four times per day for 14 days. Contraception 2007; 76:245-249.
12. Barnhart KT, Rosenberg MJ, MacKay HT, et al. Contraceptive efficacy of a novel spermicidal microbicide used with a diaphragm: a randomized controlled trial. Obstet Gynecol 2007; 110:577-586.
13. Trottier S, Omar RF, Désormeaux A, et al. Safety, tolerance and acceptability of the Invisible Condom and its vaginal applicator in healthy women and their male sexual partners. Contraception 2007; 76:117-125.
14. Joglekar N, Joshi S, Kakde M, et al., HIV Prevention Trial Network 047 Protocol Team. Acceptability of PRO2000 vaginal gel among HIV un-infected women in Pune, India. AIDS Care 2007; 19:817-821.
15. Jespers V, Buvé A, Van Damme L. Safety trial of the vaginal microbicide cellulose sulfate gel in HIV-positive men. Sex Transm Dis 2007; 34:519-522.
16. Kilmarx PH, van de Wijgert JH, Chaikummao S, et al. Safety and acceptability of the candidate microbicide Carraguard in Thai Women: findings from a Phase II Clinical Trial. J Acquir Immune Defic Syndr 2006; 43:327-334.
17. Kilmarx PH, Blanchard K, Chaikummao S, et al. A randomized, placebocontrolled trial to assess the safety and acceptability of use of carraguard vaginal gel by heterosexual couples in Thailand. Sex Transm Dis 2008; 35:226-232. This study evaluated the acceptability of a candidate microbicide, Carraguard during sexual intercourse among male partners of women enrolled in a clinical trial. Acceptability was assessed over a relatively longer period (six months).
18. Jones DL, Weiss SM, Chitalu N, et al. Acceptability of microbicidal surrogates among Zambian women. Sex Transm Dis 2008; 35:147-153.
19. Bukusi EA, Steele M, Cohen CR, et al. Safety, acceptability, and tolerability of 3 topical microbicides among heterosexual Kenyan men. J Acquir Immune Defic Syndr 2007; 44:423-428.
20. Schwartz JL, Ballagh SA, Kwok C, et al. Fourteen-day safety and acceptability study of the universal placebo gel. Contraception 2007; 75:136-141.
21. Short MB, Succop PA, Rupp R, Rosenthal SL. Adolescents' reasons for using a microbicide-like product over time. International Journal of Std and AIDS 2008; 19:115-117.
22. Nodin N, Carballo-Diéguez A, Ventuneac AM, et al. Knowledge and acceptability of alternative HIV prevention bio-medical products among MSM who bareback. AIDS Care 2008; 20:106-115.
23. Carballo-Diéguez A, Bauermeister JA, Ventuneac A, et al. The use of rectal douches among HIV-uninfected and infected men who have unprotected receptive anal intercourse: implications for rectal microbicides. AIDS Behav 2007; Aug 18 [Epub ahead of print].
24. Weeks MM, Abbott M, Liao S, et al. Opportunities for woman-initiated HIV prevention methods among female sex workers in southern China. J Sex Res 2007; 44:190-201.
25. Carballo-Diéguez A, O'Sullivan LF, Lin P, et al. Awareness and attitudes regarding microbicides and Nonoxynol-9 use in a probability sample of gay men. AIDS Behav 2007; 11:271-276.
26. Wang Y, Liao SS, Weeks MR, et al. Acceptability of hypothetical microbicides among women in sex establishments in rural areas in Southern China. Sex Transm Dis 2008; 35:102-110.
27. Morrow KM, Fava JL, Rosen RK, et al. Willingness to use microbicides varies by race/ethnicity, experience with prevention products, and partner type. Health Psychol 2007; 26:777-786.
28. Short MB, Perfect MM, Auslander BA, et al. Measurement of microbicide acceptability among U.S. adolescent girls. Sex Transm Dis 2007; 34:362-366.
29. Morrow KM, Fava JL, Rosen RK, et al. Willingness to use microbicides is affected by the importance of product characteristics, use parameters, and protective properties. J Acquir Immune Defic Syndr 2007; 45:93-101.
30. Morrow KM, Ruiz MS. Assessing microbicide acceptability: a comprehensive and integrated approach. AIDS Behav 2008; 12:272-283.
31. Cohen JA, Steele MS, Ureña FI, Beksinska ME. Microbicide applicators: understanding design preferences among women in the Dominican Republic and South Africa. Sex Transm Dis 2007; 34:15-19.
32. Sunder PK, Ramos S, Short MB, Rosenthal SL. Adolescent girls' communication with "mothers" about topical microbicides. J Pediatr Adolesc Gynecol 2006; 19:373-379.