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The Motivations and Experiences of Young Women in a Microbicide Trial in the USA and Puerto Rico

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DOI: 10.4236/wja.2013.33023    3,389 Downloads   5,297 Views   Citations

ABSTRACT

Young women are an important target group in microbicide research, yet little is known about why they participate and stay in microbicide trials. Our study examined motivations for participating in a Phase I microbicide trial among 61 women ages 18 - 24 years in the continental USA and Puerto Rico. We also examined their perspectives on study participation. Participants underwent a semi-structured in-depth interview in which they were asked about factors that motivated enrollment and their experiences while participating. They also completed a Web-based Computer Assisted Self Interview in which they were asked to rate study burden (1 = low to 4 = high). Factors that motivated enrollment were altruism (29%), compensation (17%), a combination of altruism and compensation (37%) and free medical exams (17%). Factors that encouraged participants to stay in the study were study staff (95%), confirmation of good health (41%), and the opportunity to learn about their bodies (17%). Mean ratings of study burden ranged from 1.83 (having to travel to site) to 2.41 (colposcopy), indicating that participants were not highly bothered by visits or procedures. Although Phase I trials require invasive procedures, participants were not highly bothered by them and recognized them as necessary. Good relationships with staff and clear information about how procedures contribute to study goals may encourage participants to remain in trials. Young women may be motivated to enter microbicide trials by stressing the role they will play in discovering better HIV-prevention methods and highlighting the comprehensive preventive exams they will receive.

Conflicts of Interest

The authors declare no conflicts of interest.

Cite this paper

R. Giguere, G. Zimet, J. Kahn, C. Dolezal, C. Leu, M. Mabragaña, I. McGowan and A. Carballo-Diéguez, "The Motivations and Experiences of Young Women in a Microbicide Trial in the USA and Puerto Rico," World Journal of AIDS, Vol. 3 No. 3, 2013, pp. 179-186. doi: 10.4236/wja.2013.33023.

References

[1] Q. Abdool Karim, S. S. Abdool Karim, J. A. Frohlich, A. C. Grobler, C. Baxter, L. E. Mansoor, et al., “Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women,” Science, Vol. 329, No. 5996, 2010, pp. 1168-1174. doi:10.1126/science.1193748
[2] M. E. Quinones-Mateu and G. Vanham, “HIV Microbicides: Where Are We Now?” Current HIV Research, Vol. 10, No. 1, 2012, pp. 1-2.
[3] A. van der Straten, L. Van Damme, J. E. Haberer and D. R. Bangsberg, “Unraveling the Divergent Results of Pre-Exposure Prophylaxis Trials for HIV Prevention,” AIDS, Vol. 26, No. 7, 2012, pp. F13-F19. doi:10.1097/QAD.0b013e3283522272
[4] UNAIDS, “AIDS at 30: Nations at the Crossroads,” 2011. http://www.unaids.org/unaids_resources/aidsat30/aids-at-30.pdf
[5] UNAIDS, “UNAIDS Report on the Global AIDS Epidemic 2010,” 2010. http://www.unaids.org/globalreport/global_report.htm
[6] R. J. DiClemente, M. S. Ruiz and J. M. Sales, “Barriers to Adolescents’ Participation in HIV Biomedical Prevention Research,” Journal of Acquired Immune Deficiency Syndromes, Vol. 54 No. S1, 2010, pp. S12-S17. doi:10.1097/QAI.0b013e3181e1e2c0
[7] G. Colfax, S. Buchbinder, G. Vamshidar, C. Celum, D. McKirnan, J. Neidig, et al., “Motivations for Participating in an HIV Vaccine Efficacy Trial,” Journal of Acquired Immune Deficiency Syndromes, Vol. 39, No. 3, 2005, pp. 359-364. doi:10.1097/01.qai.0000152039.88422.ec
[8] P. A. Newman, N. Duan, K. J. Roberts, D. Seiden, E. T. Rudy, D. Swendeman, et al., “HIV Vaccine Trial Participation among Ethnic Minority Communities: Barriers, Motivators, and Implications for Recruitment,” Journal of Acquired Immune Deficiency Syndromes, Vol. 41, No. 2, 2006, pp. 210-217. doi:10.1097/01.qai.0000179454.93443.60
[9] C. D. Voytek, K. T. Jones and D. S. Metzger, “Selectively Willing and Conditionally Able: HIV Vaccine Trial Participation among Women at ‘High Risk’ of HIV Infection,” Vaccine, Vol. 29, No. 36, 2011, pp. 6130-6135. doi:10.1016/j.vaccine.2011.06.064
[10] S. P. Buchbinder, B. Metch, S. E. Holte, S. Scheer, A. Coletti and E. Vittinghoff, “Determinants of Enrollment in a Preventive HIV Vaccine Trial: Hypothetical versus Actual Willingness and Barriers to Participation,” Journal of Acquired Immune Deficiency Syndromes, Vol. 36, No. 1, 2004, pp. 604-612. doi:10.1097/00126334-200405010-00009
[11] R. P. Strauss, S. Sengupta, S. Kegeles, E. McLellan, D. Metzger, S. Eyre, et al., “Willingness to Volunteer in Future Preventive HIV Vaccine Trials: Issues and Perspectives from Three US Communities,” Journal of Acquired Immune Deficiency Syndromes, Vol. 26, No. 1, 2001, pp. 63-71.
[12] L. Balfour, K. Corace, G. A. Tasca, C. Tremblay, J.-P. Routy and J. B. Angel, “Altruism Motivates Participation in a Therapeutic HIV Vaccine Trial (CTN 173),” AIDS Care, Vol. 22, No. 11, 2010, pp. 1403-1409. doi:10.1080/09540121003693522
[13] R. A. Jenkins, S. Chinaworapong, P. A. Morgan, C. Ruangyuttikarn, A. Sontirat, J. Chiu, et al., “Motivation, Recruitment, and Screening of Volunteers for a Phase I/II HIV Preventive Vaccine Trial in Thailand,” Journal of Acquired Immune Deficiency Syndromes, Vol. 18, No. 2, 1998, pp. 171-177. doi:10.1097/00042560-199806010-00009
[14] K. Tharawan, C. Manopaiboon, C. Ellertson, K. Limpakarnjanarat, S. Chaikummao, P. H. Kilmarx, et al., “Women’s Willingness to Participate in Microbicide Trials in Northern Thailand,” Journal of Acquired Immune Deficiency Syndromes, Vol. 28, No. 2, 2001, pp. 180-186.
[15] E. R. Volkmann, D. Claiborne and J. S. Currier, “Determinants of Participation in HIV Clinical Trials: The Importance of Patients’ Trust in Their Provider,” HIV Clinical Trials, Vol. 10, No. 2, 2009, pp. 104-109. doi:10.1310/hct1002-104
[16] C. Woodsong, P. Alleman, P. Musara, A. Chandipwisa, M. Chirenje, F. Martinson, et al., “Preventive Misconception as a Motivation for Participation and Adherence in Microbicide Trials: Evidence from Female Participants and Male Partners in Malawi and Zimbabwe,” AIDS Behavior, Vol. 16, No. 3, 2012, pp. 785-790. doi:10.1007/s10461-011-0027-7
[17] E. Ruzagira, S. Wandiembe, L. Bufumbo, J. Levin, M. A. Price, H. Grosskurth, et al., “Willingness to Participate in Preventive HIV Vaccine Trials in a Community-Based Cohort in South Western Uganda,” Tropical Medicine & International Health, Vol. 14, No. 2, 2009, pp. 196-203. doi:10.1111/j.1365-3156.2008.02200.x
[18] J. M. O’Connell, R. S. Hogg, K. Chan, S. A. Strathdee, N. McLean, S. L. Martindale, et al., “Willingness to Participate and Enroll in a Phase 3 Preventive HIV-1 Vaccine Trial,” Journal of Acquired Immune Deficiency Syndromes, Vol. 31, No. 5, 2002, pp. 521-528. doi:10.1097/00126334-200212150-00010
[19] G. deBruyn, M. G. Hudgens, P. S. Sullivan and A. C. Duerr, “Participant Retention in Clinical Trials of Candidate HIV Vaccines,” Journal of Acquired Immune Deficiency Syndromes, Vol. 39, No. 4, 2005, pp. 499-501. doi:10.1097/01.qai.0000148532.12329.df
[20] P. J. Feldblum, V. Halpern, C.-C. Lie, O. Obunge, F. Ogunsola, W. Ampofo, et al., “What Predicts Non-Retention in Microbicide Trials?” Contemporary Clinical Trials, Vol. 32, No. 4, 2011, pp. 512-516. doi:10.1016/j.cct.2011.03.008
[21] A. Carballo-Diéguez, R. Giguere, C. Dolezal, B. A. Chen, J. Kahn, G. Zimet, et al., “Tell Juliana’: Acceptability of the Candidate Microbicide VivaGel? and Two Placebo Gels among Ethnically Diverse, Sexually Active Young Women Participating in a Phase 1 Microbicide Study,” AIDS Behavior, Vol. 16, No. 7, 2012, pp. 1761-1774. doi:10.1007/s10461-011-0028-6
[22] I. McGowan, K. Gomez, K. Bruder, I. Febo, B. A. Chen, B. A. Richardson, et al., “Phase 1 Randomized Trial of the Vaginal Safety and Acceptability of SPL7013 Gel (VivaGel) in Sexually Active Young Women (MTN-004),” AIDS, Vol. 25, No. 8, 2011, pp. 1057-1064. doi:10.1097/QAD.0b013e328346bd3e
[23] R. Giguere, A. Carballo-Diéguez, A. Ventuneac, M. Mabragana, C. Dolezal, B. A. Chen, et al., “Variations in Microbicide Gel Acceptability among Young Women in the USA and Puerto Rico,” Cult Health Sexuality, Vol. 14, No. 2, 2011, pp. 151-166. doi:10.1080/13691058.2011.630099
[24] K. M. MacQueen, E. McLellan, K. Kay and B. Milstein, “Codebook Development for Team-Based Qualitative Analysis,” Cultural Anthropology Methods, Vol. 10, No. 2, 1998, pp. 31-36.
[25] “NVivo Qualitative Data Analysis Software; QSR International Pty Ltd. Version 8, 2008,” 2008.
[26] M. Q. Patton, “Qualitative Research and Evaluation Methods,” SAGE, Thousand Oaks, 2002.
[27] “PASW Statistics 18, Release Version 18.0.0 (SPSS, Inc., 2009, Chicago, IL, www.spss.com).”
[28] R. W. Grant and J. Sugarman, “Ethics in Human Subjects Research: Do Incentives Matter?” Journal of Medicine and Philosophy, Vol. 29, No. 6, 2004, pp. 717-738. doi:10.1080/03605310490883046
[29] E. B. D. Ripley, “A Review of Paying Research Participants: It’s Time to Move beyond the Ethical Debate,” Journal of Empirical Research on Human Research Ethics: An International Journal, Vol. 1, No. 4, 2006, pp. 9-20. doi:10.1525/jer.2006.1.4.9
[30] S. T. Callahan and W. O. Cooper, “Uninsurance and Health Care Access among Young Adults in the United States,” Pediatrics, Vol. 116, No. 1, 2005, pp. 88-95. doi:10.1542/peds.2004-1449
[31] C. Scott, J. Walker, P. White and G. Lewith, “Forging Convictions: The Effects of Active Participation in a Clinical Trial,” Social Science & Medicine, Vol. 72, No. 12, 2011, pp. 2041-2048. doi:10.1016/j.socscimed.2011.04.021

  
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