Integrating behavioral and social science research into microbicide clinical trials: Challenges and opportunities

American Journal of Public Health

Volumn 96, Issue 1, 2006, Pages 79-83

  Tolley, Elizabeth E ^a   Severy, Lawrence J ^a  

^a FAMILY HEALTH INTERNATIONAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MICROBICIDE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; BEHAVIORAL SCIENCE; CONDOM; DRUG INDUSTRY; FAMILY PLANNING; HEALTH PROMOTION; HEALTH SERVICES RESEARCH; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; REVIEW; SEXUAL BEHAVIOR; SEXUALLY TRANSMITTED DISEASE; SOCIOLOGY; VIRUS TRANSMISSION;

ADMINISTRATION, TOPICAL; ANTI-INFECTIVE AGENTS; BEHAVIORAL RESEARCH; BIOMEDICAL RESEARCH; CLINICAL TRIALS; HIV INFECTIONS; HUMANS; RESEARCH DESIGN; SOCIAL SCIENCES;

EID: 29944444844     PISSN: 00900036     EISSN: None     Source Type: Journal    
DOI: 10.2105/AJPH.2004.043471     Document Type: Review

References (39)

1. Glasgow RE, Lightenstein E, Marcus AC. Why don't we see more translation of health promotion research to practice? Rethinking the efficacy-to- effectiveness transition. Am J Public Health. 2003;93:1261-1267.
2. UNAIDS. Women, Girls, HIV and AIDS-World AIDS Campaign 2004. Available at: http://www.unaids.org/wac_2004/index_en.htm. Accessed October 6, 2005.
3. Boonstra H. Campaign to accelerate microbicide development for STD prevention gets under way. Guttmacher Rep Public Pol. 2000;Feb:3-5.
4. Kresge K. Agreeing to disagree: the future of microbicides. HIV/AIDS Treatment Insider. 2003;4:1-6.
5. Speiler J. Behavior Issues in Dual Protection. Washington, DC: Population Association of America; 1997.
6. Stone A. Clinical Trials of Microbicides. Microbicide Q. 2003;1:13-18.
7. Elias C, Coggins C. Acceptability research on female-controlled barrier methods to prevent heterosexual transmission of HIV: Where have we been? Where are we going? J Women's Health Gender-Based Med. 2001;10:163-173.
8. Bentley ME, Fullem AM, Tolley EE, et al. Acceptability of a microbicide among women and their partners in a 4-country Phase I trial. Am J Public Health. 2004;94:1159-1164.
9. Bentley ME, Morrow KM, Fullem A, et al. Acceptability of a novel vaginal microbicide during a safety trial among low-risk women. Fam Plann Perspect. 2000;32:184-188.
10. Morrow K, Rosen R, Richter L, et al. The acceptability of an investigational vaginal microbicide, PRO 2000 Gel, among women in a phase 1 clinical trial. J Women's Health. 2003;12:655-666.
11. Auerbach JD, Coates TJ. HIV prevention research: accomplishments and challenges for the third decade of AIDS. Am J Public Health. 2000;90:1029-1032.
12. Bachrach CA, Abeles RP. Social science and health research: growth at the National Institutes of Health. Am J Public Health. 2004;94:22-28.
13. Folkers GK, Fauci AS. The AIDS research model: implications for other infectious diseases of global health importance. JAMA. 2001;286:458-461.
14. Warner DL, Hatcher RA. Male condoms. In: Hatcher RA, Trussell J, Stewart F, et al., eds. Contraceptive Technology. 17th ed. New York, NY: Ardent Media Inc; 1998:325-355.
15. Steiner MJ, Cates WJr, Warner L. The real problem with male condoms is nonuse. Sex Transm Dis. 1999;26:459-462.
16. Gardner R, Blackburn RD, Upadhyay UD. Closing the Condom Gap. Baltimore, Md: Johns Hopkins University School of Public Health, Population Information Program; 1999.
17. Misovich SJ, Fisher JD, Fisher WA. Close relationships and elevated HIV risk behavior: evidence and possible underlying psychological processes. Rev General Psychol. 1997;1:72-107.
18. Castaneda D. The close relationship context and HIV/AIDS risk reduction among Mexican Americans. Sex Roles. 2000;42:551-579.
19. Worth D. Sexual decision-making and AIDS: why condom promotion among vulnerable women is likely to fail. Stud Fam Plann. 1989;20:297-307.
20. de Zoysa I, Sweat MD, Denison JA. Faithful but fearful: reducing HIV transmission in stable relationships. AIDS. 1996;10(suppl A):S197-S203.
21. Heise LL, Elias C. Transforming AIDS prevention to meet women's needs: a focus on developing countries. Soc Sci Med. 1995;40:931-943.
22. Varga C. The condom conundrum: barriers to condom use among commercial sex workers in Durban, South Africa. Afr J Reprod Health. 1997;1:74-88.
23. Ortiz-Torres B, Williams SP, Ehrhardt A. Urban women's gender scripts: implications for HIV prevention. Culture, Health Sexual. 2003;5:1-17.
24. Beckman LJ, Harvey M. Factors affecting the consistent use of barrier methods of contraception. Obstet Gynecol. 1996;88:65S-71S.
25. Stein ZA, Myer L, Susser M. The design of prophylactic trials for HIV: the case of microbicides. Epidemiology. 2002;14:80-83.
26. Pedhazur EJ, Schmelkin LP. Artifacts and pitfalls in research. In: Pedhazur ED, Schmelkin LP, eds. Measurement, Design, and analysis: An Integrated Approach. Hillsdale, NJ: Lawrence Erlbaum Associates; 1991:234-241.
27. Alary M, Mukenge-Tshibaka L, Bernier F, et al. Decline in the prevalence of HIV and sexually transmitted diseases among female sex workers in Cotonou, Benin, 1993-1999. AIDS. 2002;16:463-470.
28. Folkers GK, Fauci AS. AIDS Agenda Still Daunting. Available at: http://www.nap.edu/issues/19.4/folkers.html. Accessed August 26, 2003.
29. Simmons R, Hall P, Diaz J, Diaz M, Fajans P, Satia J. The strategic approach to contraceptive introduction. Stud Fam Plann. 1997;28:79-94.
30. Potter JE. The persistence of out-moded contraceptive regimes: the cases of Mexico and Brazil. Popul Dev Rev. 1999;25:703-739.
31. Rao Gupta G, Weiss E. Women's lives and sex: implications for AIDS prevention. Cult Med Psychiatry. 1993;17:399-412.
32. Bernard HR; Social Research Methods Qualitative and Quantitative Approaches. Thousand Oaks, Calif: Sage; 2000.
33. Mahoney CA, Thombs DL, Howe CZ. The art and science of scale development in health education research. Health Educ Res. 1995;10:1-10.
34. DeVellis R. Scale Development Theory and Applications. Newbury Park, Calif: Sage; 1991.
35. Fitzpatrick R, Davey C, Buxton MJ, Jones DR. Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess. 1998;2:1-73.
36. Silverman D. The quality of qualitative health research: the open-ended interview and its alternatives. Soc Sci Health. 1998;4:104-118.
37. Ulin PR, Robinson ET, Tolley EE; Qualitative Methods in Public Health: A Field Guide for Applied Research. Indianapolis, Ind: Jossey-Bass; 2005.
38. Lincoln Y, Guba E. Establishing trustworthiness. In: Lincoln Y, Guba E, eds. Naturalistic Inquiry. Beverly Hills, Calif: Sage; 1985:397-444.
39. Guest G, McLellan E, Matia D, et al. HIV vaccine efficacy trial participation: men-who-have-sex-with-men's experiences of risk reduction counseling and perceptions of risk behavior change. AIDS Care. 2005;17:46-57.