Behavioral risk assessment in HIV Vaccine Trials Network (HVTN) clinical trials: A qualitative study exploring HVTN staff perspectives

Vaccine

Volumn 31, Issue 40, 2013, Pages 4398-4405

  Andrasik, Michele Peake ^a   Karuna, Shelly T ^a   Nebergall, Michelle ^b   Koblin, Beryl A ^c   Kublin, Jim G ^a  

^a Fred Hutchinson Cancer Research Center   (United States)

^b UNIVERSITY OF CAPE TOWN   (South Africa)

^c NEW YORK BLOOD CENTER   (United States)

Author keywords

Biomedical interventions; HIV; Risk behavior; Vaccine clinical trials

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS VACCINE;

ARTICLE; BEHAVIORAL RESEARCH; HIGH RISK BEHAVIOR; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LONGITUDINAL STUDY; OBSERVATIONAL STUDY; PRIORITY JOURNAL; QUALITATIVE RESEARCH; RISK ASSESSMENT;

BIOMEDICAL INTERVENTIONS; HIV; RISK BEHAVIOR; VACCINE CLINICAL TRIALS;

AIDS VACCINES; ATTITUDE OF HEALTH PERSONNEL; BEHAVIOR; BEHAVIORAL RISK FACTOR SURVEILLANCE SYSTEM; HIV INFECTIONS; HUMANS; PATIENT COMPLIANCE; QUESTIONNAIRES; RISK ASSESSMENT;

EID: 84882832381     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2013.07.003     Document Type: Article

References (21)

1. Ulrich C.M., Wallen G.R., Feister A., Grady C. Respondent burden in clinical research: when are we asking too much of subjects?. IRB 2005, 27(4):17-20.
2. Bradburn N. Respondent burden. Health survey research methods: second biennial conference (Williamsburg, VA) 1977, U.S. Government Printing Office, Washington, DC.
3. Buchbinder S.P., Mehotra D.V., Duerr A., Fitzgerald D.W., Mogg R., Li D., et al. Efficacy assessment of cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomized, placebo-controlled, test-of-concept trial. Lancet 2008, 372(9653):1881-1893.
4. Koblin B.A., Mayer K.H., Noonan E., Wang C.Y., Marmor M., Sanchez J., et al. Sexual risk behaviors, circumcision status, and preexisting immunity to adenovirus type 5 among Men Who Have Sex with Men participating in a randomized HIV-1 efficacy trial: Step Study. J Acquir Immune Defic Syndr 2012, 60(4):405-413.
5. Strauss A., Corbin J. Basics of qualitative research: grounded theory procedures and techniques 1990, Sage, Newbury Park, CA.
6. Saldana J. The coding manual for qualitative researchers 2009, Sage, Thousand Oaks, CA.
7. Miles M.B., Huberman A.M. Qualitative data analysis: a sourcebook of new methods 1994, Sage, Thousand Oaks, CA. 2nd ed.
8. Gray G., Buchbinder S., Duerr A. Overview of Step and Phambili trial results: two phase IIb test-of-concept studies investigating the efficacy of MRK adenovirus type 5 gag/pol/neg subtype B HIV vaccine. Curr Opin HIV AIDS 2010, 5(5):357-361.
9. Newman P.A. Integrating social and biomedical science in HIV vaccine research: obstacles, opportunities and ways forward. Expert Rev Vaccines 2012, 11(1):1-3.
10. Lau C.Y., Stansbury J.P., Gust D.A., Kafaar Z. Social and behavioral science in HIV vaccine trials: a gap assessment of the literature. Expert Rev Vaccines 2009, 8(2):179-190.
11. Bogart L.M., Walt L.C., Pavlovic J.D., Ober A.J., Brown N., Kalichman S.C. Cognitive strategies affecting recall of sexual behavior among high-risk men and women. Health Psychol 2007, 26:787-793.
12. Jaccard J., McDonald R., Wan C.K., Dittus P.J., Quinlan S. The accuracy of self-reports of condom use and sexual behavior. J Appl Soc Psychol 2002, 32:1863-1905.
13. Fals-Stewart W., O'Farrell T.J., Freitas T.T., McFarlin S.K., Rutigliano P. The timeline followback reports of psychoactive substance use by drug-abusing patients: psychometric properties. J Consult Clin Psychol 2000, 68:134-144.
14. Levy S., Sherritt L., Harris S.K., Gates E.C., Holder D.W., Kulig J.W., et al. Test-retest reliability of adolescents' self-report of substance use. Alcohol Clin Exp Res 2004, 28(8):1236-1241.
15. Scheurich A., Muller M.J., Anghelescu I., Lorch B., Dreher M., Hautzinger M., et al. Reliability and validity of the form 90 interview. Eur Addict Res 2005, 11(1):50-56.
16. Slesnick N., Tonigan J.S. Assessment of alcohol and other drug use by runaway youths: a test-retest study of the form 90. Alcohol Treat Q 2004, 22(2):21-34.
17. Carey M.P., Carey K.B., Maisto S.A., Gordon C.M., Weinhardt L.S. Assessing sexual risk behavior with the Timeline Followback (TLFB) approach: continued development and psychometric evaluation with psychiatric outpatients. Int J STD AIDs 2001, 12:365-375.
18. Sieving R., Hellerstedt W., McNeely C., Fee R., Snyder J., Resnick M. Reliability of self-reported contraceptive use and sexual behaviors among adolescent girls. J Sex Res 2005, 42(2):159-166.
19. Sneed C.D., Chin D., Rotheram-Borus M.J., Milburn N.G., Murphy D.A., Corby N., et al. Test-retest reliability for self-reports of sexual behavior among Thai and Korean respondents. AIDS Educ Prev 2001, 13(4):302-310.
20. Boekeloo B.O., Schiavo L., Rabin D.L., Conion R.T., Jordan C.S., Mundt D.J. Self-reports of HIV risk factors by patients at a sexually transmitted disease clinic: audio vs. written questionnaires. Am J Public Health 1994, 84(5):754-760.
21. Turner C.F., Ku L., Rogers S.M., Lindberg L.D., Pleck J.H., Sonenstein F.L. Adolescent sexual behavior, drug use, and violence: increased reporting with computer survey technology. Science 1998, 208(5365):867-873.