The 130th Annual Meeting of APHA

4221.0: Tuesday, November 12, 2002 - 4:00 PM

Abstract #38010

Assessing the accuracy of self-reported behavioral data in a Phase II clinical microbicide trial using audio computer-assisted self-interview (ACASI)

Abigail Norris Turner, BS1, Alana De Kock2, Mohlatlego Sebola3, Amy Meehan4, Kelly Blanchard5, Anwar Hoosen3, Nicol Coetzee2, and Charlotte Ellertson, MPA, PhD6. (1) Population Council, Escondida 110, Colonia Villa Coyoacan, Mexico, DF, 04000, Mexico, +(52) 555 659 5517, anorristurner@popcouncil.org.mx, (2) Department of Public Health and Primary Health Care, University of Cape Town, Level 3, Falmouth Building, Observatory, Cape Town, 7925, South Africa, (3) Department of Medical Microbiology, Medical University of Southern Africa (MEDUNSA), P. O. Box 211, Room n315, 3rd Floor, Clinical Pathology Building, Medunsa, 0204, South Africa, (4) School of Public Health, University of California, Berkeley, 140 Warren Hall #7360, Berkeley, CA 94720-7360, (5) Reproductive Health, Population Council, One Dag Hammarskjold Plaza, New York, NY 10017, (6) Reproductive Health Program, Population Council. Latin America and the Caribbean office., Escondida 110, Colonia Villa Coyoacan, Mexico City, 04000, Mexico

Assessing the reliability of self-reports of sensitive behavior, particularly in microbicide trials, is critically important. If participants report their use of study drugs or devices inaccurately, study conclusions about safety and effectiveness could be wrong. We used audio computer-assisted self-interviewing (ACASI) to ask about the accuracy of face-to-face interviews conducted during a Phase II, double-blinded, randomized clinical trial of a vaginal microbicide. We explored whether embarrassment, fear of criticism, desire to be polite, or other motivations led women to under- or over-report sensitive sexual behavior. The ACASI interviews (n=141) took place in August 2001 at two South African sites participating in the Phase II trial. Up to 36% of ACASI participants reported that they sometimes or always lied to interviewers during the Phase II trial; more women lied to be polite (36%) than because of fear of criticism (25%) or embarrassment (19%). Among sexually active women (n=98), 5% lied about how often they had vaginal sex, 24% lied about using the study gel alone (without condoms), and 16% lied about using the study gel together with condoms. In general, women who lied had actually had vaginal sex more often, used the study gel together with condoms less often, and used the study gel alone more often than they reported to the Phase II interviewers. Over half the participants believed other women sometimes or always lied about sensitive behaviors. These results may allow the Phase II investigators to better understand their findings about this microbicide’s apparent safety, acceptability and preliminary effectiveness.

Learning Objectives: At the conclusion of the session, the participant in this session will be able to

Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.

Broadening the Scope of Reproductive Health: International Perspectives

The 130th Annual Meeting of APHA