AEGiS-14IAC: Telling the truth in microbicide trials: using audio computer-assisted self-interview (ACASI) to assess the accuracy of self-reported behavioral data in a Phase II clinical trial.

14th International AIDS Conference

Barcelona, Spain - July 7-12, 2002

Telling the truth in microbicide trials: using audio computer-assisted self-interview (ACASI) to assess the accuracy of self-reported behavioral data in a Phase II clinical trial.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. LbPeC9028)

Turner AN, De Kock A, Sebola M, Meehan A, Blanchard K, Hoosen A, Coetzee N, Ellertson C
Population Council, Mexico City, Mexico

BACKGROUND: Assessing the reliability of self-reports of sensitive behavior, particularly in HIV-prevention 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.

METHODS: 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=132) took place in August 2001 at two South African sites participating in the Phase II trial.

RESULTS: More than half the ACASI participants (53%) reported that they lied for one or more reasons during the Phase II trial. More women lied to be polite (34%) than because of fear of criticism (24%) or embarrassment (18%). Among sexually active women (n=95), 5% reported that they lied about how often they had vaginal sex, 24% lied about how often they used the study gel alone (without condoms), and 17% lied about how often they used 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. Only 8% of participants preferred being interviewed by a person (instead of the computer) and 97% found the computer interview easy.

CONCLUSIONS: The results may allow the Phase II investigators to better understand their findings about this microbicide's apparent safety, acceptability and preliminary effectiveness. In addition, the data also suggest that ACASI is a feasible research method for use in this population, and is perhaps preferable to face-to-face interviewing for subsequent microbicide trials.

Keywords: AEGIS, Interviews, Computers, Data Collection, Sex Behavior, Condoms, Anti-Infective Agents, HIV Infections, Ego, HIV Seropositivity, Attitude to Computers, Human, Female, methods, utilization

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