Measure of HIV/STD risk-reduction: strategies for enhancing the utility of behavioral and biological outcome measures for African American couples.

OBJECTIVE: Numerous studies have discussed the value of including biological outcome measures as a complement to behavioral outcome measures to assess the efficacy of HIV risk-reduction interventions. This article highlights strategies used to minimize the limitations of including both self-reported sexual behaviors and biologically confirmed sexually transmitted diseases as primary outcome measures in an HIV/sexually transmitted disease (STD) prevention program for African American serodiscordant couples (Eban).

DESIGN: Couples receiving an HIV intervention condition (Eban) were compared with couples receiving a time-equivalent General Health Promotion condition on behavioral and biological outcomes. Both behavioral and biological data were collected at baseline, immediately postintervention, and at 6 and 12 months postintervention.

METHODS: Literature reviews, consulting other researchers who conducted couples studies, our investigative team's experience in previous HIV interventions, and formative work were used to develop procedures to minimize potential limitations associated with the inclusion of behavioral and biological outcome measures for Eban.

RESULTS: Given the strengths of including behavioral and biological outcome measures, the Eban study chose to have both measures serve as primary outcomes. The primary behavioral outcome for the trial is the proportion of protected vaginal and anal intercourse episodes that occurred within the index couple in 90 days before each follow-up assessment and over the 12-month postintervention follow-up period. The primary biological outcome is the proportion of participants (male or female study partners) with an incident STD (Chlamydia, gonorrhea, or trichomoniasis) over the 12-month postintervention follow-up period.

CONCLUSIONS: Employing procedures to minimize limitations of using self-reported sexual behaviors and STDs as complementary primary outcomes enhances their utility as measures of the efficacy of HIV/STD prevention interventions.