A Prognostic Model for HIV Seroconversion Among Injection Drug Users As a Tool for Stratification in Clinical Trials

Objective: The main goal of this study was to construct a prognostic model for HIV seroconversion among injection drug users (IDUs) using easy-to-measure risk indicators.

Design: Cox proportional hazards regression modeling was used for risk stratification in a heterogeneous population of IDUs with regards to HIV risk-taking behaviors.

Methods: Subjects were recruited in a prospective cohort of IDUs followed between September 1992 and October 2001. A total of 1602 men, seronegative at enrollment with at least 1 follow-up visit, were included in the analyses. Only variables that consistently predict HIV seroconversion in several settings were considered. The final model was used to assign a risk score for each participant.

Results: Three risk indicators were included in the risk score to predict HIV seroconversion: unstable housing, average cocaine injections per day, and having shared a syringe with a known HIV-positive partner. Kaplan-Meier survival functions were generated and risk score values stratified in 3 groups. HIV incidence rates per 100 person-years were as follows: 0.91 (95% CI, 0.55-1.52) for the low-risk group, 3.10 (95% CI, 2.49-3.84) for the moderate-risk group, and 7.82 (95% CI, 6.30-9.73) for the high-risk group (log-rank P value < 0.0001).

Conclusion: If validated in other settings, this risk score may improve the prediction of outcome and allow more accurate stratification in clinical trials.