A prognostic model for HIV seroconversion among injection drug users as a tool for stratification in clinical trials

J Acquir Immune Defic Syndr. 2005 Aug 1;39(4):489-95. doi: 10.1097/01.qai.0000153424.56379.61.

Abstract

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.

Publication types

  • Evaluation Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Clinical Trials as Topic / methods
  • Cohort Studies
  • HIV Seropositivity / epidemiology*
  • Humans
  • Male
  • Models, Statistical*
  • Prospective Studies
  • Reproducibility of Results
  • Research Subjects
  • Risk Factors
  • Substance Abuse, Intravenous*