Effects of written informed consent requirements on HIV testing rates: evidence from a natural experiment.

OBJECTIVES

I evaluated the effects of written informed consent requirements on HIV testing rates in New York State to determine whether such consent creates barriers that discourage HIV testing.

METHODS

New York streamlined its HIV testing consent procedures on June 1, 2005. If written informed consent creates barriers to HIV testing, then New York's streamlining exercise should have reduced such barriers and increased HIV testing rates. I used logistic regression to estimate the effects of New York's policy change.

RESULTS

New York's streamlined consent procedures led to a 31.4% (95% confidence interval [CI] = 20.9%, 41.9%) increase in the state's HIV testing rate. In absolute terms, 7% of the state's population had been tested for HIV in the preceding 6 months under the streamlined procedures, whereas only 5.3% would have been tested under the original procedures. These estimates imply that the streamlined consent procedures accounted for approximately 328 000 additional HIV tests in the 6 months after the policy change.

CONCLUSIONS

Written informed consent requirements are a substantial barrier to HIV testing in the United States.There may be a trade-off between efforts to increase HIV testing rates and efforts to improve patient awareness.