|
|
|||
|
Research |
|||
Risk of Pregnancy Should be Considered When Designing Effectiveness Trials of HIV-Prevention DrugsA recently published article, supported by USAID and the National Institute of Child Health and Human Development, summarizes key issues related to pregnancy that should be carefully considered during the design of trials that test the effectiveness of HIV-prevention drugs. The issues were raised during several meetings of HIV-prevention researchers and selected experts. Because trials that test the effectiveness of HIV-prevention drugs require the enrollment of sexually active women of reproductive age, study participants are simultaneously exposed to the risks of HIV and pregnancy. The risk of pregnancy in particular has important — yet often complicated — implications for how trials are conducted, and how data are interpreted. For example, trial organizers need to protect participants by preventing pregnancies or by identifying pregnancies before a fetus is unnecessarily exposed to a study drug. Preventing pregnancies is also important because the results of a trial can be skewed when pregnant women stop taking a study drug. Yet lack of access to contraception can be a problem. Also, some contraceptive methods could alter the effectiveness of a study drug, or their side effects could mimic a drug's toxic effects. Other major issues identified during the meetings include ensuring the safety of trial participants; concerns related to the interpretation of data when participants become pregnant; strategies for preventing pregnancy; and the reliable, safe identification and care of pregnant women during trials. To read more about this topic, click here. |
|||
|
|||
