Ethical complexities in contraceptive mandates for adolescent clinical trial participation: a qualitative analysis of U.S. adolescents' perspectives.

BACKGROUND

Clinical trials often require women and girls of childbearing potential to adhere to contraceptive mandates, typically requiring the use of two forms of contraceptives for the duration of the study. Understanding adolescent perspectives on contraceptive mandates within HIV prevention and treatment trials is critical for evaluating whether and when such requirements are ethically justified and, if so, how they might be appropriately applied in trials involving this group.

METHODS

We conducted semi-structured interviews with adolescents age 15-24 in the U.S. on their perspectives about contraceptive requirements. Interviews were audio-recorded and transcribed verbatim. We used Nvivo qualitative analysis software to code transcripts, and then conducted thematic analysis to identify emergent patterns in adolescents' perceptions of the advantages and disadvantages of requiring contraception use for adolescent participants of HIV research studies.

RESULTS

Forty adolescents were interviewed in total. Overall, most participants expressed support for a contraceptive requirement. Regardless of their stance, perceived advantages and disadvantages of such requirements stood in tension, including the ability to prevent pregnancy and desires to become pregnant, desirable health benefits and concerning side effects, and voluntary participation and violated decisional autonomy.

CONCLUSION

Our findings illustrate that although contraceptive mandates are intended to facilitate and promote inclusion in research, they can simultaneously work to restrict adolescent participation in research and limit access to its potential benefits. In doing so, these requirements risk undermining their ethical justification and obstructing the generation of data needed to advance health outcomes for adolescents.