Peer-reviewed article
Ethical complexities in contraceptive mandates for adolescent clinical trial participation: a qualitative analysis of U.S. adolescents' perspectives.
Waltz M, Lyerly AD, Baron HC, Masese RV, Day S ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study explored how U.S. adolescents aged 15-24 view contraceptive requirements in clinical trials, particularly HIV prevention and treatment research. Forty adolescents were interviewed about their perspectives on mandatory dual-contraceptive use policies. While most supported such requirements, adolescents identified significant tensions, including concerns about restricted autonomy, potential health side effects, and barriers to accessing trial benefits. The researchers conclude that contraceptive mandates, intended to protect adolescents and enable their participation, may paradoxically limit both participation and access to potential health advances.
Key points
- Most of the 40 adolescents interviewed expressed support for contraceptive requirements in HIV trials
- Adolescents perceived tensions between pregnancy prevention goals and personal desires to become pregnant
- Concerns about side effects competed with perceived health benefits of trial participation
- Mandatory contraceptive policies may restrict rather than facilitate adolescent participation in research
- The ethical justification for contraceptive mandates is undermined when they obstruct data generation needed for adolescent health outcomes
Limitations
This is a qualitative study capturing adolescent perspectives and perceptions in the U.S., which may not generalise to other contexts or populations. The study does not measure actual trial participation rates or health outcomes resulting from contraceptive mandates.
Abstract
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.