Abstract / Summary
Abstract Background Clinical HIV research involving investigational or newly approved medications requires women of childbearing potential to use two forms of contraception to minimize fetal risk. These requirements also apply to adolescents who can become pregnant, yet ethical and legal guidelines rarely address their unique experiences and concerns, and little is known about whether and how such requirements influence adolescents’ participation in research. This study explores the perspectives of adolescents in Malawi and Botswana on contraception use requirements for participation in clinical HIV research. Methods We conducted in-depth interviews with adolescents aged 15 to 20 years in Botswana and Malawi who had experienced pregnancy and were either living with HIV or at risk of HIV acquisition. Participants were purposively recruited from clinics and peer support groups. Interview transcripts were coded using a collaboratively developed codebook that combined a-priori codes with codes inductively generated from detailed transcript review. Thematic analysis was applied to identify patterns and emergent themes in perceived advantages and disadvantages of requiring contraception use for participation in clinical HIV research. Results A total of 80 adolescents were interviewed (40 living with HIV, 40 at risk of HIV acquisition). Participants’ mean age was 17.8 years (SD = 1.2). 60% were single and about a quarter (26.3%) reported having a non-cohabitating partner. The mean age at the first pregnancy was 16.9 years (SD = 1.4). Most (72.5%) expressed support for contraception requirements. Participants described three perceived advantages of requiring two forms of contraception for clinical HIV research participation: prevention of pregnancy via required contraceptive use, protection from HIV and other sexually transmitted infections, and preservation of the study quality and integrity. Perceived disadvantages included concerns about side effects associated with required contraception use, lack of choice and autonomy related to the contraception requirement, and misalignment between required contraception use and current lifestyle. Conclusions Most adolescents supported requiring contraception for research participation but expressed concerns about side effects and constraints on autonomy. These findings highlight the need for approaches that support adolescents’ autonomy and reproductive choices while appropriately balancing the need to protect against potential harms of exposure to investigational medication during pregnancy.