Written on the Skin: Participants’ Perspectives on Scarring, Discolouration and Implant Site Reactions Experienced During a Phase I Clinical Trial for a Subdermal HIV Prevention Implant in KwaZulu-Natal, South Africa

Abstract

To address challenges associated with the uptake of daily oral pre-exposure prophylaxis (PrEP) by young women at high risk of acquiring HIV, a range of novel, long-acting, slow-release products are being developed and clinically evaluated. One such technology is an annual implant of tenofovir alafenamide (TAF). This study explores the perspectives of participants from a first-in-human trial of an annual TAF implant to inform considerations for future PrEP implant innovation. The study, conducted in Durban, South Africa between 2022 and 2023, included 29 in-depth interviews (IDIs) and three focus group discussions (FGDs) with 18 participants. All participants experienced some form of implant site reaction (ISR). In some instances, these were minor, and in others, the implant removal process left longer-lasting and more severe skin changes. Participants' perceptions of these ISRs were influenced by concerns about their appearance, social stigma, and associations between scars and gender-based violence. Mild skin changes were deemed acceptable, while severe scarring and discolouration caused concerns about attracting negative attention. Few participants expressed concerns about their own scars, however, visible scars which might be mistaken for a contraceptive implant caused concern. Despite the ISRs experienced, there was positive feedback for this type of technology, and many considered that other women would be interested in adopting a sub-dermal implant should it be effective in preventing HIV. Continued enhancements of next generation implants to enhance drug release rates should consider how to minimise the severity and visibility of ISRs.