Feasibility of adjuvant self-administered intravaginal 5-fluorouracil cream following primary treatment of cervical intraepithelial neoplasia grade 2 or 3 among women living with HIV in Kenya: study protocol for a pilot trial

Background Women living with HIV (WLWH), the majority of whom live in low- and middle-income countries (LMICs), are at higher risk of cervical precancer, known as cervical intraepithelial neoplasia (CIN), and are up to six times more likely to get cervical cancer. Current CIN treatment methods, primarily ablation or excision, have high treatment failure rates among WLWH, up to 30% for CIN grade 2 or 3 (CIN2/3) at 24 months following ablation. Without strong follow-up many WLWH with treatment failure are at risk of developing invasive cervical cancer, highlighting the urgent need for improved CIN treatment methods. Prior studies in high-income countries (HICs) have demonstrated that 5-Fluorouracil (5-FU) cream, an antimetabolite drug that is easily accessible in LMICs, can be used intravaginally as adjuvant therapy following primary CIN2/3 treatment in WLWH to reduce CIN2/3 recurrence. While the safety, acceptability, and efficacy of self-administered 5-FU for cervical precancer treatment has been demonstrated in HICs, it has not been studied among WLWH in LMICs who bear the greatest burden of cervical cancer.