Perceived acceptability of self-administered topical therapy for cervical precancer treatment among women undergoing cervical cancer screening in Kenya

Mungo, Chemtai; Ellis, Grace K; Rop, Mercy; Zou, Yating; Omoto, Jackton; Rahangdale, Lisa

doi:10.1101/2024.03.05.24303779

Cited by 3 publications

References 37 publications

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Safety and adherence to self‐administered intravaginal 5‐fluorouracil cream following cervical intraepithelial neoplasia (CIN) 2/3 treatment among HIV‐positive women in Kenya: A phase 1 clinical trial

Mungo,

Omoto,

Ogollah

et al. 2024

Intl J Gynecology & Obste

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ObjectiveTo determine the safety, tolerance, and adherence to self‐administered intravaginal 5% fluorouracil (5FU) cream as adjuvant therapy following cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3) treatment among women living with HIV (WLWH) in Kenya.MethodsA phase I pilot trial was performed among 12 WLWH in Kenya, aged 18–49 years between March 2023 and February 2024 (ClinicalTrial.gov NCT05362955). Participants self‐administered 2 g of 5FU intravaginally every other week for eight applications. Safety was assessed using a standardized grading scale, and adherence was evaluated using self‐report, inspection of used applicators, and weighing of the study drug.ResultsThe mean age and CD4 count were 43.9 years and 781 cells/mm3, respectively. Seven (58%) had an eighth‐grade education or less. All 12 reported at least one grade I adverse event (AE), one (8%) reported a grade 2 AE, no grade 3 or 4 AEs were reported. Increased vaginal discharge (n = 9, 75%) and irritation (n = 5, 42%), with a mean duration of 3.2 and 2.8 days, respectively, were the most commonly reported AEs. Provider‐observed AEs included grade 1 cervical erythema and superficial abrasions. All participants tolerated all eight 5FU doses, and 96% adherence was demonstrated.ConclusionSelf‐administered 5FU following CIN2/3 treatment among WLWH in Kisumu, Kenya, was safe, tolerable, and associated with high adherence. Randomized trials are needed to investigate whether adjuvant 5FU can improve treatment outcomes or serve as primary cervical precancer treatment in sub‐Saharan Africa. A self‐administered therapy may be transformative in increasing access to treatment and, hence, secondary prevention of cervical cancer.

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Safety and adherence to self‐administered intravaginal 5‐fluorouracil cream following cervical intraepithelial neoplasia (CIN) 2/3 treatment among HIV‐positive women in Kenya: A phase 1 clinical trial

Mungo,

Omoto,

Ogollah

et al. 2024

Intl J Gynecology & Obste

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Men’s perceptions and perceived acceptability of their female partner’s use of self-administered intravaginal therapies for treatment of cervical precancer in Kenya

Mungo,

Adewumi,

Ellis

et al. 2024

Preprint

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Background: Cervical cancer continues to be a major health issue in low- and middle-income countries (LMICs). Despite increasing access to screening, access to precancer treatment remains a significant challenge in LMICs, highlighting a need for innovative, accessible, and resource-appropriate treatment approaches, including self-administered therapies. Methods: A cross-sectional mixed-methods study was conducted among men aged 25-65 with a current female partner in Kisumu County, Kenya. Participants were sequentially recruited and surveyed to evaluate their understanding of HPV and cervical cancer, their views on screening and treatment, and their attitudes toward self-administered therapies. Focus group discussions with a subset of the survey participants further explored their treatment preferences and perceptions. Results: Two hundred fourteen men participated in the survey, and 39 men participated in focus group discussions. The median age was 39 years, and 51% had a primary school education or less. Most (96%) were in a committed relationship, and 74% earned $10 or less daily. There was strong support for self-administered topical therapies, with 98% willing to support their partners using such treatments if available. Additionally, most participants were open to supporting necessary abstinence or condom use, though 76% believed their partners might hesitate to request condom use. When given an option, most preferred their partner to self-administer such therapies at home compared to provider administration at a health facility, citing convenience, cost-effectiveness, and privacy. Preferences varied between two potential therapies, 5-Fluorouracil (5FU) and Artesunate, based on their administration frequency, duration, and abstinence requirements. Qualitative findings largely supported the quantitative analysis. Conclusions: The study demonstrates strong support for self-administered topical therapies for cervical precancer among Kenyan men. Additional research on acceptability, feasibility, and efficacy in different LMICs could pave the way for these therapies to help bridge current cervical precancer treatment gaps in these settings.

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Women’s experiences and acceptability of self-administered, home delivered, intravaginal 5-Fluorouracil cream for cervical precancer treatment in Kenya

Mungo,

Adewumi,

Rop

et al. 2024

Preprint

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BACKGROUND: Innovative strategies are essential to meet the World Health Organizations 90/70/90 cervical cancer elimination targets, aiming for 90% access to precancer treatment globally by 2030. In low-and middle-income countries (LMICs) where most cervical cancer cases occur, access to precancer treatment is severely limited. Scalable solutions like self-administered topical therapies can help close this gap. In a recent Phase I trial (ClinicalTrials.govNCT05362955), we demonstrated safety and adherence to self-administered intravaginal 5% 5-Fluorouracil (5FU) cream as an adjuvant therapy for cervical precancer among women living with HIV (WLWH) in rural Kenya. To understand womens experiences with self-administered 5FU, we evaluated the acceptability of this intervention among trial participants. METHODS: All 12 participants from the Phase I trial completed a structured questionnaire and in-depth semi-structured interviews in their preferred language, focusing on their experiences with 5FU self-administration, challenges faced, and overall acceptability of the intervention, including whether they would use it again or recommend it to someone who needed it. Quantitative data were analyzed using descriptive statistics. In the qualitative study, acceptability was defined as ″the perception that a given treatment is agreeable, palatable, or satisfactory.″ A thematic analysis was conducted using five dimensions of acceptability: content, complexity, comfort, delivery, and credibility. RESULTS: The mean age was 43.9 years (SD 4.4), and 7 (58%) had primary education or less. While some participants reported feelings of uncertainty when they started using 5FU, at the end of the study, all twelve participants strongly agreed that the cream was safe and were confident they used it correctly. Most participants (91.7%) experienced no discomfort with the vaginal applicator, and most reported using tampons overnight after 5FU use, as recommended. Qualitative findings revealed that favorable perceptions of self-administered 5FU were driven by its ease of use, the discrete nature of the treatment, and the comfort of home application. The main challenges included correctly measuring the study drug, finding a private place at home to self-administer, and the need to use condoms during treatment. Compared to their previous ablation or excision treatments, participants found 5FU to be less painful, and all would prefer a self-administered treatment instead of a procedure if it were an option. CONCLUSION: Self-administered intravaginal 5FU as an adjuvant treatment for cervical precancer among women living with HIV in Kenya was highly acceptable. Randomized studies of 5FU and other topical therapies in LMICs are needed to evaluate their use in closing the current precancer treatment gaps in these settings.

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Perceived acceptability of self-administered topical therapy for cervical precancer treatment among women undergoing cervical cancer screening in Kenya

Cited by 3 publications

References 37 publications

Safety and adherence to self‐administered intravaginal 5‐fluorouracil cream following cervical intraepithelial neoplasia (CIN) 2/3 treatment among HIV‐positive women in Kenya: A phase 1 clinical trial

Safety and adherence to self‐administered intravaginal 5‐fluorouracil cream following cervical intraepithelial neoplasia (CIN) 2/3 treatment among HIV‐positive women in Kenya: A phase 1 clinical trial

Men’s perceptions and perceived acceptability of their female partner’s use of self-administered intravaginal therapies for treatment of cervical precancer in Kenya

Women’s experiences and acceptability of self-administered, home delivered, intravaginal 5-Fluorouracil cream for cervical precancer treatment in Kenya

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