Dataset Information

Point-of-care testing with Xpert HPV for single-visit, screen-and-treat for cervical cancer prevention: a demonstration study in South Africa.

ABSTRACT: Human papillomavirus (HPV)-based screen-and-treat (SAT) is recommended but implementation presents operational challenges. We implemented HPV-SAT at a research site in Khayelitsha, South Africa, screening 3062 women aged 30-65 years (44% women living with HIV [WHIV]). All were screened using point-of-care Xpert HPV and almost all received their HPV results on the same day. HPV-positivity occurred in 41.5% of WHIV and 17.4% of women without HIV (WNoH) reducing to 26.2% in WHIV and 10.4% in WNoH applying treatment eligibility criteria based on high viral load in the channels detecting HPV16, 18, 45, 16, 18, 31, 33, 35, 52, 58. Among those eligible for treatment, 91.3% were considered suitable for ablative therapy, and 94.6% underwent thermal ablation on the same day, with no serious adverse events. Twelve months later, 39.0% of WHIV and 65.2% of WNoH treated with ablative therapy were clear of HPV. In women who were HPV-positive but ineligible for treatment, 19.1% and 12.9% had histologically-confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+) at 12 months. SAT programs need to weigh trade-offs between overtreatment versus delayed or no treatment for women who test positive for HPV. Treatment modalities for precancerous lesions need to be improved.

SUBMITTER: Denny L

PROVIDER: S-EPMC10533854 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Point-of-care testing with Xpert HPV for single-visit, screen-and-treat for cervical cancer prevention: a demonstration study in South Africa.

Denny Lynette L Saidu Rakiya R Boa Rosalind R Mbatani Nomonde N Castor Delivette D Moodley Jennifer J Kuhn Louise L

Scientific reports 20230927 1

Human papillomavirus (HPV)-based screen-and-treat (SAT) is recommended but implementation presents operational challenges. We implemented HPV-SAT at a research site in Khayelitsha, South Africa, screening 3062 women aged 30-65 years (44% women living with HIV [WHIV]). All were screened using point-of-care Xpert HPV and almost all received their HPV results on the same day. HPV-positivity occurred in 41.5% of WHIV and 17.4% of women without HIV (WNoH) reducing to 26.2% in WHIV and 10.4% in WNoH a ...[more]

PMID: 37758811

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Project description:BackgroundCervical cancer is a preventable cancer; however, decreasing its prevalence requires early detection and treatment strategies that reduce rates of loss to follow-up. This study explores factors associated with loss to follow-up among HPV-positive women after implementation of a new HPV-based screen-and-treat approach for cervical cancer prevention in Iquitos, Peru.MethodsWe conducted semi-structured interviews with "obstetras" (i.e., midwives) (n = 15) working in cervical cancer prevention and women (n = 24) who were recorded as lost to follow-up after positive HPV results. We used the Health Care Access Barriers Model to guide analyses. We utilized manifest content analysis to describe barriers to follow-up according to the obstetras and thematic analysis to report themes from the women's perspectives. We also report the steps and time taken to contact women.ResultsWe found an incomplete and fragmented patient monitoring system. This incomplete system, in conjunction with challenges in contacting some of the women, led to structural barriers for the obstetras when attempting to deliver positive results. Women in this study expressed a desire to receive treatment, however, faced cognitive barriers including a lack of understanding about HPV results and treatment procedures, fear or anxiety about HPV or treatment, and confusion about the follow-up process. Women also reported having important work matters as a barrier and reported frequently using natural medicine. Reported financial barriers were minimal.ConclusionThis study highlights the barriers to follow-up after implementation of a primary-level HPV-based screen-and-treat approach. While some barriers that have previously been associated with loss to follow-up were not as prominently observed in this study (e.g., financial), we emphasize the need for screen-and-treat programs to focus on strategies that can address incomplete registry systems, structural challenges in results delivery, cognitive barriers in understanding results and treatment, and work-related barriers.

Project description:BackgroundCervical cancer is the leading cause of cancer incidence and mortality among Malawian women, despite being a largely preventable disease. Implementing a cervical cancer screening and preventive treatment (CCSPT) program that utilizes rapid human papillomavirus (HPV) testing on self-collected cervicovaginal samples for screening and thermal ablation for treatment may achieve greater coverage than current programs that use visual inspection with acetic acid (VIA) for screening and cryotherapy for treatment. Furthermore, self-sampling creates the opportunity for community-based screening to increase uptake in populations with low screening rates. Malawi's public health system utilizes regularly scheduled outreach and village-based clinics to provide routine health services like family planning. Cancer screening is not yet included in these community services. Incorporating self-sampled HPV testing into national policy could address cervical cancer screening barriers in Malawi, though at present the effectiveness, acceptability, appropriateness, feasibility, and cost-effectiveness still need to be demonstrated.MethodsWe designed a cluster randomized feasibility trial to determine the effectiveness, acceptability, appropriateness, feasibility, and budget impact of two models for integrating a HPV-based CCSPT program into family planning (FP) services in Malawi: model 1 involves only clinic-based self-sampled HPV testing, whereas model 2 includes both clinic-based and community-based self-sampled HPV testing. Our algorithm involves self-collection of samples for HPV GeneXpert® testing, visual inspection with acetic acid for HPV-positive women to determine ablative treatment eligibility, and same-day thermal ablation for treatment-eligible women. Interventions will be implemented at 14 selected facilities. Our primary outcome will be the uptake of cervical cancer screening and family planning services during the 18 months of implementation, which will be measured through an Endline Household Survey. We will also conduct mixed methods assessments to understand the acceptability, appropriateness, and feasibility of the interventions, and a cost analysis to assess budget impact.DiscussionOur trial will provide in-depth information on the implementation of clinic-only and clinic-and-community models for integrating self-sampled HPV testing CCSPT with FP services in Malawi. Findings will provide valuable insight for policymakers and implementers in Malawi and other resource-limited settings with high cervical cancer burden.Trial registrationClinicalTrials.gov identifier: NCT04286243 . Registered on February 26, 2020.

Project description:BackgroundSelf-sampling HPV test and thermal ablation are effective tools to increase screening coverage and treatment compliance for accelerating cervical cancer elimination. We assessed the cost-effectiveness of their combined strategies to inform accessible, affordable, and acceptable cervical cancer prevention strategies.MethodsWe developed a hybrid model to evaluate costs, health outcomes, and incremental cost-effectiveness ratios (ICER) of six screen-and-treat strategies combining HPV testing (self-sampling or physician-sampling), triage modalities (HPV genotyping, colposcopy or none) and thermal ablation, from a societal perspective. A designated initial cohort of 100,000 females born in 2015 was considered. Strategies with an ICER less than the Chinese gross domestic product (GDP) per capita ($10,350) were considered highly cost-effective.ResultsCompared with current strategies in China (physician-HPV with genotype or cytology triage), all screen-and-treat strategies are cost-effective and self-HPV without triage is optimal with the most incremental quality-adjusted life-years (QALYs) gained (220 to 440) in rural and urban China. Each screen-and-treat strategy based on self-collected samples is cost-saving compared with current strategies (-$818,430 to -$3540) whereas more costs are incurred using physician-collected samples compared with current physician-HPV with genotype triage (+$20,840 to +$182,840). For screen-and-treat strategies without triage, more costs (+$9404 to +$380,217) would be invested in the screening and treatment of precancerous lesions rather than the cancer treatment compared with the current screening strategies. Notably, however, more than 81.6% of HPV-positive women would be overtreated. If triaged with HPV 7 types or HPV16/18 genotypes, 79.1% or 67.2% (respectively) of HPV-positive women would be overtreated with fewer cancer cases avoided (19 cases or 69 cases).ConclusionsScreen-and-treat strategy using self-sampling HPV test linked to thermal ablation could be the most cost-effective for cervical cancer prevention in China. Additional triage with quality-assured performance could reduce overtreatment and remains highly cost-effective compared with current strategies.

Project description:ObjectiveTo explore the utility of extended Human Papillomavirus (HPV) genotyping to detect cervical intraepithelial neoplasia grade 2 or more (CIN2+) in a 'screen-and-treat' strategy for HPV-positive women in low-resource settings.DesignProspective study of diagnostic accuracy.SettingThe study took place in West Cameroon between September 2018 and March 2020.Participants2014 women were recruited. Asymptomatic, non-pregnant women aged 30-49 years without history of CIN treatment, anogenital cancer or hysterectomy were eligible.InterventionsParticipants performed self-sampling for HPV testing with GeneXpert followed by visual inspection with acetic acid and Lugol's iodine (VIA) triage before treatment if required.Main outcome measuresLiquid-based cytology, biopsies and endocervical brushing were performed in HPV-positive women as quality control. We assessed the detection rate of CIN2+ by HPV genotyping (two pools of genotypes obtained from the Xpert system, pool_1 (HPV 16, 18, 45) and pool_2 (HPV 16, 18, 45, 31, 33, 35, 52, 58)), VIA and cytology.Results382 (18.2%) women were HPV-positive among which 11.5% (n=44) were CIN2+. Of those 44 participants, 41 were triaged positive by extended genotyping, versus 35 by VIA and 33 by cytology. Overall, triage positivity was of 68.4% for extended genotyping, 59.3% for VIA and 14.8% for cytology, with false positive rates of 83.4%, 84.1% and 37.7%, respectively. Extended genotyping had a higher sensitivity for CIN2+ detection (93.2%, CI: 81.3 to 98.6) than VIA (79.5%, CI: 64.7 to 90.2, p=0.034) and cytology (75.0%, CI: 59.7 to 86.8, p=0.005). No significant difference was observed in the overtreatment rate in triaged women by extended genotyping or VIA (9.9%, CI: 8.6 to 11.3, and 8.8%, CI: 7.7 to 10.1), with a ratio of 6.0 and 6.3 women treated per CIN2+ diagnosed.ConclusionTriage of HPV-positive women with extended HPV genotyping improves CIN2+ detection compared with VIA with a minor loss of specificity and could be used to optimize the management of HPV-positive women.Trial registration numberNCT03757299.

Project description:BackgroundMalawi has the world's highest cervical cancer incidence and mortality due to high rate of HIV coupled with inadequate screening and treatment services. The country's cervical cancer control program uses visual inspection with acetic acid (VIA) and cryotherapy, but screening is largely limited by poor access to facilities, high cost of cryotherapy gas, and high loss-to-follow-up. To overcome these limitations, we implemented a community-based screen-and-treat pilot program with VIA and thermocoagulation. Through a qualitative study, we explore the experiences of women who underwent this community-based pilot screening program.MethodsWe implemented our pilot program in rural Malawi and conducted an exploratory qualitative sub-study. We conducted in-depth interviews with women who were treated with thermocoagulation during the program. We used semi-structured interviews to explore screen-and-treat experience, acceptability of the program and attitudes towards self-sampling for HPV testing as an alternative screening method. Content analysis was conducted using NVIVO v12.ResultsBetween July - August 2017, 408 participants eligible for screening underwent VIA screening. Thirty participants had VIA positive results, of whom 28 underwent same day thermocoagulation. We interviewed 17 of the 28 women who received thermocoagulation. Thematic saturation was reached at 17 interviews. All participants reported an overall positive experience with the community-based screen-and-treat program. Common themes were appreciation for bringing screening directly to their villages, surprise at the lack of discomfort, and the benefits of access to same day treatment immediately following abnormal screening. Negative experiences were rare and included discomfort during speculum exam, long duration of screening and challenges with complying with postprocedural abstinence. Most participants felt that utilizing self-collected HPV testing could be acceptable for screening in their community.ConclusionsOur exploratory qualitative sub-study demonstrated that the community-based screen-and-treat with VIA and thermocoagulation was widely accepted. Participants valued the accessible, timely, and painless thermocoagulation treatment and reported minimal side effects. Future considerations for reaching rural women can include community-based follow-up, cervical cancer education for male partners and self-sampling for HPV testing.

Dataset Information

Point-of-care testing with Xpert HPV for single-visit, screen-and-treat for cervical cancer prevention: a demonstration study in South Africa.

Publications

Point-of-care testing with Xpert HPV for single-visit, screen-and-treat for cervical cancer prevention: a demonstration study in South Africa.

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