Feasibility and Acceptability of HPV Self-Collection Cervical Cancer Screening and Treatment in Clinics and the Community in Botswana
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Jhpiego
- 入组人数
- 1,022
- 试验地点
- 5
- 主要终点
- Screening-to-treatment completion rates for assessing feasibility of HPV self collection, VAT screening and treatment
研究概览
简要总结
Aims of the Study: To assess feasibility and acceptability of introducing HPV testing of self-collected vaginal specimens (self-collection for HPV) of women age 30-49 years, followed by visual assessment of the cervix for treatment (VAT) and treatment of women testing HPV positive at a district hospital, surrounding clinics and communities in Botswana.
Background and Rationale:
High HIV prevalence correlates with high rates of precancerous and cancerous changes on the cervix, and Botswana has the third highest HIV prevalence rate (22.2%) in the world. In Botswana, cervical cancer is the leading cause of cancer and cancer-related deaths among women. While the Government of Botswana has made cervical cancer a public health priority, and has provided cytology-based screening (Pap smears) for the past 20 years and in recent years began also offering VIA coupled with immediate cryotherapy for eligible precancerous lesions in a screen-and-treat (S&T) approach, the program still encounters multiple challenges. These include delays in reporting/receiving cytology results, referral bottlenecks for specialist care, and ultimately far fewer women being screened and treated than set targets. In response, in 2012 Botswana's Ministry of Health and Wellness (MoHW) developed a National Cervical Cancer Prevention Programme (NCCPP) Comprehensive Prevention and Control Strategy that includes implementing a demonstration project to gauge acceptability and obtain lessons that will be used in planning the roll-out of this screening method.
As a result, the MoHW is exploring human papillomavirus (HPV) testing as a primary screening method with the future service delivery in mind through HPV testing, specifically using self-collected samples, as a primary screening method. HPV testing is more sensitive and reliable for the detection of cervical precancer and cancer than Pap testing and VIA. This increased sensitivity translates into two important benefits: 1) earlier detection of significant precancerous lesions that if treated results in a ~50% reduction in the incidence of cervical cancer within 4-5 years compared to Pap testing and 50% reduction in related deaths within 8 years compared to Pap testing and VIA and 2) lower cancer risk for many years for those with a negative result, which permits screening at an extended interval of 5-10 years. The Xpert HPV test, which will be used in this study, has high sensitivity (100%) and relatively high specificity (81.5%) for CIN. HPV tests run on the GeneXpert® machine allow multiple tests (four in the model to be used in this study) to be run in an hour.
详细描述
A. Study Objectives:
Research Question 1. Is it feasible to implement HPV self-collection for cervical cancer prevention at a District Hospital, four surrounding clinics, and in the community among women eligible for cervical cancer screening per national guidelines, followed by VAT triage of HPV positive women at the clinic; and then treatment at the clinic or hospital?
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What is the HPV positivity rate (prevalence) for women age 30 - 49 years and disaggregated by HIV status and clinic location?
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What are the screening-to-treatment completion rates with this strategy for women with HPV-positive test, by HIV status and clinic location?
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Can at least 75% of women doing HPV self-collection receive their results within 3 weeks self-collection?
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Can at least 75% of women with an HPV positive result undergo VAT within 3 weeks of receiving their HPV result?
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Can at least 90% of women with an HPV positive result undergo VAT and receive treatment within 3 months of initial HPV self-collection?
Research Question 2a, 2b. Do (2a) health care providers, community health workers, laboratory personnel, and managers and (2b) women consider the HPV self-collection, VAT and treatment acceptable? For each group of these participants, what are some of the enablers and the barriers to implementing an HPV self-collection screen-and-treat strategy?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The District Health Management Team (DHMT), estimates that in 2011 there were 31,574 women 30-49 years of age on the Kweneng East catchment area, serviced by Scottish Livingstone Hospital and the 4 selected Health Clinics.
- •Women will be clients of the health facility at one of the clinics (described below under recruitment), may come to the facility for cervical cancer screening after having been contacted by a community mobilizer, or women attending a community health campaign event (in the community).
- •Participants under Research Question 1: 1022 women Participants under Research Question 2a: 24 providers and other stakeholders Participants under Research Question 2b: 27 women for in-depth interviews; 250 women for structured surveys.
- •Inclusion Criteria: Service Delivery Model
- •Age 30 to 49 years,
- •Not screened recently/never screened before, defined as:
- •No prior history of cervical cancer screening: Pap smear, VIA or HPV testing), or
- •Prior screening, but result unknown and no treatment
- •Prior screening occurred more than 5 years ago for HIV negative women or 3 years ago for HIV positive women
- •HIV status is known (HIV positive result, or documented HIV negative result is less than 12 months ago).
- •No history of prior abnormal screening or treatment/procedure on her cervix due to abnormal screening
- •No history of cervical cancer
- •Not currently pregnant; not less than 6 weeks postpartum
- •Intact uterus/ no prior hysterectomy with a cervix present
- •Accesses services in Kweneng East District study catchment area
- •Able and willing to provide consent
- •Inclusion Criteria: Qualitative Research with Providers and Other Stakeholders
- •Working as one of the cadres in Sampling Table 1 at the time of the interview.
- •Working in cervical cancer prevention currently.
- •Manager agrees the participant can take part in interview.
- •Has been trained by the study regarding HPV self-collection and VAT.
- •Willing to participate in in-depth interview and gives informed consent.
排除标准
- •Woman does not meet the criteria for inclusion age 29 years or younger and age 50 years or older.
- •Screened for cervical cancer in last 3 years if HIV positive, or in the last 5 years if HIV negative.
- •Had an abnormal cervical cancer screening and/ or treatment of cervix ,
- •History of cervical cancer HIV status unknown,
- •Pregnant (self-report or by pregnancy test confirmation.
- •Less than 6 weeks postpartum, prior hysterectomy,
- •Unable to participate and give informed consent.
- •Not interested in HPV self-collection.
- •Unwilling to give informed consent
研究组 & 干预措施
HPV Screening
Study eligible participants will be screened for HPV using a self collected vaginal sample using a collection device and kit. Those who test positive for HPV will be offered visual assessment of the cervix for treatment (VAT) and treatment as appropriate.
干预措施: HPV self collection, followed by visual assessment of the cervix for treatment (VAT) and treatment (Diagnostic Test)
结局指标
主要结局
Screening-to-treatment completion rates for assessing feasibility of HPV self collection, VAT screening and treatment
时间窗: 3 months per participant
This outcome will be assessed by: the screening-to-treatment completion rates with this strategy for women with HPV-positive test, by HIV status and clinic location;
Qualitative interviews and surveys to assess acceptability of HPV Self Collection from health providers and managers
时间窗: 6 months after the intervention has started at each facility, with a sampling of types of personnel
Qualitative interview field guides and surveys will be given to elicit opinions from providers, staff, managers, community health workers, laboratory personnel on the acceptability and feasibility of using HPV in their facilities including self-collection, VAT and treatment
Qualitative interviews and surveys to assess acceptability of HPV Self Collection from women
时间窗: At time of return for VAT for women who are HPV positive; At the time of declining VAT for women who are HPV positive; At the time of decline to self collect at all.
Qualitative interview field guides and surveys will be given to elicit opinions from women on the acceptability and feasibility of using HPV self-collection and VAT at the facility and community-level
次要结局
未报告次要终点