Feasibility and Acceptability of HPV Self-Collection Cervical Cancer Screening and Treatment in Botswana

NCT03345875 | Completed

• 1 other identifier: IRB00007974
• Study Type: interventional
• Target: 1,022
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Human Papillomavirus Infection; Cervical Cancer

Keywords

human papillomavirus; cervical cancer; self-collection

Outcome Measures

Primary Outcomes (3)

• Screening-to-treatment completion rates for assessing feasibility of HPV self collection, VAT screening and treatment

  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;

  3 months per participant

• Qualitative interviews and surveys to assess acceptability of HPV Self Collection from women

  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

  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 interviews and surveys to assess acceptability of HPV Self Collection from health providers and managers

  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

  6 months after the intervention has started at each facility, with a sampling of types of personnel

Study Arms (1)

HPV Screening

OTHER

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.

Diagnostic Test: HPV self collection, followed by visual assessment of the cervix for treatment (VAT) and treatment

Interventions

HPV self collection, followed by visual assessment of the cervix for treatment (VAT) and treatment DIAGNOSTIC_TEST

Women who test HPV positive are offered visual assessment for treatment, with treatment method (cryotherapy, LEEP, or biopsy) based on visual assessment findings.

HPV Screening

Eligibility Criteria

• Age: 30 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jhpiego: lead
• Botswana Ministry of Health: collaborator

Study Sites (5)

Kopong Health Clinic

Kopong, Botswana

Location

Lephepe Health Clinic

Lephepe, Botswana

Location

Phuthadikobo

Molepolole, Botswana

Location

Scottish Livingstone Hospital

Molepolole, Botswana

Location

Thamaga Health Clinic

Thamaga, Botswana

Location

Related Publications (18)

• WHO Guidelines for Screening and Treatment of Precancerous Lesions for Cervical Cancer Prevention. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK195239/

  PMID: 24716265 BACKGROUND

• UNAIDS. "AIDSinfo." At: http://aidsinfo.unaids.org/. Accessed 11 November 2016

  BACKGROUND

• Botswana, Ministry of Health, "Five-year Comprehensive Prevention and Control Strategy (2012 - 2016)"

  BACKGROUND

• Cuzick J, Clavel C, Petry KU, Meijer CJ, Hoyer H, Ratnam S, Szarewski A, Birembaut P, Kulasingam S, Sasieni P, Iftner T. Overview of the European and North American studies on HPV testing in primary cervical cancer screening. Int J Cancer. 2006 Sep 1;119(5):1095-101. doi: 10.1002/ijc.21955.

  PMID: 16586444 BACKGROUND

• Mayrand MH, Duarte-Franco E, Rodrigues I, Walter SD, Hanley J, Ferenczy A, Ratnam S, Coutlee F, Franco EL; Canadian Cervical Cancer Screening Trial Study Group. Human papillomavirus DNA versus Papanicolaou screening tests for cervical cancer. N Engl J Med. 2007 Oct 18;357(16):1579-88. doi: 10.1056/NEJMoa071430.

  PMID: 17942871 BACKGROUND

• Naucler P, Ryd W, Tornberg S, Strand A, Wadell G, Elfgren K, Radberg T, Strander B, Johansson B, Forslund O, Hansson BG, Rylander E, Dillner J. Human papillomavirus and Papanicolaou tests to screen for cervical cancer. N Engl J Med. 2007 Oct 18;357(16):1589-97. doi: 10.1056/NEJMoa073204.

  PMID: 17942872 BACKGROUND

• Rijkaart DC, Berkhof J, Rozendaal L, van Kemenade FJ, Bulkmans NW, Heideman DA, Kenter GG, Cuzick J, Snijders PJ, Meijer CJ. Human papillomavirus testing for the detection of high-grade cervical intraepithelial neoplasia and cancer: final results of the POBASCAM randomised controlled trial. Lancet Oncol. 2012 Jan;13(1):78-88. doi: 10.1016/S1470-2045(11)70296-0. Epub 2011 Dec 14.

  PMID: 22177579 BACKGROUND

• Ronco G, Giorgi-Rossi P, Carozzi F, Confortini M, Dalla Palma P, Del Mistro A, Ghiringhello B, Girlando S, Gillio-Tos A, De Marco L, Naldoni C, Pierotti P, Rizzolo R, Schincaglia P, Zorzi M, Zappa M, Segnan N, Cuzick J; New Technologies for Cervical Cancer screening (NTCC) Working Group. Efficacy of human papillomavirus testing for the detection of invasive cervical cancers and cervical intraepithelial neoplasia: a randomised controlled trial. Lancet Oncol. 2010 Mar;11(3):249-57. doi: 10.1016/S1470-2045(09)70360-2. Epub 2010 Jan 18.

  PMID: 20089449 BACKGROUND

• Castle PE, Stoler MH, Wright TC Jr, Sharma A, Wright TL, Behrens CM. Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older: a subanalysis of the ATHENA study. Lancet Oncol. 2011 Sep;12(9):880-90. doi: 10.1016/S1470-2045(11)70188-7. Epub 2011 Aug 22.

  PMID: 21865084 BACKGROUND

• Castle PE, Wheeler CM, Solomon D, Schiffman M, Peyton CL; ALTS Group. Interlaboratory reliability of Hybrid Capture 2. Am J Clin Pathol. 2004 Aug;122(2):238-45. doi: 10.1309/BA43-HMCA-J26V-WQH3.

  PMID: 15323141 BACKGROUND

• Carozzi FM, Del Mistro A, Confortini M, Sani C, Puliti D, Trevisan R, De Marco L, Tos AG, Girlando S, Palma PD, Pellegrini A, Schiboni ML, Crucitti P, Pierotti P, Vignato A, Ronco G. Reproducibility of HPV DNA Testing by Hybrid Capture 2 in a Screening Setting. Am J Clin Pathol. 2005 Nov;124(5):716-21. doi: 10.1309/84E5-WHJQ-HK83-BGQD.

  PMID: 16203283 BACKGROUND

• Stoler MH, Schiffman M; Atypical Squamous Cells of Undetermined Significance-Low-grade Squamous Intraepithelial Lesion Triage Study (ALTS) Group. Interobserver reproducibility of cervical cytologic and histologic interpretations: realistic estimates from the ASCUS-LSIL Triage Study. JAMA. 2001 Mar 21;285(11):1500-5. doi: 10.1001/jama.285.11.1500.

  PMID: 11255427 BACKGROUND

• Ronco G, Dillner J, Elfstrom KM, Tunesi S, Snijders PJ, Arbyn M, Kitchener H, Segnan N, Gilham C, Giorgi-Rossi P, Berkhof J, Peto J, Meijer CJ; International HPV screening working group. Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials. Lancet. 2014 Feb 8;383(9916):524-32. doi: 10.1016/S0140-6736(13)62218-7. Epub 2013 Nov 3.

  PMID: 24192252 BACKGROUND

• Sankaranarayanan R, Nene BM, Shastri SS, Jayant K, Muwonge R, Budukh AM, Hingmire S, Malvi SG, Thorat R, Kothari A, Chinoy R, Kelkar R, Kane S, Desai S, Keskar VR, Rajeshwarkar R, Panse N, Dinshaw KA. HPV screening for cervical cancer in rural India. N Engl J Med. 2009 Apr 2;360(14):1385-94. doi: 10.1056/NEJMoa0808516.

  PMID: 19339719 BACKGROUND

• Dillner J, Rebolj M, Birembaut P, Petry KU, Szarewski A, Munk C, de Sanjose S, Naucler P, Lloveras B, Kjaer S, Cuzick J, van Ballegooijen M, Clavel C, Iftner T; Joint European Cohort Study. Long term predictive values of cytology and human papillomavirus testing in cervical cancer screening: joint European cohort study. BMJ. 2008 Oct 13;337:a1754. doi: 10.1136/bmj.a1754.

  PMID: 18852164 BACKGROUND

• Castle PE, Glass AG, Rush BB, Scott DR, Wentzensen N, Gage JC, Buckland J, Rydzak G, Lorincz AT, Wacholder S. Clinical human papillomavirus detection forecasts cervical cancer risk in women over 18 years of follow-up. J Clin Oncol. 2012 Sep 1;30(25):3044-50. doi: 10.1200/JCO.2011.38.8389. Epub 2012 Jul 30.

  PMID: 22851570 BACKGROUND

• Katki HA, Kinney WK, Fetterman B, Lorey T, Poitras NE, Cheung L, Demuth F, Schiffman M, Wacholder S, Castle PE. Cervical cancer risk for women undergoing concurrent testing for human papillomavirus and cervical cytology: a population-based study in routine clinical practice. Lancet Oncol. 2011 Jul;12(7):663-72. doi: 10.1016/S1470-2045(11)70145-0. Epub 2011 Jun 16.

  PMID: 21684207 BACKGROUND

• Integrating HPV testing in cervical cancer screening program: a manual for program managers. Washington, D.C.: PAHO, 2016.

  BACKGROUND

Related Links

• UNAIDS Accessed 11 November 2016
• 2014 Botswana AIDS Response Progress Report
• GLOBOCAN 2012. Population Factsheet. Accessed 10 November 2016

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• John Varallo, MD

  Jhpiego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective cohort study of women in an HPV self-collection screen-and-treat strategy for cervical cancer prevention to assess collection, triage and treatment through a service delivery model using descriptive, quantitative methods, and formative, qualitative research with providers and women. Methods to assess feasibility of the service model are electronic medical record (EMR) documentation of women's progression from eligibility for and receipt of services through each step of the HPV self-collection screen-and-treat strategy, from self-collection through test results to treatment of precancer, including referral for suspect cancer. Acceptability will entail: a) in-depth interviews with health providers, community mobilizers, health facility staff and managers and b) in-depth interviews and surveys with women who receive services as well as women that are eligible and decline services.

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 17, 2017
• Study Start: October 16, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

BO (5)