Comparison of Cervical Cancer Screening Tests in HIV-infected Women in Lusaka, Zambia

NCT02688816 | Completed

• 2 other identifiers: 14-03993 D43 CA15378403S1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the test performance characteristics of visual inspection with acetic acid (VIA), Xpert HPV, and OncoE6 in HIV-infected women, to inform the possible inclusion of these molecular tests in future cervical cancer screening

Conditions

Cervical Cancer

Keywords

visual inspection with acetic acid; Xpert HPV; OncoE6; screening

Outcome Measures

Primary Outcomes (2)

• Proportion of VIA-, Xpert HPV-, and OncoE6-positive results that are correctly identified

  True positive rate (i.e., sensitivity) for CIN2+

  once, at the enrollment visit

• Proportion of VIA-, Xpert HPV-, and OncoE6-negative results that are correctly identified

  True negative rate (i.e., specificity) for CIN2+

  once, at the enrollment visit

Study Arms (1)

Women undergoing cervical cancer screening

HIV-infected women will undergo a cervical cancer screening examination using the VIA method. A digital photograph of the cervix will also be taken to aide visual screening. This is known as digital cervicography, and it is currently standard of care within cervical cancer screening clinics in Zambia. Cervical samples will be collected for molecular testing using Xpert HPV, and OncoE6. Cervical biopsy samples will also be obtained for confirmatory histopathologic diagnosis.

Device: Xpert HPV; Device: OncoE6

Interventions

Xpert HPV DEVICE

Point-of-care HPV DNA PCR test

Women undergoing cervical cancer screening

OncoE6 DEVICE

Point-of-care E6 oncoprotein test

Women undergoing cervical cancer screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected women undergoing cervical cancer screening in Lusaka, Zambia

You may qualify if:

• Women 18 years and older.
• Women with documented HIV-infection in their medical record or by on-site testing through voluntary counseling and testing.
• Women willing to undergo pelvic examination and cervical cancer screening.
• Women willing to provide written, informed consent.

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Carla Chibwesha, MD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Adult Infectious Disease Centre at the University Teaching Hospital

Lusaka, Zambia

Location

Related Publications (24)

• Andersson S, Dillner L, Elfgren K, Mints M, Persson M, Rylander E. A comparison of the human papillomavirus test and Papanicolaou smear as a second screening method for women with minor cytological abnormalities. Acta Obstet Gynecol Scand. 2005 Oct;84(10):996-1000. doi: 10.1111/j.0001-6349.2005.00702.x.

  PMID: 16167918 BACKGROUND

• Abreu AL, Souza RP, Gimenes F, Consolaro ME. A review of methods for detect human Papillomavirus infection. Virol J. 2012 Nov 6;9:262. doi: 10.1186/1743-422X-9-262.

  PMID: 23131123 BACKGROUND

• Bosch FX, Manos MM, Munoz N, Sherman M, Jansen AM, Peto J, Schiffman MH, Moreno V, Kurman R, Shah KV. Prevalence of human papillomavirus in cervical cancer: a worldwide perspective. International biological study on cervical cancer (IBSCC) Study Group. J Natl Cancer Inst. 1995 Jun 7;87(11):796-802. doi: 10.1093/jnci/87.11.796.

  PMID: 7791229 BACKGROUND

• Davidson M, Schnitzer PG, Bulkow LR, Parkinson AJ, Schloss ML, Fitzgerald MA, Knight JA, Murphy CM, Kiviat NB, Toomey KE, et al. The prevalence of cervical infection with human papillomaviruses and cervical dysplasia in Alaska Native women. J Infect Dis. 1994 Apr;169(4):792-800. doi: 10.1093/infdis/169.4.792.

  PMID: 8133094 BACKGROUND

• Elfgren K, Kalantari M, Moberger B, Hagmar B, Dillner J. A population-based five-year follow-up study of cervical human papillomavirus infection. Am J Obstet Gynecol. 2000 Sep;183(3):561-7. doi: 10.1067/mob.2000.106749.

  PMID: 10992174 BACKGROUND

• Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.

  PMID: 21351269 BACKGROUND

• Folpe AL, Agoff SN, Willis J, Weiss SW. Parachordoma is immunohistochemically and cytogenetically distinct from axial chordoma and extraskeletal myxoid chondrosarcoma. Am J Surg Pathol. 1999 Sep;23(9):1059-67. doi: 10.1097/00000478-199909000-00008.

  PMID: 10478665 BACKGROUND

• Goel A, Gandhi G, Batra S, Bhambhani S, Zutshi V, Sachdeva P. Visual inspection of the cervix with acetic acid for cervical intraepithelial lesions. Int J Gynaecol Obstet. 2005 Jan;88(1):25-30. doi: 10.1016/j.ijgo.2004.09.018.

  PMID: 15617701 BACKGROUND

• Gravitt PE, Paul P, Katki HA, Vendantham H, Ramakrishna G, Sudula M, Kalpana B, Ronnett BM, Vijayaraghavan K, Shah KV; CATCH Study Team. Effectiveness of VIA, Pap, and HPV DNA testing in a cervical cancer screening program in a peri-urban community in Andhra Pradesh, India. PLoS One. 2010 Oct 28;5(10):e13711. doi: 10.1371/journal.pone.0013711.

  PMID: 21060889 BACKGROUND

• Grulich AE, van Leeuwen MT, Falster MO, Vajdic CM. Incidence of cancers in people with HIV/AIDS compared with immunosuppressed transplant recipients: a meta-analysis. Lancet. 2007 Jul 7;370(9581):59-67. doi: 10.1016/S0140-6736(07)61050-2.

  PMID: 17617273 BACKGROUND

• Manos MM, Kinney WK, Hurley LB, Sherman ME, Shieh-Ngai J, Kurman RJ, Ransley JE, Fetterman BJ, Hartinger JS, McIntosh KM, Pawlick GF, Hiatt RA. Identifying women with cervical neoplasia: using human papillomavirus DNA testing for equivocal Papanicolaou results. JAMA. 1999 May 5;281(17):1605-10. doi: 10.1001/jama.281.17.1605.

  PMID: 10235153 BACKGROUND

• Miller AB, Nazeer S, Fonn S, Brandup-Lukanow A, Rehman R, Cronje H, Sankaranarayanan R, Koroltchouk V, Syrjanen K, Singer A, Onsrud M. Report on consensus conference on cervical cancer screening and management. Int J Cancer. 2000 May 1;86(3):440-7. doi: 10.1002/(sici)1097-0215(20000501)86:33.0.co;2-a. No abstract available.

  PMID: 10760836 BACKGROUND

• Mwanahamuntu MH, Sahasrabuddhe VV, Blevins M, Kapambwe S, Shepherd BE, Chibwesha C, Pfaendler KS, Mkumba G, Vwalika B, Hicks ML, Vermund SH, Stringer JS, Parham GP. Utilization of cervical cancer screening services and trends in screening positivity rates in a 'screen-and-treat' program integrated with HIV/AIDS care in Zambia. PLoS One. 2013 Sep 18;8(9):e74607. doi: 10.1371/journal.pone.0074607. eCollection 2013.

  PMID: 24058599 BACKGROUND

• Mwanahamuntu MH, Sahasrabuddhe VV, Kapambwe S, Pfaendler KS, Chibwesha C, Mkumba G, Mudenda V, Hicks ML, Vermund SH, Stringer JS, Parham GP. Advancing cervical cancer prevention initiatives in resource-constrained settings: insights from the Cervical Cancer Prevention Program in Zambia. PLoS Med. 2011 May;8(5):e1001032. doi: 10.1371/journal.pmed.1001032. Epub 2011 May 17.

  PMID: 21610859 BACKGROUND

• Mwanahamuntu MH, Sahasrabuddhe VV, Pfaendler KS, Mudenda V, Hicks ML, Vermund SH, Stringer JS, Parham GP. Implementation of 'see-and-treat' cervical cancer prevention services linked to HIV care in Zambia. AIDS. 2009 Mar 27;23(6):N1-5. doi: 10.1097/QAD.0b013e3283236e11. No abstract available.

  PMID: 19279439 BACKGROUND

• Ngan HY, Garland SM, Bhatla N, Pagliusi SR, Chan KK, Cheung AN, Chu TY, Domingo EJ, Qiao YL, Park JS, Tay EH, Supakarapongkul W. Asia oceania guidelines for the implementation of programs for cervical cancer prevention and control. J Cancer Epidemiol. 2011;2011:794861. doi: 10.1155/2011/794861. Epub 2011 Apr 13.

  PMID: 21559068 BACKGROUND

• Parkin DM. The global health burden of infection-associated cancers in the year 2002. Int J Cancer. 2006 Jun 15;118(12):3030-44. doi: 10.1002/ijc.21731.

  PMID: 16404738 BACKGROUND

• Poljak M, Kocjan BJ. Commercially available assays for multiplex detection of alpha human papillomaviruses. Expert Rev Anti Infect Ther. 2010 Oct;8(10):1139-62. doi: 10.1586/eri.10.104.

  PMID: 20954880 BACKGROUND

• Roden R, Wu TC. How will HPV vaccines affect cervical cancer? Nat Rev Cancer. 2006 Oct;6(10):753-63. doi: 10.1038/nrc1973.

  PMID: 16990853 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

• Schiffman MH, Castle P. Epidemiologic studies of a necessary causal risk factor: human papillomavirus infection and cervical neoplasia. J Natl Cancer Inst. 2003 Mar 19;95(6):E2. doi: 10.1093/jnci/95.6.e2. No abstract available.

  PMID: 12644550 BACKGROUND

• Schweizer J, Lu PS, Mahoney CW, Berard-Bergery M, Ho M, Ramasamy V, Silver JE, Bisht A, Labiad Y, Peck RB, Lim J, Jeronimo J, Howard R, Gravitt PE, Castle PE. Feasibility study of a human papillomavirus E6 oncoprotein test for diagnosis of cervical precancer and cancer. J Clin Microbiol. 2010 Dec;48(12):4646-8. doi: 10.1128/JCM.01315-10. Epub 2010 Oct 6.

  PMID: 20926711 BACKGROUND

• Vedantham H, Silver MI, Kalpana B, Rekha C, Karuna BP, Vidyadhari K, Mrudula S, Ronnett BM, Vijayaraghavan K, Ramakrishna G, Sowjanya P, Laxmi S, Shah KV, Gravitt PE; CATCH Study Team. Determinants of VIA (Visual Inspection of the Cervix After Acetic Acid Application) positivity in cervical cancer screening of women in a peri-urban area in Andhra Pradesh, India. Cancer Epidemiol Biomarkers Prev. 2010 May;19(5):1373-80. doi: 10.1158/1055-9965.EPI-09-1282.

  PMID: 20447927 BACKGROUND

• Zhao FH, Lewkowitz AK, Chen F, Lin MJ, Hu SY, Zhang X, Pan QJ, Ma JF, Niyazi M, Li CQ, Li SM, Smith JS, Belinson JL, Qiao YL, Castle PE. Pooled analysis of a self-sampling HPV DNA Test as a cervical cancer primary screening method. J Natl Cancer Inst. 2012 Feb 8;104(3):178-88. doi: 10.1093/jnci/djr532. Epub 2012 Jan 23.

  PMID: 22271765 BACKGROUND

Related Links

• University of North Carolina website

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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; Urogenital Diseases; Genital Diseases

Study Officials

• Carla Chibwesha, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 23, 2016
• Study Start: August 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 23, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)