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

An observational study of Cervical Cancer, run by Carla Chibwesha, MD at 1 site in Zambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Cervical Cancer
What is being tested?: Xpert HPV and OncoE6
Type of treatment: Medical device
How many people: 200 participants
Where: 1 siteZambia
Study dates: Aug 2014to Jun 2015
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

Pregnancy

Trial locations and contacts

1 site in 1 country.

Zambia1 site

Adult Infectious Disease Centre at the University Teaching Hospital
Lusaka

Other trials in Zambia

About this study

Official title: Z 1313 - Comparison of Point-of-care Molecular Tests and Visual Inspection With Acetic Acid for Cervical Cancer Screening in HIV-infected Women in Lusaka, Zambia

Read the detailed description

This is a cross-sectional study taking place at cervical cancer prevention clinics in Lusaka, Zambia to determine the test performance characteristics (sensitivity, specificity, positive predictive value, and negative predictive value) of (1) visual inspection with acetic acid, (2) Xpert HPV, and (3) OncoE6 for the detection of CIN2+ among HIV-infected women. All cervical screening tests will be evaluated against a gold standard of histopathology obtained from cervical biopsies.

Conditions: Cervical Cancer
Being tested: Xpert HPV, OncoE6
Keywords: visual inspection with acetic acid, Xpert HPV, OncoE6, screening
Medical subject headings: Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Xpert HPVDevice
Point-of-care HPV DNA PCR test
OncoE6Device
Point-of-care E6 oncoprotein test

Study groups in NCT02688816
Study group	Role	What they receive
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. Receives: Device: Xpert HPV; Device: OncoE6

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of VIA-, Xpert HPV-, and OncoE6-positive results that are correctly identified
True positive rate (i.e., sensitivity) for CIN2+
Measured: 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+
Measured: once, at the enrollment visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Jun 2015

First posted23 Feb 2016 (estimated)
Study startAug 2014
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Cervical CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02688816
Sponsor's protocol ID: 14-0399
Other IDs: 3 D43 CA15378403S1
Status last verified: Feb 2016
First submitted: 11 Feb 2016
Last updated: 23 Feb 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 16167918
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.
PubMed 23131123
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.
PubMed 7791229
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.
PubMed 8133094
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.
PubMed 10992174
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.
PubMed 21351269
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.
PubMed 10478665
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.
PubMed 15617701
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.
PubMed 21060889
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.
PubMed 17617273
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.
PubMed 10235153
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.
PubMed 10760836
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.
PubMed 24058599
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.
PubMed 21610859
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.
PubMed 19279439

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cervical Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Z 1313 - Comparison of Point-of-care Molecular Tests and Visual Inspection With Acetic Acid for Cervical Cancer Screening in HIV-infected Women in Lusaka, Zambia
ClinicalTrials.gov ID: NCT02688816
Acronym / sponsor ID: 14-0399
Conditions: Cervical Cancer
Keywords: visual inspection with acetic acid, Xpert HPV, OncoE6, screening
Study type: Observational
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Carla Chibwesha, MDUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Aug 2014
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 23 Feb 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Women undergoing cervical cancer screening	–	Device: Xpert HPV, Device: OncoE6HIV-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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: HIV-infected women undergoing cervical cancer screening in Lusaka, Zambia

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (1 listed)

Pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Xpert HPVPoint-of-care HPV DNA PCR test	Device	Women undergoing cervical cancer screening
OncoE6Point-of-care E6 oncoprotein test	Device	Women undergoing cervical cancer screening

Primary outcome

Proportion of VIA-, Xpert HPV-, and OncoE6-positive results that are correctly identified
Time frame: once, at the enrollment visit
True positive rate (i.e., sensitivity) for CIN2+
Proportion of VIA-, Xpert HPV-, and OncoE6-negative results that are correctly identified
Time frame: once, at the enrollment visit
True negative rate (i.e., specificity) for CIN2+

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
Background: PubMed 16167918Andersson 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.
Background: PubMed 23131123Abreu 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.
Background: PubMed 7791229Bosch 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.
Background: PubMed 8133094Davidson 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.
Background: PubMed 10992174Elfgren 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.
Background: PubMed 21351269Ferlay 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.
Background: PubMed 10478665Folpe 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.
Background: PubMed 15617701Goel 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.
Background: PubMed 21060889Gravitt 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.
Background: PubMed 17617273Grulich 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.
Background: PubMed 10235153Manos 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.
Background: PubMed 10760836Miller 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.
University of North Carolina websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carla Chibwesha, MD principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Cancer, run by Carla Chibwesha, MD at 1 site in Zambia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of VIA-, Xpert HPV-, and OncoE6-positive results that are correctly identified (time frame: once, at the enrollment visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02688816, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.