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Cervical CancerNCT04401670

Cervical Cancer Screening in Cameroon

A study testing HPV screening and triage tests and HPV self-sampling in people with Cervical Cancer and HIV/AIDS, run by Albert Einstein College of Medicine at 1 site in Cameroon.

Completed

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

Official record
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Trial summary

Human immunodeficiency virus-infected (HIV[+]) women have a several-fold increased risk of invasive cervical cancer (ICC) as well as increased risk of cervical pre-cancer. In low- and middle-income countries (LMICs), ICC is the 1st or 2nd most common cause of cancer and cancer-related death in women. Read more about this study

Who is it for?
Ages 25 to 56 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cervical Cancer, HIV/AIDS
What is being tested?
HPV screening and triage tests and HPV self-sampling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
873 participants
Where
1 siteCameroon
Study dates
25 Apr 2017to 1 May 2020
Phase
Interventional
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 25 to 56 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women living in Limbe town and neighborhood
  • Confirmed to be HIV[+] or HIV[-]
  • Have never undergone cervical cancer screening, with no history of ICC
  • Willing and able to competently understand and provide written, informed paper-based consent
  • Women who are having a menstrual period will be deferred for 2 weeks from participating in the study

Who cannot join

  • Pregnant women
  • Women with signs of abnormalities
  • Non-menstrual bleeding suggestive of ICC
  • Without a cervix because they have undergone hysterectomy
  • Based on the judgment of the clinicians not sufficiently healthy to participate in a research study

Trial locations and contacts

1 site in 1 country.

Cameroon1 site

  • Limbé Regional Hospital

    Limbe

Other trials in Cameroon

About this study

Official title: Cervical Cancer Screening Strategies in Women Living With HIV and HIV Uninfected Women in Cameroon

Human immunodeficiency virus-infected (HIV[+]) women have a several-fold increased risk of invasive cervical cancer (ICC) as well as increased risk of cervical pre-cancer. In low- and middle-income countries (LMICs), ICC is the 1st or 2nd most common cause of cancer and cancer-related death in women. Rates of ICC and ICC-related mortality are particularly high in Sub-Saharan Africa, which also has the highest rates of HIV infection in the world. Although prophylactic HPV vaccines may be the optimal cervical cancer prevention strategy, 2-3 generations of at-risk HIV[+] and HIV[-] women are already highly exposed to human papillomavirus (HPV) and would not benefit from (and will not be immunized with) HPV vaccine. Thus cervical cancer screening is needed for the foreseeable future. However, Pap testing is expensive and requires a complex clinical and lab infrastructure that does not generally exist in LMICs; strategies based on high-risk HPV (hrHPV) testing or visual inspection after acetic acid (VIA) are promising but are either too non-specific, leading to over-referral for colposcopy or over-treatment, or are too insensitive, respectively. Thus, inexpensive, easily implemented, and effective cervical cancer screening methods are greatly needed in Sub-Saharan Africa, especially for HIV[+] women. This cervical cancer screening study of 1,200 women (800 HIV[+] and 400 HIV[-] women), aged 25-59 years, living in Cameroon, utilized our existing research site. The investigators evaluated screening tests (hrHPV testing, VIA and Pap), traditional triage tests (HPV16/18/45 detection, VIA, Pap), and promising new biomarkers for triage (Ki-C67, TOP2a, CDKN2A, and HPV viral load) of screen-positive women. All screen positives underwent rigorous disease ascertainment to obtain unbiased estimates of sensitivity, specificity, and positive and negative predictive value. The goal of this study was to establish the foundation and capacity for future studies designed to reduce the burden of HPV-associated cancers in the Cameroon population. It will inform Cameroon and other countries with high HIV burdens on the best strategies for cervical cancer screening in their HIV[+] and HIV[-] women.

Being tested
HPV screening and triage tests, HPV self-sampling
Keywords
HIV, HPV screening, cervical cancer, self sampling, human papillomavirus
Medical subject headings
Uterine Cervical Neoplasms, Acquired Immunodeficiency Syndrome

What participants receive

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

  • HPV screening and triage testsOther

    The participants underwent a pelvic exam to have a provider-collected sample placed in PreservCyt [Hologic, Inc., Bedford, MA, USA] and a visual inspection by acetic acid (VIA) by a nurse.

  • HPV self-samplingBehavioural

    The participant was escorted by the nurse to a private room and given instructions on how to self-collect their sample using "Just for Me" sampler [Preventive Oncology International, Cleveland, OH, USA].

Study groups in NCT04401670
Study groupRoleWhat they receive
Triage with different optionsOther* Self-Collection: hrHPV and Biomarkers Testing (among hrHPV+) * ThinPrep Specimen: Liquid-Based Cytology (LBC), hrHPV Testing, and Biomarker Testing (among hrHPV+) * Visual Inspection after Acetic Acid (VIA)
Receives: Other: HPV screening and triage tests; Behavioral: HPV self-sampling

What is being measured

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

  1. Triage Testing of HIV[+] and HIV[-] Women for Detection of CIN2+ and CIN3+

    To evaluate and compare the clinical performance of high-risk human papillomavirus (hrHPV) DNA testing using provider-collected specimens (Provider/hrHPV) and self-collected specimens (Self/hrHPV), visual inspection after acetic acid (VIA), and liquid-based cytology (LBC) for detection of cervical intraepithelial neoplasia (CIN) grade 2 or more severe diagnoses (CIN2+) and grade 3 or more severe diagnoses (CIN3+) in HIV[+] and HIV[-] women.

    Measured: 0 days

  2. Triage Testing of HPV-Positive Women for the Detection of CIN2+ and CIN3+

    To compare the clinical performance of VIA, detection of the most carcinogenic hrHPV genotypes HPV16, 18, or/and 45, and biomarkers Ki-67, p16INK4a, and TOP2A mRNA, HPV viral load, and LBC as triage strategies for hrHPV-positive women for detection of CIN2+ and CIN3+.

    Measured: 0 days

  3. Age-Specific Prevalence of Screen Positives in Limbé

    To measure the age-group specific prevalence of hrHPV DNA, LBC, and VIA positivity, and CIN2+ and CIN3+ in HIV[+] and HIV[-] women living in Limbé, Cameroon.

    Measured: 0 days

Secondary outcomes (1)

  1. Qualitative interviews to assess acceptability and feasibility of self-collection from women

    To identify micro- and meso-level factors from an exploratory qualitative analysis using data obtained through focus group discussions and in-depth interviews to evaluate acceptability and feasibility of self-sampling for hrHPV testing among HIV[+] and HIV[-] women living in Limbé, Cameroon. This approach was used to better understand and describe women's knowledge, attitudes, and practices regarding cancers in general, cervical cancer, HPV infection, screening as well as behavioral and structural facilitators and barriers to cervical cancer prevention. Additional information was obtained to assess and compare perceptions and preferences for self-versus health provider-collected biological specimens to understand women's preferences given peculiar contextual factors that facilitate or inhibit access to cervical cancer screening for women at risk.

    Measured: 0 days

Timeline

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

  1. First posted26 May 2020
  2. Study start25 Apr 2017
  3. Primary completion1 Aug 2019
  4. Study completion1 May 2020

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
873 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04401670
Sponsor's protocol ID
2016-6070
Other IDs
3P30CA013330
Status last verified
May 2020
First submitted
18 May 2020
Last updated
26 May 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Castle PE, Ajeh R, Dzudie A, Kendowo E, Fuhngwa N, Simo-Wambo AG, Nsame D, Orock E, Hebert TM, Pierz AJ, Murokora D, Anastos K, Adedimeji A. A comparison of screening tests for detection of high-grade cervical abnormalities in women living with HIV from Cameroon. Infect Agent Cancer. 2020 Jul 11;15:45. doi: 10.1186/s13027-020-00311-w. eCollection 2020.

    PubMed 32676125

Questions about this trial

What is this clinical trial studying?

A study testing HPV screening and triage tests and HPV self-sampling in people with Cervical Cancer and HIV/AIDS, run by Albert Einstein College of Medicine at 1 site in Cameroon.

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 5 inclusion and 5 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 26 May 2020. 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 Cameroon. 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?

Triage Testing of HIV[+] and HIV[-] Women for Detection of CIN2+ and CIN3+ (time frame: 0 days). The study lists 3 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 NCT04401670, which also lists 1 linked publication.

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 26 May 2020; AzTrials last refreshed its copy on 28 Oct 2026.

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