Feasibility of a single-visit approach using rapid HPV-testing in Cameroon

Cervical cancer screening in Cameroon: feasibility of a single-visit approach using rapid HPV-testing

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN99459678

Enrollment

1000

Registered

2015-11-01

Start date

2015-07-08

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical cancer Cancer Cervical cancer

Interventions

All women will take an HPV test. HPV-negative women will be reassured and counseled to repeat the test in 5 to 10 years. HPV-positive women with normal VIA/VILI test will undergo an endocervical curet

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women aged 30-49 2. Understanding of study procedures

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Previous hysterectomy 3. Conditions that can interfere with visualization of the cervix (menstruation) 4. Women who not able to comply with protocol study

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 26/09/2017: The feasibility of HPV cervical cancer screen-and-treat approach in a low-resource context, assessed by measuring the number of women who took part in the screening campaign and the relative number of drop-outs and invalid test results at baseline Previous primary outcome measures: The prevalence of HPV infection and cervical pre-cancer and cancer will be determined among Cameroonian women at baseline, 6 months and 1 year	—

Measure

Time frame

Current primary outcome measures as of 26/09/2017: The feasibility of HPV cervical cancer screen-and-treat approach in a low-resource context, assessed by measuring the number of women who took part in the screening campaign and the relative number of drop-outs and invalid test results at baseline Previous primary outcome measures: The prevalence of HPV infection and cervical pre-cancer and cancer will be determined among Cameroonian women at baseline, 6 months and 1 year

—

Secondary

Measure	Time frame
Current secondary outcome measures as of 26/09/2017: 1. The prevalence of HPV infection, cervical pre-cancer and cancer among Cameroonian women, determined using rapid HPV testing, cytology and histology at baseline 2. Performance of VIA/VILI and HPV16/18/45 genotyping for detection of high grade cervical lesions, determined using the kappa statistic at baseline 3. The association of risk factors leading to high-risk HPV infection and cervical pre-cancer and cancer, determined using calculated odds ratio (OR) at baseline Previous secondary outcome measures: 1. To compare the agreement between histology and VIA results as well as cervical picture and VIA results, measured using the kappa statistic at 6 and 12 months 2. To evaluate the association of risk factors leading to high-risk HPV infection and promoting cervical neoplasia using calculated odds ratio (OR) at 6 months follow up 3. Verification as to whether HPV self-testing alone is an accurate test and can reduce the need for physician-cervical sampling, measured at 6 months follow up 4. HPV clearance is measured at 6 and 12 months	—

Measure

Time frame

Current secondary outcome measures as of 26/09/2017: 1. The prevalence of HPV infection, cervical pre-cancer and cancer among Cameroonian women, determined using rapid HPV testing, cytology and histology at baseline 2. Performance of VIA/VILI and HPV16/18/45 genotyping for detection of high grade cervical lesions, determined using the kappa statistic at baseline 3. The association of risk factors leading to high-risk HPV infection and cervical pre-cancer and cancer, determined using calculated odds ratio (OR) at baseline Previous secondary outcome measures: 1. To compare the agreement between histology and VIA results as well as cervical picture and VIA results, measured using the kappa statistic at 6 and 12 months 2. To evaluate the association of risk factors leading to high-risk HPV infection and promoting cervical neoplasia using calculated odds ratio (OR) at 6 months follow up 3. Verification as to whether HPV self-testing alone is an accurate test and can reduce the need for physician-cervical sampling, measured at 6 months follow up 4. HPV clearance is measured at 6 and 12 months

—

Countries

Cameroon

Contacts

Public ContactPatrick Petignat

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 11, 2026