Clinical trial NCT03757299: Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon
Official title: Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 4473
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In sub-Saharan Africa, cervical cancer is the leading cause of cancer death among women because of the difficulty in implementing screening programs. The main obstacles in these countries are poverty, lack of healthcare infrastructures and trained practitioners. With the availability of new technologies, researchers are looking for new strategies adapted to low- and middle-income countries to identify cervical precancerous lesions.

Current evidence shows that Human Papilloma Virus (HPV) testing is more effective than cytology (Pap smear) for cervical cancer screening in resource-limited settings. Indeed, the GeneXpert® HPV test offers the opportunity to prevent cervical cancer (CC) in a single visit: rapid detection of high-risk HPV (HPV) infection followed by same day treatment of HPV-positive women during the same visit (screen-and-treat approach).

However only a small proportion of HPV-positive women will develop cervical (pre)cancer, making it important to select those to treat. This triage can be achieved by colposcopy, cytology and visual inspection after application of acetic acid (VIA). Though VIA is the triage test recommended by WHO for resource-limited countries, it has not yet been widely assessed in sub-Saharan Africa (SSA).

The main objective of the investigators is to assess the performance of HPV-test followed by Visual Inspection after application of Acetic acid and Lugol's iodine VIA/VILI to detect cervical precancerous lesions in a screen-and-treat strategy in Cameroon (sub-Saharan Africa) where there is no cervical cancer-screening program.

The investigators organized a successful free screening campaign in Cameroon in 2015 that allowed to identify the expectations of women and their eagerness to benefit from prevention of gynecological cancers and sexually transmitted diseases.


Eligibility criteria: Inclusion Criteria:

* Women aged 30-49 years, able to comply with the study protocol

Exclusion Criteria:

* Pregnancy
* Previous total hysterectomy
* Conditions impairing examination of the cervix

Primary outcomes:
measure: Sensitivity and specificity of HPV test followed by VIA/VILI to detect cervical precancerous lesions in sub-Saharan Africa using histology as gold standard
timeFrame: 3 - 5 years
Secondary outcomes:
measure: Prevalence of HPV infection
timeFrame: 3 - 5 years
measure: Prevalence of cervical pre-cancer and cancer among Cameroonian women
timeFrame: 3 - 5 years
measure: HPV clearance
timeFrame: 3 - 5 years
measure: Persistance of CIN2+ disease at the 12-month follow-up
timeFrame: 3 - 5 years
measure: Provide teaching material for professional training on cervical cancer prevention through VIA/VILI (cervical images database)
timeFrame: 3 - 5 years
measure: Acceptability rate of self-HPV test and cervical cancer screening procedures
timeFrame: 3 years
measure: Proportion of side effects and complications after thermoablation or LEEP
timeFrame: 3 - 5 years
measure: VIA test-positive rate (HPV-positive women);
timeFrame: 3 - 5 years
measure: VIA test-positive rate after 1- year follow-up of VIA-negative tests
timeFrame: 3 - 5 years
measure: Thermal ablation efficacy rate
timeFrame: 3 - 5 years
measure: Acceptability rate of thermoablation
timeFrame: 3 years
measure: Sexual dysfunction score, score of anxiety and method of contraception after screening procedures,
timeFrame: 2 years
measure: Number of women screened with and without community health care workers.
timeFrame: 2 years
measure: Increase awareness on gynecological pathologies, including cervical cancer, sexually transmitted diseases and HIV, vaginal fistula in the community of the study area,
timeFrame: 3-5 years
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University of Geneva
Study officials:
References:
citation: Petignat P, Kenfack B, Wisniak A, Saiji E, Tille JC, Tsuala Fouogue J, Catarino R, Tincho E, Vassilakos P. ABCD criteria to improve visual inspection with acetic acid (VIA) triage in HPV-positive women: a prospective study of diagnostic accuracy. BMJ Open. 2022 Apr 4;12(4):e052504. doi: 10.1136/bmjopen-2021-052504.
citation: Metaxas T, Kenfack B, Sormani J, Tincho E, Lemoupa Makajio S, Wisniak A, Vassilakos P, Petignat P. Acceptability and safety of thermal ablation to prevent cervical cancer in sub-Saharan Africa. BMC Cancer. 2022 Feb 2;22(1):132. doi: 10.1186/s12885-022-09202-2.