Improving Cervical Cancer Screening in Women Living With HIV Attending Chronic Disease Clinics in Semi-rural Tanzania

Cervical Cancer Screening Clinical Trial

Official title:

Improving Cervical Cancer Screening in Women Living With HIV Attending Chronic Disease Clinics in Semi-rural Tanzania

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05256862
• Other study ID #: AO_2021-00006; bb22Kind
• Status: Recruiting
• Start date: July 27, 2021
• Est. completion date: June 2022

Study information

• Verified date: February 2022
• Source: University Hospital, Basel, Switzerland
• Contact: Ivana Di Salvo, MD
• Phone: +41 764832968
• Email: ivana.disalvo[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is to analyse the effect of a bundle of measures on the proportion of females being screened for cervical cancer in the Kilombero and Ulanga Antiretroviral Cohort (KIULARCO), comparing the time period before implementation (01/2017-01/2020) and after implementation (02/2020-06/2022). It is to assess the performance of two novel diagnostic tests (QuantiGene-molecular profiling histology (QG-MPH) and PT Monitor® immunoassay) and established tests (Seegene Anyplex™ II 28 HPV Test and Prevo-check®) as potential triage tests for the development of future clinical decision algorithms for CC screening.

Description:

Cervical cancer (CC) is the most common cancer among women living with HIV (WLWH) and the leading cause of cancer-related death in women in East Africa. Currently there are around 2800 WLWH in care at the Chronic Disease Clinic of Ifakara (CDCI), of whom only 8% attended CC screening services in the last three years.

This research project is to assess (with a mixed-method, before-/after-study) the impact of a bundle of procedures, which consists of: portable colposcopy, Human Papilloma Virus (HPV) testing and treatment of precancerous cervical lesions by Loop electrosurgical excision procedure (LEEP).

This study is also to analyze the prevalence of cervical disease in the cohort, stratified by stage and co-infections, as well as the acceptability, feasibility and costs.

Additionally, it will assess the performance of two novel diagnostic tests (QG-MPH and PT Monitor® immunoassay) and established tests (Seegene Anyplex™ II 28 HPV Test and Prevo-check®) as potential triage tests for the development of future clinical decision algorithms for CC screening. This is an implementational study nested within the KIULARCO study consisting of two interacting parts: a pre/post assessment of the impact of the bundle of interventions with mixed-methods study design and the diagnostic tests accuracy (evaluated with a cross-sectional study). The treatment investigated is regarded as standard treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• WLWH enrolled in KIULARCO, who are at least 3 months on Anti-Retroviral Treatment (ART)

• 18-65 years of age

• Non-pregnant (reported)

• Signed informed consent

Exclusion Criteria:

• Pregnancy

• Known invasive cervical cancer

• Any condition interfering with visualization of the cervix

Related Conditions & MeSH terms

• Cervical Cancer Screening
• Chronic Disease
• Uterine Cervical Neoplasms

Intervention

Other:
• Data collection
Data collection on the effect of a bundle of measures on the proportion of females being screened for cervical cancer in the Kilombero and Ulanga Antiretroviral Cohort (KIULARCO) comparing the time period before implementation (01/2017-01/2020) and after implementation (02/2020-06/2022) on the performance of three novel tests as triage tool in the screening algorithm, QG-MPH, Prevo-check® and PT Monitor®

Locations

Country	Name	City	State
Tanzania	Saint Francis Referral Hospital, Ifakara Health Institute (IHI, United Republic of Tanzania)	Ifakara

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Abviris Deutschland GmbH, Charité-University Medicine (Berlin, Germany), Krebsforschung Schweiz, Bern, Switzerland, Swiss Tropical and Public Health Institute (Switzerland)

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of WLWH attending CC screening	Number of WLWH attending CC screening in the period 08/2021 - 06/2022; Attendance of screening: for the pre-phase women undergoing Visual inspection with acetic acid (VIA), for the post- phase women performing cervical self-sampling.	one time assessment at Screening
Secondary	Number of detected High Grade Squamous Intraepithelial Lesion /Cervical Cancer (HSIL/CC) in cervical self-samples by QuantiGene-molecular profiling histology (QG-MPH)	Diagnostic test accuracy in detecting High Grade Squamous Intraepithelial Lesion /Cervical Cancer (HSIL/CC) in cervical self-samples by QuantiGene-molecular profiling histology (QG-MPH)	one time assessment at Screening
Secondary	Number of detected patients with Human Papilloma Virus (HPV) 16 and 18 induced Cervical Intraepithelial Neoplasia grade 3 or above (CIN3+) by Serum PT Monitor®.	Diagnostic test accuracy in detecting patients with Human Papilloma Virus (HPV) 16 and 18 induced Cervical Intraepithelial Neoplasia grade 3 or above (CIN3+) by Serum PT Monitor®.	one time assessment at Screening