Clinical trial NCT05256862: Improving Cervical Cancer Screening in Women Living With HIV Attending Chronic Disease Clinics in Semi-rural Tanzania
Official title: Improving Cervical Cancer Screening in Women Living With HIV Attending Chronic Disease Clinics in Semi-rural Tanzania
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer Screening
Keywords: women living with HIV (WLWH)
cervical cancer
cervical cancer prevention clinic
cervical intraepithelial neoplasia
Human Papilloma Virus
Human Immunodeficiency Virus
Squamous Intraepithelial Lesion
Kilombero and Ulanga Anti-retroviral Cohort
QuantiGene-molecular profiling histology
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Krebsforschung Schweiz, Bern, Switzerland
name: Abviris Deutschland GmbH
name: Charité-University Medicine (Berlin, Germany)
name: Swiss Tropical and Public Health Institute (Switzerland)
First posted: 2022-02-25
Enrollment: 2974
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women will be informed during their routine control within HIV care about the study on improved CC screening procedures and referred to the study team if consenting.

All interventions will be offered routinely to patients, but are not mandatory if they refuse them. Patients not consenting will be advised to seek regular services for CC screening according to the national guidelines. Apart from routine clinical visits, no additional visits are scheduled for this study unless medically indicated.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of WLWH attending CC screening
timeFrame: one time assessment at Screening
Secondary outcomes:
measure: Number of detected High Grade Squamous Intraepithelial Lesion /Cervical Cancer (HSIL/CC) in cervical self-samples by QuantiGene-molecular profiling histology (QG-MPH)
timeFrame: one time assessment at Screening
measure: 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®.
timeFrame: one time assessment at Screening
Other outcomes:
Locations:
city: Ifakara
country: Tanzania
facility: Saint Francis Referral Hospital, Ifakara Health Institute (IHI, United Republic of Tanzania)
Study officials:
affiliation: University Women's Hospital Basel
name: Ivana Di Salvo, MD
role: PRINCIPAL_INVESTIGATOR
References: