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

NCT05256862 | Completed

• 1 other identifier: AO_2021-00006; bb22Kind
• Study Type: observational
• Target: 2,974
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of detected 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

• 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®.

  one time assessment at Screening

Interventions

Data collection OTHER

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®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• WLWH enrolled in KIULARCO, who are at least 3 months on Anti-Retroviral Treatment (ART)
• years of age
• Non-pregnant (reported)
• Signed informed consent

You may not qualify if:

• Pregnancy
• Known invasive cervical cancer
• Any condition interfering with visualization of the cervix

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Krebsforschung Schweiz, Bern, Switzerland: collaborator
• Abviris Deutschland GmbH: collaborator
• Charité-University Medicine (Berlin, Germany): collaborator
• Swiss Tropical and Public Health Institute (Switzerland): collaborator

Study Sites (1)

Saint Francis Referral Hospital, Ifakara Health Institute (IHI, United Republic of Tanzania)

Ifakara, Tanzania

Location

Related Publications (1)

• Di Salvo I, Mnzava D, Nicoletti GJ, Senkoro E, Ndege RC, Huang DJ, Makunja NT, Kassiga GI, Kaufmann AM, Weisser M, Kind AB. Upscaling cervical cancer screening and treatment for women living with HIV at a rural referral hospital in Tanzania: protocol of a before-and-after study exploring HPV testing and novel diagnostics. BMC Health Serv Res. 2023 Mar 10;23(1):234. doi: 10.1186/s12913-023-09113-3.

  PMID: 36894985 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Acquired Immunodeficiency Syndrome; Squamous Intraepithelial Lesions

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ivana Di Salvo, MD

  University Women's Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 25, 2022
• Study Start: July 27, 2021
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

TA (1)