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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2974 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-27

Study Completion Date

2024-10-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cervical Cancer Screening

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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®

Intervention Type OTHER

Eligibility Criteria

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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