Screening Study for Cervical Pre-cancer and Cancer Prevention in South African Women.

NCT02956031 | Recruiting

• 1 other identifier: DiaVACCS
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Nearly 8 000 new cervical cancer cases are diagnosed in South Africa per year; many are still undiagnosed and about 50% of diagnosed cases succumb per year. Although the current prevalence of pre-cancer cervical disease is largely unknown, data from local studies suggest regional differences and an increase in the prevalence of cytological abnormalities when compared with historical data. Low frequency in cytology screening is the primary factor attributable to development of invasive cervical cancer and almost one-third of all cervical cancer patients had previous negative cytology. Due to the low sensitivity of cytology it can be assumed that the true prevalence of pre-cancer disease is underestimated by all available data. One round of optimal cervical cytology will detect around 50% of existing pre-cancer cervical disease as identified and proven using colposcopy and directed biopsy. It is now widely accepted that primary screening with a human papilloma virus (HPV) test can improve the sensitivity of screening and that even a single round of HPV screening can rapidly reduce the incidence of invasive cervical cancer and related mortality within a few years. South Africa has a high prevalence of HIV infection and a delay in or failure to initiate antiretroviral therapy (ART). These facts, together with the largely unscreened status of the female population and the high incidence of cervical cancer all suggest that HPV infection and precursors to cervical cancer are both unusually common among South African women. Accurate current knowledge of the performance of newer generation HPV based screening tests in HIV-infected and general female population are essential for cost-analysis and planning for national prevention and screening programs. This study will aim to demonstrate the feasibility and efficacy of new generation HPV deoxyribonucleic acid (DNA) based screening assays in a South African setting. The investigators hypothesize that HPV testing followed by normal and special cytology tests will be a successful screening model for a South African population.

Conditions

Cervical Cancer; High Grade Sil; CIN2

Keywords

cancer prevention; cervical screening; cervical cancer; cervical disease; cervical neoplasm; HPV testing; immunocytochemistry; triage techniques

Outcome Measures

Primary Outcomes (1)

• Number of women with histologically proven cervical intraepithelial neoplasia grade 2+ (CIN2+) detected using HPV DNA analysis with partial genotyping as primary screen test followed by cervical cytology and immunocytochemistry as triage tests

  Detected on histology biopsy at colposcopy after initial HPV screening with simultaneous cytology and immunocytochemistry testing

Secondary Outcomes (1)

• Number of women with CIN2+ detected using HPV DNA analysis with partial genotyping that is associated with HPV types 16, 18, 16 and/or 18, only other high risk types

  Detected on histology biopsy at colposcopy after initial HPV screening with simultaneous cytology and immunocytochemistry testing

Study Arms (3)

HIV pos

those who serologically tested positive for HIV

Other: Screening; Other: Colposcopy; Procedure: LLETZ

HIV neg

those who serologically tested negative for HIV

Other: Screening; Other: Colposcopy; Procedure: LLETZ

HIV unk

those with no available serological test for HIV

Other: Screening; Other: Colposcopy; Procedure: LLETZ

Interventions

Screening OTHER

Cervical specimen obtained using speculum examination and cervical collection bush.

HIV neg; HIV pos; HIV unk

Colposcopy OTHER

Vaginal speculum examination followed by application of 2% acetic acid and lugol's iodine with inspection with colposcope and punch biopsies taken of abnormal areas.

HIV neg; HIV pos; HIV unk

LLETZ PROCEDURE

The above (see colposcopy) is followed by local anaesthetic with two dentist's ampoules of lignocaine and large loop excision using coagulation of the abnormal area (usually 2 x 3 x 1 cm).

HIV neg; HIV pos; HIV unk

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a multicentric study carried out in South Africa. Women with unknown HIV status will be recruited from the general population, and HIV positive women from adult antiretroviral treatment (ART) clinics.

You may qualify if:

• Informed consent accepted and signed
• Health seeking behaviour or request for a cervical cancer screening test
• Willing and able to receive test result by automated text message or clinic visit

You may not qualify if:

• Current pregnancy
• Hysterectomy
• Current or previous treatment for gynaecological cancer
• Hesitant or unable to undergo screening and treatment if indicated

Sponsors & Collaborators

• University of Pretoria: lead
• University of Stellenbosch: collaborator

Study Sites (1)

Steve Biko Academic Hospital

Pretoria, Gauteng, South Africa

RECRUITING

Related Publications (1)

• Snyman LC, Richter KL, Lukhwareni A, Dreyer G, Botha MH, Van Der Merwe FH, Visser C, Dreyer G. Cytology compared with Hybrid Capture 2 human papilloma virus cervical cancer screening in HIV positive and HIV negative South African women. Int J Gynecol Cancer. 2023 May 1;33(5):669-675. doi: 10.1136/ijgc-2022-003897.

  PMID: 36650011 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Squamous Intraepithelial Lesions; Uterine Cervical Diseases

Interventions

Mass Screening; Colposcopy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Diagnostic Techniques, Obstetrical and Gynecological; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Greta D Dreyer, PhD

  University of Pretoria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Greta Dreyer, PhD

CONTACT

+(27) 12 354 3900; greta.dreyer@up.ac.za

Cathy Visser, MSc

CONTACT

+(27) 12 354 3900; cathy.visser@up.ac.za

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 4, 2016
• Study Start: December 1, 2016
• Primary Completion (Estimated): December 1, 2038
• Study Completion (Estimated): December 1, 2038
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)