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

Sponsor

University of Pretoria (Other)

Overall Status

Completed

CT.gov ID

NCT02956031

Collaborator

University of Stellenbosch (Other)

1,104

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer High Grade Sil CIN2	Other: Screening Other: Colposcopy Procedure: LLETZ

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1104 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Primary HPV Screening as an Indicator of Cervical Pre-invasive and Invasive Neoplasia in HIV-positive and -Negative Southern African Women

Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
HIV pos those who serologically tested positive for HIV	Other: Screening Cervical specimen obtained using speculum examination and cervical collection bush. Other: Colposcopy 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. Procedure: LLETZ 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 those who serologically tested negative for HIV	Other: Screening Cervical specimen obtained using speculum examination and cervical collection bush. Other: Colposcopy 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. Procedure: LLETZ 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 unk those with no available serological test for HIV	Other: Screening Cervical specimen obtained using speculum examination and cervical collection bush. Other: Colposcopy 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. Procedure: LLETZ 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).

Arm

Intervention/Treatment

HIV pos

those who serologically tested positive for HIV

Other: Screening

Cervical specimen obtained using speculum examination and cervical collection bush.

Other: Colposcopy

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.

Procedure: LLETZ

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

those who serologically tested negative for HIV

Other: Screening

Cervical specimen obtained using speculum examination and cervical collection bush.

Other: Colposcopy

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.

Procedure: LLETZ

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 unk

those with no available serological test for HIV

Other: Screening

Cervical specimen obtained using speculum examination and cervical collection bush.

Other: Colposcopy

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.

Procedure: LLETZ

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).

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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