Cervical CancerDiaVACCSNCT02956031
Screening Study for Cervical Pre-cancer and Cancer Prevention in South African Women.
An observational study of Cervical Cancer and High Grade Sil, run by University of Pretoria at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, High Grade Sil, CIN2
- What is being tested?
- Screening, Colposcopy and LLETZ
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteSouth Africa
- Study dates
- Dec 2016to Dec 2038
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Current pregnancy
- Hysterectomy
- Current or previous treatment for gynaecological cancer
- Hesitant or unable to undergo screening and treatment if indicated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
Steve Biko Academic Hospital
Pretoria, Gauteng
Cathy Visser, MSc, +27 12 354 3900, visser.cathy@gmail.com
Leon C Snyman, MMedO&G;FCOG
About this study
Official title: Primary HPV Screening as an Indicator of Cervical Pre-invasive and Invasive Neoplasia in HIV-positive and -Negative Southern African Women
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
- Being tested
- Screening, Colposcopy, LLETZ
- Keywords
- cancer prevention, cervical screening, cervical cancer, cervical disease, cervical neoplasm, HPV testing, immunocytochemistry, triage techniques
- Medical subject headings
- Uterine Cervical Neoplasms, Squamous Intraepithelial Lesions, Uterine Cervical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
Cervical specimen obtained using speculum examination and cervical collection bush.
ColposcopyOther
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.
LLETZProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| HIV pos | those who serologically tested positive for HIV Receives: Other: Screening; Other: Colposcopy; Procedure: LLETZ | |
| HIV neg | those who serologically tested negative for HIV Receives: Other: Screening; Other: Colposcopy; Procedure: LLETZ | |
| HIV unk | those with no available serological test for HIV Receives: Other: Screening; Other: Colposcopy; Procedure: LLETZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Detected on histology biopsy at colposcopy after initial HPV screening with simultaneous cytology and immunocytochemistry testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2038 (estimated)
- Study completionDec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- University of Pretoria
- Sponsor type
- University, hospital or other
- Collaborators
- University of Stellenbosch
- Responsible party
- Principal investigator, Professor Greta Dreyer, University of Pretoria
- Investigators
- Greta D Dreyer, PhD, Principal investigator, University of Pretoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956031
- Sponsor's protocol ID
- DiaVACCS
- Acronym
- DiaVACCS
- Status last verified
- Jul 2026
- First submitted
- 2 Nov 2016
- Last updated
- 7 Jul 2026
- Results posted
- No
Publications
van der Merwe FH, Dreyer G, Visser C, Dreyer GJ, Richter K, Snyman LC, Adams R, Botha MH. Extended Genotyping as Triage of HPV Positive Screened Women in Low-and-Middle Income Countries. J Med Virol. 2026 May;98(5):e70981. doi: 10.1002/jmv.70981.
PubMed 42171389Snyman 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.
PubMed 36650011
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary HPV Screening as an Indicator of Cervical Pre-invasive and Invasive Neoplasia in HIV-positive and -Negative Southern African Women
- ClinicalTrials.gov ID
- NCT02956031
- Acronym / sponsor ID
- DiaVACCS / DiaVACCS
- Conditions
- Cervical Cancer, High Grade Sil, CIN2
- Keywords
- cancer prevention, cervical screening, cervical cancer, cervical disease, cervical neoplasm, HPV testing, immunocytochemistry, triage techniques
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of PretoriaUniversity, hospital or other
- Collaborators
- University of Stellenbosch
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2038 (estimated)
- Study completion
- Dec 2038 (estimated)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 15 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV pos | – | Other: Screening, Other: Colposcopy, Procedure: LLETZthose who serologically tested positive for HIV |
| HIV neg | – | Other: Screening, Other: Colposcopy, Procedure: LLETZthose who serologically tested negative for HIV |
| HIV unk | – | Other: Screening, Other: Colposcopy, Procedure: LLETZthose with no available serological test for HIV |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Current pregnancy
- Hysterectomy
- Current or previous treatment for gynaecological cancer
- Hesitant or unable to undergo screening and treatment if indicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScreeningCervical specimen obtained using speculum examination and cervical collection bush. | Other | HIV neg, HIV pos, HIV unk |
| ColposcopyVaginal speculum examination followed by application of 2% acetic acid and lugol's iodine with inspection with colposcope and punch biopsies taken of abnormal areas. | Other | HIV neg, HIV pos, HIV unk |
| LLETZThe 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). | Procedure or surgery | HIV neg, HIV pos, HIV unk |
Primary outcome
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
Time frame: Detected on histology biopsy at colposcopy after initial HPV screening with simultaneous cytology and immunocytochemistry testing
1 secondary outcome
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
Time frame: Detected on histology biopsy at colposcopy after initial HPV screening with simultaneous cytology and immunocytochemistry testing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Derived from this study: PubMed 42171389van der Merwe FH, Dreyer G, Visser C, Dreyer GJ, Richter K, Snyman LC, Adams R, Botha MH. Extended Genotyping as Triage of HPV Positive Screened Women in Low-and-Middle Income Countries. J Med Virol. 2026 May;98(5):e70981. doi: 10.1002/jmv.70981.
- Derived from this study: PubMed 36650011Snyman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Greta D Dreyer, PhD principal investigator
University of Pretoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and High Grade Sil, run by University of Pretoria at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Greta Dreyer, PhD (+(27) 12 354 3900, greta.dreyer@up.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Detected on histology biopsy at colposcopy after initial HPV screening with simultaneous cytology and immunocytochemistry testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02956031, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.