Human Papillomavirus 16ASPIRENCT04000503
Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge)
A study testing Self-collected HPV testing for cervical cancer screening in people with Human Papillomavirus 16 and Human Papillomavirus 18, run by University of British Columbia at 1 site in Uganda.
Trial summary
The purpose of this pragmatic cluster randomized control trial is to test the effectiveness of cervical cancer screening follow-up completion using two implementation approaches for self-collected HPV testing in a rural, low-resource setting: 1) community health workers recruiting women door-to-door and 2) community… Read more about this study
- Who is it for?
- Ages 25 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus 16, Human Papillomavirus 18, Papillomavirus Infections
- What is being tested?
- Self-collected HPV testing for cervical cancer screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,019 participants
- Where
- 1 siteUganda
- Study dates
- 1 Aug 2019to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with no previous history of hysterectomy
- aged 25-49 years old
- no previous history of treatment for cervical cancer
- provided written informed consent.
Who cannot join
- Women who are under 25 or over 49 years of age,
- who have previously had a hysterectomy or been treated for cervical cancer
- unable to provided informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge): A Pragmatic Cluster Randomized Control Trial
The purpose of this pragmatic cluster randomized control trial is to test the effectiveness of cervical cancer screening follow-up completion using two implementation approaches for self-collected HPV testing in a rural, low-resource setting: 1) community health workers recruiting women door-to-door and 2) community health workers recruiting women at community health meetings.
This study will also help to further understand how current patient referral systems are working between health facilities, patient and provider preferences for integrated care and health system related barriers to integrated cervical cancer screening.
Hypothesis: More women will receive screening via the community health meeting but the engagement to care (i.e., visual inspection with acetic acid-our main outcome) will be greater in the door-to-door arm.
Read the detailed description
A cluster randomized control trial will be conducted with the objective of understanding differences in the effectiveness of cervical cancer screening models using self-collected HPV testing on engagement in care. In 31 villages, women will be recruited for self-collected cervical cancer and sexually transmitted infection (STI) screening by: 1) Community health worker recruitment for self-collection (door-to-door), 2) community health meetings. Visual inspection with acetic acid (VIA), cryotherapy and thermocoagulation will be offered in local health facilities for all women who test positive for high-risk (HR)-HPV types. Women needing advanced cancer care will be referred to the Uganda Cancer Institute in Kampala.
The unit of randomization (2 arms) will be villages and the analysis will also account for clustering within this unit or randomization. All participants will receive an integrated package of cervical cancer screening and education and will participate in a survey at baseline. Samples will be tested using GeneXpert (XpertHPV) point of care testing at the Kigandalo health facility for HPV and high risk HPV (HR-HPV). Intervention arms will be implemented in phases by year to avoid temporal contamination.
- Conditions
- Human Papillomavirus 16, Human Papillomavirus 18, Papillomavirus Infections, Cervical Cancer, Pre-Cancerous Dysplasia
- Being tested
- Self-collected HPV testing for cervical cancer screening
- Keywords
- Human Papillomavirus DNA Tests, Visual inspection with acetic acid, Global Health, Developing Countries, Self-collection, Cervical Cancer Screening
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-collected HPV testing for cervical cancer screeningBehavioural
Self-collection cervical cancer screening, STI screening, and education on HIV by a community health worker. Women who test positive for high-risk HPV types will be referred to a designated health centre for VIA follow-up and treatment if indicated.
| Study group | Role | What they receive |
|---|---|---|
| Community Health Worker Self-Collection | Experimental | Door-to-door recruitment of women for self-collected HPV testing Receives: Behavioral: Self-collected HPV testing for cervical cancer screening |
| Community Health Meeting Self-Collection | Experimental | Community health meeting recruitment of women for self-collected HPV testing Receives: Behavioral: Self-collected HPV testing for cervical cancer screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
VIA follow-up and treatment when indicated (screen and treat)
Proportion of total screened women who complete VIA follow-up and treatment after testing positive for high-risk HPV type
Measured: Outcome measured within 6 weeks of self-collection for HPV test
Secondary outcomes (5)
HPV prevalence
Total number of women who test positive for HPV out of the total number of samples obtained
Measured: Baseline
STI-HPV co-infection rate (Gonorrhea, Syphilis, etc.)
Total number of women who test positive for STIs out of total number of women who test positive for HPV; total number of women who test negative for STIs out of total number of women who test positive for HPV; total number of women who test positive for STIs out of total number of women who test negative for HPV; total number of women who test negative for STIs out of total number of women who test negative for HPV
Measured: Baseline
HPV and co-morbid conditions
Association (adjusted OR) estimated between HPV and HIV; other STIs
Measured: Baseline
Barriers and facilitators of engagement in care
Semi-structured focus group discussions with women who did and did not attend follow-up screening in each study arm.
Measured: FGDs within 3 months of recruitment completion
Identify mediators of engagement of care
Mediation analysis using counterfactual approach to assess mediating effect of patient reported experience, knowledge change and co-infection status with other STIs on engagement in care after positive HR-HPV test
Measured: Outcome measured within 6 weeks of self-collection for HPV test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start1 Aug 2019
- Primary completion31 Jul 2021
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus 16Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic cluster randomized control trial
- Masking
- None (open label)
- Enrolment
- 2,019 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Uganda Cancer Institute
- Responsible party
- Principal investigator, Gina Ogilvie, University of British Columbia
- Investigators
- Gina Ogilvie, MD, Principal investigator, Women's Health Research Institute of British ColumbiaSheona Mitchell-Foster, MD, Principal investigator, University of Northern British ColumbiaCarolyn Nakisige, MD, Principal investigator, Uganda Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000503
- Sponsor's protocol ID
- H17-03332
- Acronym
- ASPIRE
- Status last verified
- Oct 2022
- First submitted
- 18 Jun 2019
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available on request through study investigators.
Publications
Leahy W, Abomoslim M, Booth A, Gottschlich A, Mwandacha N, Dau H, Naguti P, Payne B, Smith L, Nakisige C, Ogilvie G. Women's cellphone access and ownership in rural Uganda: implications for self-care interventions. BMC Glob Public Health. 2024 Feb 5;2(1):8. doi: 10.1186/s44263-024-00038-5.
PubMed 39681893Gottschlich A, Payne BA, Trawin J, Albert A, Jeronimo J, Mitchell-Foster S, Mithani N, Namugosa R, Naguti P, Pedersen H, Rawat A, Simelela PN, Singer J, Smith LW, van Niekerk D, Orem J, Nakisige C, Ogilvie G. Community-integrated self-collected HPV-based cervix screening in a low-resource rural setting: a pragmatic, cluster-randomized trial. Nat Med. 2023 Apr;29(4):927-935. doi: 10.1038/s41591-023-02288-6. Epub 2023 Apr 10.
PubMed 37037880Gottschlich A, Payne BA, Trawin J, Albert A, Jeronimo J, Mitchell-Foster S, Mithani N, Namugosa R, Naguti P, Orem J, Rawat A, Simelela PN, Singer J, Smith LW, van Niekerk D, Nakisige C, Ogilvie G. Experiences with thermal ablation for cervical precancer treatment after self-collection HPV-based screening in the ASPIRE Mayuge randomized trial. Int J Cancer. 2023 Apr 15;152(8):1630-1639. doi: 10.1002/ijc.34369. Epub 2022 Nov 28.
PubMed 36408923Rawat A, Mithani N, Sanders C, Namugosa R, Payne B, Mitchell-Foster S, Orem J, Ogilvie G, Nakisige C. "We Shall Tell them with Love, Inform them what we have Learnt and then Allow them to go" - Men's Perspectives of Self-Collected Cervical Cancer Screening in Rural Uganda: A Qualitative Inquiry. J Cancer Educ. 2023 Apr;38(2):618-624. doi: 10.1007/s13187-022-02163-x. Epub 2022 Apr 6.
PubMed 35384556Nakisige C, Trawin J, Mitchell-Foster S, Payne BA, Rawat A, Mithani N, Amuge C, Pedersen H, Orem J, Smith L, Ogilvie G. Integrated cervical cancer screening in Mayuge District Uganda (ASPIRE Mayuge): a pragmatic sequential cluster randomized trial protocol. BMC Public Health. 2020 Jan 31;20(1):142. doi: 10.1186/s12889-020-8216-9.
PubMed 32005202
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge): A Pragmatic Cluster Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04000503
- Acronym / sponsor ID
- ASPIRE / H17-03332
- Conditions
- Human Papillomavirus 16, Human Papillomavirus 18, Papillomavirus Infections, Cervical Cancer, Pre-Cancerous Dysplasia
- Keywords
- Human Papillomavirus DNA Tests, Visual inspection with acetic acid, Global Health, Developing Countries, Self-collection, Cervical Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,019 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Uganda Cancer Institute
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 27 Jun 2019 (actual)
- 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.
The purpose of this pragmatic cluster randomized control trial is to test the effectiveness of cervical cancer screening follow-up completion using two implementation approaches for self-collected HPV testing in a rural, low-resource setting: 1) community health workers recruiting women door-to-door and 2) community health workers recruiting women at community health meetings.
This study will also help to further understand how current patient referral systems are working between health facilities, patient and provider preferences for integrated care and health system related barriers to integrated cervical cancer screening.
Hypothesis: More women will receive screening via the community health meeting but the engagement to care (i.e., visual inspection with acetic acid-our main outcome) will be greater in the door-to-door arm.
Detailed description
A cluster randomized control trial will be conducted with the objective of understanding differences in the effectiveness of cervical cancer screening models using self-collected HPV testing on engagement in care. In 31 villages, women will be recruited for self-collected cervical cancer and sexually transmitted infection (STI) screening by: 1) Community health worker recruitment for self-collection (door-to-door), 2) community health meetings. Visual inspection with acetic acid (VIA), cryotherapy and thermocoagulation will be offered in local health facilities for all women who test positive for high-risk (HR)-HPV types. Women needing advanced cancer care will be referred to the Uganda Cancer Institute in Kampala.
The unit of randomization (2 arms) will be villages and the analysis will also account for clustering within this unit or randomization. All participants will receive an integrated package of cervical cancer screening and education and will participate in a survey at baseline. Samples will be tested using GeneXpert (XpertHPV) point of care testing at the Kigandalo health facility for HPV and high risk HPV (HR-HPV). Intervention arms will be implemented in phases by year to avoid temporal contamination.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic cluster randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker Self-Collection | Experimental | Behavioral: Self-collected HPV testing for cervical cancer screeningDoor-to-door recruitment of women for self-collected HPV testing |
| Community Health Meeting Self-Collection | Experimental | Behavioral: Self-collected HPV testing for cervical cancer screeningCommunity health meeting recruitment of women for self-collected HPV testing |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women with no previous history of hysterectomy
- aged 25-49 years old
- no previous history of treatment for cervical cancer
- provided written informed consent.
Key exclusion criteria (3 listed)
- Women who are under 25 or over 49 years of age,
- who have previously had a hysterectomy or been treated for cervical cancer
- unable to provided informed consent.
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 |
|---|---|---|
| Self-collected HPV testing for cervical cancer screeningSelf-collection cervical cancer screening, STI screening, and education on HIV by a community health worker. Women who test positive for high-risk HPV types will be referred to a designated health centre for VIA follow-up and treatment if indicated. | Behavioural | Community Health Meeting Self-Collection, Community Health Worker Self-Collection |
Primary outcome
VIA follow-up and treatment when indicated (screen and treat)
Time frame: Outcome measured within 6 weeks of self-collection for HPV test
Proportion of total screened women who complete VIA follow-up and treatment after testing positive for high-risk HPV type
5 secondary outcomes
HPV prevalence
Time frame: Baseline
STI-HPV co-infection rate (Gonorrhea, Syphilis, etc.)
Time frame: Baseline
HPV and co-morbid conditions
Time frame: Baseline
Barriers and facilitators of engagement in care
Time frame: FGDs within 3 months of recruitment completion
Identify mediators of engagement of care
Time frame: Outcome measured within 6 weeks of self-collection for HPV test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 39681893Leahy W, Abomoslim M, Booth A, Gottschlich A, Mwandacha N, Dau H, Naguti P, Payne B, Smith L, Nakisige C, Ogilvie G. Women's cellphone access and ownership in rural Uganda: implications for self-care interventions. BMC Glob Public Health. 2024 Feb 5;2(1):8. doi: 10.1186/s44263-024-00038-5.
- Derived from this study: PubMed 37037880Gottschlich A, Payne BA, Trawin J, Albert A, Jeronimo J, Mitchell-Foster S, Mithani N, Namugosa R, Naguti P, Pedersen H, Rawat A, Simelela PN, Singer J, Smith LW, van Niekerk D, Orem J, Nakisige C, Ogilvie G. Community-integrated self-collected HPV-based cervix screening in a low-resource rural setting: a pragmatic, cluster-randomized trial. Nat Med. 2023 Apr;29(4):927-935. doi: 10.1038/s41591-023-02288-6. Epub 2023 Apr 10.
- Derived from this study: PubMed 36408923Gottschlich A, Payne BA, Trawin J, Albert A, Jeronimo J, Mitchell-Foster S, Mithani N, Namugosa R, Naguti P, Orem J, Rawat A, Simelela PN, Singer J, Smith LW, van Niekerk D, Nakisige C, Ogilvie G. Experiences with thermal ablation for cervical precancer treatment after self-collection HPV-based screening in the ASPIRE Mayuge randomized trial. Int J Cancer. 2023 Apr 15;152(8):1630-1639. doi: 10.1002/ijc.34369. Epub 2022 Nov 28.
- Derived from this study: PubMed 35384556Rawat A, Mithani N, Sanders C, Namugosa R, Payne B, Mitchell-Foster S, Orem J, Ogilvie G, Nakisige C. "We Shall Tell them with Love, Inform them what we have Learnt and then Allow them to go" - Men's Perspectives of Self-Collected Cervical Cancer Screening in Rural Uganda: A Qualitative Inquiry. J Cancer Educ. 2023 Apr;38(2):618-624. doi: 10.1007/s13187-022-02163-x. Epub 2022 Apr 6.
- Derived from this study: PubMed 32005202Nakisige C, Trawin J, Mitchell-Foster S, Payne BA, Rawat A, Mithani N, Amuge C, Pedersen H, Orem J, Smith L, Ogilvie G. Integrated cervical cancer screening in Mayuge District Uganda (ASPIRE Mayuge): a pragmatic sequential cluster randomized trial protocol. BMC Public Health. 2020 Jan 31;20(1):142. doi: 10.1186/s12889-020-8216-9.
- Individual participant dataSharing planned: No. Data will be available on request through study investigators.
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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. This study is not recruiting at the moment.
Gina Ogilvie, MD principal investigator
Women's Health Research Institute of British Columbia
Sheona Mitchell-Foster, MD principal investigator
University of Northern British Columbia
Carolyn Nakisige, MD principal investigator
Uganda Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-collected HPV testing for cervical cancer screening in people with Human Papillomavirus 16 and Human Papillomavirus 18, run by University of British Columbia at 1 site in Uganda.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 3 Nov 2022. 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 Uganda. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VIA follow-up and treatment when indicated (screen and treat) (time frame: Outcome measured within 6 weeks of self-collection for HPV test). 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 NCT04000503, which also lists 5 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 3 Nov 2022.