Human Papilloma Virus InfectionNCT02124252
Community-Driven Cervical Cancer Prevention in Western Kenya
A study testing Community-based testing with standard linkage to care and Community-based HPV testing with enhanced linkage to care in people with Human Papilloma Virus Infection and Carcinoma in Situ of Uterine Cervix, run by Duke University at 1 site in Kenya.
Trial summary
There are many challenges to implementation of cervical cancer prevention in resource-limited countries, despite evidence based screening and treatment strategies. The investigators hypothesize that self-collected HPV specimens offered in a community health campaign setting will Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus Infection, Carcinoma in Situ of Uterine Cervix
- What is being tested?
- Community-based testing with standard linkage to care and Community-based HPV testing with enhanced linkage to care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,200 participants
- Where
- 1 siteKenya
- Study dates
- Jan 2016to Mar 2019
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female, ages 25-65 Willing to sign informed consent Lives in community where randomization arm is
Who cannot join
- Prior hysterectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Community-Driven Cervical Cancer Prevention Strategy in Western Kenya
There are many challenges to implementation of cervical cancer prevention in resource-limited countries, despite evidence based screening and treatment strategies. The investigators hypothesize that self-collected HPV specimens offered in a community health campaign setting will
- Being tested
- Community-based testing with standard linkage to care, Community-based HPV testing with enhanced linkage to care
- Keywords
- cervical cancer screening, human papillomavirus testing, Kenya, implementation science
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based testing with standard linkage to careBehavioural
Women will be offered HPV-based cervical cancer screening followed by standard linkage to care for women who test positive (to subdistrict or district hospitals).
Community-based HPV testing with enhanced linkage to careBehavioural
Women will be offered HPV-based cervical cancer screening followed by enhanced linkage to care using the strategies determined in partnership with the key stakeholders in the communities.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Women will be offered HPV testing within the health facilities in the communities randomized to this arm. Women who test HPV positive will be referred to care at the sub-district and district hospitals (current standard of care). |
| Standard Intervention | Active comparator | Women will be offered HPV-based cervical cancer screening followed by standard linkage to care for women who test positive (to subdistrict or district hospitals). Receives: Behavioral: Community-based testing with standard linkage to care |
| Enhanced Intervention | Active comparator | Women will be offered HPV-based cervical cancer screening followed by enhanced linkage to care using the strategies determined in partnership with the key stakeholders in the communities. Receives: Behavioral: Community-based HPV testing with enhanced linkage to care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach of cervical cancer screening using self-collected HPV specimens in community health campaigns compared to clinics
The investigators will compare the number of women who uptake HPV testing in the community health campaign arms compared to the number who uptake HPV testing in the clinic-based arms.
Measured: 2 years
Secondary outcomes (1)
Determine the Efficacy of the cervical cancer prevention program
The investigators will compare the number of women accessing treatment for positive HPV results with standard linkage to care compared to the enhanced linkage to treatment strategy.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Human Papilloma Virus InfectionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 7,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan J Huchko, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124252
- Sponsor's protocol ID
- Pro00077442
- Status last verified
- Jan 2019
- First submitted
- 24 Apr 2014
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Olwanda EE, Kahn JG, Choi Y, Islam JY, Huchko M. Comparison of the costs of HPV testing through community health campaigns versus home-based testing in rural Western Kenya: a microcosting study. BMJ Open. 2020 Oct 27;10(10):e033979. doi: 10.1136/bmjopen-2019-033979.
PubMed 33109637Huchko M, Adewumi K, Oketch S, Saduma I, Bukusi E. 'I'm here to save my life': a qualitative study of experiences navigating a cryotherapy referral system for human papillomavirus-positive women in western Kenya. BMJ Open. 2019 Jul 24;9(7):e028669. doi: 10.1136/bmjopen-2018-028669.
PubMed 31345973Swanson M, Ibrahim S, Blat C, Oketch S, Olwanda E, Maloba M, Huchko MJ. Evaluating a community-based cervical cancer screening strategy in Western Kenya: a descriptive study. BMC Womens Health. 2018 Jul 3;18(1):116. doi: 10.1186/s12905-018-0586-0.
PubMed 29970063Shen J, Olwanda E, Kahn JG, Huchko MJ. Cost of HPV screening at community health campaigns (CHCs) and health clinics in rural Kenya. BMC Health Serv Res. 2018 May 25;18(1):378. doi: 10.1186/s12913-018-3195-6.
PubMed 29801496Huchko MJ, Kahn JG, Smith JS, Hiatt RA, Cohen CR, Bukusi E. Study protocol for a cluster-randomized trial to compare human papillomavirus based cervical cancer screening in community-health campaigns versus health facilities in western Kenya. BMC Cancer. 2017 Dec 6;17(1):826. doi: 10.1186/s12885-017-3818-z.
PubMed 29207966Huchko MJ, Ibrahim S, Blat C, Cohen CR, Smith JS, Hiatt RA, Bukusi E. Cervical cancer screening through human papillomavirus testing in community health campaigns versus health facilities in rural western Kenya. Int J Gynaecol Obstet. 2018 Apr;141(1):63-69. doi: 10.1002/ijgo.12415. Epub 2018 Jan 3.
PubMed 29197067
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Community-Driven Cervical Cancer Prevention Strategy in Western Kenya
- ClinicalTrials.gov ID
- NCT02124252
- Acronym / sponsor ID
- Pro00077442
- Keywords
- cervical cancer screening, human papillomavirus testing, Kenya, implementation science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,200 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 28 Apr 2014 (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.
There are many challenges to implementation of cervical cancer prevention in resource-limited countries, despite evidence based screening and treatment strategies. The investigators hypothesize that self-collected HPV specimens offered in a community health campaign setting will
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Women will be offered HPV testing within the health facilities in the communities randomized to this arm. Women who test HPV positive will be referred to care at the sub-district and district hospitals (current standard of care). |
| Standard Intervention | Active comparator | Behavioral: Community-based testing with standard linkage to careWomen will be offered HPV-based cervical cancer screening followed by standard linkage to care for women who test positive (to subdistrict or district hospitals). |
| Enhanced Intervention | Active comparator | Behavioral: Community-based HPV testing with enhanced linkage to careWomen will be offered HPV-based cervical cancer screening followed by enhanced linkage to care using the strategies determined in partnership with the key stakeholders in the communities. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female, ages 25-65 Willing to sign informed consent Lives in community where randomization arm is
Key exclusion criteria (1 listed)
- Prior hysterectomy
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 |
|---|---|---|
| Community-based testing with standard linkage to careWomen will be offered HPV-based cervical cancer screening followed by standard linkage to care for women who test positive (to subdistrict or district hospitals). | Behavioural | Standard Intervention |
| Community-based HPV testing with enhanced linkage to careWomen will be offered HPV-based cervical cancer screening followed by enhanced linkage to care using the strategies determined in partnership with the key stakeholders in the communities. | Behavioural | Enhanced Intervention |
Primary outcome
Reach of cervical cancer screening using self-collected HPV specimens in community health campaigns compared to clinics
Time frame: 2 years
The investigators will compare the number of women who uptake HPV testing in the community health campaign arms compared to the number who uptake HPV testing in the clinic-based arms.
1 secondary outcome
Determine the Efficacy of the cervical cancer prevention program
Time frame: 4 years
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 10 Apr 2019.
- Derived from this study: PubMed 33109637Olwanda EE, Kahn JG, Choi Y, Islam JY, Huchko M. Comparison of the costs of HPV testing through community health campaigns versus home-based testing in rural Western Kenya: a microcosting study. BMJ Open. 2020 Oct 27;10(10):e033979. doi: 10.1136/bmjopen-2019-033979.
- Derived from this study: PubMed 31345973Huchko M, Adewumi K, Oketch S, Saduma I, Bukusi E. 'I'm here to save my life': a qualitative study of experiences navigating a cryotherapy referral system for human papillomavirus-positive women in western Kenya. BMJ Open. 2019 Jul 24;9(7):e028669. doi: 10.1136/bmjopen-2018-028669.
- Derived from this study: PubMed 29970063Swanson M, Ibrahim S, Blat C, Oketch S, Olwanda E, Maloba M, Huchko MJ. Evaluating a community-based cervical cancer screening strategy in Western Kenya: a descriptive study. BMC Womens Health. 2018 Jul 3;18(1):116. doi: 10.1186/s12905-018-0586-0.
- Derived from this study: PubMed 29801496Shen J, Olwanda E, Kahn JG, Huchko MJ. Cost of HPV screening at community health campaigns (CHCs) and health clinics in rural Kenya. BMC Health Serv Res. 2018 May 25;18(1):378. doi: 10.1186/s12913-018-3195-6.
- Derived from this study: PubMed 29207966Huchko MJ, Kahn JG, Smith JS, Hiatt RA, Cohen CR, Bukusi E. Study protocol for a cluster-randomized trial to compare human papillomavirus based cervical cancer screening in community-health campaigns versus health facilities in western Kenya. BMC Cancer. 2017 Dec 6;17(1):826. doi: 10.1186/s12885-017-3818-z.
- Derived from this study: PubMed 29197067Huchko MJ, Ibrahim S, Blat C, Cohen CR, Smith JS, Hiatt RA, Bukusi E. Cervical cancer screening through human papillomavirus testing in community health campaigns versus health facilities in rural western Kenya. Int J Gynaecol Obstet. 2018 Apr;141(1):63-69. doi: 10.1002/ijgo.12415. Epub 2018 Jan 3.
- Individual participant dataSharing planned: Undecided
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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.
Megan J Huchko, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based testing with standard linkage to care and Community-based HPV testing with enhanced linkage to care in people with Human Papilloma Virus Infection and Carcinoma in Situ of Uterine Cervix, run by Duke University at 1 site in Kenya.
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 1 inclusion and 1 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 10 Apr 2019. 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 Kenya. 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?
Reach of cervical cancer screening using self-collected HPV specimens in community health campaigns compared to clinics (time frame: 2 years). 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 NCT02124252, which also lists 6 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 10 Apr 2019.