HPV InfectionHPVNCT03229603
A Pilot Study on HPV and Cervical Cancer Screening in Mumbai
A study testing Cluster of 3000 women in people with HPV Infection, run by Tata Memorial Hospital at 1 site in India.
Trial summary
The Study goals are to test feasibility and acceptability of point of care HPV testing with 227 women already accessing an existing cancer screening program in Mumbai, India. Describe HPV infection types in women screened. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection
- What is being tested?
- Cluster of 3000 women
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2018to May 2018
- 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 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females aged 30 to 55 years (the age when screening for HPV and cervical cancer is recommended) who participate in the TMH cancer screening outreach program.
Who cannot join
- Women with a known diagnosis of cancer, any other terminal diagnosis, or who are pregnant
Trial locations and contacts
1 site in 1 country.
India1 site
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Gauravi A Mishra, M.D PSM, +912224177000 ext. 4634, gauravi2005@yahoo.co.in
About this study
The Study goals are to test feasibility and acceptability of point of care HPV testing with 227 women already accessing an existing cancer screening program in Mumbai, India. Describe HPV infection types in women screened. Compare if the quality of HPV clinician-collected and self-collected samples are equally efficient to detect HPV and cervical cancer precursor lesions. Compare the agreement between HPV GeneXpert and HPV HC2 test on the clinician-collected sample
Read the detailed description
In this pilot study, Investigators will assess the feasibility and acceptability of point of care HPV testing in an existing SVA program. There is no control group since neither the efficacy nor effectiveness is to be tested. In the pilot study the screen positive women will be referred to the Tata Memorial Hospital for further diagnostic work-up to restrict the programme logistics. While in the main study, Colposcopy and Cryotherapy will be conducted at the community level. The evaluation framework will be based on a robust D\&I model called REAIM.
i.TMH staff will hold health camps to mobilize women to attend. Providers already trained in the TMH outreach program will identify women eligible for screening. After obtaining the consent, the medical social worker will collect baseline data and record the results of the GeneXpert HPV testing on self sample and health care provider collected sample.
Data Collection:
ii. Quantitative data: Data will be collected in-person by the Medical Social worker. De-identified data will be uploaded to Own Cloud, a file-sharing program in the University of Arizona, College of Nursing.
ii. Qualitative data: There will be a discussion on cultural appropriateness and possible adjustments to the procedures based on the healthcare providers' experiences with a small subset of the 227 women already screened. Between one to two focus groups will be conducted by the study investigators with assistance from local staff with a subset of women, separately to qualitatively assess acceptability of HPV testing using GeneXpert.
The focus group discussions with women participants will be audio-recorded and transcribed verbatim. The moderator will be guided by a semi-structured set of questions to facilitate discussion, and will specifically probe to elicit distinctive/ unusual behaviors or symptoms related to the program, screening and HPV testing.
In keeping with standards for objective evaluation, Dr. Menon or Kue will conduct a focus group discussion with Medical Social workers at the end of the study period for program evaluation (i.e., acceptability, potential changes in delivery, etc.). Discussions will be recorded by a note-taker, not previously associated with the study.
Given the small numbers, a think-aloud group, in a question and answer format with a note-taker to record the main points will be simply conducted with the providers. Both the facilitator and note-taker will not be among TMH staff as this may introduce bias to the conversation.
iii: Training of TMH staff to use GeneXpert: Personnel from the India office of Cepheid will train providers on how to use GeneXpert using standardized training protocols. The quality of the self- collected sample will be compared to the quality of the provider collected sample (by running two separate GeneXpert tests on each sample) to establish the feasibility of self-sampling.
- Conditions
- HPV Infection
- Being tested
- Cluster of 3000 women
- Keywords
- HPV infection and Cervical cancer
- 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.
Cluster of 3000 womenOther
An evaluation of the feasibility, reach, adoption and implementation of a cervical cancer screening program where we diagnose HPV using the GeneXpert point of care testing kit prior to VIA and cryotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Cluster of 3000 women | Other | Cluster will be selected from an existing cervical, breast, and oral cancer screening program in Mumbai, India and its surrounding semi-urban and rural areas. Receives: Other: Cluster of 3000 women |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of HPV testing as a single visit approach will be summarized using the appropriate descriptive statistics.
This will be predominantly for counts and percentages for categorical variables (e.g., number of women screened, number of women with incomplete self-collected specimens). In addition to the numbers of participants, the notes from the providers' debriefing regarding culturally appropriateness of HPV testing will be considered.
Measured: 3 months
Secondary outcomes (6)
Overall agreement between clinician-collected versus self-collected samples will be compared using pairwise t tests
For all pairwise comparisons, the agreement will be estimated with the kappa statistic and corresponding 95% confidence intervals. McNemar's test shall be used to detect significant differences in the discordant results (p<0.05), indicating systematic differences by assay or sample type in the detection of HPV.
Measured: 3 months
The focus group data will be analyzed using constant comparative data analysis to identify thematic components and sub-themes.
The research team will conduct a content analysis taking the following approach set forth by Huberman and Miles.
Measured: 3 months
The HPV GeneXpert by health care provider and HPV HC2 samples by health care provider will be compared to study the agreement rates.
For all pairwise comparisons, the agreement will be estimated with the kappa statistic and corresponding 95% confidence intervals. McNemar's test shall be used to detect significant differences in the discordant results (p<0.05), indicating systematic differences by assay or sample type in the detection of HPV.
Measured: 3 months
Documentation of six different genotypes/ genotype families of HPV from cervical tissue samples, which will inform the development of HPV vaccinations specific to the strains of HPV in India.
The prevalence and distribution of HPV genotypes in Indian women with cervical cancer and the trends in HPV infections will be summarized using the appropriate descriptive statistics.
Measured: 3 months
Probe for perceptions about self-collection of vaginal samples to describe acceptability of this process.
Mainly descriptive statistics in percentage, numbers and description
Measured: 3 months
Fit a predictive model of HPV infection(s).
This will be predicted by sexual behavior, sociodemographic and clinical characteristics of the women screened, controlling for the two screening sites. A positive intra-class correlation (ICC) is expected among participants at the same screening site due to commonalities in selection, exposure, mutual interaction, or a combination of those factors. We will fit Linear Mixed Models (LMMs) and Generalized Linear Mixed Models (GLMMs) to account for various levels of correlation among participants (also known as a "mixed-model ANCOVA" (Brown, 2009). We will fit these models using SAS PROC MIXED and GLIMMIX, Version 9.3.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study startApr 2018 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 227 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Collaborators
- University of Arizona
- Responsible party
- Principal investigator, Gauravi Ashish Mishra, Tata Memorial Hospital
- Investigators
- Gauravi A Mishra, M.D PSM, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229603
- Sponsor's protocol ID
- TMHPO1763
- Acronym
- HPV
- Status last verified
- Jul 2017
- First submitted
- 18 Apr 2017
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on HPV and Cervical Cancer Screening in Mumbai
- ClinicalTrials.gov ID
- NCT03229603
- Acronym / sponsor ID
- HPV / TMHPO1763
- Conditions
- HPV Infection
- Keywords
- HPV infection and Cervical cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 227 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Collaborators
- University of Arizona
- Study start
- Apr 2018 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 25 Jul 2017 (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 Study goals are to test feasibility and acceptability of point of care HPV testing with 227 women already accessing an existing cancer screening program in Mumbai, India. Describe HPV infection types in women screened. Compare if the quality of HPV clinician-collected and self-collected samples are equally efficient to detect HPV and cervical cancer precursor lesions. Compare the agreement between HPV GeneXpert and HPV HC2 test on the clinician-collected sample
Detailed description
In this pilot study, Investigators will assess the feasibility and acceptability of point of care HPV testing in an existing SVA program. There is no control group since neither the efficacy nor effectiveness is to be tested. In the pilot study the screen positive women will be referred to the Tata Memorial Hospital for further diagnostic work-up to restrict the programme logistics. While in the main study, Colposcopy and Cryotherapy will be conducted at the community level. The evaluation framework will be based on a robust D\&I model called REAIM.
i.TMH staff will hold health camps to mobilize women to attend. Providers already trained in the TMH outreach program will identify women eligible for screening. After obtaining the consent, the medical social worker will collect baseline data and record the results of the GeneXpert HPV testing on self sample and health care provider collected sample.
Data Collection:
ii. Quantitative data: Data will be collected in-person by the Medical Social worker. De-identified data will be uploaded to Own Cloud, a file-sharing program in the University of Arizona, College of Nursing.
ii. Qualitative data: There will be a discussion on cultural appropriateness and possible adjustments to the procedures based on the healthcare providers' experiences with a small subset of the 227 women already screened. Between one to two focus groups will be conducted by the study investigators with assistance from local staff with a subset of women, separately to qualitatively assess acceptability of HPV testing using GeneXpert.
The focus group discussions with women participants will be audio-recorded and transcribed verbatim. The moderator will be guided by a semi-structured set of questions to facilitate discussion, and will specifically probe to elicit distinctive/ unusual behaviors or symptoms related to the program, screening and HPV testing.
In keeping with standards for objective evaluation, Dr. Menon or Kue will conduct a focus group discussion with Medical Social workers at the end of the study period for program evaluation (i.e., acceptability, potential changes in delivery, etc.). Discussions will be recorded by a note-taker, not previously associated with the study.
Given the small numbers, a think-aloud group, in a question and answer format with a note-taker to record the main points will be simply conducted with the providers. Both the facilitator and note-taker will not be among TMH staff as this may introduce bias to the conversation.
iii: Training of TMH staff to use GeneXpert: Personnel from the India office of Cepheid will train providers on how to use GeneXpert using standardized training protocols. The quality of the self- collected sample will be compared to the quality of the provider collected sample (by running two separate GeneXpert tests on each sample) to establish the feasibility of self-sampling.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cluster of 3000 women | Other | Other: Cluster of 3000 womenCluster will be selected from an existing cervical, breast, and oral cancer screening program in Mumbai, India and its surrounding semi-urban and rural areas. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Females aged 30 to 55 years (the age when screening for HPV and cervical cancer is recommended) who participate in the TMH cancer screening outreach program.
Key exclusion criteria (1 listed)
- Women with a known diagnosis of cancer, any other terminal diagnosis, or who are pregnant
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 |
|---|---|---|
| Cluster of 3000 womenAn evaluation of the feasibility, reach, adoption and implementation of a cervical cancer screening program where we diagnose HPV using the GeneXpert point of care testing kit prior to VIA and cryotherapy. | Other | Cluster of 3000 women |
Primary outcome
The feasibility of HPV testing as a single visit approach will be summarized using the appropriate descriptive statistics.
Time frame: 3 months
This will be predominantly for counts and percentages for categorical variables (e.g., number of women screened, number of women with incomplete self-collected specimens). In addition to the numbers of participants, the notes from the providers' debriefing regarding culturally appropriateness of HPV testing will be considered.
6 secondary outcomes
Overall agreement between clinician-collected versus self-collected samples will be compared using pairwise t tests
Time frame: 3 months
The focus group data will be analyzed using constant comparative data analysis to identify thematic components and sub-themes.
Time frame: 3 months
The HPV GeneXpert by health care provider and HPV HC2 samples by health care provider will be compared to study the agreement rates.
Time frame: 3 months
Documentation of six different genotypes/ genotype families of HPV from cervical tissue samples, which will inform the development of HPV vaccinations specific to the strains of HPV in India.
Time frame: 3 months
Probe for perceptions about self-collection of vaginal samples to describe acceptability of this process.
Time frame: 3 months
Fit a predictive model of HPV infection(s).
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- 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.
Gauravi A Mishra, M.D PSM principal investigator
Tata Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cluster of 3000 women in people with HPV Infection, run by Tata Memorial Hospital at 1 site in India.
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: status not confirmed, as of the sponsor's last update on 22 Dec 2017. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gauravi A Mishra, M.D PSM (+912224177000 ext. 4634, gauravi2005@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of HPV testing as a single visit approach will be summarized using the appropriate descriptive statistics. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2017.