Clinical trial NCT03229603: A Pilot Study on HPV and Cervical Cancer Screening in Mumbai
Official title: A Pilot Study on HPV and Cervical Cancer Screening in Mumbai
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HPV Infection
Keywords: HPV infection and Cervical cancer
Lead sponsor: Tata Memorial Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Arizona
First posted: 2017-07-25
Enrollment: 227
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Women with a known diagnosis of cancer, any other terminal diagnosis, or who are pregnant

Primary outcomes:
measure: The feasibility of HPV testing as a single visit approach will be summarized using the appropriate descriptive statistics.
timeFrame: 3 months
Secondary outcomes:
measure: Overall agreement between clinician-collected versus self-collected samples will be compared using pairwise t tests
timeFrame: 3 months
measure: The focus group data will be analyzed using constant comparative data analysis to identify thematic components and sub-themes.
timeFrame: 3 months
measure: The HPV GeneXpert by health care provider and HPV HC2 samples by health care provider will be compared to study the agreement rates.
timeFrame: 3 months
measure: 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.
timeFrame: 3 months
measure: Probe for perceptions about self-collection of vaginal samples to describe acceptability of this process.
timeFrame: 3 months
measure: Fit a predictive model of HPV infection(s).
timeFrame: 3 months
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Mharashtra
Study officials:
affiliation: Tata Memorial Hospital
name: Gauravi A Mishra, M.D PSM
role: PRINCIPAL_INVESTIGATOR
References: