Feasibility and Acceptability of HPV Self-Collection Cervical Cancer Screening and Treatment in Botswana

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03345875
• Date of registration: 26/10/2017
• Prospective Registration: No
• Primary sponsor: Jhpiego
• Public title: Feasibility and Acceptability of HPV Self-Collection Cervical Cancer Screening and Treatment in Botswana
• Scientific title: Feasibility and Acceptability of HPV Self-Collection Cervical Cancer Screening and Treatment in Clinics and the Community in Botswana
• Date of first enrolment: October 16, 2017
• Target sample size: 1022
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03345875
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Botswana

Contacts

• Name: John Varallo, MD
• Affiliation: Jhpiego

Key inclusion & exclusion criteria

The District Health Management Team (DHMT), estimates that in 2011 there were 31,574 women
30-49 years of age on the Kweneng East catchment area, serviced by Scottish Livingstone
Hospital and the 4 selected Health Clinics.

Women will be clients of the health facility at one of the clinics (described below under
recruitment), may come to the facility for cervical cancer screening after having been
contacted by a community mobilizer, or women attending a community health campaign event
(in the community).

Participants under Research Question 1: 1022 women Participants under Research Question 2a:
24 providers and other stakeholders Participants under Research Question 2b: 27 women for
in-depth interviews; 250 women for structured surveys.

Inclusion Criteria: Service Delivery Model

- Age 30 to 49 years,

- Not screened recently/never screened before, defined as:

- No prior history of cervical cancer screening: Pap smear, VIA or HPV testing), or

- Prior screening, but result unknown and no treatment

- Prior screening occurred more than 5 years ago for HIV negative women or 3 years
ago for HIV positive women

- HIV status is known (HIV positive result, or documented HIV negative result is less
than 12 months ago).

- No history of prior abnormal screening or treatment/procedure on her cervix due to
abnormal screening

- No history of cervical cancer

- Not currently pregnant; not less than 6 weeks postpartum

- Intact uterus/ no prior hysterectomy with a cervix present

- Accesses services in Kweneng East District study catchment area

- Able and willing to provide consent

Inclusion Criteria: Qualitative Research with Providers and Other Stakeholders

- Working as one of the cadres in Sampling Table 1 at the time of the interview.

- Working in cervical cancer prevention currently.

- Manager agrees the participant can take part in interview.

- Has been trained by the study regarding HPV self-collection and VAT.

- Willing to participate in in-depth interview and gives informed consent.

Exclusion Criteria:

- Woman does not meet the criteria for inclusion age 29 years or younger and age 50
years or older.

- Screened for cervical cancer in last 3 years if HIV positive, or in the last 5 years
if HIV negative.

- Had an abnormal cervical cancer screening and/ or treatment of cervix ,

- History of cervical cancer HIV status unknown,

- Pregnant (self-report or by pregnancy test confirmation.

- Less than 6 weeks postpartum, prior hysterectomy,

- Unable to participate and give informed consent.

- Not interested in HPV self-collection.

- Unwilling to give informed consent



Age minimum: 30 Years
Age maximum: 49 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Human Papillomavirus Infection

Cervical Cancer

Intervention(s)

Diagnostic Test: HPV self collection, followed by visual assessment of the cervix for treatment (VAT) and treatment

Primary Outcome(s)

Qualitative interviews and surveys to assess acceptability of HPV Self Collection from women [Time Frame: At time of return for VAT for women who are HPV positive; At the time of declining VAT for women who are HPV positive; At the time of decline to self collect at all.]

Qualitative interviews and surveys to assess acceptability of HPV Self Collection from health providers and managers [Time Frame: 6 months after the intervention has started at each facility, with a sampling of types of personnel]

Screening-to-treatment completion rates for assessing feasibility of HPV self collection, VAT screening and treatment [Time Frame: 3 months per participant]

Secondary ID(s)

IRB00007974

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Botswana Ministry of Health