Table 1

Overview of data collected in the CONCEPT cohort

MeasurementsInstrumentStorage and analysis
Baseline
17 August 2015–6 July 2017		Biological samples
1 provider-collected cervical swab for:

  • careHPV DNA testing

  • Aryes spatula

  • Samples stored on-site in laboratories at room temperature

  • Kept in careHPV collection medium

  • When 90 samples were available they were processed on-site on a careHPV machine

  • Results registered on careHPV sheet and stored on-site

1 provider-collected cervical swab for:

  • Cytology

  • ThinPrep Pap test plastic spatula

  • Samples stored on-site in laboratories at room temperature until enrolment had finished

  • HC2

  • Kept in PreServCyt solution

  • Then the samples were sent to the Pathology Department at Lillebaelt Hospital, Denmark and processed on the ThinPrep5000 Autoloader Instrument, Hologic for cytology

  • Genotyping

  • Remaining materials of the samples were sent to the Section for Experimental Virology, Tubingen University, Germany and underwent HC2 DNA testing and genotyping using LiPaExtra

  • Cytology and HC2 and genotype results were sent to OUH, Denmark

Venous blood from index finger for:

  • HIV test

  • Quick HIV-1/2 test

  • Immediate results registered on registration form and stored on-site

Visual assessment

  • VIA

  • Acetic acid applied to cervix and abnormal tissue temporarily appears white

  • Immediate results registered on registration form and stored on-site

Anthropometric measures

  • Weight

  • Scale and altitude metre

  • Immediate results registered on registration form and stored on-site

  • Height

Personal interview

  • Sociodemographic factors

  • Structured questionnaire

  • Interviewed by nurse and stored on-site

  • Sexual and reproductive factor


  • Lifestyle factors

  • HIV treatment and CD4 count

  • CD4 count abstracted from CTC cards and further traced in patient files

14-month follow-up (first) 17 October 2016–6 October 2018Biological samples
1 provider-collected cervical swab or self-collected swab for:

  • HC2

  • ThinPrep Pap test plastic spatula (provider-based)

  • Self-swabs were conducted in the women’s home (cf. tracing method III) and transferred to the study sites where they were stored with ThinPrep samples similarly to baseline until first follow-up had finished

  • Genotyping

  • Evalyn brush (self-swab)

  • Then the samples were sent to the Section for Experimental Virology, Tubingen University, Germany and underwent HC2 DNA testing and genotyping using LiPaExtra

  • Kept in PreServCyt solution

  • HC2 and genotype results were sent to OUH, Denmark

Venous blood from index finger for:

  • HIV test (if negative at baseline)

  • Quick HIV-1/2 test

  • Immediate results registered on registration form and stored on-site

  • HIV test was not conducted on women who participated from home (cf. tracing method III)

Visual assessment

  • VIA

  • Acetic acid applied to cervix and abnormal tissue temporarily appears white

  • Immediate results registered on registration form and stored on-site

  • Not conducted on women who participated from home (cf. tracing method III)

Personal interview

  • Sexual factors

  • Structured questionnaire

  • Interviewed by nurse at clinic or at home and stored on-site

  • HIV treatment and CD4 count

  • CD4 count abstracted from CTC cards and further traced in patient files

28-month follow-up (second)
(17 December 2017–primo October 2020)		Biological samples
1 provider-collected cervical swab or self-swab only for HPV positive women:

  • ThinPrep Pap test plastic spatula (provider-based)

  • Same procedure as in first follow-up

  • HC2

  • Evalyn brush (self-swab)

  • Genotyping

  • Kept in PreServCyt solution

Venous blood from index finger for:

  • HIV test (if negative at first follow-up)

  • Quick HIV-1/2 test

Same procedure as in first follow-up
Visual assessment

  • VIA

  • Acetic acid applied to cervix and abnormal tissue temporarily appears white

  • Same procedure as in first follow-up

Personal interview

  • Sexual factors

  • Structured questionnaire

  • Same procedure as in first follow-up

  • HIV treatment and CD4 count

  • CONCEPT, Comprehensive Cervical Cancer Prevention in Tanzania; CTC, care and treatment clinics; HC2, hybrid caputure 2; HIV, human immunodeficiency virus; HPV, human papillomavirus; OUH, Odense University Hospital; VIA, visual inspection with acetic acid.