Health-related quality of life of women after HPV testing as triage strategy for an abnormal Pap smear: a nested randomized pragmatic trial in a middle-income country.

BACKGROUND: Information obtained in studies on the impact of human papilloma virus (HPV) testing on health-related quality of life is contradictory. OBJECTIVE: To assess the impact on health-related quality of life of the HPV test, colposcopy, and cytology as triage strategies after a cytology with atypical squamous cells of undetermined significance (ASCUS) in Medellín, Colombia. METHODS: We carried out a nested analysis on the randomized pragmatic trial (ASCUS-COL). Women with ASCUS were assigned randomly to one of the 3 arms (Pap smear, colposcopy, HPV). Participants completed a questionnaire at baseline, two weeks after receiving the results of the triage tests and one year after the second questionnaire. We used the SF-36 to assess health-related quality of life. RESULTS: The sum score of the physical health component (PHC) and mental health component (MHC) increased significantly over time for the whole sample and there were no statistically significant differences between arms of PHC = survey 1: mean 52.4 (SD 8.21) vs. survey 3: mean 54.4 (SD 8.16) p < 0.0001 and of MHC = survey 1: mean 44.9 (SD 11.72) vs. survey 3: mean 48.1 (SD 11.20) p < 0.0001. A lower MHC occurred in women with lesser schooling, belonging to the public health care regimen, higher number of live births, and separated. A lower PHC was associated with the cytology arm, higher age, lesser schooling, and belonging to the subsidized regime. The risk of having depression went from 42% in the first survey to 26% in the third. CONCLUSION: The triage strategies affected health-related quality of life in the same manner. ClinicalTrials.gov Identifier: NCT02067468.

Psychosocial impact of inclusion of HPV test on the management of women with atypical squamous cells of undetermined significance: a study within a randomised pragmatic trial in a middle-income country.

Objective: To assess the psychosocial impact of human papillomavirus (HPV) testing, colposcopy, and Pap-smear, as triage strategies after a Pap-smear with atypical squamous cells of undetermined significance (ASCUS). We also sought to evaluate the psychosocial impact based on the results of the strategies. Methods: Nested within a randomised pragmatic trial, which compared an immediate colposcopy, repeat Pap-smear, and high risk HPV test, we enrolled 675 women between 2012 and 2014. Participants completed surveys at enrollment, two weeks after triage test results, and 1 year thereafter to assess cervical cancer and HPV knowledge, self-esteem, anxiety and HPV impact (HIP). Results: Knowledge, self-esteem, anxiety and HIP improved with no differences among arms. At the baseline, 31.4% and 32.7% of the participants had state anxiety and trait anxiety, respectively, which decreased to 10.7% and 13.3% in the last survey. Compared to HPV-negative women, HPV-positive women in the second survey had worse HIP scores (HPV-: M 22.9 [SD: 15.20]; HPV+: M 35.9 [SD: 19.91]; p < 0.001), trait anxiety (HPV-: M 15.4 [SD 12.73]; HPV+: M 22.9 [SD 13.29]; p = 0.001), and state anxiety (HPV-: M 10.7 [SD 11.25]; HPV+: M 21.4 [SD 14.81]; p < 0.001). Conclusions: HPV testing as a triage strategy for women with ASCUS does not differ from colposcopies or Pap-smears in terms of psychosocial outcomes.