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  1. Jose Jeronimo, MD*,
  2. Pooja Bansil, MPH*,
  3. Jeanette Lim, MPH*,
  4. Roger Peck, BS*,
  5. Proma Paul, MHS*,
  6. Juan Jose Amador, MD, MPH,
  7. Florence Mirembe, MD, PhD,
  8. Josaphat Byamugisha, MD, PhD§,
  9. Usha Rani Poli, MBBSD, DNB, DGO,
  10. Labani Satyanarayana, PhD and
  11. Smita Asthana, MBBS
  1. *Program for Appropriate Technology in Health (PATH), Reproductive Health Global Program, Seattle, WA;
  2. PATH, Reproductive Health Program, Kampala, Uganda;
  3. Department of Obstetrics and Gynecology, Makerere University, Kampala, Uganda;
  4. §Department of Obstetrics and Gynecology, Mulago Hospital, Kampala, Uganda;
  5. MNJ Cancer Institute, Oncology and Regional Cancer Center, Hyderabad, India; and
  6. Institute of Cytology and Preventive Oncology, Uttar Pradesh, India.
  1. Address correspondence and reprint requests to Jose Jeronimo, PATH, Reproductive Health Global Program, 2201 Westlake Ave, Suite 200, Seattle, WA 98121. E-mail: jjeronimo{at}path.org.

Abstract

Objective This study evaluates the feasibility and performance of careHPV, a novel human papillomavirus (HPV) DNA test, when used for screening women for cervical cancer in low-resource settings.

Methods and Materials Clinician-collected (cervical) and self-collected (vaginal) careHPV specimens, visual inspection with acetic acid (VIA), and Papanicolaou test were evaluated among 16,951 eligible women in India, Nicaragua, and Uganda. Women with positive screening results received colposcopy and histologic follow-up as indicated. The positivity of each screening method was calculated overall, by site, and age. In addition, the clinical performance of each screening test was determined for detection of cervical intraepithelial neoplasia (CIN) grade 2 (CIN2+) and CIN grade 3.

Results Moderate or severe dysplasia or cancer (taken together as CIN2+) was diagnosed in 286 women. The positivity rate ranged between 2.4% to 19.6% for vaginal careHPV, 2.9% to 20.2% for cervical careHPV, 5.5% to 34.4% for VIA, and 2.8% to 51.8% for Papanicolaou test. Cervical careHPV was the most sensitive for CIN2+ (81.5%; 95% confidence interval [CI], 76.5–85.8) and CIN grade 3 (85.3%; 95% CI, 78.6–90.6) at all sites, followed by vaginal careHPV (69.6% and 71.3%, respectively). The sensitivity of VIA ranged from 21.9% to 73.6% and Papanicolaou test from 40.7% to 73.7%. The pooled specificities of cervical careHPV, vaginal careHPV, VIA, and Papanicolaou test were 91.6%, 90.6%, 84.2%, and 87.7%, respectively.

Conclusions careHPV performed well in large multicountry demonstration studies conducted in resource-limited settings that have not previously been conducted this type of testing; its sensitivity using cervical samples or vaginal self-collected samples was better than VIA or Papanicolaou test. The feasibility of using careHPV in self-collected vaginal samples opens the possibility of increasing coverage and early detection in resource-constrained areas.

  • Cancer prevention and control
  • Early detection
  • Cervical cancer
  • Low-resource settings
  • HPV

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Footnotes

  • The START-UP project was funded by a grant from the Bill & Melinda Gates Foundation.

  • Supplemental digital content is available for this article. Direct URL citation appears in the printed text and is provided in the HTML and PDF versions of this article on the journal’s Web site (www.ijgc.net).

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