Constance Mao, MD
OMB No. 0925-0046, Biographical Sketch Format Page

OMB No. 0925-0001 and 0925-0002 (Rev. 09/17 Approved Through 03/31/2020)


Provide the following information for the Senior/key personnel and other significant contributors.
Follow this format for each person.  DO NOT EXCEED FIVE PAGES.

NAME: Constance Mao

eRA COMMONS USER NAME (credential, e.g., agency login): conniemao

POSITION TITLE: Associate Professor Emeritus

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)



(if applicable)


Completion Date





Princeton University, Princeton NJ




University of Southern CA, Los Angeles CA

University of Washington, Seattle WA






Obstetrics and Gynecology






A.     Personal Statement


During the past 23 years I have worked with the University of Washington HPV (Human Papillomavirus) Research Group on numerous clinical trials sponsored by NIH and industry in the areas of HPV vaccination, cervical cancer screening and management of genital dysplasia. I was Director of the Harborview Medical Center Women’s Dysplasia Clinic for 21 years. I continue to train residents, medical students, mid-level practitioners, and other primary care physicians in colposcopy and the treatment of lower genital tract disease. I am board-certified in Obstetrics and Gynecology, and I received ASCCP Certificate of Achievement in Colposcopy 1997. 


B.     Positions, Honors and Government Committees


Positions and Employment

1997-2003               Acting Assistant Professor University of Washington Obstetrics and Gynecology

2003-2011              Assistant Professor, University of Washington

2011-2020                 Associate Professor, University of Washington

2020-present              Associate Professor Emeritus, University of Washington             


Honors and Government Committees

1984                            BA Cum Laude              Princeton University             

1984                            E.R. Squibb and Sons Senior Thesis Prize

1984                            Sigma Xi Membership                                         

1985                            AMSA Health Promotion Grant             

1986                            1st Place Community Project Winner AAFP                           

1988               Dean’s List University of Southern California School of Medicine

1997                            Certificate of Achievement in Colposcopy ASCCP

1999                            Plenary Award Western Medical Student Research Forum                           

2000                                Resident Teaching Award

2011                                American Association of Cancer Research Team Research Award

2015                   University of Washington/Harborview Medical Center Cares Award                                                                     



C.              Contribution to Science


  1. The ALTS (ASCUS/LSIL Triage Study) study was the first multi-center randomized trial designed to evaluate management strategies for abnormal pap results.  I joined the ALTS team at the University of Washington as the lead clinician in 1997. I quickly learned about participation in a large clinical trial, and I supervised clinicians and quality assurance at our site.  I collaborated with investigators on numerous publications.  The results of this trial directly changed management of patients with lower grade pap abnormalities.  Following the ALTS study, HPV triage of ASCUS pap smears has become standard of care.


The Hall Health study was a long-term cohort study of young college age women at the University of Washington. I served as study clinician for the last years of this study and findings have informed clinicians about the signs and symptoms of HPV infection as well as contributed to current Pap recommendations.


  1. ASCUS-LSIL Triage Study (ALTS) Group.  Results of a randomized trial on the management of cytology interpretations of atypical squamous cells of undetermined significance.  Am J Obstet Gyn 2003:188:1383
  2. Baer A, Kiviat NB, Kulasingam S, Kuypers J, Mao C, Koutsky L.  Liquid-based pap smears without a transformation zone component: should clinicians worry?  Obstet Gyn 2002;99:1053-9.
  3. Mao C, Koutsky L, Kiviat N, Hughes J, Kuypers J.  Clinical findings among young women with genital human papillomavirus infection.  Am J Obstet Gyn 2003;188:677-84.
  4. Mao C, Balasubramanian A, Koutsky L.  Should liquid cytology be repeated at the time of colposcopy?  J Lower Genital Tract Dis 2005;9:82-8.


  1. The award winning UW HPV research team has a long history of innovative clinical trials designed to evaluate new screening strategies for cervical cancer.  The EVA (Evaluation of new cervical cancer screening technologies) was one of the first in the United States to examine both HPV primary screening and p16 ELISA screening. In 2014, the FDA has approved the first primary HPV screening test that could be used in lieu of Pap testing.  Currently, I am co-investigator for the HOPE (Home HPV or Pap Exam) study, a randomized clinical trial to evaluate the efficacy and cost-effectiveness of this novel approach to screening.


  1. Kulasingam SL, Hughes JP, Kiviat NB, Mao C, Weiss NS, Kuypers JM, Koutsky LA.  Evaluation of new cervical cancer screening technologies: part 1.  Comparison of sensitivity, specificity, and referral rates. JAMA 2002;288:1749-57.
  2. Mao C, Balasubramanian A, Yu M, Kiviat N, Ridder R, Reichert A, Herkert M, vonKnebel Doeberitz M, Koutsky LA.  Evaluation of a new p16INK4a ELISA test and a high-risk HPV DNA test for cervical cancer screening: results from proof-of-concept study. Int J Cancer, 2007;120(11):2435-8.
  3.                Balasubramanian A, Hughes J, Mao C, Ridder R, Herkert M, Kiviat NB, and Koutsky LA. Evaluation of an ELISA Assay for p16INK4a as a Screening Test for Cervical Cancer.  Cancer Epidemiol Biomarkers Prev, 2009;12(11):3008-17.
  4.                Balasubramanian A, Kulasingam SL, Baer A, Hughes J, Mao C, Kiviat NB, Koutsky LA, Cost-Effectiveness of Cervical Cancer Screening by HPV Testing of Self-Collected Vaginal Swab Samples, J Low Genit Tract Dis. 2010 Jul;14(3):185-95.


  1. The first Merck and Company L1 VLP (Virus Like Particle) HPV vaccine trial design began in collaboration with Dr. Laura Koutsky and the HPV research team at the University of Washington.  We have been conducting HPV vaccine trials since the original phase I trials of the HPV 16 VLP vaccine began in 1998.  I have served as lead clinician and principal investigator for multiple vaccine trials.  Many significant findings have come from these trials including; HPV VLP vaccines are immunogenic, and vaccination can prevent both persistent HPV infections and genital dysplasia.  Adverse events have been similar in both the vaccine and placebo groups for all trialsThe quadrivalent HPV vaccine and the newly approved nine-valent HPV vaccine will have significant public health benefits worldwide with the potential to reducing the rates of cervical cancer and genital warts by about 90%.  Although not yet seen, vaccination is also expected to significantly decrease rates of oral, anal, vuvlar and penile cancers as well.


  1. Mao C, Koutsky LA, Ault KA, Wheeler CM, Brown Dr. Wiley D, et al.  Efficacy of human papillomavirus-16 vaccine to prevent cervical intraepithelial neoplasia: a randomized controlled trial.  Obstet Gynecol 2006;107:18-27.
  2. Rowhani-Rahbar A, Mao C, Hughes JP, Alvarez FB, Bryan JT, Hawes SE, Weiss NS, Koutsky LA. Longer term efficacy of a prophylactic monovalent human papillomavirus type 16 vaccine. Vaccine. 2009 Sep 18;27(41):5612-9.
  3. Joura, AR, Giuliano O, Iverson E, Bouchard C, Mao C, et al.  a 9-Valent HPV Vaccine Against Infection and Intraepithelial Neoplaisa in Women.  N Enl J Med  372 (8) 2015, 711-


List of Published Work in My Bibliography descending


C.     Research Support


Ongoing Research Support

R01 CA213130-02 (Madeleine, Wald PI)                                                                                                                                                          02/22/2017 – 01/31/2022


VIVA Trial: Therapeutic use of HPV L1 Vaccine in Anogenital Neoplasia

A randomized placebo controlled study for secondary prevention of HPV related anogenital neoplasia (AVN) by vaccination with Gardasil 9 HPV vaccine.

Role: Investigator


U01CA163304 (Barlow PI)                            09/19/2011-08/31/2016

NIH/NCI                                          04/15/2018-03/30/2022

PROSPR (Population Based Research Optimizing Screening through Personalized Regimes) I&II Statistical Coordinating Center for Cervical Cancer. 

A Multi-center trial aimed at documenting and improving screening outcomes for breast, colon and cervical cancer.

Role: Consultant



Recently Completed


R01CA157469-01 (Kiviat, Kulasingam PI)                            10/2011– 07/31/2017


HOPE study (home HPV or Pap Exam).

Randomized clinical trial comparing home HPV test to clinical collected Pap exam to evaluate efficacy, acceptability, and cost effectiveness.

Role: Investigator



R01 CA168598-03 (PI Winer)                            04/24/2013-03/31/2018


Randomized Trial of In-Home Cervical Cancer Screening in Under-screened Women



2R44 AI 068160-03A1 (Schweizer PI)                            06/01/2011–04/30/2015


Development of an E6 based Bead Assay for Cervical CA collaboration with Arbor Vita Corporation.

Collection of samples from women in colposcopy clinic to be used in development of new technology for cervical cancer screening.

Role: Investigator


No grant  # (Mao, PI)                            01/01/2007 – 04/30/2016

Merck Research Laboratories             

Second Generation HPV vaccine study. 

Double blind placebo trial to comparing Gardasil to an Experimental 9 valent HPV VLP vaccine for safety and efficacy.

Role: PI



No grant # (Mao, PI)                            08/2015-2016             

Cephied Corporation              

Clinical Evaluation of the Xpert® HPV Assay as a Primary Screening Test for the Detection of High-grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening

Multi-center trial of a new point of care HPV assay.

Role: PI