|Grant Number:||5R01CA076502-09 Interpret this number|
|Primary Investigator:||Manetta, Alberto|
|Organization:||University Of California-Irvine|
|Project Title:||Enhanced Single-Visit Cervical Cancer Screening Program|
DESCRIPTION (provided by investigator): An innovative approach to screen women for cervix cancer and provide early treatment for severe cervix dysplasia in a single-visit program (SVP) is ongoing in a Latino/Hispanic community as part of the current Single-Visit Cervical Cancer Prevention Program application (7/1/98-6/30/03). This continuation application is designed to further increase the effectiveness of the single-visit program (SVP). The first aim is to implement and evaluate a process to identify women in local Latino/Hispanic communities who have oncogenic type human Papilloma virus (HPV) infections, known precursors for cervix dysplasia and cervical cancer, and recruit them for the SVP. Health disparities exist in the incidence of cervical cancer among racial/ethnic groups with Hispanic women (Latinas) among the groups experiencing higher rates. Screening procedures to identify Latinas with oncogenic type HPV infections may contribute to identification of women at most risk for cervix cancer. HPV self-sampling in the home, as proposed in this study, has not been tested. The process will involve the distribution of HPV Home Self-administered Sample Collection (HSASC) kits to 4000 Latinas. Recruitment will continue until a minimum of 1840 self-samples has been returned, of which 9.14% (N=168) are expected to be HPV-positive. Latinas with HPV-positive self-samples will be invited to come to one of two clinics offering the SVP. A 60% response rate (N=135) is expected. Additionally, twice as many women with HPV-negative samples matched by age and recruitment method will be invited to participate (N=270). Sensitivity and specificity analysis will be done using samples obtained by a provider during the subsequent clinic visit as the reference. Satisfaction with self-sampling compared to provider sampling will be evaluated. An increase of approximately 60% is estimated in the proportion of women with severe cervix dysplasia who enter the SVP. The second aim is to evaluate the impact of Promotoras on the recruitment of Latinas in the clinical trial. Two recruitment and HSASC kit distribution methods will be used: media-based ad campaign with mail distribution and Promotora distribution. Promotoras will recruit 3,200 Latinas to receive HSASC kits with an estimated self-sample return rate of 50% (1,600 self-samples). The media-based ad campaign will be used to recruit another 800 Latinas who will receive the HSASC kit in the mail. A 30% (N=240) self-sample return rate is expected. Comparisons of return rates and satisfaction with recruitment and distribution method will be tested. The third aim is to evaluate the cost-effectiveness of the HSASC program and HPV testing as an adjunct to the SVP program. Cost-effectiveness analysis will be used to measure the ratio of program dollar net costs or cost savings to program effectiveness, which are the non-dollar net program outcomes. The incremental net cost associated with an incremental improvement in outcomes in terms of quality-adjusted life years (QALYs) will be measured.