This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The overall goal of this University of California, Irvine (UCI) study is to find out how many Latinas will use and mail in a home sample kit to test themselves for a virus that may sometimes cause cervical cancer and to study the cost effectiveness of the process. To do this, the investigators will compare how many kits are returned in the mail if given to them by a Latino Health Access promotora (Latina community health worker) or as a result of a Hispanic newspaper or television advertisement with a phone call request for the home sampling kit from the interested Latina. The UCI study expects to contact approximately 4,000 eligible Latina participants. A 30-50% return of the home sampling kit is expected. From this group of 2000 participants a 20% sample of participants will be invited to have a pap test in a single visit clinic appointment. The study will compare test results of home sampling kits with this random sample of clinic results on about 400 selected participants.
Specific Aims : 1. To implement and evaluate a process to identify women in local Latino/Hispanic communities who have oncogenic type HPV infections. The proposed process will involve the distribution of HPV Home Self-administered Sample Collection (HSASC) kits to 4,000 Latinas. 2. To evalute the impact of Promotoras on the recruitment of Latinas in the clinical trial. Latino Health Access (LHA), an organization that employs Promotoras as lay community health workers in the medically underserved Hispanic communities of interest to this study, will provide three Promotoras for recruitment of 3,200 Latinas who will agree to receive HSASC kits. A media based ad campaign will be used to distribute 800 kits by mail to those who call in, are eligible, and wish to receive a home sampling HPV kit. 3. To evaluate the cost-effectiveness of the HSASC program and HPV testing as an adjunct to the SVP program. We plan to use cost-effectiveness analysis to measure the ratio of program dollar net costs or cost savings to program effectiveness which are the non-dollar net program outcomes. The hypotheses to be tested within these specific aims are: 1. The specificity and sensitivity of the samples collected using the HSASC kits will be similar to the sensitivity and specificity of samples taken by the health care provider in the clinic. 2. HPV self-sampling will lead to a higher percentage of women with pre-cancerous cervical dysplasia who are eligible to undergo treatment in the SVP compared to rates in teh current SVP trial. 3. The HPV self-sample collection kit return rate will be higher in the Promotora-distributed arm of the study than in the media-recruited, mail-distributed arm. 4. Satisfaction will be greater when HSASC kits are distributed by Promotoras as compared to mail distribution. 5. Satisfaction will be greater with HPV self-sample collection at home compared to collection by a health care provider at the clinic. Two methods of determining the presence of HPV DNA are currently available, Hybrid Capture 2 (HC2) assay and polymerase chain reaction (PCR) testing. Only HC2 is FDA-approved andis the method that will be used in this study. HC2 technology is a nucleic acid, hybridization assay designed to detect nucleic acid targets using signal amplification and chemiluminescent microplate methods. RNA probes specific for 18 viral type genomes are used. Of these, 13 are high-risk types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. It is recommended that HC2 analysis be completed within two weeks of obtaining the sample (reference: Digene Corporation. HPV Detection: A New Era in Cervical Cancer Prevention. Physician Brochure. Gaithersburg, MD, 2002). Cytology remains the standard of care for screening and for treatment decisions. HC2 assays will not be used to make treatment decisions. All Latinas who receive the HSASC kits will be told that the standard of care for cervical cancer screening is a Pap test. All will be advised to get a Pap test yearly whether or not they return the HPV HCASC kit or are selected to continue in the study. A random sample of those (approximately 2,000 Latinas who return the kit for testing at UCI will be invited to a single visit pap smear and HPV clinic test appointment. Those with high grade squamous intraepithelia neoplasia (HSIL designated CIN grade 3) or atypical glandular cells of undermined significance (AGUS) will be offered a diathermy loop excision treatment of the transformation zone that day at no cost to the participant. If acceptable, they are given a pregnancy test and if they are not pregnant they have the DLE and return in 2 weeks and at 3 months for standard of care follow-up. The participant also may opt out of the DLE treatment and study and instead choose a referral to a UCI clinic for other offered options that are standard of care.

National Institute of Health (NIH)
National Center for Research Resources (NCRR)
General Clinical Research Centers Program (M01)
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University of California San Diego
Schools of Medicine
La Jolla
United States
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