|Start date of study (mm/yy)||04/2019|
|Launching of Self- Sampling (mm/yy)||01/2019|
|Completion Date of Study (mm/yy)||12/2023|
|Study Type||Randomized Controlled Trial|
|Intervention Group||Mailed self-sample HPV testing kit (intervention).|
Mailed self-sample HPV testing kit and Patient
|Control Group||Recall for Pap testing|
|Funding Agency||National Institutes of Health/National Institute for|
Minority Health and Health Disparities
|Location||Safety net healthcare system in Houston, Texas:|
Harris Health System
|Setting||Health system (network of hospitals, primary care|
|Number of women screened with HPV self-sampling||2,268|
|Follow up of HPV-positive women||Yes|
|Percentage of HPV-positive women with completed treatment||–|
Clinic-based Papanicolaou (Pap) test screenind for cervical cancer has dramatically reduced the incidence of this disease in countries with widespread screening programs. However, many women remain at highrisk for cervical cancer due to their inability or unwillingness to periodically attend for clinic-based screening.
At present, evidenc-based, client-directed strategies such as patient reminders and recalls, patient education, and patient navigation are the basis for many behavioral interventions to increase screening participation. However, these strategies alone are often unable to resolve many of the barriers faced by screening non-attendees.
Maled self-sampple HPV testing kits may overcome multiple barriers to clinic-based screening. However, this strategy has not been evaluated in safety net health systems in the US that provide care for a large portion of socioeconomically disadvantaged individuals.
We hypothesis that in the context of a safety net health system, pairing mailed self-sampled HPV testing with patient navigation, an outreach intervention with strong evidence among underserved minority population, will hace a synergetic effect increasing screening participation among underscreened women.
PRESTIS (Prospective Evaluation of Self-Testing to Increase Screening) is a randomized controlled trial to compare the effectiveness of three outreached interventions to increase primary screenins participation and clinical follow-up among underscreened women aged 30 – 65 years in a safety net health system.
Study arms are:
1) Control: Telephone recall
2) Intervention: Tellephone recall with mailed self-sample HPV testing kits.
3) Intervention plus: Telephone recall with mailed self-sample Hov testing kits and patient navigation.
The primary outcome is primary screening participation. Secondary outcomes are predictors of screening and attendance for clinical follow-up among screen-positive women. Our study will also identify attitudes and experiences toward self-sampling among women who receive a mailed self-sampling kit and toward clinical follow-up among women who test positive for high-risk HPV. Finally, our study will evaluate the cost-effectiveness of mailed self-sample HPV testing, alone and in combination with patient navigation, to increase screenins participation and reduce cervical cacer risk in safety net health system.
The pre-trial lessons learned are:
1. Engaged with health system stakeholders on multiple levels to integrate self-sample HPV testing within health system
2. Leverage existing plataforms (e.g. Existing patient navigation program, mailed fecal inmunochemical test [FIT] procedures) to the greatest extent possible.
3. Communicate regularly (and through several channels) with health system providers to obtain buy-in and awareness of study.
|Principal Investigator||Jane R. Montealegre|