Human Papilloma Virus Related Cervical Carcinoma
Conditions
Keywords
Human Immunodeficiency Virus, Self swab, Mozambique, Cervical cancer, Implementation science
Brief summary
This proposal directly addresses the ability to safely scale-up a Screen-Triage-Treat approach to cervical cancer screening. The investigators propose to capitalize on a pool of screen-eligible women accessing routine care within targeted human immunodeficiency virus (HIV) care and treatment services. The primary outcome of interest is the number of women screened and the proportion of screen-positive women undergoing treatment. Secondary outcomes will focus on other implementation outcomes, and if successful, will be utilized to inform future research to take this approach to scale across Mozambique.
Detailed description
This study will use a hybrid type III effectiveness-implementation design. In a hybrid type III design, the primary focus is on testing of an implementation strategy, while simultaneously continuing to observe and gather information on the effectiveness of a clinical intervention, under real world conditions, for which effectiveness data has already largely been determined. Best practices for deploying the Screen-Triage-Treat approach to cervical cancer screening utilizing self-collected human papilloma virus (HPV) deoxyribonucleic acid (DNA) testing within Mozambique´s HIV care and treatment services will be evaluated. The study will employ a mixed-methods approach, collecting both quantitative and qualitative data. The primary outcome of interest is the number of women screened and the proportion of HPV screen-positive women undergoing treatment, while secondary outcomes will focus on other implementation outcomes, and if successful, will be utilized to inform future research to take this approach to scale across Mozambique.
Interventions
DIAGNOSTIC_TESTHPV DNA testing be self-collected vaginal swab
Directly following collection of the vaginal self-swab sample, the participant will be taken back to the waiting area and her sample will be taken to the laboratory for HPV testing using the Xpert HPV Test on the GeneXpert platform (Cepheid, Sunnyvale, CA, USA). This point-of-care test takes approximately 45 minutes to get results.
Sponsors
Tulane University
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Women 25-49 years * Accessing HIV care and treatment services * Not being pregnant * Patients with a cervix
Exclusion criteria
* Physical or mental impairment that inhibits participation in the study * Pregnant women or \<6 weeks post-partum * Women who have undergone a total hysterectomy with removal of the cervix
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of women screened and the proportion of screen-positive women successfully undergoing treatment or evaluation/referral. | 2.5 Years | Baseline data will be retrospectively collected for the prior 12 months at each of the selected study sites, including the number of women accessing care for HIV care and treatment services each month; the number of women screened for cervical cancer through standard of care protocols; the proportion of screen-positive women who then received treatment or referral for treatment, and the length of time between screening positive and receiving treatment if appropriate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Test Result Notification Rate | 2.5 Years | The proportion of women who were notified of their HPV DNA test result on the same day as sample collection. |
| Treatment Rate | 2.5 Years | The proportion of screen-positive women who were treated with thermal ablation, if appropriate, or referred for higher level of care or return appointment. |
Countries
Mozambique
Contacts
CONTACTKathryn Kampa, MPH
CONTACTHarriett Myers, MPH
PRINCIPAL_INVESTIGATORD. Troy Moon, MD, MPH
Tulane University
Outcome results
None listed