An interventional study of HPV DNA testing be self-collected vaginal swab in Human Papilloma Virus Related Cervical Carcinoma, sponsored by Tulane University. Recruiting at 1 site in Mozambique. Open to female participants aged 25 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Tulane University · Not applicable, Interventional, and Screening
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.
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 8,445 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Tulane University is the lead sponsor of 96 studies on the registry; 23 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.
Compared within Uterine Cervical Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After providing informed consent, the study clinician will open a Case Report Form (CRF) for each patient which starts with a brief questionnaire which will include the participant's demographic information and medical history, including HIV viral load and CD4 counts, previous cervical cancer screening results if previously screened, and result of rapid pregnancy test performed that day with a urine sample. Each participant will then be accompanied to a private location where the study nurse will provide counseling and instruction on how to appropriately perform the self-collection vaginal swab technique. Data on HPV testing, VAT results, and referrals along each step of the process will be documented in the CRF.
Diagnostic Test: HPV 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.
The number of women screened and the proportion of screen-positive women successfully undergoing treatment or evaluation/referral.
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.
Time frame: 2.5 Years
Test Result Notification Rate
The proportion of women who were notified of their HPV DNA test result on the same day as sample collection.
Time frame: 2.5 Years
Treatment Rate
The proportion of screen-positive women who were treated with thermal ablation, if appropriate, or referred for higher level of care or return appointment.
Time frame: 2.5 Years
Plan to share: No
Started Jul 2026 (actual). Primary completion is estimated for Jun 2028, 23 months after the start.
Of 445 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 71. This study's planned 23 months is below that.
Counting every sponsor, half of 461 studies reached it within 33 months; a quarter within 15 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
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Tulane University