Supporting the National Expansion of HPV-based Cervical Cancer Screening in Tanzania Among Women … (NCT06402383) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Supporting the National Expansion of HPV-based Cervical Cancer Screening in Tanzania Among Women Living With HIV
Tanzania2,000 participantsStarted 2024-05-25
Plain-language summary
* Cervical cancer is caused by persistent infections with one of \~13 carcinogenic human papillomavirus (HPV) types and causes substantial morbidity and mortality worldwide.
* Highly effective strategies exist, including HPV vaccination and HPV-based screening for early detection and treatment of precancerous lesions.
* The investigators are proposing an innovative implementation research program and randomized trial evaluating HPV DNA testing as a primary screening tool for cervical cancer screening in HIV Care and Treatment clinics within Tanzania's National Cervical Cancer Prevention (CECAP) program.
* The investigators will combine HPV DNA testing with high quality visual assessment of the cervix for treatment and management of cervical precancerous lesions among HPV+ Women Living with HIV (WLWH).
* At 12-month follow up women will be recalled for repeat screening for HPV and visual assessment of the cervix for treatment combined with a second therapeutic dose of HPV vaccine.
* The investigators propose to recruit 2000 WLWH from 4 HIV Clinics in Kilimanjaro Region. Two clinics will be randomized to the test, treat and vaccinate strategy and two clinics will be randomized to test, treat and re-screen and then vaccinate strategy.
* Currently, there is no Standard of Care (SOC) for vaccination of women who are at risk for HPV in the country. These two arms of the study will allow for treatment and observation to occur that would not be available otherwise.
Who can participate
Age range
25 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Gender: person with an intact cervix
* HIV type 1 (HIV-1) positive status and receiving care at one of the study CTC sites randomized for the trial
* Not pregnant and utilizing contraception if sexually active and willing to undergo a urine pregnancy test prior to enrolment
* Residence in the study-defined catchment area
* Willing to consent to receive follow-up phone calls from the health provider to provide reminders and counselling about follow-up visits required for the study procedures
* Willing to receive HPV Vaccination in a 2-dose strategy
* Language: able to speak/understand English or Kiswahili (if the participant cannot read, the consent will be read to her, and thumbprint will suffice for consent as per the Tanzanian National Institute for Medical Research Ethical Guidelines for Informed Consent Processes)
Exclusion Criteria:
* Women will be excluded for a prior history of invasive or microinvasive cervical, vaginal, vulvar, or anal cancer; prior hysterectomy; cervical treatments within 1 year prior to study; cervical, vaginal, or vulvar lesions suspicious for cancer; prior HPV vaccination; receipt of anticoagulants; known sensitivity to vaccine components; hemophilia or bleeding diathesis; use of antineoplastic or immunomodulatory treatment; breastfeeding; and \<3 months postpartum. Any potential participant who appears unable to provide informed consent or does not want to participate in the research study will be excluded.
Women that d…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evidence Generation for use of a 4-step HPV testing, triage and vaccinate strategy