Supporting the National Expansion of HPV-based Cervical Cancer Screening in Tanzania Among Women Living With HIV

Cervical Cancer Clinical Trial

Official title:

Supporting the National Expansion of HPV-based Cervical Cancer Screening in Tanzania Among Women Living With HIV: NECST-HIV

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06402383
• Other study ID #: 102030
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: April 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

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 do not want to receive the vaccine will be excluded.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Biological:
• Vaccination Provision
HPV vaccination #1 will be offered by provider at the first visit when the HPV self-sample is collected. HPV Vaccination #2 will be offered at 6 months for HPV negative women and at 12 months for HPV positive women.
• Vaccination Provision 2
HPV vaccination #1 will be offered by the provider after an HPV negative result is received with vaccine #2 given at 3 months after negative test results obtained. For HPV positive women - vaccination #1 will be offered at 12 months and vaccination #2 will be offered at the 15 month mark.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Merck Canada Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence Generation for use of a 4-step HPV testing, triage and vaccinate strategy	The primary endpoint will be a composite of HSIL on cervical histology at 12 months re-screening (follow-up). Secondary endpoints will include CIN3 on cervical histology, and grade 3 or 4 adverse events related to vaccination. Additional secondary endpoints will include participant-level predictors that may act as moderators of participation in cervical cancer screening and/or HPV vaccination. The investigators will also collect qualitative and quantitative data on the feasibility, impact, and cost-effectiveness of the different screening strategies through key informant interviews and focus groups comprised on clinic leadership, health providers and study participants.	15 months