NCT06402383Active, not recruiting
Supporting the National Expansion of HPV-based Cervical Cancer Screening in Tanzania Among Women Living With HIV
Supporting the National Expansion of HPV-based Cervical Cancer Screening in Tanzania Among Women Living With HIV: NECST-HIV
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
* 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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 2000 (estimated)
- First submitted
- 5 Apr 2024
- Start date
- 25 May 2024
- Primary completion date
- Jan 2027
- Lead sponsor
- Dr. Karen Yeates
- Diseases
- HIV, Cervical cancer
- NCT number
- NCT06402383
What you commit to
- Study type: Interventional
- Planned participants: 2000
- From 25 May 2024 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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)
Age in the registry: 25 years to 40 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pamoja Tunaweza Women's Centre Coordinator of this site? Confirm its status | Moshi | Tanzania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.