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A One-Two punch against cervical cancer: testing plus vaccination in HIV-Positive women

NCT ID NCT06402383

Prevention Sponsor: Dr. Karen Yeates Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This trial tests two strategies for preventing cervical cancer in women living with HIV in Tanzania. Both strategies involve HPV self-sampling and visual checks of the cervix, but they differ in the timing of HPV vaccination. The study aims to see which approach better reduces precancerous lesions at a 12-month follow-up, potentially informing national screening programs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HPV vaccine (offered alongside HPV DNA testing and visual assessment of the cervix)
What this could lead to
If successful, this could establish a practical, effective strategy for preventing cervical cancer in women living with HIV, potentially reducing cervical cancer rates in Tanzania and similar settings.
What could go wrong
The trial is early-stage and may face challenges in implementation, such as adherence to follow-up visits. The vaccine's benefit in women already exposed to HPV is uncertain, and outcomes may not generalize beyond the study population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease Uterine Cervical Neoplasms cervical cancer prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer

Contacts and locations

Locations

  • Pamoja Tunaweza Women's Centre

    Moshi, Tanzania

More trials for these conditions

Other studies related to the condition(s) this trial covers.