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Can 'Queen Mothers' bring HIV testing to the doorstep?

NCT ID NCT07829133

Diagnosis Sponsor: University of North Carolina, Chapel Hill 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing whether sex work managers, called queen mothers, can hand out and collect HIV self-tests and self-collected STI test kits at places where female sex workers meet and work in Lusaka. The study compares this peer-supported approach with the current standard of care. About 232 female sex workers and some queen mothers complete questionnaires and testing at the start and again about three months later. The goal is to see if the approach increases HIV and STI diagnosis and links people to treatment or prevention services.

What this could mean

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

Active substance
A venue-based, peer-supported strategy where sex work managers distribute and collect HIV self-tests and self-collected STI test kits
What this could lead to
If the strategy works, it could give health programs a low-cost way to reach female sex workers with HIV and STI testing and link those who test positive to treatment.
What could go wrong
This is a small pilot study in one city, so results may not hold in other settings. Self-testing can miss infections or lead to unclear results, and some participants may not complete confirmatory testing or seek care.

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 232 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 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

18 years and older

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.

FSW Inclusion Criteria: * Born biologically female * Identifies as a woman * Aged 18 years or older * Exchanged sex for money, goods, or services in the last 6 months * Lived and/or worked in Lusaka for at least the last 3 months * Planning to remain in Lusaka for at least the next 3 months * Willing and able to provide contact information, including a reachable telephone number * Willing and able to provide informed consent in Nyanja, Bemba, or English FSW Exclusion Criteria: * Under the age of 18 years * Does not identify as a woman * Unable and/or unwilling to provide contact information * Unable and/or unwilling to provide informed consent Queen Mother Eligibility Criteria: * Aged 18 years or older * Currently engaged as a sex work manager ("queen mother") * Lived and/or worked in Lusaka for at least the last 3 months * Planning to remain in Lusaka for at least the next 6 months * Willing and able to provide contact information, including a reachable telephone number * Willing and able to provide informed consent in Nyanja, Bemba, or English Implementer Focus Group Discussion Eligibility Criteria: * Aged 18 years old or older * Working as a queen mother OR civil society organization/Ministry of Health/non-governmental organization clinician or peer navigator OR member of a civil society or implementing partner organization serving FSW * Willing and able to provide verbal informed consent in English, Nyanja, or Bemba

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Conditions

The condition(s) this trial relates to.

chlamydia infectious disease chlamydia trachomatis infectious disease gonorrhea HIV infectious disease sexually transmitted disease syphilis

As listed by the trial registrant

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

Chlamydia Gonorrhea HIV Syphilis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre for Infectious Disease Research in Zambia (CIDRZ) Head Office

    Lusaka, Lusaka Province, 10101, Zambia

More trials for these conditions

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