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New study aims to help HIV patients in botswana kick the habit

NCT ID NCT05694637

Disease control Sponsor: University of Maryland, Baltimore 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a program to help people living with HIV in Botswana stop smoking. It combines counseling with a medication called varenicline. The goal is to see if this approach helps them quit and improves their health. The study involves 750 participants who are daily smokers and on HIV treatment.

What this could mean

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

Active substance
varenicline
What this could lead to
If successful, this could provide an effective, scalable way to help people with HIV quit smoking, reducing HIV complications and deaths.
What could go wrong
This is a phase 4 trial, but results may not apply to all populations. Adherence to medication and counseling can be challenging, and the intervention may not work for everyone.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 750 people

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

Started

Jul 2023

Expected to finish

Aug 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

Anyone

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: * HIV infected * Self reported current daily smoker * Age 18 and older * Engaged in HIV care as defined by being on ART for at least 6 months * Willing/able to provide informed consent in English or Setswana Exclusion Criteria: * Less than 18 years of age * Pregnant * Unable or cognitively impaired to provide consent

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease nicotine dependence Smoking Cessation

As listed by the trial registrant

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

HIV Smoking cessation

How to take part

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

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Airstrip Clinic

    Mahalapye, Central District, Botswana

  • Goodhope Primary Hospital

    Good Hope, Botswana

  • Itekeng Clinic

    Francistown, Central District, Botswana

  • Kanye Adventist Hospital

    Kanye, Botswana

  • Kediretswe Clinic

    Palapye, Botswana

  • Mahalapye District Hospital

    Mahalapye, Central District, Botswana

  • Masego Clinic

    Francistown, Central District, Botswana

  • Morwa Clinic

    Mochudi, Central District, Botswana

  • Nyangabgwe Referral Hospital

    Francistown, Central District, Botswana

  • Palpye Primary Hospital

    Palapye, Central District, Botswana

  • Sefhare Primary Hospital

    Sefhare, Central District, Botswana

  • Sekgoma District Hospital

    Serowe, Botswana

  • Serowe Clinic

    Serowe, Botswana

  • Thamaga Primary Hospital

    Thamaga, Kweneng District, Botswana

  • Tutume Primary Hospital

    Tutume, Central District, Botswana

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