Adapting and Evaluating a Tobacco Use Cessation Program for People Living With HIV in Uganda and Zambia

What Was Tested

This registered phase 1 trial tested Therapeutic nicotine (patch, non-peptide).

It had four arms (groups): Standard of Care (no intervention), Nicotine Replacement (active comparator), Text Messaging (active comparator) and Nicotine replacement and text messaging (active comparator).

This is the baseline group receiving advice to quit.

This group will receive the standard of care and be prescribed nicotine replacement therapy.

This group will receive the standard of care and receive text message support.

The registry classes the interventions as behavioral and drug.

More on the Plan

While there is substantial evidence supporting interventions to help tobacco users in the general population quit, little is available relevant to the challenges facing HIV+ tobacco users, especially those living in low-income African countries.

Who Took Part

Enrollment: 800 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

The full record lists 0 inclusion and 7 exclusion criteria; among the exclusions: females who are pregnant, planning to get pregnant, or breastfeeding; \<18 years (underage of consent); visitor, not receiving continuous care at study site.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

It started in 2023-09-13 with completion listed for 2025-08-31.

It ran at 2 sites in Uganda (1) and Zambia (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Prolonged tobacco abstinence (time frame: 6 months post enrollment).

It also tracked 1 secondary outcome, for example Point Prevalence.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 800 people.

With 800 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.