Clinical trial NCT05694637: Botswana Smoking and Abstinence Reinforcement Trial
Official title: Botswana Smoking and Abstinence Reinforcement Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Smoking Cessation
Hiv
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: University of Maryland, Baltimore County
name: University of Maryland, College Park
name: University of Chicago
First posted: 2023-01-23
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a stepped wedge cluster randomization trial
Primary purpose: PREVENTION

Brief summary: Many people living with HIV in southern Africa, specifically Botswana use tobacco products. Using tobacco makes some of the effects of HIV worse and even causes excess deaths. The investigators plan to use an intervention called Screening, Brief Intervention and Referral to Treatment (SBIRT) to help people to quit smoking and also a drug called varenicline. Apart from helping people to stop smoking, the investigators will also test to see how task shifting can be used to help people stop smoking in a sustainable way. Finally, the investigators will estimate the cost of the intervention.

Detailed description: The investigators will utilize a stepped wedge cluster randomized trial to implement BSMART. BSMART will be sequentially rolled out to 15 participating HIV treatment and care facilities assigned in three steps. Each step will provide data for a 12- month control/pre-implementation, a 12-month implementation, and a 12-month maintenance period. The investigators will stratify Botswana's HIV treatment and care facilities into three levels of facilities. The investigative team will randomly assign each of the three levels of facilities to one of three study steps. Each step will comprise (i.e. have representation) from 3 levels of facilities, giving each level of facilities the same probability of beginning the intervention at any step).

Eligibility criteria: 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

Primary outcomes:
measure: Smoking Abstinence
timeFrame: Week 24
Secondary outcomes:
measure: Adherence to medication
timeFrame: Weeks 0, 1, 2, 4, 8, and 12
Other outcomes:
Locations:
city: Francistown
country: Botswana
facility: Itekeng Clinic
state: Central
city: Francistown
country: Botswana
facility: Masego Clinic
state: Central
city: Francistown
country: Botswana
facility: Nyangabgwe Referral Hospital
state: Central
city: Mahalapye
country: Botswana
facility: Airstrip Clinic
state: Central
city: Mahalapye
country: Botswana
facility: Mahalapye District Hospital
state: Central
city: Mochudi
country: Botswana
facility: Morwa Clinic
state: Central
city: Palapye
country: Botswana
facility: Palpye Primary Hospital
state: Central
city: Sefhare
country: Botswana
facility: Sefhare Primary Hospital
state: Central
city: Tutume
country: Botswana
facility: Tutume Primary Hospital
state: Central
city: Thamaga
country: Botswana
facility: Thamaga Primary Hospital
state: Kweneng
Study officials:
affiliation: University of Maryland, Baltimore
name: Manhattan Charurat, PhD
role: PRINCIPAL_INVESTIGATOR
References: