Smoking-related health risks among persons with HIV in the Strategies for Management of Antiretroviral Therapy clinical trial.
Alan R Lifson, Jacqueline Neuhaus, Jose Ramon Arribas...
https://pubmed.ncbi.nlm.nih.gov/20724677Actively Recruiting
Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
ID05487807
Quit4Life+: Adapting and Evaluating a Phone-Based Tobacco Use Cessation Program for People Living With HIV in Uganda and Zambia
Led by University of Southern California · Updated on 2023-11-28
800
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Southern California
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a phone-based tobacco cessation program specifically designed for people living with HIV (PLWH) in Uganda and Zambia. This study compares this intervention to the standard care, which includes brief advice to quit smoking and nicotine replacement therapy using nicotine patches. The research aims to understand how well this approach works, how feasible it is to deliver, and how affordable it might be in healthcare settings with varying tobacco use, policies, and resources. Participants are assigned to one of four groups: standard care with advice to quit, standard care plus nicotine patches, standard care plus supportive text messaging, or a combination of all three. The study uses a previously tested SMS platform to provide tailored support messages. This design allows researchers to see which combination helps maintain tobacco abstinence over six months after starting the program. During the study, participants will be monitored for tobacco use abstinence at several points, including 4 weeks, 8 weeks, 3 months, and especially at 6 months after enrollment, which is the main outcome. The study also tracks feasibility and acceptability of the interventions within HIV treatment centers. Participants will undergo assessments to support these measurements, with ongoing engagement through text messaging and nicotine therapy where applicable, providing insight into the best ways to support quitting tobacco among PLWH in these regions.
CONDITIONS
Brief Title
Adapting and Evaluating a Tobacco Use Cessation Program for People Living With HIV in Uganda and Zambia
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Current daily tobacco user
- Receiving continuous care at the study site
- Able to read English or local languages
- Provide consent to participate
You will not qualify if you...
- Females who are pregnant, planning to get pregnant, or breastfeeding
- Under 18 years of age
- Visitors not receiving continuous care at the study site
- Not a current daily tobacco user
- Any physical, cognitive, or psychological disabilities preventing participation
- Illiteracy in English and/or local languages
- Does not consent to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants receive tobacco cessation interventions which may include nicotine replacement therapy, text message support, or both, along with standard advice to quit.
Visits at 4 weeks, 8 weeks, and 3 months post enrollment
Trial Site Locations
Total: 2 locations
1
Makerere University
Kampala, Uganda
Actively Recruiting
2
University of Zambia
Lusaka, Zambia
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
Clearing the smoke around the TB-HIV syndemic: smoking as a critical issue for TB and HIV treatment and care.
A Jackson-Morris, P I Fujiwara, E Pevzner
https://pubmed.ncbi.nlm.nih.gov/26260816Smoking and HIV in Sub-Saharan Africa: A 25-Country Analysis of the Demographic Health Surveys.
John D Murphy, Benmei Liu, Mark Parascandola
https://pubmed.ncbi.nlm.nih.gov/30165688Smoking cessation after engagement in HIV care in rural Uganda.
Julian A Mitton, Crystal M North, Daniel Muyanja...
https://pubmed.ncbi.nlm.nih.gov/29879856Barriers to the Use of Mobile Health in Improving Health Outcomes in Developing Countries: Systematic Review.
Clemens Kruse, Jose Betancourt, Stephanie Ortiz...
https://pubmed.ncbi.nlm.nih.gov/31593543Tobacco use among adults initiating treatment for HIV infection in rural Uganda.
Gina R Kruse, David R Bangsberg, Judith A Hahn...
https://pubmed.ncbi.nlm.nih.gov/24638166Measures of abstinence in clinical trials: issues and recommendations.
John R Hughes, Josue P Keely, Ray S Niaura...
https://pubmed.ncbi.nlm.nih.gov/12745503Summary measures of adherence using pill counts in two HIV prevention trials: the need for standardisation in reporting.
Kathy Baisley, Jared M Baeten, James P Hughes...
https://pubmed.ncbi.nlm.nih.gov/23801018Effectiveness of extended-duration transdermal nicotine therapy: a randomized trial.
Robert A Schnoll, Freda Patterson, E Paul Wileyto...
https://pubmed.ncbi.nlm.nih.gov/20124230Usability and cultural adaptation of a text message-based tobacco cessation intervention for people living with HIV in Uganda and Zambia.
Heather Wipfli, Jim Arinaitwe, Fastone Goma...
https://pubmed.ncbi.nlm.nih.gov/40684230