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

Nicotine Dependence Clinical Trial

— Quit4Life  

Official title:

Quit4Life+: Adapting and Evaluating a Phone-Based Tobacco Use Cessation Program for People Living With HIV in Uganda and Zambia (Quit4Life+ )

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05487807
• Other study ID #: 00006
• Secondary ID: 1U01CA261624
• Status: Recruiting
• Phase: Phase 1
• Start date: September 13, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: November 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This proposal tests the efficacy of a phone-based tobacco cessation intervention for people living with HIV (PLWH) in comparison to the standard of care (brief advice to quit) and nicotine replacement therapy (nicotine patches) in Uganda and Zambia. This study will provide insight into the efficacy, feasibility, applicability, and affordability of delivering tobacco cessation interventions through health care professionals at HIV treatment centers in two countries with different tobacco use patterns, policy environments, and health care resources. The previously tested SMS-platform to be used in this study is uniquely positioned to be scaled in low- and middle-income countries worldwide, in which case rigorous research showing even modest success in reducing the prevalence of tobacco consumption among PLWH could confer substantial health and economic benefits.

Description:

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. This study approaches this gap with the first randomized control trial (RCT) to test the efficacy of a tailored short message service (SMS) based tobacco use cessation intervention on prolonged tobacco use abstinence at 6 months post program initiation in comparison to the standard of care (brief advice to quit) and nicotine replacement therapy (nicotine patches) among PLWH in Uganda and Zambia. This study will provide insight into the efficacy, feasibility, applicability, and affordability of delivering tobacco cessation interventions through health care professionals at HIV treatment centers in two countries with different tobacco use patterns, policy environments, and health care resources and provide needed information to providers and policymakers looking for cost-effective tobacco cessation interventions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-

Exclusion Criteria:

• Females who are pregnant, planning to get pregnant, or breastfeeding

• <18 years (underage of consent)

• Visitor, not receiving continuous care at study site

• Not a current daily tobacco user

• Any physical, cognitive, or psychological disabilities that would prevent them from participating in the study

• Illiterate in English and/or local languages

• Does not consent

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Nicotine patch
Will be receiving nicotine therapy

Behavioral:
• text messaging
Will be enrolled in an texting app

Locations

Country	Name	City	State
Uganda	Makerere University	Kampala
Zambia	University of Zambia	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Countries where clinical trial is conducted

Uganda,  Zambia, 

References & Publications (9)

Baisley K, Baeten JM, Hughes JP, Donnell DJ, Wang J, Hayes R, Watson Jones D, Celum C. Summary measures of adherence using pill counts in two HIV prevention trials: the need for standardisation in reporting. AIDS Behav. 2013 Nov;17(9):3108-19. doi: 10.100 — View Citation

Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE. Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res. 2003 Feb;5(1):13-25. Erratum In: Nicotine Tob Res. 2003 Aug;5(4):603. — View Citation

Jackson-Morris A, Fujiwara PI, Pevzner E. Clearing the smoke around the TB-HIV syndemic: smoking as a critical issue for TB and HIV treatment and care. Int J Tuberc Lung Dis. 2015 Sep;19(9):1003-6. doi: 10.5588/ijtld.14.0813. — View Citation

Kruse C, Betancourt J, Ortiz S, Valdes Luna SM, Bamrah IK, Segovia N. Barriers to the Use of Mobile Health in Improving Health Outcomes in Developing Countries: Systematic Review. J Med Internet Res. 2019 Oct 9;21(10):e13263. doi: 10.2196/13263. — View Citation

Kruse GR, Bangsberg DR, Hahn JA, Haberer JE, Hunt PW, Muzoora C, Bennett JP, Martin JN, Rigotti NA. Tobacco use among adults initiating treatment for HIV infection in rural Uganda. AIDS Behav. 2014 Jul;18(7):1381-9. doi: 10.1007/s10461-014-0737-8. — View Citation

Lifson AR, Neuhaus J, Arribas JR, van den Berg-Wolf M, Labriola AM, Read TR; INSIGHT SMART Study Group. Smoking-related health risks among persons with HIV in the Strategies for Management of Antiretroviral Therapy clinical trial. Am J Public Health. 2010 Oct;100(10):1896-903. doi: 10.2105/AJPH.2009.188664. Epub 2010 Aug 19. — View Citation

Mitton JA, North CM, Muyanja D, Okello S, Vorechovska D, Kakuhikire B, Tsai AC, Siedner MJ. Smoking cessation after engagement in HIV care in rural Uganda. AIDS Care. 2018 Dec;30(12):1622-1629. doi: 10.1080/09540121.2018.1484070. Epub 2018 Jun 7. — View Citation

Murphy JD, Liu B, Parascandola M. Smoking and HIV in Sub-Saharan Africa: A 25-Country Analysis of the Demographic Health Surveys. Nicotine Tob Res. 2019 Jul 17;21(8):1093-1102. doi: 10.1093/ntr/nty176. — View Citation

Schnoll RA, Patterson F, Wileyto EP, Heitjan DF, Shields AE, Asch DA, Lerman C. Effectiveness of extended-duration transdermal nicotine therapy: a randomized trial. Ann Intern Med. 2010 Feb 2;152(3):144-51. doi: 10.7326/0003-4819-152-3-201002020-00005. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quit attempts	Self-reported quit attempts and changes in tobacco use, monitoring survey, health assessment form	4 weeks, 8 weeks, and 3 months post enrollment
Other	Nicotine patch adherence	Self-reported adherence to nicotine patch treatment, monitoring survey, health assessment form	4 weeks, 8 weeks, and 3 months post enrollment
Primary	Prolonged tobacco abstinence	The primary outcome for this efficacy trial is the proportion of study participants that have prolonged abstinence (i.e., no tobacco use from the target quit date through follow-up) at 3 and 6 months post enrollment measured by self-report and biochemically-verified as recommended by the Society for Research on Nicotine and Tobacco, the biomarker being assessed is urinary cotinine (<12 ng/mL) at 6 months post enrollment	6 months post enrollment
Secondary	Point Prevalence	7 consecutive days of no tobacco use, biochemically-verified at 4 weeks, 8 weeks, and 3 months post enrollment, the biomarker being assessed is urinary cotinine (<12 ng/mL) at 6 months post enrollment, the measurement tool is urine cotinine dip sticks	4 weeks, 8 weeks, and 3 months post enrollment