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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Nicotine patch
  Will be receiving nicotine therapy
• Поведенческое text messaging
  Will be enrolled in an texting app

Первичные конечные точки

• Prolonged tobacco abstinence [Срок оценки: 6 months post enrollment]

Вторичные конечные точки (1)

• Point Prevalence [Срок оценки: 4 weeks, 8 weeks, and 3 months post enrollment]

Критерии участия

Критерии включения

\-

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Uganda · 1 центр

• Makerere University — Kampala

Zambia · 1 центр

• University of Zambia — Lusaka

Публикации

• 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. PMID 20724677
• 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. PMID 26260816
• 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. PMID 30165688
• 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. PMID 29879856
• 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. PMID 31593543
• 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. PMID 24638166
• 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. PMID 12745503
• 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: 10.1007/s10461-013-0542-9. PMID 23801018

Идентификаторы

NCT: NCT05487807 · 00006 · 1U01CA261624

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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