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

NCT ID: NCT05487807

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-13

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nicotine Dependence Tobacco Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial with 4 arms
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of Care

This is the baseline group receiving advice to quit.

Group Type NO_INTERVENTION

No interventions assigned to this group

Nicotine Replacement

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

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

Will be receiving nicotine therapy

Text Messaging

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

Group Type ACTIVE_COMPARATOR

text messaging

Intervention Type BEHAVIORAL

Will be enrolled in an texting app

Nicotine replacement and text messaging

This group will receive the standard of care, be prescribed nicotine replacement therapy, and receive text message support

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

Will be receiving nicotine therapy

text messaging

Intervention Type BEHAVIORAL

Will be enrolled in an texting app

Interventions

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Nicotine patch

Will be receiving nicotine therapy

Intervention Type DRUG

text messaging

Will be enrolled in an texting app

Intervention Type BEHAVIORAL

Other Intervention Names

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NicoDerm Text2Quit

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Heather Wipfli

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Makerere University

Kampala, , Uganda

Site Status RECRUITING

University of Zambia

Lusaka, , Zambia

Site Status RECRUITING

Countries

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Uganda Zambia

Facility Contacts

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Jim Arinaitwe, MBcHB, MPH

Role: primary

[email protected]
256772404985

Fastone Goma, BSc, MB ChB, Mac, PhD

Role: primary

[email protected]
260977772301

References

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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.

Reference Type BACKGROUND
PMID: 20724677 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26260816 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30165688 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29879856 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31593543 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24638166 (View on PubMed)

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.

Reference Type RESULT
PMID: 12745503 (View on PubMed)

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.

Reference Type RESULT
PMID: 23801018 (View on PubMed)

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.

Reference Type RESULT
PMID: 20124230 (View on PubMed)

Wipfli H, Arinaitwe J, Goma F, Atuyambe L, Guwatudde D, Phiri MM, Rutebemberwa E, Wabwire-Mangen F, Zulu R, Zyambo C, Guy K, Kusolo R, Mukupa M, Musasizi E, Tucker JS. Usability and cultural adaptation of a text message-based tobacco cessation intervention for people living with HIV in Uganda and Zambia. Addict Sci Clin Pract. 2025 Jul 20;20(1):55. doi: 10.1186/s13722-025-00580-z.

Reference Type DERIVED
PMID: 40684230 (View on PubMed)

Guy K, Arinaitwe J, Goma FM, Atuyambe L, Guwatudde D, Zyambo C, Kusolo R, Mukupa M, Musasizi E, Wipfli H. Understanding stigma as a barrier to cancer prevention and treatment: a qualitative study among people living with HIV in Uganda and Zambia. BMJ Open. 2025 Mar 12;15(3):e090817. doi: 10.1136/bmjopen-2024-090817.

Reference Type DERIVED
PMID: 40074264 (View on PubMed)

Wipfli H, Arinaitwe J, Goma F, Atuyambe L, Guwatudde D, Phiri MM, Rutebemberwa E, Wabwire-Mangen F, Zulu R, Zyambo C, Guy K, Kusolo R, Mukupa M, Musasizi E, Tucker JS. A phone-based tobacco use cessation program for people living with HIV in Uganda and Zambia: study protocol for a randomized controlled trial. Addict Sci Clin Pract. 2024 Jan 19;19(1):6. doi: 10.1186/s13722-024-00438-w.

Reference Type DERIVED
PMID: 38243301 (View on PubMed)

Other Identifiers

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1U01CA261624

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00006

Identifier Type: -

Identifier Source: org_study_id