NCT05487807

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_1

Timeline
4mo left

Started Sep 2023

Typical duration for phase_1

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Sep 2023Aug 2026

First Submitted

Initial submission to the registry

July 18, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 13, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

July 18, 2022

Last Update Submit

November 27, 2023

Conditions

Nicotine DependenceTobacco Dependence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Point Prevalence

    4 weeks, 8 weeks, and 3 months post enrollment

Other Outcomes (2)

  • Quit attempts

    4 weeks, 8 weeks, and 3 months post enrollment

  • Nicotine patch adherence

    4 weeks, 8 weeks, and 3 months post enrollment

Study Arms (4)

Standard of Care

NO INTERVENTION

This is the baseline group receiving advice to quit.

Nicotine Replacement

ACTIVE COMPARATOR

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

Drug: Nicotine patch

Text Messaging

ACTIVE COMPARATOR

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

Behavioral: text messaging

Nicotine replacement and text messaging

ACTIVE COMPARATOR

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

Drug: Nicotine patchBehavioral: text messaging

Interventions

Nicotine patchDRUG

Will be receiving nicotine therapy

Also known as: NicoDerm
Nicotine ReplacementNicotine replacement and text messaging
text messagingBEHAVIORAL

Will be enrolled in an texting app

Also known as: Text2Quit
Nicotine replacement and text messagingText Messaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Makerere University

Kampala, Uganda

RECRUITING

University of Zambia

Lusaka, Zambia

RECRUITING

Related Publications (12)

  • 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: 20724677BACKGROUND

  • 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: 26260816BACKGROUND

  • 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: 30165688BACKGROUND

  • 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: 29879856BACKGROUND

  • 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: 31593543BACKGROUND

  • 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: 24638166BACKGROUND

  • 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: 12745503RESULT

  • 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: 23801018RESULT

  • 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.

    PMID: 20124230RESULT

  • 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.

    PMID: 40684230DERIVED

  • 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.

    PMID: 40074264DERIVED

  • 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.

    PMID: 38243301DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Use Cessation DevicesNicotine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control trial with 4 arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 18, 2022

First Posted

August 4, 2022

Study Start

September 13, 2023

Primary Completion

August 31, 2025

Study Completion (Estimated)

August 31, 2026

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Our dissemination strategy will target tobacco and HIV stakeholders including Ministry of Health and other government officials, health care organizations, health facility managers, HIV health care providers, tobacco control professionals, non-governmental organizations engaged in HIV and tobacco control, and PLWH. Our investigators will publish study results through peer-reviewed journals and scientific conferences; generate fact sheets and policy briefs; and disseminate our results through websites, social media, television and radio. We will share the study results in the participating Districts and the Cancer Treatments Centers of America will host a workshop in the final year with regional stakeholders to share the study results and promote tobacco use cessation programming for PLWH throughout Sub-saharan Africa. World Health Organization will assist in disseminating the study findings to other low/middle income countries.

Locations

ZA(1)UG(1)