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Nicotine DependencePhase 1Quit4LifeNCT05487807

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

A Phase 1 study testing Nicotine patch and text messaging in people with Nicotine Dependence and Tobacco Dependence, run by University of Southern California at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Nicotine Dependence, Tobacco Dependence
What is being tested?
Nicotine patch and text messaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
2 sitesin 2 countries
Study dates
13 Sep 2023to 31 Aug 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • -

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Uganda1 site, 1 recruiting

  • Makerere University

    Kampala

    Jim Arinaitwe, MBcHB, MPH, 256772404985, arinaitwej@ctc-africa.org

    Anthony Mbonye, PhD

    Recruiting

Other trials in Uganda

Zambia1 site, 1 recruiting

  • University of Zambia

    Lusaka

    Fastone Goma, BSc, MB ChB, Mac, PhD, 260977772301, gomafm@yahoo.co.uk

    Cosmas Zyambo, BSc MB ChB MPhi PhD

    Recruiting

Other trials in Zambia

About this study

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

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.

Read the detailed 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.

Being tested
Nicotine patch, text messaging
Medical subject headings
Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nicotine patchDrug

    Also called NicoDerm

    Will be receiving nicotine therapy

  • text messagingBehavioural

    Also called Text2Quit

    Will be enrolled in an texting app

Study groups in NCT05487807
Study groupRoleWhat they receive
Standard of CareNo interventionThis is the baseline group receiving advice to quit.
Nicotine ReplacementActive comparatorThis group will receive the standard of care and be prescribed nicotine replacement therapy
Receives: Drug: Nicotine patch
Text MessagingActive comparatorThis group will receive the standard of care and receive text message support
Receives: Behavioral: text messaging
Nicotine replacement and text messagingActive comparatorThis group will receive the standard of care, be prescribed nicotine replacement therapy, and receive text message support
Receives: Drug: Nicotine patch; Behavioral: text messaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months post enrollment

Secondary outcomes (1)

  1. 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

    Measured: 4 weeks, 8 weeks, and 3 months post enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2022
  2. Study start13 Sep 2023
  3. Primary completion31 Aug 2025 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized control trial with 4 arms
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05487807
Sponsor's protocol ID
00006
Other IDs
1U01CA261624
Acronym
Quit4Life
Status last verified
Nov 2023
First submitted
18 Jul 2022
Last updated
28 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 23801018

  • 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.

    PubMed 20124230

  • 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.

    PubMed 40684230

  • 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.

    PubMed 40074264

  • 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.

    PubMed 38243301

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nicotine patch and text messaging in people with Nicotine Dependence and Tobacco Dependence, run by University of Southern California at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Uganda, Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prolonged tobacco abstinence (time frame: 6 months post enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05487807, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.

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