Adapting and Evaluating a Tobacco Use Cessation Program for People Living With HIV in Uganda and Zambia (Quit4Life)

November 27, 2023 updated by: Heather Wipfli, University of Southern California

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Recruiting
        • Makerere University
        • Contact:
        • Sub-Investigator:
          • Anthony Mbonye, PhD
        • Sub-Investigator:
          • Eizeus Rutebemberwa, MD, PhD
        • Sub-Investigator:
          • David Guwatudde, Bstat,MCs, PhD
        • Sub-Investigator:
          • Lynn Atuyambe, PhD
        • Sub-Investigator:
          • Fred Wabwire Mangen, MBChB, MPH, PhD
  • Zambia
      • Lusaka, Zambia
        • Recruiting
        • University of Zambia
        • Contact:
          • Fastone Goma, BSc, MB ChB, Mac, PhD
          • Phone Number: 260977772301
          • Email: gomafm@yahoo.co.uk
        • Sub-Investigator:
          • Cosmas Zyambo, BSc MB ChB MPhi PhD
        • Sub-Investigator:
          • Richard Zulu, BA MA MPhil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
This is the baseline group receiving advice to quit.
Active Comparator: Nicotine Replacement
This group will receive the standard of care and be prescribed nicotine replacement therapy
Drug: Nicotine patch
Will be receiving nicotine therapy
Other Names:
  • NicoDerm
Active Comparator: Text Messaging
This group will receive the standard of care and receive text message support
Behavioral: text messaging
Will be enrolled in an texting app
Other Names:
  • Text2Quit
Active Comparator: Nicotine replacement and text messaging
This group will receive the standard of care, be prescribed nicotine replacement therapy, and receive text message support
Drug: Nicotine patch
Will be receiving nicotine therapy
Other Names:
  • NicoDerm
Behavioral: text messaging
Will be enrolled in an texting app
Other Names:
  • Text2Quit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prolonged tobacco abstinence
Time Frame: 6 months post enrollment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Point Prevalence
Time Frame: 4 weeks, 8 weeks, and 3 months post enrollment
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quit attempts
Time Frame: 4 weeks, 8 weeks, and 3 months post enrollment
Self-reported quit attempts and changes in tobacco use, monitoring survey, health assessment form
4 weeks, 8 weeks, and 3 months post enrollment
Nicotine patch adherence
Time Frame: 4 weeks, 8 weeks, and 3 months post enrollment
Self-reported adherence to nicotine patch treatment, monitoring survey, health assessment form
4 weeks, 8 weeks, and 3 months post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2023

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

July 18, 2022

First Submitted That Met QC Criteria

August 1, 2022

First Posted (Actual)

August 4, 2022

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00006
  • 1U01CA261624 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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