Evaluating Smoking Cessation Interventions for PWH in South Africa

Last updated: August 6, 2024
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

2/3

Condition

Smoking Cessation

Diabetes Prevention

Hiv

Treatment

Varenicline

Nicotine gum

Nicotine patch

Clinical Study ID

NCT05413122
IRB00335707
1U01CA261626-01
  • Ages > 18
  • All Genders

Study Summary

The overall objective of the study is to optimize a smoking cessation treatment package for people with HIV (PWH) that can be integrated into existing HIV care in South Africa.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥18 years of age, and

  2. attend one of the selected study clinics, and

  3. have a confirmed diagnosis of HIV (evidenced by one of: clinic or hospitalprescription for combination antiretroviral therapy (ART), or a current ARTmedication pack that has the patient's name documented thereon) and

  4. have been taking ART for at least three consecutive months (to ensure engagement incare at the recruitment clinic), and

  5. are current tobacco smokers (smoked at least 100 cigarettes in the subject'slifetime, have smoked daily for the past 30 days, have exhaled breath carbonmonoxide (CO) ≥ 7 parts per million (ppm), and have a positive urine cotinine test),and

  6. either own or have household access to a mobile phone, and

  7. provide written informed consent.

Exclusion

Exclusion Criteria:

  1. Currently (within the previous 14 days) receiving or using smoking cessationcounselling or pharmacotherapy, or

  2. are unable to participate due to severity of medical illness, guided by a Karnofskyscore of ≤ 40, or

  3. have a history of seizures, cancer, heart disease, stroke, myocardial infarction,stomach ulcers, kidney failure, or liver failure, or

  4. have generalized eczema or psoriasis, or

  5. have cognitive dysfunction or psychosis as defined by the Mini-InternationalNeuropsychiatric Interview (M.I.N.I.), or

  6. have suicide risk as defined by the Columbia-Suicide Severity Rating Scale (C-SSRS),or

  7. are pregnant, planning to become pregnant in the next four months, lactating, or areunwilling to use effective birth control, or

  8. have a history of adverse reactions to varenicline or nicotine patch, or

  9. are not planning to continue to receive care at the clinic for the next 52 weeks.

  10. In the opinion of the attending investigator are not a candidate for the clinicaltrail.

Study Design

Total Participants: 660
Treatment Group(s): 5
Primary Treatment: Varenicline
Phase: 2/3
Study Start date:
November 27, 2023
Estimated Completion Date:
August 31, 2028

Study Description

This project will evaluate the main and interaction effects of four evidence-based smoking cessation components integrated within HIV care in South Africa: (1) intensive behavioural counselling, (2) peer support, (3) combination nicotine replacement therapy (c-NRT), and (4) varenicline. The investigators will also evaluate the implementation and cost-effectiveness of these interventions. This study is a balanced full factorial randomised trial of 660 adults with HIV and will be implemented in two diverse sites in Gauteng, South Africa representing both peri-urban and urban settings.

Participants will be recruited via health care worker-referral or self-referral. Interested patients will be further screened for eligibility. Eligible participants will be administered written informed consent (see "Informed Consent and Assent" section below), and participants will be randomized into one of 16 study conditions for a 12-week intervention period. This will be an open-label trial; neither the participants nor study personnel will be blinded to treatment assignment post randomization, but randomization block assignment will be concealed from the study personnel who will be enrolling participants.

Connect with a study center

  • Perinatal HIV Research Unit (PHRU)

    Soweto, Gauteng
    South Africa

    Active - Recruiting

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