Wellness Intervention for Smoking and HIV

Summary

The investigators propose to use a parallel group, randomized controlled trial to test the efficacy of a 13-week personalized approach to reducing smoking intervention versus a second approach using a different health intervention on smoking cessation, healthy sleep metrics, and biomarkers of cardiovascular risk in a sample of 200 treatment-seeking smokers who are adults living with HIV (ALHIV). To enroll in the study, treatment-seeking ALHIV smokers will undergo phone and in-person study eligibility assessments, including a history, physical examination, screening laboratory tests, and an overnight in-home objective sleep assessment. Eligible subjects (N=200) will be randomized to the 13-week Approach 1 (N=100) or Approach 2 (N=100) condition. All subjects will receive a 12-week course of varenicline (beginning in week 2) and 8 individual 15-minute smoking cessation counseling sessions \[weeks 1, 2, 3 (target quit date), 5, 7, 9, 11, 13\]. At each in-person counseling session, 30-45 minutes of Approach 1 or Approach 2 counseling will be provided as well. While receiving varenicline, the study team will monitor for side effects and changes to blood pressure at each study visit for safety reasons. Study measures are collected at all time points including EOT (week 13), and 6-month follow-up (6MFU).

Conditions

• HIV
• Sleep
• Smoking Cessation
• Cardiovascular Diseases

Interventions

DRUG

Varenicline

Standard smoking cessation treatment.

BEHAVIORAL

Smoking Cessation Counseling

Standard smoking cessation treatment

BEHAVIORAL

Health Approach 1 to Reduce Smoking

Behavioral health intervention option 1

OTHER

Health Approach 2 to Reduce Smoking

Behavioral health intervention option 2

Sponsors & Collaborators

• University of Delaware

  collaborator OTHER

• University of Arizona

  lead OTHER

Principal Investigators

• Elizabeth Connick, MD · University of Arizona

• Michael Grandner, PhD · University of Arizona

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-16

Primary Completion

2025-09-28

Completion

2025-09-28

Countries

• United States

Study Locations