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Objectives: The identification of key protocol elements and implementation challenges critical to achieve: 1) high enrollment rates of a gender and racially diverse sample and 2) retention rates over 80%, in a smoking cessation clinical trial among people living with HIV.
Methods: Analyses of recruitment, retention and adherence of an ongoing clinical trial with 5 times points. Seven blocks of candidate risk adjustors were included: 1) Type of recruitment, 2) Education, 3) Smoking history, 4) Attitudes toward nicotine replacement therapy (NRT), 5) Type of retention strategy 6) HIV status, and 7) Socio-demographics
Results: Positive outcomes include timely recruitment of 200 participants over 18 months, with a large proportion of women and minorities. Word-of-mouth referral (53%) was the most effective recruitment strategy. Hispanics and males were more responsive to flyers (p=0.04). Females were more likely to be recruited from target clinics or by participating in prior studies (p=0.004). The expectation set forth for the behavioral intervention attendance was a 100% and 99% completed it. However, adherence to pharmacotherapy was 65% instead of 85%. We achieved 88% retention rates in a population characterized by rates as low as 42%. Analyses revealed that Non-Hispanic Whites were less likely to believe in nicotine replacement being effective, and consequently, were often lost to follow-up.
Conclusion: Recruitment and retention of a diverse population of smokers living with HIV can be successful using a combination of methods. However, adherence and attitudes toward pharmacotherapy should be addressed to reach the full therapeutic potential of treatments