Motivational Interviewing for encouraging quit attempts among unmotivated smokers: Study protocol of a randomized, controlled, efficacy trial

ABSTRACT: BACKGROUND: Although current clinical practice guidelines recommend Motivational Interviewing for use with smokers not ready to quit, the strength of evidence for its use is rated as not optimal. The purpose of the present study is to address key methodological limitations of previous studies by ensuring fidelity in the delivery of the Motivational Interviewing intervention, using an attention-matched control condition, and focusing on unmotivated smokers whom meta-analyses have indicated may benefit most from Motivational Interviewing. It is hypothesized that MI will be more effective at inducing quit attempts and smoking cessation at 6-month follow-up than brief advice to quit and an intensity-matched health education condition. METHODS: A sample of adult community resident smokers (N= 255) who report low motivation and readiness to quit are being randomized using a 2:2:1 treatment allocation to Motivational Interviewing, Health Education, or Brief Advice. Over 6 months, participants in Motivational Interviewing and Health Education receive 4 individual counseling sessions and participants in Brief Advice receive one brief in-person individual session at baseline. Rigorous monitoring and independent verification of fidelity will assure the counseling approaches are distinct and delivered as planned. Participants complete surveys at baseline, week 12 and 6-month follow-up to assess demographics, smoking characteristics, and smoking outcomes. Participants who decide to quit are provided with a self-help guide to quitting, help with a quit plan, and free pharmacotherapy. The primary outcome is self-report of one or more quit attempts lasting at least 24 hours between randomization and 6-month follow-up. The secondary outcome is biochemically confirmed 7-day point prevalence cessation at 6-month follow-up. Hypothesized mediators of the presumed treatment effect on quit attempts are greater perceived autonomy support and autonomous motivation. Use of pharmacotherapy is a hypothesized mediator of Motivational Interviewing's effect on cessation. DISCUSSION: This trial will provide the most rigorous evaluation to date of Motivational Interviewing's efficacy for encouraging unmotivated smokers to make a quit attempt. It will provide also provide effect-size estimates of MI's impact on smoking cessation to inform future clinical trials and inform the clinical practice guidelines. Trial registration ClinicalTrials.gov NCT01188018.     

Patient communication tools to enhance ART adherence counseling in low and high resource settings

Objective

Few articles have examined specific counseling tools used to increase antiretroviral therapy (ART) adherence. We present communication tools used in the context of Project MOTIV8, a randomized clinical trial.

Methods

We developed, piloted, and evaluated pictorial images to communicate the importance of consistent dose timing and the concept of drug resistance. Electronic drug monitoring (EDM) review was also used to provide visual feedback and facilitate problem solving discussions. Adherence knowledge of all participants (n = 204) was assessed at baseline and 48 weeks. Participant satisfaction with counseling was also assessed.

Results

Adherence knowledge did not differ at baseline, however, at 48 weeks, intervention participants demonstrated significantly increased knowledge compared to controls F(1, 172) = 10.76, p = 0.001 (12.4% increase among intervention participants and 1.8% decrease among controls). Counselors reported that the tools were well-received, and 80% of participants felt the counseling helped them adhere to their medications.

Conclusions

Counseling tools were both positively received and effective in increasing ART adherence knowledge among a diverse population.

Practice implications

While developed for research, these counseling tools can be implemented into clinical practice to help patients; particularly those with lower levels of education or limited abstract thinking skills to understand medical concepts related to ART adherence.     

Seroprevalence of SARS-CoV-2-Specific IgG Antibodies Among Adults Living in Connecticut: Post-Infection Prevalence (PIP) Study

BackgroundA seroprevalence study can estimate the percentage of people with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in the general population; however, most existing reports have used a convenience sample, which may bias their estimates.MethodsWe sought a representative sample of Connecticut residents, ages ≥18 years and residing in noncongregate settings, who completed a survey between June 4 and June 23, 2020, and underwent serology testing for SARS-CoV-2-specific immunoglobulin G (IgG) antibodies between June 10 and July 29, 2020. We also oversampled non-Hispanic black and Hispanic subpopulations. We estimated the seroprevalence of SARS-CoV-2-specific IgG antibodies and the prevalence of symptomatic illness and self-reported adherence to risk-mitigation behaviors among this population.ResultsOf the 567 respondents (mean age 50 [± 17] years; 53% women; 75% non-Hispanic white individuals) included at the state level, 23 respondents tested positive for SARS-CoV-2-specific antibodies, resulting in weighted seroprevalence of 4.0 (90% confidence interval [CI] 2.0-6.0). The weighted seroprevalence for the oversampled non-Hispanic black and Hispanic populations was 6.4% (90% CI 0.9-11.9) and 19.9% (90% CI 13.2-26.6), respectively. The majority of respondents at the state level reported following risk-mitigation behaviors: 73% avoided public places, 75% avoided gatherings of families or friends, and 97% wore a facemask, at least part of the time.ConclusionsThese estimates indicate that the vast majority of people in Connecticut lack antibodies against SARS-CoV-2, and there is variation by race and ethnicity. There is a need for continued adherence to risk-mitigation behaviors among Connecticut residents to prevent resurgence of COVID-19 in this region.     

A qualitative examination of the indirect effects of modified directly observed therapy on health behaviors other than adherence

Modified directly observed therapy (mDOT), in which a portion of doses in a medication regimen are ingested under supervision, has had some demonstrated success in improving the high levels of adherence necessary to achieve maximum benefit from antiretroviral medications. Consistent with the Information-Motivation-Behavioral skills (IMB) model, mDOT's success is likely due to its direct impact on patients' knowledge, motivation, and behaviors related to adherence. However, mDOT's potential impact on patients' information, motivation, and behaviors related to health activities other than adherence to antiretroviral medications has not been explored. Data from participants enrolled in Project MOTIV8, a randomized controlled trial to test the efficacy of novel behavioral adherence interventions, were analyzed to explore the potential impact of mDOT on health behaviors other than adherence. Participants were recruited from local HIV clinics from 2004-2008. Thirty-four percent of those approached, agreed to participate in the study. Data from all participants randomized to the mDOT intervention arm thus far (n = 50, mean age 39.7 standard deviation [SD] = 9.0, 78% male 64% African American, and 86% infected via sexual transmission) were included. Overall, participants reported a high level of satisfaction with the mDOT intervention. Qualitative data revealed that mDOT had a positive impact on participants' adherence to nonantiretroviral medications as well as their involvement and communication with health care providers. In addition, participants reported that the daily mDOT visits had indirect effects on their daily functioning, including improvements in their daily living activities (e.g., earlier awakenings, getting dressed, and cleaning their homes) and an increased level of community involvement.     

Impact of age on CD4 recovery and viral suppression over time among adults living with HIV who initiated antiretroviral therapy in the African Cohort Study

The pressing need to expand the biomedical HIV prevention evidence base during pregnancy is now increasingly recognized. Women’s views regarding participation in such trials and initiating PrEP while pregnant are critical to inform evolving policy and best practices aimed at responsibly expanding evidence-based access for this population. We conducted 35 semi-structured interviews with reproductive-aged women in Malawi in the local language, Chichewa. Participants were HIV-negative and purposively sampled to capture a range of experience with research during pregnancy. Women’s perspectives on enrolling in three hypothetical HIV prevention trial vignettes while pregnant were explored, testing: (1) oral PrEP (Truvada) (2) a vaginal ring (dapivirine), and (3) a randomized trial comparing the two. The vignettes were read aloud to participants and a simple visual was provided. Interviews were audio-recorded, transcribed, translated, and coded using NVivo 11. Thematic analysis informed the analytic approach. A majority of women accepted participation in all trials. Women’s views on research participation varied largely based on their assessment of whether participation or nonparticipation would best protect their own health and that of their offspring. Women interested in participating described power dynamics with their partner as fueling their HIV exposure concerns and highlighted health benefits of participation—principally, HIV protection and access to testing/treatment and ancillary care, and perceived potential risks of the vignettes as low. Women who were uninterested in participating highlighted potential maternal and fetal health risks of the trial, challenges of justifying prevention use to their partner, and raised some modality-specific concerns. Women also described ways their social networks, sense of altruism and adherence requirements would influence participation decisions. The majority of participants conveyed strong interest in participating in biomedical HIV prevention research during pregnancy, largely motivated by a desire to protect themselves and their offspring. Our results are consistent with other studies that found high acceptance of HIV prevention products during pregnancy, and support the current direction of HIV research policies and practices that are increasingly aimed at protecting the health of pregnant women and their offspring through responsible research, rather than defaulting to their exclusion.