Randomized trial promoting cancer genetic risk assessment when genetic counseling cost removed: 1-year follow-up.

PURPOSE: Cancer genetic risk assessment (CGRA) is recommended for women with ovarian and high-risk breast cancer. However, the underutilization of CGRA has long been documented, and cost has been a major barrier. In this randomized controlled trial, a tailored counseling and navigation (TCN) intervention significantly improved CGRA uptake at 6-month follow-up, compared with targeted print (TP) and usual care (UC). We aimed to examine the effect of removing genetic counseling costs on CGRA uptake by 12 months. METHODS: We recruited racially and geographically diverse women with breast and ovarian cancer from cancer registries in Colorado, New Jersey, and New Mexico. Participants assigned to TCN received telephone-based psychoeducation and navigation. After 6 months, the trial provided free genetic counseling to participants in all arms. RESULTS: At 12 months, more women in TCN obtained CGRA (26.6%) than those in TP (11.0%; odds ratio [OR] = 2.77, 95% confidence interval [CI] = 1.56 to 4.89) and UC (12.2%; OR = 2.46, 95% CI = 1.41 to 4.29). There were no significant differences in CGRA uptake between TP and UC. The Kaplan-Meier curve shows that the divergence of cumulative incidence slopes (TCN vs UC, TCN vs TP) appears primarily within the initial 6 months. CONCLUSION: TCN significantly increased CGRA uptake at the 12-month follow-up. Directly removing the costs of genetic counseling attenuated the effects of TCN, highlighting the critical enabling role played by cost coverage. Future policies and interventions should address multilevel cost-related barriers to expand patients' access to CGRA. TRIAL REGISTRATION: This trial was registered with the NIH clinical trial registry, clinicaltrials.gov, NCT03326713. https://clinicaltrials.gov/ct2/show/NCT03326713.

Reproductive Interconception Care Among Women Recently Pregnant and Homeless: A Qualitative Analysis.

Reproductive interconception care provided at maternal postpartum visits may help reduce unintended pregnancies and elongate birth intervals for women experiencing homelessness. To improve interconception care uptake, this qualitative study aimed to identify barriers and facilitators to reproductive interconception care from the perspectives of women who were recently pregnant and homeless. A semi-structured interview guide and demographic survey were developed based on epidemiological findings, Information-Motivation-Behavioral Skill framework components, and a review by community health workers for content validity. After conducting 12 interviews with women recently pregnant and homeless in a local continuum of care in 2022, audio-recorded interviews were transcribed, iteratively coded using a priori and emerging codes, and thematically analyzed. Key themes were identified to determine implications and next steps to improving reproductive interconception care uptake. Interrelated themes focused on information (e.g., knowledge and misconceptions about pregnancy, birth intervals, contraception), motivation (e.g., attitudes about interconception care experiences, perinatal social influences), behavioral skills (e.g., objective ability to obtain interconception care and perceived self-efficacy related to attending maternal postpartum visits and increasing birth intervals), and macro-level factors (e.g., obtaining housing, contextualizing socioeconomic factors, navigating COVID-19). The findings suggest the need for flexible, streamlined, and personalized interconception care delivery that acknowledges pressing housing and relationship considerations and supports women's autonomy. Improvements to reproductive interconception care may reduce future unintended pregnancies, increase birth intervals, and improve birth outcomes among women experiencing homelessness.

Homelessness in the Perinatal Period and Associations With Reproductive Interconception Care: 2016-2019 Pregnancy Risk Assessment Monitoring System.

OBJECTIVES: Women experiencing homelessness have higher rates of unintended pregnancy than stably housed women and may benefit from reproductive interconception care. How reproductive interconception care differs between women who did and did not experience perinatal homelessness is not known. We estimated prevalence ratios of reproductive interconception behaviors among US women experiencing homelessness during the perinatal period. METHODS: We used data from the 2016-2019 Pregnancy Risk Assessment Monitoring System to calculate the prevalence of 5 reproductive interconception care outcomes: attending a maternal postpartum checkup, participating in a conversation with a health care provider about birth intervals, receiving family planning counseling, obtaining a prescription for short-acting contraception, and having a long-acting reversible contraceptive inserted. We used complex survey weights, stratified by perinatal homelessness, and converted adjusted logistic regression odds ratios between housing status and outcome variables to adjusted prevalence ratios (aPRs) and 95% CIs. RESULTS: Among participants, approximately 2.4% (weighted percentage; unweighted 2953 of 100 706) experienced homelessness sometime in the 12 months before their children were born; the majority were non-Hispanic (83.2%) and White (69.4%), were not married (82.2%), and had public health insurance (56.8%). Perinatal homelessness was significantly associated with a lower prevalence of attending a postpartum maternal visit (aPR = 0.90; 95% CI, 0.87-0.94) and a higher prevalence of having a conversation about birth intervals with their health care providers (aPR = 1.13; 95% CI, 1.03-1.21). CONCLUSIONS: Findings suggest that improving attendance at postpartum visits and evaluating birth interval conversations may strengthen interconception care practices while contextualizing social determinants such as housing stability. Improving uptake of postpartum visits may reduce unintended pregnancy, short birth intervals, and adverse birth outcomes in future pregnancies among women experiencing homelessness.

Identifying Mediators of Intervention Effects Within a Randomized Controlled Trial to Motivate Cancer Genetic Risk Assessment Among Breast and Ovarian Cancer Survivors.

BACKGROUND: A theory-guided Tailored Counseling and Navigation (TCN) intervention successfully increased cancer genetic risk assessment (CGRA) uptake among cancer survivors at increased risk of hereditary breast and ovarian cancer (HBOC). Understanding the pathways by which interventions motivate behavior change is important for identifying the intervention's active components. PURPOSE: We examined whether the TCN intervention exerted effects on CGRA uptake through hypothesized theoretical mediators. METHODS: Cancer survivors at elevated risk for HBOC were recruited from three statewide cancer registries and were randomly assigned to three arms: TCN (n = 212), Targeted Print (TP, n = 216), and Usual Care (UC, n = 213). Theoretical mediators from the Extended Parallel Process Model, Health Action Planning Approach, and Ottawa Decision Support Framework were assessed at baseline and 1-month follow-up; CGRA uptake was assessed at 6 months. Generalized structural equation modeling was used for mediation analysis. RESULTS: The TCN effects were most strongly mediated by behavioral intention alone (ß = 0.49 and 0.31) and by serial mediation through self-efficacy and intention (ß = 0.041 and 0.10) when compared with UC and TP, respectively. In addition, compared with UC, the TCN also increased CGRA through increased perceived susceptibility, knowledge of HBOC, and response efficacy. CONCLUSIONS: Risk communication and behavioral change interventions for hereditary cancer should stress a person's increased genetic risk and the potential benefits of genetic counseling and testing, as well as bolster efficacy beliefs by helping remove barriers to CGRA. System-level and policy interventions are needed to further expand access.

It is recommended that cancer survivors at increased risk for heredity seek cancer genetic risk assessment (CGRA), which includes cancer genetic counseling and genetic testing. A Tailored Counseling and Navigation (TCN) intervention successfully increased CGRA uptake among women with a history of cancer who enrolled in a randomized controlled trial. Understanding reasons for TCN's effectiveness can guide future interventions that use risk messages and behavior change techniques. We conducted mediation analyses, which enabled identification of the TCN's active components. Eligible breast and ovarian cancer survivors (n = 641) were recruited from three statewide cancer registries and were assigned to three groups: TCN, Targeted Print, and Usual Care. Mediator variables drawn from behavioral and risk communication theories were assessed at baseline and 1-month follow-up; CGRA uptake was assessed at 6 months. The strongest mediator was intention to obtain a CGRA, followed by self-efficacy, perceived risk, knowledge of hereditary breast and ovarian cancer, and perceived CGRA benefits. Risk communication and behavioral change interventions for hereditary cancer should stress a person's increased genetic risk and the potential benefits of genetic counseling and testing, as well as bolster efficacy beliefs by helping remove CGRA barriers. System-level and policy interventions are needed to further expand access.

What's theory got to do with it: measuring effects of theory on lifestyle behaviors and weight in the Better Me Within Randomized Trial.

Background: Knowing which theoretical constructs work best to design effective interventions is essential for populations with increased disease burden. African American women (AAW) experience greater prevalence of chronic diseases and fewer benefits from weight loss interventions compared to White women. Purpose: To examine how theoretical constructs were associated with lifestyle behaviors and weight outcomes in the Better Me Within (BMW) Randomized Trial. Methods: BMW used a tailored diabetes prevention program implemented in churches among AAW with BMI ≥ 25. Regression models assessed relationships between constructs (self-efficacy, social support and motivation), and outcomes (physical activity (PA), calories, and weight). Results: Among 221 AAW (mean (SD) age 48.8 years (11.2); mean weight 215.1 pounds (50.5), several significant relationships were found including an association between change in motivation for activity and change in PA (p=.003), and change in motivation for diet and weight at follow-up (p=<.001). Discussion: The clearest relationships emerged for PA with motivation for activity and weight management social support demonstrating significance in all models. Translation to Practice: Self-efficacy, motivation and social support show promise to promote changes in PA and weight among church-going AAW. Opportunities to keep engaging AAW in research are essential for eliminating health inequities in this population.

Improving Uptake of Cancer Genetic Risk Assessment in a Remote Tailored Risk Communication and Navigation Intervention: Large Effect Size but Room to Grow.

PURPOSE: Cancer genetic risk assessment (CGRA) is recommended for women with ovarian cancer or high-risk breast cancer, yet fewer than 30% receive recommended genetic services, with the lowest rates among underserved populations. We hypothesized that compared with usual care (UC) and mailed targeted print (TP) education, CGRA uptake would be highest among women receiving a phone-based tailored risk counseling and navigation intervention (TCN). METHODS: In this three-arm randomized trial, women with ovarian or high-risk breast cancer were recruited from statewide cancer registries in Colorado, New Jersey, and New Mexico. Participants assigned to TP received a mailed educational brochure. Participants assigned to TCN received the mailed educational brochure, an initial phone-based psychoeducational session with a health coach, a follow-up letter, and a follow-up navigation phone call. RESULTS: Participants' average age was 61 years, 25.4% identified as Hispanic, 5.9% identified as non-Hispanic Black, and 17.5% lived in rural areas. At 6 months, more women in TCN received CGRA (18.7%) than those in TP (3%; odds ratio, 7.4; 95% CI, 3.0 to 18.3; P < .0001) or UC (2.5%; odds ratio, 8.9; 95% CI, 3.4 to 23.5; P < .0001). There were no significant differences in CGRA uptake between TP and UC. Commonly cited barriers to genetic counseling were lack of provider referral (33.7%) and cost (26.5%), whereas anticipated difficulty coping with test results (14.0%) and cost (41.2%) were barriers for genetic testing. CONCLUSION: TCN increased CGRA uptake in a group of geographically and ethnically diverse high-risk breast and ovarian cancer survivors. Remote personalized interventions that incorporate evidence-based health communication and behavior change strategies may increase CGRA among women recruited from statewide cancer registries.

Relationship Between Valence and Arousal for Subjective Experience in a Real-life Setting for Supportive Housing Residents: Results From an Ecological Momentary Assessment Study.

BACKGROUND: The circumplex model of affect posits that valence and arousal are the principal dimensions of affect. The center of the 2D space represents a neutral state of valence and a medium state of arousal. The role of valence and arousal in human emotion has been studied extensively. However, no consistent relationship between valence and arousal has been established. Most of the prior studies investigating the relationship have been conducted in relatively controlled laboratory settings. OBJECTIVE: Ecological momentary assessment (EMA) of affect from participants residing in permanent supportive housing was used to study the relationship between valence and arousal in real-life settings. The goal of this study was to explore the relationship between valence and arousal in a person's natural environment. METHODS: Participants were recruited from housing agencies in Fort Worth, Texas, United States. All participants had a history of chronic homelessness and reported at least one mental health condition. A subset of participants completed daily (morning) EMAs of emotions and other behaviors. The sample comprised 78 women and 77 men, and the average age was 52 (SD 8) years. From the circumplex model of affect, the EMA included 9 questions related to the participant's current emotional state (happy, frustrated, sad, worried, restless, excited, calm, bored, and sluggish). The responses were used to calculate 2 composite scores for valence and arousal. RESULTS: Statistical models uniformly showed a dominant linear relation between valence and arousal and a significant difference in the slopes among races. None of the other effects were statistically significant. Compared with previous studies, the effects were quite robust. CONCLUSIONS: Our findings may provide a window to the fundamental structure of affect. We found a strong positive linear relationship between valence and arousal at the nomothetic level, which may provide insight into a universal structure of affect. However, the study needs to be replicated for different populations to determine whether our findings can be generalized beyond the population studied here.

Understanding cancer genetic risk assessment motivations in a remote tailored risk communication and navigation intervention randomized controlled trial.

Background: National guidelines recommend cancer genetic risk assessment (CGRA) (i.e. genetic counseling prior to genetic testing) for women at increased risk for hereditary breast and ovarian cancer (HBOC). Less than one-half of eligible women obtain CGRA, leaving thousands of women and their family members without access to potentially life-saving cancer prevention interventions. Purpose: The Genetic Risk Assessment for Cancer Education and Empowerment Project (GRACE) addressed this translational gap, testing the efficacy of a tailored counseling and navigation (TCN) intervention vs. a targeted print brochure vs. usual care on CGRA intentions. Selected behavioral variables were theorized to mediate CGRA intentions. Methods: Breast and ovarian cancer survivors meeting criteria for guideline-based CGRA were recruited from three state cancer registries (N = 654), completed a baseline survey, and were randomized. TCN and targeted print arms received the brochure; TCN also participated in a tailored, telephone-based decision coaching and navigation session grounded in the Extended Parallel Process Model and Ottawa Decision Support Framework. Participants completed a one-month assessment. Logistic regression was used to compare the rate of CGRA intentions. CGRA intentions and theorized mediator scores (continuous level variables) were calculated using mixed model analysis. Results: CGRA intentions increased for TCN (53.2%) vs. targeted print (26.7%) (OR = 3.129; 95% CI: 2.028, 4.827, p < .0001) and TCN vs. usual care (23.1%) (OR = 3.778, CI: 2.422, 5.894, p < .0001). Perceived risk (p = 0.023) and self-efficacy (p = 0.035) mediated CGRA intentions in TCN. Conclusions: Improvements in CGRA intentions and theorized mediators support the use of a tailored communication intervention among women at increased HBOC risk. (Clinicaltrials.gov: NCT03326713.)Trial registration: ClinicalTrials.gov identifier: NCT03326713.

Delta-8 THC Retail Availability, Price, and Minimum Purchase Age.

Background: Retail sales of Delta-8 tetrahydrocannabinol (THC) products have increased in the U.S. market since the passing of the 2018 Farm Bill, and there is currently little regulation of marketing/sales and limited related safety standards in many states. After thousands of calls to poison control centers (40% for individuals under 18 years old and 70% requiring health care facility evaluation), the Food and Drug Administration issued warnings on Delta-8 THC products, stating their psychoactive effects and that some manufacturers may synthesize Delta-8 using unsafe household chemicals. The current study describes the Delta-8 THC retail sales environment in Fort Worth, Texas. Given its relatively inexpensive manufacturing and that low prices are a major determinant of cannabis use, the price of Delta-8 THC products was examined. This study also examined whether retail outlets in areas with greater socioeconomic deprivation had higher odds of selling Delta-8 THC products. This is important because if Delta-8 THC retailers are disproportionately located in more socioeconomically deprived communities, residents of these communities can more easily access these products and may have higher risk of adverse consequences. Methods: Potential Delta-8 THC retailers were selected by identifying lists of current retail locations with alcohol, cannabidiol, and/or tobacco licenses in Fort Worth. Trained research assistants called outlets in September and October 2021 to query about sales of products containing Delta-8 THC. The response rate was 69% (n=1,223). Outlets' 9-digit zip codes were merged with Area Deprivation Index scores. Products and purported minimum age were described. Chi-squared and Student's t-tests were used. Results: Eleven percent of outlets (n=133) reported selling Delta-8 THC. Ninety-six percent sold vapes and/or "flower" (i.e., hemp leaves coated with Delta-8 THC distillate) and 76% sold edibles. Among the least expensive products available, edibles cost, on average, $8.58 less than flower/vapes (p<0.001). Outlets that sold Delta-8 THC were located in areas with greater deprivation (p=0.02). Most reported a minimum purchase age of 21; however, 4% reported 18 years or no minimum age. Conclusions: Delta-8 THC retail outlets were disproportionately located in areas with more socioeconomic deprivation. Legal intervention such as zoning, minimum age, and tax laws may help reduce Delta-8 THC-related disparities.

Ecological Momentary Assessment of Alcohol Consumption and Its Concordance with Transdermal Alcohol Detection and Timeline Follow-Back Self-report Among Adults Experiencing Homelessness.

BACKGROUND: Studies of alcohol use presume valid assessment measures. To evaluate this presumption, we examined the concordance of alcohol use as measured by ecological momentary assessment (EMA) self-reports, transdermal alcohol concentration readings via the Secure Continuous Remote Alcohol Monitor (SCRAM), and retrospective self-reports via the Timeline Follow-Back (TLFB) among adults experiencing homelessness. METHODS: Forty-nine adults who reported alcohol misuse (mean age = 47, SD = 9; 57% Black; 82% men) were recruited from a homeless shelter. For 4 weeks, alcohol use was assessed: (i) 5 times or more per day by EMA, (ii) every 30 minutes by a SCRAM device worn on the ankle, and (iii) by TLFB for the past month at the end of the study period. There were 1,389 days of observations of alcohol use and alcohol use intensity for 49 participants. RESULTS: EMA and SCRAM alcohol use data agreed on 73% of days, with an interrater agreement Kappa = 0.46. A multilevel analysis of concordance of 3 measures for alcohol use yielded statistically significant correlations of 0.40 (day level) and 0.63 (person level) between EMA and SCRAM. Alcohol use was detected on 49, 38, and 33% of days by EMA, SCRAM, and TLFB, respectively. For alcohol use intensity, EMA and SCRAM resulted in statistically significant correlations of 0.46 (day level) and 0.78 (person level). The concordance of TLFB with either EMA or SCRAM was weak, especially at the day level. CONCLUSIONS: This is the first study to examine concordance of alcohol use estimates using EMA, SCRAM, and TLFB methods in adults experiencing homelessness. EMA is a valid approach to quantifying alcohol use, especially given its relatively low cost, low participant burden, and ease of use. Furthermore, any stigma associated with wearing the SCRAM or reporting alcohol use in person may be attenuated by using EMA, which may be appealing for use in studies of stigmatized and underserved populations.

What happens to agreement over time? A longitudinal study of self-reported substance use compared to saliva toxicological testing among subsidized housing residents.

The agreement between self-reported and toxicologically verified substance use provides important information about the validity of self-reported use. While some studies report aggregate agreement across follow-up points, only a few have examined the agreement at each time point separately. An overall rate of agreement across time may miss changes that occur as people progress through a research study. In this study, a sample of 644 adults (43.8% male, 32.6% White, 57.0% Black, 90.2% ages 36+) residing in subsidized housing was used to determine the agreement between self-reported use and saliva toxicological testing for marijuana, cocaine, PCP, amphetamine, and methamphetamine at three different time points. Agreement between saliva toxicological testing and self-report ranged between 84.2% and 94.3% for different substances over time. Higher rates of agreement were found for cocaine than had been reported by previous studies. Statistically significant differences in the odds ratios of concordance over time (baseline, 6-month, and 12-month follow-up) were found for marijuana and the combined category for PCP, amphetamine, and methamphetamine. Our findings suggest that oral fluid drug tests generally withstand community field assessments and result in relatively high levels of agreement for marijuana, cocaine, PCP, amphetamine, and methamphetamine use, when compared to self-report. Because of the ease of sample collection and low chance of adulteration, we conclude that saliva testing is a viable method for toxicological confirmation of substance use behavior in this setting.

Identifying Behaviors Predicting Early Morning Emotions by Observing Permanent Supportive Housing Residents: An Ecological Momentary Assessment.

BACKGROUND: Behavior and emotions are closely intertwined. The relationship between behavior and emotions might be particularly important in populations of underserved people, such as people with physical or mental health issues. We used ecological momentary assessment (EMA) to examine the relationship between emotional state and other characteristics among people with a history of chronic homelessness who were participating in a health coaching program. OBJECTIVE: The goal of this study was to identify relationships between daily emotional states (valence and arousal) shortly after waking and behavioral variables such as physical activity, diet, social interaction, medication compliance, and tobacco usage the prior day, controlling for demographic characteristics. METHODS: Participants in m.chat, a technology-assisted health coaching program, were recruited from housing agencies in Fort Worth, Texas, United States. All participants had a history of chronic homelessness and reported at least one mental health condition. We asked a subset of participants to complete daily EMAs of emotions and other behaviors. From the circumplex model of affect, the EMA included 9 questions related to the current emotional state of the participant (happy, frustrated, sad, worried, restless, excited, calm, bored, and sluggish). The responses were used to calculate two composite scores for valence and arousal. RESULTS: Nonwhites reported higher scores for both valence and arousal, but not at a statistically significant level after correcting for multiple testing. Among momentary predictors, greater time spent in one-on-one interactions, greater time spent in physical activities, a greater number of servings of fruits and vegetables, greater time spent interacting in a one-on-one setting as well as adherence to prescribed medication the previous day were generally associated with higher scores for both valence and arousal, and statistical significance was achieved in most cases. Number of cigarettes smoked the previous day was generally associated with lower scores on both valence and arousal, although statistical significance was achieved for valence only when correcting for multiple testing. CONCLUSIONS: This study provides an important glimpse into factors that predict morning emotions among people with mental health issues and a history of chronic homelessness. Behaviors considered to be positive (eg, physical activity and consumption of fruits and vegetables) generally enhanced positive affect and restrained negative affect the following morning. The opposite was true for behaviors such as smoking, which are considered to be negative.

Promoting guideline-based cancer genetic risk assessment for hereditary breast and ovarian cancer in ethnically and geographically diverse cancer survivors: Rationale and design of a 3-arm randomized controlled trial.

BACKGROUND: Although national guidelines for cancer genetic risk assessment (CGRA) for hereditary breast and ovarian cancer (HBOC) have been available for over two decades, less than half of high-risk women have accessed these services, especially underserved minority and rural populations. Identification of high-risk individuals is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, and treatment. METHODS: This paper describes community-engaged formative research and the protocol of the ongoing randomized 3-arm controlled Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) trial. Ethnically and geographically diverse breast and ovarian cancer survivors at increased risk for hereditary cancer predisposition who have not had a CGRA are recruited through the three statewide cancer registries. The specific aims are to: 1) compare the effectiveness of a targeted intervention (TP) vs. a tailored counseling and navigation(TCN) intervention vs. usual care (UC) on CGRA utilization at 6 months post-diagnosis (primary outcome); compare the effectiveness of the interventions on genetic counseling uptake at 12 months after removal of cost barriers (secondary outcome); 2) examine potential underlying theoretical mediating and moderating mechanisms; and 3) conduct a cost evaluation to guide dissemination strategies. DISCUSSION: The ongoing GRACE trial addresses an important translational gap by developing and implementing evidence-based strategies to promote guideline-based care and reduce disparities in CGRA utilization among ethnically and geographically diverse women. If effective, these interventions have the potential to reach a large number of high-risk families and reduce disparities through broad dissemination. TRIAL REGISTRATION NUMBER: NCT03326713; clinicaltrials.gov.

Cost and cost-effectiveness of computerized vs. in-person motivational interventions in the criminal justice system.

INTRODUCTION: Although substance use is common among probationers in the United States, treatment initiation remains an ongoing problem. Among the explanations for low treatment initiation are that probationers are insufficiently motivated to seek treatment, and that probation staff have insufficient training and resources to use evidence-based strategies such as motivational interviewing. A web-based intervention based on motivational enhancement principles may address some of the challenges of initiating treatment but has not been tested to date in probation settings. The current study evaluated the cost-effectiveness of a computerized intervention, Motivational Assessment Program to Initiate Treatment (MAPIT), relative to face-to-face Motivational Interviewing (MI) and supervision as usual (SAU), delivered at the outset of probation. METHODS: The intervention took place in probation departments in two U.S. cities. The baseline sample comprised 316 participants (MAPIT = 104, MI = 103, and SAU = 109), 90% (n = 285) of whom completed the 6-month follow-up. Costs were estimated from study records and time logs kept by interventionists. The effectiveness outcome was self-reported initiation into any treatment (formal or informal) within 2 and 6 months of the baseline interview. The cost-effectiveness analysis involved assessing dominance and computing incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. Implementation costs were used in the base case of the cost-effectiveness analysis, which excludes both a hypothetical license fee to recoup development costs and startup costs. An intent-to-treat approach was taken. RESULTS: MAPIT cost $79.37 per participant, which was ~$55 lower than the MI cost of $134.27 per participant. Appointment reminders comprised a large proportion of the cost of the MAPIT and MI intervention arms. In the base case, relative to SAU, MAPIT cost $6.70 per percentage point increase in the probability of initiating treatment. If a decision-maker is willing to pay $15 or more to improve the probability of initiating treatment by 1%, estimates suggest she can be 70% confident that MAPIT is good value relative to SAU at the 2-month follow-up and 90% confident that MAPIT is good value at the 6-month follow-up. CONCLUSIONS: Web-based MAPIT may be good value compared to in-person delivered alternatives. This conclusion is qualified because the results are not robust to narrowing the outcome to initiating formal treatment only. Further work should explore ways to improve access to efficacious treatment in probation settings.

Efficacy of a Telehealth Intervention on Colonoscopy Uptake When Cost Is a Barrier: The Family CARE Cluster Randomized Controlled Trial.

BACKGROUND: We tested the efficacy of a remote tailored intervention Tele-Cancer Risk Assessment and Evaluation (TeleCARE) compared with a mailed educational brochure for improving colonoscopy uptake among at-risk relatives of colorectal cancer patients and examined subgroup differences based on participant reported cost barriers. METHODS: Family members of colorectal cancer patients who were not up-to-date with colonoscopy were randomly assigned as family units to TeleCARE (N = 232) or an educational brochure (N = 249). At the 9-month follow-up, a cost resource letter listing resources for free or reduced-cost colonoscopy was mailed to participants who had reported cost barriers and remained nonadherent. Rates of medically verified colonoscopy at the 15-month follow-up were compared on the basis of group assignment and within group stratification by cost barriers. RESULTS: In intent-to-treat analysis, 42.7% of participants in TeleCARE and 24.1% of participants in the educational brochure group had a medically verified colonoscopy [OR, 2.37; 95% confidence interval (CI) 1.59-3.52]. Cost was identified as a barrier in both groups (TeleCARE = 62.5%; educational brochure = 57.0%). When cost was not a barrier, the TeleCARE group was almost four times as likely as the comparison to have a colonoscopy (OR, 3.66; 95% CI, 1.85-7.24). The intervention was efficacious among those who reported cost barriers; the TeleCARE group was nearly twice as likely to have a colonoscopy (OR, 1.99; 95% CI, 1.12-3.52). CONCLUSIONS: TeleCARE increased colonoscopy regardless of cost barriers. IMPACT: Remote interventions may bolster screening colonoscopy regardless of cost barriers and be more efficacious when cost barriers are absent.

Motivational tools to improve probationer treatment outcomes.

BACKGROUND: Motivational interviewing (MI) is a promising practice to increase motivation, treatment retention, and reducing recidivism among offender populations. Computer-delivered interventions have grown in popularity as a way to change behaviors associated with drug and alcohol use. METHODS/DESIGN: Motivational Assistance Program to Initiate Treatment (MAPIT) is a three arm, multisite, randomized controlled trial, which examines the impact of Motivational interviewing (MI), a motivational computer program (MC), and supervision as usual (SAU) on addiction treatment initiation, engagement, and retention. Secondary outcomes include drug/alcohol use, probation progress, recidivism (i.e., criminal behavior) and HIV/AIDS testing and treatment among probationers. Participant characteristics are measured at baseline, 2, and 6 months after assignment. The entire study will include 600 offenders, with each site recruiting 300 offenders (Baltimore City, Maryland and Dallas, Texas). All participants will go through standard intake procedures for probation and participate in probation requirements as usual. After standard intake, participants will be recruited and screened for eligibility. DISCUSSION: The results of this clinical trial will fill a gap in knowledge about ways to motivate probationers to participate in addiction treatment and HIV care. This randomized clinical trial is innovative in the way it examines the use of in-person vs. technological approaches to improve probationer success. TRIAL REGISTRATION: NCT01891656.

Examining the challenges of family recruitment to behavioral intervention trials: factors associated with participation and enrollment in a multi-state colonoscopy intervention trial.

BACKGROUND: Colonoscopy is one of the most effective methods of cancer prevention and detection, particularly for individuals with familial risk. Recruitment of family members to behavioral intervention trials remains uniquely challenging, owing to the intensive process required to identify and contact them. Recruiting at-risk family members involves contacting the original cancer cases and asking them to provide information about their at-risk relatives, who must then be contacted for study enrollment. Though this recruitment strategy is common in family trials, few studies have compared influences of patient and relative participation to nonparticipation. Furthermore, although use of cancer registries to identify initial cases has increased, to our knowledge no study has examined the relationship between registries and family recruitment outcomes. METHODS: This study assessed predictors of case participation and relative enrollment in a recruitment process that utilized state cancer registries. Participation characteristics were analyzed with separate multivariable logistic regressions in three stages: (1) cancer registry-contacted colorectal cancer (CRC) cases who agreed to study contact; (2) study-contacted CRC cases who provided at-risk relative information; and (3) at-risk relatives contacted for intervention participation. RESULTS: Cancer registry source was predictive of participation for both CRC cases and relatives, though relative associations (odds ratios) varied across registries. Cases were less likely to participate if they were Hispanic or nonwhite, and were more likely to participate if they were female or younger than 50 at cancer diagnosis. At-risk relatives were more likely to participate if they were from Utah, if another family member was also participating in the study, or if they had previously had a colonoscopy. The number of eligible cases who had to be contacted to enroll one eligible relative varied widely by registry, from 7 to 81. CONCLUSIONS: Family recruitment utilizing cancer registry-identified cancer cases is feasible, but highly dependent on both the strategies and protocols of those who are recruiting and on participant characteristics such as sex, race, or geography. Devising comprehensive recruitment protocols that specifically target those less likely to enroll may help future research meet recruitment goals. TRIAL REGISTRATION: Family Colorectal Cancer Awareness and Risk Education Project NCT01274143.

Motivation-based intervention to promote colonoscopy screening: an integration of a fear management model and motivational interviewing.

Colorectal cancer (CRC) screening rates have been low despite effectiveness of screening in reducing CRC mortality. This article outlines the theoretical background and development of an innovative, telephone-based risk communication designed to promote screening among individuals at increased risk for familial CRC. This ongoing intervention integrates the Extended Parallel Process Model of fear management and the motivational interviewing counselling style. Tailoring and implementation intentions are incorporated. The primary outcome is self-reported colonoscopy within nine months following intervention. If proven effective, the remote intervention could be broadly disseminated to individuals at increased familial CRC risk, especially those in geographically underserved areas.

Reactivity to alcohol assessment measures: an experimental test.

AIMS: Previous research has suggested that alcohol screening and assessment may affect drinking. DESIGN: This study was a randomized test of reactivity to alcohol assessment questionnaires among a group of heavy drinking college students. SETTING AND PARTICIPANTS: A total of 147 university students completed a screening questionnaire and were randomized to either immediate assessment or delayed assessment. The immediate assessment group completed a set of drinking questionnaires at baseline, 3, 6 and 12 months, while the delayed assessment group completed questionnaires only at 12 months. MEASUREMENTS: Primary outcomes included overall volume of drinking, risky drinking and use of risk reduction behaviors. FINDINGS: We found a significant effect of assessment on measures of risky drinking and risk reduction behaviors, but not on overall volume of drinking. Specifically, at 12 months, participants who had previously completed drinking assessments had a lower peak blood alcohol concentration (BAC) (d = -0.373), were more likely to report a low score on the Alcohol Use Disorders Identification Test (AUDIT; odds ratio = 2.55) and tended to use more strategies to moderate their alcohol consumption (d = 0.352). Risk reduction behaviors that were affected tended to be those that limited alcohol consumption, rather than those that minimized consequences. CONCLUSIONS: These results may have implications for the development of brief interventions.