Optimizing enrollment methods: Lessons learned from an mHealth, pilot HIV prevention randomized controlled trial with sexual minority men

2019 ◽  
Vol 30 (7) ◽  
pp. 703-706 ◽  
Author(s):  
Jason W Mitchell ◽  
Sara Lammert ◽  
Thu Danh ◽  
Keith J Horvath

Using data from eligible participants, we evaluated procedures of a multi-step enrollment process for an mHealth, pilot randomized controlled trial aimed to promote regular HIV testing among at-risk, diverse sexual minority men. Completion rates of eligible participants were calculated and characterized for these enrollment procedures. Among 3058 men who screened, 183 were eligible and 113 enrolled. Two groups emerged: “As planned” (n = 98) followed enrollment directions as designed; “Laggers” (n = 15) did not follow these directions and required additional efforts resulting in mixed results for improving enrollment. Findings suggest the need for pre-determined enrollment decision rules based on available resources.

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 811-811
Author(s):  
Jennifer Deal ◽  
Nicholas Reed ◽  
David Couper ◽  
Kathleen Hayden ◽  
Thomas Mosley ◽  
...  

Abstract Hearing impairment in older adults is linked to accelerated cognitive decline and a 94% increased risk of incident dementia in population-based observational studies. Whether hearing treatment can delay cognitive decline is unknown but could have substantial clinical and public health impact. The NIH-funded ACHIEVE randomized controlled trial of 977 older adults aged 70-84 years with untreated mild-to-moderate hearing loss, is testing the efficacy of hearing treatment versus health education on cognitive decline over 3 years in community-dwelling older adults (Clinicaltrials.gov Identifier: NCT03243422.) This presentation will describe lessons learned from ACHIEVE’s unique study design. ACHIEVE is nested within a large, well-characterized multicenter observational study, the Atherosclerosis Risk in Communities Study. Such nesting within an observational study maximizes both operational and scientific efficiency. With trial results expected in 2022, this presentation will focus on the benefits gained in design and recruitment/retention, including dedicated study staff, well-established protocols, and established study staff-participant relationships. Part of a symposium sponsored by Sensory Health Interest Group.


2007 ◽  
Vol 84 (1) ◽  
pp. 103-108 ◽  
Author(s):  
Richard P. Whitlock ◽  
Mark A. Crowther ◽  
Theodore E. Warkentin ◽  
Mary-Helen Blackall ◽  
Forough Farrokhyar ◽  
...  

2019 ◽  
Vol 22 (9) ◽  
pp. 1596-1604
Author(s):  
Jaimee L Heffner ◽  
Kristin E Mull ◽  
Noreen L Watson ◽  
Jennifer B McClure ◽  
Jonathan B Bricker

Abstract Introduction Despite greater smoking prevalence among sexual minority (SM) individuals relative to non-SM individuals, minimal research has examined whether SM smokers have differential success at quitting, and no prior treatment studies have examined differences within SM subgroups. There is also limited knowledge of the psychosocial characteristics of treatment-seeking SM smokers, which could inform targeted treatments. To address these gaps, we compared treatment outcomes and baseline characteristics for SM and non-SM smokers and for bisexual versus lesbian or gay smokers in a large randomized controlled trial of two web-based cessation treatments. Methods Trial participants completed a survey to assess baseline characteristics, including self-identification as either SM (n = 253; lesbian or gay, n = 122; bisexual, n = 131) or non-SM (n = 2384). The primary cessation outcome was complete-case, self-reported 30-day abstinence at 12 months after randomization. Results Cessation outcomes did not differ significantly for SM versus non-SM smokers (24% vs. 25%, adjusted OR = 0.91, 95% CI = 0.65 to 1.28) or across SM subgroups (24% for bisexual vs. 23% for lesbian or gay, adjusted OR = 1.01, 95% CI = 0.51 to 2.00), and there were no interactions with treatment group assignment. At baseline, SM smokers differed from non-SM smokers on most demographics, were more likely to screen positive for all mental health conditions assessed, and had greater exposure to other smokers in the home. Conclusions Substantial differences in baseline characteristics of SM versus non-SM smokers and bisexual versus lesbian or gay smokers did not translate into differential treatment outcomes. Nonetheless, SM smokers’ willingness or ability to quit smoking could be enhanced by taking their unique psychosocial profile into account when designing targeted interventions. Implications The findings of this study, which included the largest sample of SM smokers in a prospective intervention trial to date, support those of a small extant body of literature showing no differences in treatment-assisted cessation outcomes between SM and non-SM smokers. Regardless of their quit rates relative to non-SM smokers, SM smokers’ willingness or ability to quit smoking could potentially be enhanced by taking their unique psychosocial profile into account in intervention design, including their younger age, lower socioeconomic status, greater likelihood of being racial or ethnic minorities, and greater prevalence of mental health symptoms.


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