Recruiting an underserved, difficult to reach population into a cancer trial: Strategies from the Restore-2 Rehabilitation Trial for gay and bisexual prostate cancer patients.

BACKGROUND/AIMS: Sexual minorities are small and under-researched populations that are at disproportionate risk for cancer and poor cancer outcomes. Described as a "hidden population," the principal research challenge has been to develop effective methods to identify and recruit such cancer patients into cancer studies. Online recruitment strategies, as well as targeted clinic recruitment using patient-entered sexual orientation and gender identity data from electronic medical records have potential to transform recruitment, but studies testing the effects of how to recruit using these have not been published. METHODS: In 2019, we conducted a naturalistic, three-arm, stratified prospective study to compare three recruitment strategies: (a) clinic based recruitment of prostate cancer patients from gay health and urology clinics; (b) directly from the gay community; and (c) online recruitment (through cancer support, sex/dating, and social sites). For each strategy, we estimated time, workload, and direct costs involved. To study how recruitment strategy may affect sampling, we tested for retention rates, demographic and outcome differences across sites. Using these methods, we successfully recruited 401 gay and bisexual prostate cancer patients into a randomized, controlled, 24-month trial testing an online sexual and urinary rehabilitation curriculum tailored for this population. RESULTS: There were seven key results. First, it is possible to recruit substantial numbers of sexual minority men into prostate cancer studies provided online recruitment methods are used. Second, we observed big differences in dropout during study onboarding by recruitment source. Third, within online recruitment, the online sex/dating application (app) was the most successful and efficient, followed by the cancer support site, and then the social networking site. Fourth, while clinics were the cheapest source of recruitment, they were time intensive and low in yield. Fifth, the cancer support site and sex/dating app recruits differed by several characteristics, with the former being more rehabilitation-focused while the latter were younger and more sexually active. Sixth, we found almost no differences in outcomes across the three online recruitment sites. Seventh, because retention in online studies has been a concern, we confirm very low attrition at 3- and 6 months into the trial. CONCLUSION: For sexual minority cancer research, more research on how to use sexual orientation and gender identity electronic medical record data for clinic-based recruitment is needed. For other small or hard-to-reach populations, researchers should compare and publish online versus offline recruitment strategies.

The Sexual Functioning of Gay and Bisexual Men Following Prostate Cancer Treatment: Results from the Restore Study.

Prostate cancer is the second most common cancer in gay, bisexual, and other men who have sex with men (GBM). Few studies have assessed the effects of treatment on GBM's sexual behavior. For an online survey, 193 gay and bisexual men with prostate cancer were recruited from the North American's largest online cancer support group. Sexual functioning was measured using the Expanded Prostate Cancer Index Composite (EPIC) and a tailored Gay Sexual Functioning Inventory (GSFI). GBM have worse EPIC urinary and hormonal function and worse hormonal bother, but better sexual function and bother scores than published norms. In the GSFI, two-thirds of participants described their sexual functioning, post-treatment, as fair to poor. Only 22% reported erections sufficient for insertive anal sex. For receptive anal sex, one-third met criteria for anodyspareunia. Over half reported urination problems during sex or at orgasm. Erectile difficulties were common, severe, and a reason cited for not using condoms. Three men HIV seroconverted post-prostate cancer treatment. Differences in function and bother scores were observed by type of treatment, age, race/ethnicity, sexual orientation, but not relationship status. Sexual functioning significantly predicted long-term mental and physical health. GBM scored significantly worse on mental health and better on physical health than published norms. Sexual recovery after prostate cancer treatment is problematic for most GBM. Research to develop more effective sexual recovery, tailored to the needs of GBM treated for prostate cancer, is needed. Six implications for clinicians treating GBM with prostate cancer are identified.

What Gay and Bisexual Men Treated for Prostate Cancer Want in a Sexual Rehabilitation Program: Results of the Restore Needs Assessment.

Introduction: While erectile dysfunction and urinary incontinence are well-documented effects of prostate cancer treatment, the impact of sexual concerns on the lives of gay and bisexual men treated for prostate cancer has not been well researched. Specifically there are no known studies investigating what gay and bisexual men want in sexual recovery treatment. Methods: To conduct this needs assessment, we recruited 193 gay and bisexual men with prostate cancer from the largest online cancer support group in North America. As part of a wider study of sexual functioning, participants completed a 32-item needs assessment and a qualitative question assessing their needs. Results: There was high interest in a sexual recovery program across race/ethnicity and by treatment type. The most preferred formats were a self-directed online curriculum and participation in a support group specific to gay and bisexual men with prostate cancer. A variety of formats, language and contents were deemed appropriate and important by most participants. Frank explicit language and content were preferred. Three themes emerged in the qualitative analysis. Conclusions: Gay and bisexual men treated for prostate cancer want a recovery curriculum that explicitly addresses the sexual challenges they face before, during and after treatment. While differences were identified across race and treatment type, they were relatively few and minor in magnitude, suggesting that a single online curriculum could advance rehabilitation for this population.

What Gay and Bisexual Men Treated for Prostate Cancer Are Offered and Attempt as Sexual Rehabilitation for Prostate Cancer: Results from the Restore Study.

Introduction: This is the first known study to investigate what gay and bisexual men are offered and what they try as rehabilitation to address the sexual and urinary effects of prostate cancer treatment. Methods: A total of 193 gay and bisexual men with prostate cancer were recruited from a large male cancer survivor support and advocacy website. Online participants completed survey questions asking what rehabilitation treatments were offered, what they tried and what their satisfaction was with outcomes. Results: Most participants (68.4%) reported being out as gay/bisexual to at least 1 cancer specialist. Only 8.8% reported that a sexual history was taken. The most common problems reported were loss of ejaculate (93.8%), erectile difficulties (89.6%), change in sense of orgasm (87.0%), loss of sexual confidence (76.7%), changes to the penis (65.8%), increased pain in receptive anal sex (64.8%), urinary incontinence not related to sex (64.2%) and urinary incontinence during sex (49.2%). Of these factors only loss of ejaculate, erectile difficulties and nonsexual urinary problems were commonly discussed by clinicians during prostate cancer treatment. Satisfaction with specific rehabilitation options varied widely. Conclusions: Treatment for prostate cancer lacks adequate history taking and consensus around rehabilitation practices, resulting in idiosyncratic approaches to rehabilitation. Four clinical questions may improve outcomes. Prostate cancer specialists need education to become culturally competent in addressing the unique needs of gay and bisexual patients.

The effects of gay sexually explicit media on the HIV risk behavior of men who have sex with men.

This study sought to study consumption patterns of gay-oriented sexually explicit media (SEM) by men who have sex with men (MSM); and to investigate a hypothesized relationship between gay SEM consumption and HIV risk behavior. Participants were 1,391 MSM living in the US, recruited online to complete a SEM consumption and sexual risk survey. Almost all (98.5 %) reported some gay SEM exposure over the last 90 days. While 41 % reported a preference to watch actors perform anal sex without condoms (termed "bareback SEM"), 17 % preferred to actors perform anal sex with condoms (termed "safer sex SEM") and 42 % reported no preference. Overall SEM consumption was not associated with HIV risk; however participants who watched more bareback SEM reported significantly greater odds of engaging in risk behavior. The results suggest that a preference for bareback SEM is associated with engaging in risk behavior. More research to understand how MSM develop and maintain preferences in viewing SEM, and to identify new ways to use SEM in HIV prevention, is recommended.

The Emergency Public Relations Protocol: How to Work Effectively on Controversial Projects in an Academic Health Setting.

Certain research topics - including studies of sexual behavior, substance use, and HIV risk -- are more likely to be scrutinized by the media and groups opposed to this area of research. When studying topics that others might deem controversial, it is critical that researchers anticipate potential negative media events prior to their occurrence. By developing an Emergency Public Relations Protocol at the genesis of a study, researchers can identify and plan for events that might result in higher scrutiny. For each identified risk, a good protocol details procedures to enact before, during and after a media event. This manuscript offers recommendations for developing a protocol based on both Situational Crisis Communication Theory and our experience as an HIV prevention research group who recently experienced such an event. The need to have procedures in place to monitor and address social media is highlighted.

Recruiting gay alcohol establishments for studies: lessons learned from the SILAS study.

We contacted gay bar/club managers in 16 metropolitan statistical areas (MSAs) in the US from 2008 to 2010 and invited them to participate in survey of gay bar/club identification and patronage. The annual response rates were 58%, 74%, and 71%, respectively. We convened two, 1-hr meetings with research staff to discuss lessons learned from recruitment efforts. Data were analyzed using qualitative techniques. Improved response rates appeared to be a function of developing a broader definition of gay bar/club, using multiple sources to identify gay bars/clubs, using passive data collection strategies with active follow-up, and offering multiple methods of completing surveys. Study limitations are discussed.

Can we assess blood alcohol levels of attendees leaving professional sporting events?

BACKGROUND: We measured blood alcohol content (BAC) levels of attendees at professional sporting events and assessed the factors associated with higher BACs. METHODS: We conducted BAC tests of 362 adult attendees following 13 baseball games and three football games. We ran multivariate analyses to obtain factors associated with the risk of having a higher BAC. RESULTS: In this assessment, 40% of the participants had a positive BAC, ranging from 0.005 to 0.217. Those who reported tailgating before the event had 14 times the odds of having a BAC > 0.08 and those under age 35 had nearly 8 times the odds of having a BAC > 0.08 (both compared to a zero BAC). Attendees of Monday night football games were more likely to have positive BACs compared to attendees at all other games. CONCLUSIONS: We found that it is feasible to assess BAC levels of attendees at professional sporting events. Our findings suggest that a significant number of attendees at professional sporting events may have elevated BAC levels, particularly young adults and those who participated in tailgating activities. Further research using a representative sample is warranted to confirm the findings from this preliminary study.

Alcohol control policies and practices at professional sports stadiums.

OBJECTIVE: Alcohol-related problems such as assaults and drinking-driving at or near professional sporting events are commonly reported in the media. An important strategy to reduce such problems may be the use of alcohol control policies at sports stadiums. The objective of this study was to examine alcohol control policies and practices at professional sports stadiums in the U.S. METHODS: We conducted a telephone survey of food/beverage managers from 66 of the 100 U.S professional sports stadiums that house a professional hockey, basketball, baseball, and/or football team. The survey consisted of 18 items pertaining to policies regulating alcohol sales and consumption. RESULTS: Most managers indicated that their stadium had a range of alcohol control policies and practices. For example, all or nearly all reported their stadium allows no more than two alcoholic beverages per sale and their alcohol servers are required to check age identification of patrons who appear younger than age 30. In contrast, only about half prohibit servers younger than 21 years of age from selling alcohol both in seating areas and at concession booths, and approximately one-third designate sections of their stadiums as alcohol-free. CONCLUSIONS: Although we found that some alcohol control policies appear to be common across stadiums, others are uncommon, leaving room for potential areas of improvement in reducing or preventing alcohol-related problems at professional sporting events. The results provide an important starting point for identifying policies that can be evaluated to determine their effectiveness in reducing alcohol-related injuries and deaths at sporting events.

Methods for recruiting men of color who have sex with men in prevention-for-positives interventions.

Men who have sex with men (MSM), especially MSM of color, are disproportionately impacted by HIV/AIDS compared to heterosexuals and Caucasians. Nonetheless, fewer sexual and ethnic minorities participate in prevention interventions for people with HIV. We consider recruitment for Positive Connections, a randomized controlled trial comparing unsafe sex prevention interventions primarily for HIV-positive (HIV+) MSM in six US epicenters. One community-based organization (CBO) in each city recruited adult MSM, particularly men of color and HIV+. Recruitment methods included on-line and print advertising, outreach events, health professionals, and social networks. Data on demographics, HIV status, and recruitment method were collected at registration. We tested for differences in registration proportions and attendance rates by recruitment strategy, stratified on race/ethnicity and serostatus. Of the 1,119 registrants, 889 attended the intervention. The sample comprised 41% African American, 18% Latino/Hispanic, and 77% HIV+. Friend referral was reported by the greatest proportion of registrants, particularly among African American (33%) and HIV+ men (25%). Print advertising yielded the largest proportions of non-Hispanic white (27%) and HIV-negative registrants (25%). Registrants recruited on-line were the least likely to attend (45% versus 69% average); this effect was strongest among Latino/Hispanic (27% attendance) and non-Hispanic white men (36%). Retention during the follow-up period did not differ by serostatus, race/ethnicity, or recruitment method. Differential attendance and retention according to recruitment strategy, serostatus, and racial/ethnic group can inform planning for intervention sample size goals.

Likelihood of illegal alcohol sales at professional sport stadiums.

BACKGROUND: Several studies have assessed the propensity for illegal alcohol sales at licensed alcohol establishments and community festivals, but no previous studies examined the propensity for these sales at professional sport stadiums. In this study, we assessed the likelihood of alcohol sales to both underage youth and obviously intoxicated patrons at professional sports stadiums across the United States, and assessed the factors related to likelihood of both types of alcohol sales. METHODS: We conducted pseudo-underage (i.e., persons age 21 or older who appear under 21) and pseudo-intoxicated (i.e., persons feigning intoxication) alcohol purchase attempts at stadiums that house professional hockey, basketball, baseball, and football teams. We conducted the purchase attempts at 16 sport stadiums located in 5 states. We measured 2 outcome variables: pseudo-underage sale (yes, no) and pseudo-intoxicated sale (yes, no), and 3 types of independent variables: (1) seller characteristics, (2) purchase attempt characteristics, and (3) event characteristics. Following univariate and bivariate analyses, we a separate series of logistic generalized mixed regression models for each outcome variable. RESULTS: The overall sales rates to the pseudo-underage and pseudo-intoxicated buyers were 18% and 74%, respectively. In the multivariate logistic analyses, we found that the odds of a sale to a pseudo-underage buyer in the stands was 2.9 as large as the odds of a sale at the concession booths (30% vs. 13%; p = 0.01). The odds of a sale to an obviously intoxicated buyer in the stands was 2.9 as large as the odds of a sale at the concession booths (89% vs. 73%; p = 0.02). CONCLUSIONS: Similar to studies assessing illegal alcohol sales at licensed alcohol establishments and community festivals, findings from this study shows the need for interventions specifically focused on illegal alcohol sales at professional sporting events.

A randomized trial to evaluate a management training program to prevent illegal alcohol sales.

AIMS: To evaluate effects of a training program for owners/managers of alcohol establishments-Alcohol Risk Management (ARM)-on: (i) propensity to sell alcohol to obviously intoxicated patrons; and (ii) changing establishment-level policies/practices. DESIGN: We assigned alcohol establishments randomly to intervention (full-ARM) and delayed-intervention/control (ARM Express) conditions. SETTING: One large metropolitan area in Midwestern United States. PARTICIPANTS: Owners and managers at 231 on-premise alcohol establishments (i.e. bars, restaurants). INTERVENTION: Training programs consisted of one-to-one sessions with the owner/manager at each establishment. The goal of training was to help owners/managers to select and implement alcohol control policies in their establishments. The full-ARM training consisted of four one-to-one sessions and the ARM Express was a single session. MEASUREMENTS: We measured intervention effects through baseline and follow-up pseudo-intoxicated alcohol purchase attempts (i.e. feigning intoxication while attempting to purchase alcohol) and telephone surveys of owners/managers at alcohol establishments. FINDINGS: Sales rates to pseudo-intoxicated patrons reduced 23% (relative to delayed-intervention/control condition) at the first follow-up purchase attempt (P = 0.06) but returned to baseline levels 3 months later. On average, establishments selected 13 of 18 recommended policies, but in multivariate models we observed no significant differences at follow-up in reported policies/practices across establishments. CONCLUSIONS: Reliance on manager training to promote responsible establishment alcohol policies is not sufficient to prevent illegal alcohol sales to obviously intoxicated patrons and to reduce alcohol-related problems.