Between June 2011 and September 2011, 226 men were referred to the study through the community research collaborative; 112 (49.5%) of these men contacted the study. Between June 2010 and September 2011, 96 men were referred to the study through study brochures or word-of-mouth. In total, 208 men contacted the study and were screened for eligibility; eight men were ineligible and 200 men enrolled in the study ().
Flow diagram of study participants.
One hundred men were randomized to receive a home CT/GC screening kit and 100 men were scheduled for an in-person clinic visit to complete the CT/GC screening kit. There were no significant differences in baseline demographic and behavioral characteristics between the two groups (Table 1). The mean age among men in the home and clinic groups was 31.2 and 30.3 years, respectively. The majority of participants were single at the time of enrollment (59% for home group and 61% for clinic group). Half of participants reported their current educational attainment as “high school or less” (57% for home group and 44% for clinic group). One in five men reported two or more sexual partners in the past 30 days, and one in four reported never using condoms during sex. Nearly 40% of participants reported a lifetime history of sexually transmitted infections, of which 19% reported having the infection within the past six months.
Overall, 60% (n=120) of participants completed STD screening, regardless of group assignment (Table 2). Men were more likely to complete the screening kit if they were younger, white, had a college or graduate degree, or were assigned to receive a home kit (p<0.01). In multivariate analysis, men assigned a home kit were 60% more likely to complete screening compared to men assigned to clinic screening [adjusted relative risk (RRadj)= 1.59; 95% confidence interval (CI) 1.26, 2.00]. Screening kit completion was also associated with age (RRadj=0.98; 95% CI 0.96, 0.99]) and white race (RRadj=1.46; 95% CI 1.16, 1.84]).
Among men randomized to home-based screening, 72% completed screening and 28% did not complete screening. There were no differences in baseline demographics or behavioral characteristics between the groups that did and did not complete screening. Among men randomized to clinic-based screening, 48% completed screening and 52% did not complete screening. Men were less likely to complete clinic-based screening if they were older, black, less educated, or uninsured (Table 2).
Among the men who completed an STD screening kit, we identified four cases (3.3%) of CT and three cases (2.5%) of GC. There were three cases of GC and one case of CT in the home-based screening group compared to three cases of CT in the clinic-based screening group. Men who screened positive for CT (mean age=27 years, SD=8.0) and GC (mean age=22 years, SD=2.0) were significantly younger than other participants. All seven participants with positive screening results were treated for their infections at the study clinic.
Of the participants who completed the follow-up questionnaire (N=129 or 64.5%), 65 men were in the clinic-based screening group and 64 men were in the home-based screening group. Eighty percent of these men completed the assigned screening kit. Of those who completed the follow-up questionnaire, over 80% of men reported being “very satisfied” with their assigned screening method and thought the screening process was “very convenient;” 99% of respondents stated that they would recommend their assigned screening method to their male friends. For those assigned to clinic-based screening, 79% believed it would be “very easy” to use a urine screening kit at home. For those assigned to home-based STD screening, 95% stated it was “very easy” to follow the screening kit instructions. The number one reason men reported for completing the STD screen was the convenience of the screening kit (Table 3). Conversely, the most common reason that would prevent them from STD screening in the future is lack of health insurance (Table 3). Over 75% of men believed they were “not at all likely” to become infected with an STD in the next 6 months.