HIV Testing With and Without a Clinical Consultation Among Men Who Have Sex With Men: A Randomized Controlled Trial.

Background: Increasing the frequency of HIV testing among men who have sex with men (MSM) maximizes the preventive effect of antiretroviral therapy, by reducing time to diagnosis and treatment.
Setting: Melbourne Sexual Health Centre, Australia.
Methods: This randomized controlled trial evaluated whether access to testing, without seeing a clinician would increase testing frequency. MSM attending for HIV testing between July 2014 and April 2015 were randomized in 1:1 ratio to the intervention arm (access to HIV and syphilis testing at 300 pathology centers, without requiring consultations) or the control arm (consultation at every test), without blinding. The primary outcome was the incidence of HIV testing over 12 months.
Results: Of 443 men referred, 422 were randomized, 3 HIV positives at baseline were excluded, and 419 were analyzed. Of 208 control, 202 (97.1%) and 200 (94.8%) of 211 intervention group members were followed to 12 months. The intervention group had 453 tests in 205.6 person-years, incidence rate was 2.2 (95% confidence interval [CI]: 2.0 to 2.4) tests per year. The control group had 432 tests during 204.0 person-years, incidence rate was 2.1 (95% CI: 1.9 to 2.3) tests per year, and incidence rate ratio was 1.04 (95% CI: 0.89 to 1.2; P = 0.63). The annual rate of consultations was as follows: intervention, 1.61 (95% CI: 1.44 to 1.79); controls, 2.12 (95% CI: 1.92 to 2.33); rate ratio, 0.76 (95% CI: 0.65 to 0.88; P = 0.0001). There was no difference in quality of life scores (P = 0.61).
Conclusions: MSM permitted HIV and syphilis testing outside of clinical consultations did not test more frequently than controls but had 24% fewer consultations, reducing service demand.
Trial Registration: ACTRN12614000760673.