Discussion
This cluster randomized trial did not provide sufficient evidence that targeted demand creation strategies for men aged 25–39 years were effective at significantly increasing the odds of VMMC uptake among men aged 25–39 years in the Nyanza Region of western Kenya. Overall VMMC uptake across each of the four study arms ranged from 3.2%– 4.5%. It is likely that the DSO and IPC + DSO arms had some effect, but the smaller than expected sample size prevented the detection of these effects. Based on the original sample size calculations, we estimated that 1,480 men in intervention arms and 370 in the standard of care arm would be needed to provide 80% power to detect any intervention effect. Only 109 men of the expected 1,850 men underwent VMMC. Due to higher VMMC prevalence than anticipated in study Locations, only 2,792 participants were enrolled for the study, as many men were circumcised and therefore ineligible (n = 2,847). Logistical challenges and funding limitations prevented the study team from expanding the study scope to increase the number of enrolled participants and study power.While mathematical modeling has suggested that circumcising men aged 20–34 years in several VMMC priority countries in sub-Saharan Africa would result in a more immediate reduction in HIV incidence [VMMC has been successful in Kenya in the non-traditionally circumcising communities in the former Nyanza Province with over 1.1 million males circumcised by 2016, which represents 132% of the initial target set in 2011 [Kenya is also a leader in the scale-up of VMMC for HIV prevention, as Kenya’s Ministry of Health first launched VMMC services in 2008 following development of the National Guidance on Male Circumcision and Kenya National Strategy for Voluntary Medical Male Circumcision [The low uptake of VMMC across all study arms suggests that men aged 25–39 years were likely not adequately encouraged to pursue VMMC. One recent study about post-operative follow-up in former Nyanza Province found that 98.8% of VMMC clients who returned for post-operative follow-up lived within 5km of a VMMC site, and men living farther than 5km were significantly less likely to attend VMMC post-operative follow-up visits [Another VMMC demand creation trial took place in Nyanza Region for uncircumcised men aged 25–49 years offered food vouchers of varying amounts conditional on getting circumcised [Our trial had several limitations. Firstly, two of the intervention arms showed some increased VMMC uptake, but the low sample size did not allow us to detect these effects, thus potentially large effects cannot be ruled out. Secondly, the short time of the observation (three months) may have limited the period for men, the majority of whom were employed hence needed permission to be away, to become circumcised in each of the study arms. Thirdly, some men who received circumcision may have been in the study, but RAs were unable to verify their enrollment or to find them at home to document circumcision status. And finally, participants in all four study arms received a text message reminder about VMMC, so the differential impact of this component is unknown.In conclusion, our study showed that due to low service uptake across all study arms, enhanced interpersonal communication and modified facilities did not significantly increase VMMC uptake among men aged 25–39 years in Nyanza Region, Kenya. Additional demand creation strategies need to be designed and evaluated to determine how best to encourage older men to seek VMMC for HIV prevention, especially in settings with mature VMMC programs. HIV prevention programs should explore whether men aged 20–39 years in Nyanza Region are not interested in VMMC regardless of the intervention types, and if males aged 10–19 years should be the focus of the limited HIV prevention resources.