Strategies to increase uptake of voluntary medical male circumcision among men aged 25-39 years in Nyanza Region, Kenya: Results from a cluster randomized controlled trial (the TASCO study).

INTRODUCTION: Voluntary medical male circumcision (VMMC) for HIV prevention began in Nyanza Region, Kenya in 2008. By 2014, approximately 800,000 VMMCs had been conducted, and 84.9% were among males aged 15-24 years. We evaluated the impact of interpersonal communication (IPC) and dedicated service outlets (DSO) on VMMC uptake among men aged 25-39 years in Nyanza Region. MATERIALS AND METHODS: We conducted a cluster randomized controlled trial in 45 administrative Locations (clusters) in Nyanza Region between May 2014 and June 2016 among uncircumcised men aged 25-34 years. In arm one, an IPC toolkit was used to address barriers to VMMC. In the second arm, men were referred to DSO that were modified to address their preferences. Arm three combined the IPC and DSO arms, and arm four was standard of care (SOC). Randomization was done at Location level (11-12 per arm). The primary outcome was the proportion of enrolled men who received VMMC within three months. Generalized estimating equations were used to evaluate the effect of interventions on the outcome. RESULTS: At baseline, 9,238 households with men aged 25-39 years were enumerated, 9,679 men were assessed, and 2,792 (28.8%) were eligible. For enrollment, 577 enrolled in the IPC arm, 825 in DSO, 723 in combined IPC + DSO, and 667 in SOC. VMMC uptake among men in the SOC arm was 3.2%. In IPC, DSO, and combined IPC + DSO arms, uptake was 3.3%, 4.5%, and 4.4%, respectively. The adjusted odds ratio (aOR) of VMMC uptake in the study arms compared to SOC were IPC aOR = 1.03; 95% CI: 0.50-2.13, DSO aOR = 1.31; 95% CI: 0.67-2.57, and IPC + DSO combined aOR = 1.31, 95% CI: 0.65-2.67. DISCUSSION: Using these interventions among men aged 25-39 years did not significantly impact VMMC uptake. These findings suggest that alternative demand creation strategies for VMMC services are needed to reach men aged 25-39 years. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT02497989.

Testing a social network approach to promote HIV self-testing and linkage to care among fishermen at Lake Victoria: study protocol for the Owete cluster randomized controlled trial.

BACKGROUND: Nearly 50% of men living with HIV in many countries are unaware of their HIV status; men also have lower uptake of HIV treatment and pre-exposure prophylaxis (PrEP). In SSA, highly mobile men such as those working in fishing communities alongside Lake Victoria have low uptake of HIV testing and low rates of linkage to HIV treatment and PrEP, despite increasing availability of these services. HIV self-testing (HIVST) kits hold promise for overcoming barriers to HIV testing and linkage to services for HIV-positive and HIV-negative men. We describe here a protocol for an HIV status-neutral, social network-based approach to promote HIV testing, linkage to care and prevention, and better health outcomes, including adherence, in fishermen around Lake Victoria. METHODS: Utilizing beach management unit (BMU) registries of fishermen operating in three Lake Victoria fishing communities in Siaya County, Kenya, we completed a census and social network mapping to identify close social networks of men. Network clusters identified by a socially-central lead ("promotor") and selected to ensure maximal separation between treatment and control will be randomized. Promotors in both arms will receive basic HIV training; intervention promotors are further trained in HIVST to distribute kits to their cluster, while control promotors will distribute to their cluster vouchers for free HIVST at nearby clinics. We will test whether these promoters can enhance linkage to ART and PrEP after self-testing, thereby addressing a key limitation of HIVST. We will also measure 6- and 12-month viral load in those living with HIV and PrEP adherence among those without HIV via urine tenofovir levels as objective markers of adherence. DISCUSSION: This study has the potential to improve HIV health and promote HIV prevention among a hard to reach, at-risk, and highly mobile population of men in Western Kenya-a critical population in Kenya's HIV prevention and treatment program. Further, if successful, this innovative social networks-based model could be scaled at the regional level to address HIV prevention and care among similarly at-risk populations of men in eastern Africa and inland fisheries settings across the continent. TRIAL REGISTRATION: Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men, registered on February 26, 2021, registration # NCT04772469 .

Adult male circumcision outcomes: experience in a developing country setting.

INTRODUCTION: We examined male circumcision outcomes among young adults in an African setting. MATERIALS AND METHODS: Participants were healthy, sexually active, uncircumcised, HIV-seronegative males aged 18-24 years. The main outcomes measured included complications, healing, satisfaction and resumption of activities. RESULTS: Of 1,475 procedures, 26 (1.8%) were associated with 27 adverse events, most commonly wound disruption/delayed healing (0.6%), wound infection (0.4%), and bleeding (0.3%). Adverse events per clinician averaged 3.8 and 2.1% for procedures 1-100 and 101-200, respectively, and <1% for procedures 201-300, 301-400 and >400, respectively (p < 0.001). Participants resumed normal general activities after a median of 1 postoperative day and 93% with regular employment resumed working within 1 week. After 30 days, 99% of participants reported being very satisfied. After 90 days, 65% reported having had sex, 45% reported that their partners had expressed an opinion, 92% of whom were very satisfied with the outcome. CONCLUSIONS: Safe and acceptable adult male circumcision services can be delivered in developing country settings.

Adult male circumcision: results of a standardized procedure in Kisumu District, Kenya.

OBJECTIVE: To develop a standard procedure for male circumcision in a resource-poor medical setting and prospectively evaluate the outcome in a randomized, controlled trial with the incidence of human immunodeficiency virus (HIV) as the main outcome, as studies suggest that circumcision is associated with a lower incidence of HIV and other sexually transmitted infections in high-risk populations. SUBJECTS AND METHODS: Healthy, uncircumcised, HIV-seronegative men aged 18-24 years from Kisumu District, Kenya, were offered participation in a clinical trial using a standard circumcision procedure based on "usual" medical procedures in Western Kenya. The follow-up included visits at 3, 8 and 30 days after circumcision, with additional visits if necessary. Healing, satisfaction and resumption of activities were assessed at these visits and 3 months from randomization. RESULTS: Overall, 17 (3.5%) of the 479 circumcisions were associated with adverse events judged definitely, probably or possibly related to the procedure. The most common adverse events were wound infections (1.3%), bleeding (0.8%), and delayed wound healing or suture line disruption (0.8%). After 30 days, 99% of participants reported being very satisfied with the procedure; approximately 23% reported having had sex and 15% reported that their partners had expressed an opinion, all of whom were very satisfied with the outcome. About 96% of the men resumed normal general activities within the first week after the procedure. CONCLUSION: Safe and acceptable adult male circumcision services can be delivered in developing countries should male circumcision ultimately be advocated as a public-health measure.