ShangRing versus Mogen clamp for early infant male circumcision in eastern sub-Saharan Africa: a multicentre, non-inferiority, adaptive, randomised controlled trial.

BACKGROUND: Use of medical devices represents a unique opportunity to facilitate scale-up of early infant male circumcision (EIMC) across sub-Saharan Africa. The ShangRing, a circumcision device prequalified by WHO, is approved for use in adults and adolescents and requires topical anaesthesia only. We aimed to investigate the safety and efficacy of the ShangRing versus the Mogen clamp for EIMC in infants across eastern sub-Saharan Africa. METHODS: In this multicentre, non-inferiority, open-label, randomised controlled trial, we enrolled healthy male infants (aged <60 days), with a gestational age of at least 37 weeks and a birthweight of at least 2·5 kg, from 11 community and referral centres in Kenya, Tanzania, and Uganda. Infants were randomly assigned (1:1) by a computer-generated text message service to undergo EIMC by either the ShangRing or the Mogen clamp. The primary endpoint was safety, defined as the number and severity of adverse events (AEs), analysed in the intention-to-treat population (all infants who underwent an EIMC procedure) with a non-inferiority margin of 2% for the difference in moderate and severe AEs. This trial is registered with Clinical. TRIALS: gov, NCT03338699, and is complete. FINDINGS: Between Sept 17, 2018, and Dec 20, 2019, a total of 1420 infants were assessed for eligibility, of whom 1378 (97·0%) were enrolled. 689 (50·0%) infants were randomly assigned to undergo EIMC by ShangRing and 689 (50·0%) by Mogen clamp. 43 (6·2%) adverse events were observed in the ShangRing group and 61 (8·9%) in the Mogen clamp group (p=0·078). The most common treatment-related AE was intraoperative pain (Neonatal Infant Pain Scale score ≥5), with 19 (2·8%) events in the ShangRing and 23 (3·3%) in the Mogel clamp group. Rates of moderate and severe AEs were similar between both groups (29 [4·2%] in the ShangRing group vs 30 [4·4%] in the Mogen clamp group; difference -0·1%; one-sided 95% CI upper limit of 1·7%; p=0·89). No treatment-related deaths were reported. INTERPRETATION: Use of the ShangRing device for EIMC showed safety, achieved high caregiver satisfaction, and did not differ from the Mogen clamp in other key measures. The ShangRing could be used by health systems and international organisations to further scale up EIMC across sub-Saharan Africa. FUNDING: Bill & Melinda Gates Foundation.

Men's comfort in distributing or receiving HIV self-test kits from close male social network members in Dar Es Salaam, Tanzania: baseline results from the STEP project.

BACKGROUND: A variety of strategies have been used to reach men with HIV self-testing services, including social network-based HIV self-test kits distribution. However, few studies have assessed men's comfort to distribute to or receive HIV self-test kits from close male friends within the same social network. In this study, we assessed men's comfort to distribute to and/or receive HIV self-test kits from close male friends and associated factors among men who socialize in networks locally referred to as "camps" in Tanzania. METHODS: Data are from the baseline survey of a cluster-randomized controlled trial conducted in June 2019 with 18 social networks or "camps" in Dar es Salaam, Tanzania. Participants were 18-year-old or older male camp members who were HIV-negative at the time of enrolment. We used the Generalized Estimating Equations (GEE) to assess factors associated with being comfortable to distribute to and/or receive HIV self-test kits from close male members within one's social network. RESULTS: Of 505 participants, 67.9% (n = 342) reported being comfortable to distribute to while 68.2% (n = 344) were comfortable to receive HIV self-test kits from their close male friends. Ever having heard about HIV self-testing (Adjusted Prevalence Ratio (Adj. PR): 1.6; 95% Confidence Interval [CI]: 1.3, 1.9), willingness to self-test for HIV in front of a sexual partner (Adj. PR: 3.0; 95%CI: 1.5, 6.1) and exposure to peer-led HIV self-testing education and promotion (Adj. PR: 1.4; 95%CI: 1.2, 1.7) were significantly associated with being comfortable to distribute HIV self-test kits to close male members within one's social network. Similar results were observed for being comfortable to receive HIV self-test kits from a close male friend within one's social network. CONCLUSIONS: Overall, these findings suggest that distribution of HIV self-test kits through close male friends could improve the proportion of men reached with HIV self-testing services and improve HIV testing rates in this population where uptake remains low. However, additional promotional strategies such as peer-led HIV self-testing education are needed to raise awareness and increase the proportion of men who are comfortable to receive and/or distribute HIV self-testing kits.

The Economic and Epidemiological Impact of Focusing Voluntary Medical Male Circumcision for HIV Prevention on Specific Age Groups and Regions in Tanzania.

BACKGROUND: Since its launch in 2010, the Tanzania National Voluntary Medical Male Circumcision (VMMC) Program has focused efforts on males ages 10-34 in 11 priority regions. Implementers have noted that over 70% of VMMC clients are between the ages of 10 and 19, raising questions about whether additional efforts would be required to recruit men age 20 and above. This analysis uses mathematical modeling to examine the economic and epidemiological consequences of scaling up VMMC among specific age groups and priority regions in Tanzania. METHODS AND FINDINGS: Analyses were conducted using the Decision Makers' Program Planning Tool Version 2.0 (DMPPT 2.0), a compartmental model implemented in Microsoft Excel 2010. The model was populated with population, mortality, and HIV incidence and prevalence projections from external sources, including outputs from Spectrum/AIDS Impact Module (AIM). A separate DMPPT 2.0 model was created for each of the 11 priority regions. Tanzania can achieve the most immediate impact on HIV incidence by circumcising males ages 20-34. This strategy would also require the fewest VMMCs for each HIV infection averted. Circumcising men ages 10-24 will have the greatest impact on HIV incidence over a 15-year period. The most cost-effective approach (lowest cost per HIV infection averted) targets men ages 15-34. The model shows the VMMC program is cost saving in all 11 priority regions. VMMC program cost-effectiveness varies across regions due to differences in projected HIV incidence, with the most cost-effective programs in Njombe and Iringa. CONCLUSIONS: The DMPPT 2.0 results reinforce Tanzania's current VMMC strategy, providing newfound confidence in investing in circumcising adolescents. Tanzanian policy makers and program implementers will continue to focus scale-up of VMMC on men ages 10-34 years, seeking to maximize program impact and cost-effectiveness while acknowledging trends in demand among the younger and older age groups.

Bringing Early Infant Male Circumcision Information Home to the Family: Demographic Characteristics and Perspectives of Clients in a Pilot Project in Tanzania.

Iringa region of Tanzania has had great success reaching targets for voluntary medical male circumcision (VMMC). Looking to sustain high coverage of male circumcision, the government introduced a pilot project to offer early infant male circumcision (EIMC) in Iringa in 2013. From April 2013 to December 2014, a total of 2,084 male infants were circumcised in 8 health facilities in the region, representing 16.4% of all male infants born in those facilities. Most circumcisions took place 7 days or more after birth. The procedure proved safe, with only 3 mild and 3 moderate adverse events (0.4% overall adverse event rate). Overall, 93% of infants were brought back for a second-day visit and 71% for a seventh-day visit. These percentages varied significantly by urban and rural residence (97.4% urban versus 84.6% rural for day 2 visit; 82.2% urban versus 49.9% rural for day 7 visit). Mothers were more likely than fathers to have received information about EIMC. However, fathers tended to be key decision makers regarding circumcision of their sons. This suggests the importance of addressing fathers with behavioral change communication about EIMC. Successes in scaling up VMMC services in Iringa did not translate into immediate acceptability of EIMC. EIMC programs will require targeted investments in demand creation to expand and thrive in traditionally non-circumcising settings such as Iringa.

A Randomized Evaluation of a Demand Creation Lottery for Voluntary Medical Male Circumcision Among Adults in Tanzania.

BACKGROUND: Uptake of voluntary medical male circumcision (VMMC) among adult men has fallen short of targets in Tanzania. We evaluated a smartphone raffle intervention designed to increase VMMC uptake in three regions. METHODS: Among 7 matched pairs of health facilities, 1 in each pair was randomly assigned to the intervention, consisting of a weekly smartphone raffle for clients returning for follow-up and monthly raffle for peer promoters and providers. VMMC records of clients aged 20 and older were analyzed over three months, with the number performed compared with the same months in the previous year. In multivariable models, the intervention's effect on number of VMMCs was adjusted for client factors and clustering. Focus groups with clients and peer promoters explored preferences for VMMC incentives. RESULTS: VMMCs increased 47% and 8% in the intervention and control groups, respectively; however, the changes were not significantly different from one another. In the Iringa region subanalysis, VMMCs in the intervention group increased 336% (exponentiated coefficient of 3.36, 95% CI: 1.14 to 9.90; P = 0.028), after controlling for facility pair, percentage of clients ≥ age 30, and percentage testing HIV positive; the control group had a more modest 63% significant increase (exponentiated coefficient 1.63, 95% CI: 1.18 to 2.26; P = 0.003). The changes were not significantly different. Focus group respondents expressed mixed opinions about smartphone raffles; some favored smaller cash incentive or transportation reimbursement. IMPLICATIONS: A smartphone raffle might increase VMMC uptake in some settings by helping late adopters move from intention to action; however, there is no recommendation for this intervention more generally.