Voluntary Medical Male Circumcisions for HIV Prevention - 13 Countries in Eastern and Southern Africa, 2017-2021.

In 2007, voluntary medical male circumcision (VMMC) was endorsed by the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS after it was found to be associated with approximately a 60% reduction in the risk for female-to-male transmission of HIV (1). As a result of this endorsement, the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), through partnerships with U.S. government agencies, including CDC, the U.S. Department of Defense, and the U.S. Agency for International Development, started supporting VMMCs performed in prioritized countries in southern and eastern Africa. During 2010-2016, CDC supported 5,880,372 VMMCs in 12 countries (2,3). During 2017-2021, CDC supported 8,497,297 VMMCs performed in 13 countries. In 2020, the number of VMMCs performed declined 31.8% compared with the number in 2019, primarily because of COVID-19-related disruptions to VMMC service delivery. PEPFAR 2017-2021 Monitoring, Evaluation, and Reporting data were used to provide an update and describe CDC's contribution to the scale-up of the VMMC program, which is important to meeting the 2025 Joint United Nations Programme on HIV/AIDS (UNAIDS) target of 90% of males aged 15-59 years having access to VMMC services in prioritized countries to help end the AIDS epidemic by 2030 (4).

Applying mathematical modelling to estimate the impact of COVID-19-related VMMC service disruptions on new HIV infections in Zimbabwe.

BACKGROUND: The COVID-19 pandemic has overwhelmed health systems with knock on effects on diagnosis, treatment, and care. To mitigate the impact, the government of Zimbabwe enforced a strict lockdown beginning 30 March 2020 which ran intermittently until early 2021. In this period, the Ministry of Health and Childcare strategically prioritized delivery of services leading to partial and full suspension of services considered non-essential, including HIV prevention. As a result, Voluntary Medical Male Circumcision (VMMC) services were disrupted leading to an 80% decline in circumcisions conducted in 2020. Given the efficacy of VMMC, we quantified the potential effects of VMMC service disruption on new HIV infections in Zimbabwe. METHODS: We applied the GOALS model to evaluate the impact of COVID-19-related disruptions on reducing new HIV infections over 30-years. GOALS is an HIV simulation model that estimates number of new HIV infections based on sexual behaviours of population groups. The model is parameterized based on national surveys and HIV program data. We hypothesized three coverage scenarios by 2030: scenario I - pre-COVID trajectory: 80% VMMC coverage; Scenario II - marginal COVID-19 impact: 60% VMMC coverage, and scenario III - severe COVID-19 impact: 45% VMMC coverage. VMMC coverage between 2020 and 2030 was linearly interpolated to attain the estimated coverage and then held constant from 2030 to 2050, and discounted outcomes at 3%. RESULTS: Compared to the baseline scenario I, in scenario II, we estimated that the disruption of VMMC services would generate an average of 200 (176-224) additional new infections per year and 7,200 new HIV infections over the next 30 years. For scenario III, we estimated an average of 413 (389-437) additional new HIV infections per year and 15,000 new HIV infections over the next 30 years. The disruption of VMMC services could generate additional future HIV treatment costs ranging from $27 million to $55 million dollars across scenarios II and III, respectively. CONCLUSION: COVID-19 disruptions destabilized delivery of VMMC services which could contribute to an additional 7,200 new infections over the next 30 years. Unless mitigated, these disruptions could derail the national goals of reducing new infections by 2030.

Urethrocutaneous fistula following VMMC: a case series from March 2013 to October 2019 in ZAZIC's voluntary medical male circumcision program in Zimbabwe.

BACKGROUND: Urethrocutaneous fistula (subsequently, fistula) is a rare adverse event (AE) in voluntary medical male circumcision (VMMC) programs. Global fistula rates of 0.19 and 0.28 per 100,000 VMMCs were reported. Management of fistula can be complex and requires expert skills. We describe seven cases of fistula in our large-scale VMMC program in Zimbabwe. We present fistula rates; provide an overview of initial management, surgical interventions, and patient outcomes; discuss causes; and suggest future prevention efforts. RESULTS: Case details are presented on fistulas identified between March 2013 and October 2019. Among the seven fistula clients, ages ranged from 10 to 22 years; 6 cases were among boys under 15 years of age. All clients received surgical VMMC by trained providers in an outreach setting. Clients presented with fistulae 2-42 days after VMMC. Secondary infection was identified in 6 of 7 cases. Six cases were managed through surgical repair. The number of repair attempts ranged from 1 to 10. One case healed spontaneously with conservative management. Fistula rates are presented as cases/100,000 VMMCs. CONCLUSION: Fistula is an uncommon but severe AE that requires clinical expertise for successful management and repair. High-quality AE surveillance should identify fistula promptly and include consultation with experienced urologists. Strengthening provider surgical skills and establishment of standard protocols for fistula management would aid future prevention efforts in VMMC programs.

Urethrocutaneous fistulas after voluntary medical male circumcision for HIV prevention-15 African Countries, 2015-2019.

BACKGROUND: Voluntary medical male circumcision (VMMC) is an HIV prevention strategy recommended to partially protect men from heterosexually acquired HIV. From 2015 to 2019, the President's Emergency Plan for AIDS Relief (PEPFAR) has supported approximately 14.9 million VMMCs in 15 African countries. Urethrocutaneous fistulas, abnormal openings between the urethra and penile skin through which urine can escape, are rare, severe adverse events (AEs) that can occur with VMMC. This analysis describes fistula cases, identifies possible risks and mechanisms of injury, and offers mitigation actions. METHODS: Demographic and clinical program data were reviewed from all reported fistula cases during 2015 to 2019, descriptive analyses were performed, and an odds ratio was calculated by patient age group. RESULTS: In total, 41 fistula cases were reported. Median patient age for fistula cases was 11 years and 40/41 (98%) occurred in patients aged < 15 years. Fistulas were more often reported among patients < 15 compared to ≥ 15 years old (0.61 vs. 0.01 fistulas per 100,000 VMMCs, odds ratio 50.9 (95% confidence interval [CI] = 8.6-2060.0)). Median time from VMMC surgery to appearance of fistula was 20 days (interquartile range (IQR) 14-27). CONCLUSIONS: Urethral fistulas were significantly more common in patients under age 15 years. Thinner tissue overlying the urethra in immature genitalia may predispose boys to injury. The delay between procedure and symptom onset of 2-3 weeks indicates partial thickness injury or suture violation of the urethral wall as more likely mechanisms of injury than intra-operative urethral transection. This analysis helped to inform PEPFAR's recent decision to change VMMC eligibility policy in 2020, raising the minimum age to 15 years.

Case series of glans injuries during voluntary medical male circumcision for HIV prevention - eastern and southern Africa, 2015-2018.

BACKGROUND: Male circumcision confers partial protection against heterosexual HIV acquisition among men. The President's Emergency Plan for AIDS Relief (PEPFAR) has supported > 18,900,000 voluntary medical male circumcisions (VMMC). Glans injuries (GIs) are rare but devastating adverse events (AEs) that can occur during circumcision. To address this issue, PEPFAR has supported multiple interventions in the areas of surveillance, policy, education, training, supply chain, and AE management. METHODS: Since 2015, PEPFAR has conducted surveillance of GIs including rapid investigation by the in-country PEPFAR team. This information is collected on standardized forms, which were reviewed for this analysis. RESULTS: Thirty-six GIs were reported from 2015 to 2018; all patients were < 15 years old (~ 0·7 per 100,000 VMMCs in this age group) with a decreasing annual rate (2015: 0.7 per 100,000 VMMCs; 2018: 0.4 per 100,000 VMMC; p = 0.02). Most (64%) GIs were partial or complete amputations. All amputations among 10-14 year-olds occurred using the forceps-guided (FG) method, as opposed to the dorsal-slit (DS) method, and three GIs among infants occurred using a Mogen clamp. Of 19 attempted amputation repairs, reattached tissue was viable in four (21%) in the short term. In some cases, inadequate DS method training and being overworked, were found. CONCLUSION: Following numerous interventions by PEPFAR and other stakeholders, GIs are decreasing; however, they have not been eliminated and remain a challenge for the VMMC program. Preventing further cases of complete and partial amputation will likely require additional interventions that prevent use of the FG method in young patients and the Mogen clamp in infants. Improving management of GIs is critical to optimizing outcomes.

Bleeding and Blood Disorders in Clients of Voluntary Medical Male Circumcision for HIV Prevention - Eastern and Southern Africa, 2015-2016.

Male circumcision reduces the risk for female-to-male human immunodeficiency virus (HIV) transmission by approximately 60% (1) and has become a key component of global HIV prevention programs in countries in Eastern and Southern Africa where HIV prevalence is high and circumcision coverage is low. Through September 2017, the President's Emergency Plan for AIDS Relief (PEPFAR) had supported 15.2 million voluntary medical male circumcisions (VMMCs) in 14 priority countries in Eastern and Southern Africa (2). Like any surgical intervention, VMMC carries a risk for complications or adverse events. Adverse events during circumcision of males aged ≥10 years occur in 0.5% to 8% of procedures, though the majority of adverse events are mild (3,4). To monitor safety and service quality, PEPFAR tracks and reports qualifying notifiable adverse events. Data reported from eight country VMMC programs during 2015-2016 revealed that bleeding resulting in hospitalization for ≥3 days was the most commonly reported qualifying adverse event. In several cases, the bleeding adverse event revealed a previously undiagnosed or undisclosed bleeding disorder. Bleeding adverse events in men with potential bleeding disorders are serious and can be fatal. Strategies to improve precircumcision screening and performance of circumcisions on clients at risk in settings where blood products are available are recommended to reduce the occurrence of these adverse events or mitigate their effects (5).

Scale-Up of Voluntary Medical Male Circumcision Services for HIV Prevention - 12 Countries in Southern and Eastern Africa, 2013-2016.

Countries in Southern and Eastern Africa have the highest prevalence of human immunodeficiency virus (HIV) infection in the world; in 2015, 52% (approximately 19 million) of all persons living with HIV infection resided in these two regions.* Voluntary medical male circumcision (VMMC) reduces the risk for heterosexually acquired HIV infection among males by approximately 60% (1). As such, it is an essential component of the Joint United Nations Programme on HIV/AIDS (UNAIDS) strategy for ending acquired immunodeficiency syndrome (AIDS) by 2030 (2). Substantial progress toward achieving VMMC targets has been made in the 10 years since the World Health Organization (WHO) and UNAIDS recommended scale-up of VMMC for HIV prevention in 14 Southern and Eastern African countries with generalized HIV epidemics and low male circumcision prevalence (3).† This has been enabled in part by nearly $2 billion in cumulative funding through the President's Emergency Plan for AIDS Relief (PEPFAR), administered through multiple U.S. governmental agencies, including CDC, which has supported nearly half of all PEPFAR-supported VMMCs to date. Approximately 14.5 million VMMCs were performed globally during 2008-2016, which represented 70% of the original target of 20.8 million VMMCs in males aged 15-49 years through 2016 (4). Despite falling short of the target, these VMMCs are projected to avert 500,000 HIV infections by the end of 2030 (4). However, UNAIDS has estimated an additional 27 million VMMCs need to be performed by 2021 to meet the Fast Track targets (2). This report updates a previous report covering the period 2010-2012, when VMMC implementing partners supported by CDC performed approximately 1 million VMMCs in nine countries (5). During 2013-2016, these implementing partners performed nearly 5 million VMMCs in 12 countries. Meeting the global target will require redoubling current efforts and introducing novel strategies that increase demand among subgroups of males who have historically been reluctant to undergo VMMC.

Preventing HIV Among Adolescent Boys and Young Men Through PEPFAR-Supported Voluntary Medical Male Circumcision in 15 Sub-Saharan African Countries, 2018-2021.

Voluntary medical male circumcision (VMMC) is an HIV prevention intervention that has predominantly targeted adolescent and young men, aged 10-24 years. In 2020, the age eligibility for VMMC shifted from 10 to 15 years of age. This report describes the VMMC client age distribution from 2018 to 2021, at the site, national, and regional levels, among 15 countries in southern and eastern Africa. Overall, in 2018 and 2019, the highest proportion of VMMCs were performed among 10-14-year-olds (45.6% and 41.2%, respectively). In 2020 and 2021, the 15-19-year age group accounted for the highest proportion (37.2% and 50.4%, respectively) of VMMCs performed across all age groups. Similarly, in 2021 at the site level, 68.1% of VMMC sites conducted the majority of circumcisions among men aged 15-24 years. This analysis highlights that adolescent boys and young men are the primary recipients of VMMC receiving an important lifetime reduction in HIV risk.

Retention and performance of peer educators and sustainability of HIV prevention services for adolescents in the Zimbabwe Smart-LyncAges project: an ecological study.

Introduction: in 2016, the partner-funded Smart-LyncAges participatory learning project explored the feasibility of a youth-friendly package including incentivized peer educators (PEs) to enhance adolescent sexual and reproductive health (ASRH) and voluntary medical male circumcision (VMMC) linkages. After 12 months of implementation, funding reduction resulted in reduced direct project monitoring and discontinuation of monetary incentives for PEs. We assessed if reduced funding after one year of implementation affected the performance and retention of PEs and uptake of VMMC and HIV testing in ASRH services by adolescents in Bulawayo City (urban) and Mount (Mt) Darwin District (rural) in Zimbabwe. Methods: our study was an ecological study using routine data collected from March 2016 to February 2017 (intensive support) and March 2017 to February 2018 (reduced support). All the ASRH and VMMC sites in Mt Darwin and Bulawayo were involved. Participants included 58 PEs and all adolescents accessing VMMC and ASRH services. Retention of PEs measured by the submission of monthly reports and uptake of VMMC and HIV testing were the primary outcome measures. Results: the Smart-LyncAges project engaged 58 PEs with 80% aged 20-24 years. Two-thirds were male and 60% were engaged in peer education before the project. Retention of PEs was not negatively affected by funding reduction, with 70% retained up to 11 months after funding reduction. However, their performance, measured by submission of monthly activity reports and the number of adolescents reached with VMMC and HIV messages, declined while uptake of both VMMC and HIV testing was sustained. Conclusion: sustained uptake of services was possibly due to heightened awareness of service availability and demand generation in the first year of implementation. Peer-led interventions are effective for health information dissemination. Monetary incentives determine performance, but are not the only reason for retention.

REDCap mobile data collection: Using implementation science to explore the potential and pitfalls of a digital health tool in routine voluntary medical male circumcision outreach settings in Zimbabwe.

Background: Digital data collection tools improve data quality but are limited by connectivity. ZAZIC, a Zimbabwean consortium focused on scaling up male circumcision (MC) services, provides MC in outreach settings where both data quality and connectivity is poor. ZAZIC implemented REDCap Mobile app for data collection among roving ZAZIC MC nurses. To inform continued scale-up or discontinuation, this paper details if, how, and for whom REDCap improved data quality using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Methods: Data were collected for this retrospective, cross-sectional study for nine months, from July 2019 to March 2020, before COVID-19 paused MC services. Data completeness was compared between paper- and REDCap-based tools and between two ZAZIC partners using two sample, one-tailed t-tests. Results: REDCap reached all roving nurses who reported 26,904 MCs from 1773 submissions. REDCap effectiveness, as measured by data completeness, decreased from 89.2% in paper to 76.6% in REDCap app for Partner 1 (p < 0.001, 95% CI: -0.24, -0.12) but increased modestly from 86.2% to 90.3% in REDCap for Partner 2 (p = 0.05, 95% CI: -.007, 0.12). Adoption of REDCap was 100%; paper-based reporting concluded in October 2019. Implementation varied by partner and user. Maintenance appeared high. Conclusion: Although initial transition from paper to REDCap showed mixed effectiveness, post-hoc analysis from service resumption found increased REDCap data completeness across partners, suggesting locally-led momentum for REDCap-based data collection. Staff training, consistent mentoring, and continued technical support appear critical for continued use of digital health tools for quality data collection in rural Zimbabwe and similar low connectivity settings.

Transitioning a digital health innovation from research to routine practice: Two-way texting for male circumcision follow-up in Zimbabwe.

Adult medical male circumcision (MC) is safe: global notifiable adverse event (AE) rates average below 2.0%. With Zimbabwe's shortage of health care workers (HCWs) compounded by COVID-19 constraints, two-way text-based (2wT) MC follow-up may be advantageous over routinely scheduled in-person reviews. A 2019 randomized control trial (RCT) found 2wT to be safe and efficient for MC follow-up. As few digital health interventions successfully transition from RCT to scale, we detail the 2wT scale-up approach from RCT to routine MC practice comparing MC safety and efficiency outcomes. After the RCT, 2wT transitioned from a site-based (centralized) system to hub-and-spoke model for scale-up where one nurse triaged all 2wT patients, referring patients in need to their local clinic. No post-operative visits were required with 2wT. Routine patients were expected to attend at least one post-operative review. We compare 1) AEs and in-person visits between 2wT men from RCT and routine MC service delivery; and 2) 2wT-based and routine follow-up among adults during the 2wT scale-up period, January to October 2021. During scale-up period, 5084 of 17417 adult MC patients (29%) opted into 2wT. Of the 5084, 0.08% (95% CI: 0.03, 2.0) had an AE and 71.0% (95% CI: 69.7, 72.2) responded to ≥1 daily SMS, a significant decrease from the 1.9% AE rate (95% CI: 0.7, 3.6; p<0.001) and 92.5% response rate (95% CI: 89.0, 94.6; p<0.001) from 2wT RCT men. During scale-up, AE rates did not differ between routine (0.03%; 95% CI: 0.02, 0.08) and 2wT (p = 0.248) groups. Of 5084 2wT men, 630 (12.4%) received telehealth reassurance, wound care reminders, and hygiene advice via 2wT; 64 (19.7%) were referred for care of which 50% had visits. Similar to RCT outcomes, routine 2wT was safe and provided clear efficiency advantages over in-person follow-up. 2wT reduced unnecessary patient-provider contact for COVID-19 infection prevention. Rural network coverage, provider hesitancy, and the slow pace of MC guideline changes slowed 2wT expansion. However, immediate 2wT benefits for MC programs and potential benefits of 2wT-based telehealth for other health contexts outweigh limitations.

Relative efficiency of demand creation strategies to increase voluntary medical male circumcision uptake: a study conducted as part of a randomised controlled trial in Zimbabwe.

BACKGROUND: Supply and demand-side factors continue to undermine voluntary medical male circumcision (VMMC) uptake. We assessed relative economic costs of four VMMC demand creation/service-delivery modalities as part of a randomised controlled trial in Zimbabwe. METHODS: Interpersonal communication agents were trained and incentivised to generate VMMC demand across five districts using four demand creation modalities (standard demand creation (SDC), demand creation plus offer of HIV self-testing (HIVST), human-centred design (HCD)-informed approach, HCD-informed demand creation approach plus offer of HIVST). Annual provider financial expenditure analysis and activity-based-costing including time-and-motion analysis across 15 purposively selected sites accounted for financial expenditures and donated inputs from other programmes and funders. Sites represented three models of VMMC service-delivery: static (fixed) model offering VMMC continuously to walk-in clients at district hospitals and serving as a district hub for integrated mobile and outreach services, (2) integrated (mobile) modelwhere staff move from the district static (fixed) site with their commodities to supplement existing services or to recently capacitated health facilities, intermittently and (3) mobile/outreach model offering VMMC through mobile clinic services in more remote sites. RESULTS: Total programme cost was $752 585 including VMMC service-delivery costs and average cost per client reached and cost per circumcision were $58 and $174, respectively. Highest costs per client reached were in the HCD arm-$68 and lowest costs in standard demand creation ($52) and HIVST ($55) arms, respectively. Highest cost per client circumcised was observed in the arm where HIVST and HCD were combined ($226) and the lowest in the HCD alone arm ($160). Across the three VMMC service-delivery models, unit cost was lowest in static (fixed) model ($54) and highest in integrated mobile model ($63). Overall, economies of scale were evident with unit costs lower in sites with higher numbers of clients reached and circumcised. CONCLUSIONS: There was high variability in unit costs across arms and sites suggesting opportunities for cost reductions. Highest costs were observed in the HCD+HIVST arm when combined with an integrated service-delivery setting. Mobilisation programmes that intensively target higher conversion rates as exhibited in the SDC and HCD arms provide greater scope for efficiency by spreading costs. TRIAL REGISTRATION NUMBER: PACTR201804003064160.

Innovative demand creation strategies to increase voluntary medical male circumcision uptake: a pragmatic randomised controlled trial in Zimbabwe.

INTRODUCTION: Reaching men aged 20-35 years, the group at greatest risk of HIV, with voluntary medical male circumcision (VMMC) remains a challenge. We assessed the impact of two VMMC demand creation approaches targeting this age group in a randomised controlled trial (RCT). METHODS: We conducted a 2×2 factorial RCT comparing arms with and without two interventions: (1) standard demand creation augmented by human-centred design (HCD)-informed approach; (2) standard demand creation plus offer of HIV self-testing (HIVST). Interpersonal communication (IPC) agents were the unit of randomisation. We observed implementation of demand creation over 6 months (1 May to 31 October 2018), with number of men circumcised assessed over 7 months. The primary outcome was the number of men circumcised per IPC agent using the as-treated population of actual number of months each IPC agent worked. We conducted a mixed-methods process evaluation within the RCT. RESULTS: We randomised 140 IPC agents, 35 in each arm. 132/140 (94.3%) attended study training and 105/132 (79.5%) reached at least one client during the trial period and were included in final analysis. There was no evidence that the HCD-informed intervention increased VMMC uptake versus no HCD-informed intervention (incident rate ratio (IRR) 0.87, 95% CI 0.38 to 2.02; p=0.75). Nor did offering men a HIVST kit at time of VMMC mobilisation (IRR 0.65, 95% CI 0.28 to 1.50; p=0.31). Among IPC agents that reported reaching at least one man with demand creation, both the HCD-informed intervention and HIVST were deemed useful. There were some challenges with trial implementation; <50% of IPC agents converted any men to VMMC, which undermined our ability to show an effect of demand creation and may reflect acceptability and feasibility of the interventions. CONCLUSION: This RCT did not show evidence of an effect of HCD-informed demand intervention or HIVST on VMMC uptake. Findings will inform future design and implementation of demand creation evaluations. TRIAL REGISTRATION NUMBER: PACTR201804003064160.

HIV Incidence by Male Circumcision Status From the Population-Based HIV Impact Assessment Surveys-Eight Sub-Saharan African Countries, 2015-2017.

BACKGROUND: Male circumcision (MC) offers men lifelong partial protection from heterosexually acquired HIV infection. The impact of MC on HIV incidence has not been quantified in nationally representative samples. Data from the population-based HIV impact assessments were used to compare HIV incidence by MC status in countries implementing voluntary medical MC (VMMC) programs. METHODS: Data were pooled from population-based HIV impact assessments conducted in Eswatini, Lesotho, Malawi, Namibia, Tanzania, Uganda, Zambia, and Zimbabwe from 2015 to 2017. Incidence was measured using a recent infection testing algorithm and analyzed by self-reported MC status distinguishing between medical and nonmedical MC. Country, marital status, urban setting, sexual risk behaviors, and mean population HIV viral load among women as an indicator of treatment scale-up were included in a random-effects logistic regression model using pooled survey weights. Analyses were age stratified (15-34 and 35-59 years). Annualized incidence rates and 95% confidence intervals (CIs) and incidence differences were calculated between medically circumcised and uncircumcised men. RESULTS: Men 15-34 years reporting medical MC had lower HIV incidence than uncircumcised men [0.04% (95% CI: 0.00% to 0.10%) versus 0.34% (95% CI: 0.10% to 0.57%), respectively; P value = 0.01]; whereas among men 35-59 years, there was no significant incidence difference [1.36% (95% CI: 0.32% to 2.39%) versus 0.55% (95% CI: 0.14% to 0.67%), respectively; P value = 0.14]. DISCUSSION: Medical MC was associated with lower HIV incidence in men aged 15-34 years in nationally representative surveys in Africa. These findings are consistent with the expected ongoing VMMC program impact and highlight the importance of VMMC for the HIV response in Africa.

Usability and acceptability of a two-way texting intervention for post-operative follow-up for voluntary medical male circumcision in Zimbabwe.

BACKGROUND: Voluntary medical male circumcision (MC) is safe and effective. Nevertheless, MC programs require multiple post-operative visits. In Zimbabwe, a randomized control trial (RCT) found that post-operative two-way texting (2wT) between clients and MC providers instead of in-person reviews reduced provider workload and safeguarded patient safety. A critical component of the RCT assessed usability and acceptability of 2wT among providers and clients. These findings inform scale-up of the 2wT approach to post-operative follow-up. METHODS: The RCT assigned 362 adult MC clients with cell phones into 2wT; these men responded to 13 automated daily texts supported by interactive texting or in-person follow-up, when needed. A subset of 100 texting clients filled a self-administered usability survey on day 14. 2wT acceptability was ascertained via 2wT response rates. Among 2wT providers, eight key informant interviews focused on 2wT acceptability and usability. Influences of wage and age on response rates and client-reported potential AEs were explored using linear and logistic regression models, respectively. RESULTS: Clients felt confident, comfortable, satisfied, and well-supported with 2wT-based follow-up; few noted texting challenges or concerns about healing. Clients felt 2wT saved them time and money. Response rates (92%) suggested 2wT acceptability. Both clients and providers felt 2wT was highly usable. Providers noted 2wT saved them time, empowered clients to engage in their healing, and closed gaps in MC service quality. For scale, providers reinforced good post-operative counseling on AEs and texting instructions. Wage and age did not influence text response rates or potential AE texts. CONCLUSION: Results strongly suggest that 2wT is highly usable and acceptable for providers and patients. Men with concerns solicited provider guidance and reassurance offered via text. Providers noted that men engaged proactively in their healing. 2wT between providers and patients should be expanded for MC and considered for other short-term care contexts. The trial is registered on ClinicalTrials.gov, trial NCT03119337, and was activated on April 18, 2017. https://clinicaltrials.gov/ct2/show/NCT03119337.

Cost-effectiveness analysis of two-way texting for post-operative follow-up in Zimbabwe's voluntary medical male circumcision program.

OBJECTIVE: Although adverse events (AEs) following voluntary medical male circumcision (VMMC) are rare, their prompt ascertainment and management is a marker of quality care. The use of two-way text messaging (2wT) for client follow-up after VMMC reduces the need for clinic visits (standard of care (SoC)) without compromising safety. We compared the cost-effectiveness of 2wT to SoC for post-VMMC follow-up in two, high-volume, public VMMC sites in Zimbabwe. MATERIALS AND METHODS: We developed a decision-analytic (decision tree) model of post-VMMC client follow-up at two high-volume sites. We parameterized the model using data from both a randomized controlled study of 2wT vs. SoC and from the routine VMMC program. The perspective of analysis was the Zimbabwe government (payer). The time horizon covered the time from VMMC to wound healing. Costs included text messaging; both in-person and outreach follow-up; and AE management. Costs were estimated in 2018 U.S. dollars. The outcome of analysis was AE yield relative to the globally accepted safety standard of a 2% AE rate. We estimated the incremental cost per percentage increase in AE ascertainment and the incremental cost per additional AE identified. We conducted univariate and probabilistic sensitivity analyses. RESULTS: 2wT increased the costs due to text messaging by $4.42 but reduced clinic visit costs by $2.92 and outreach costs by $3.61 -a net savings of $2.10. 2wT also increased AE ascertainment by 50% (92% AE yield in 2wT compared to 42% AE yield in SoC). Therefore, 2wT dominated SoC in the incremental analysis: 2wT was less costly and more effective. Results were generally robust to univariate and probabilistic sensitivity analysis. CONCLUSIONS: 2wT is cost-effective for post-VMMC follow-up in Zimbabwe. Countries in which VMMC is a high-priority HIV prevention intervention should consider this mHealth intervention to reduce overall cost per VMMC, increasing the likelihood of current and future VMMC program sustainability.

Balancing competing priorities: Quantity versus quality within a routine, voluntary medical male circumcision program operating at scale in Zimbabwe.

BACKGROUND: Since 2013, the ZAZIC consortium supported the Zimbabwe Ministry of Health and Child Care (MOHCC) to implement a high quality, integrated voluntary medical male circumcision (VMMC) program in 13 districts. With the aim of significantly lowering global HIV rates, prevention programs like VMMC make every effort to achieve ambitious targets at an increasingly reduced cost. This has the potential to threaten VMMC program quality. Two measures of program quality are follow-up and adverse event (AE) rates. To inform further VMMC program improvement, ZAZIC conducted a quality assurance (QA) activity to assess if pressure to do more with less influenced program quality. METHODS: Key informant interviews (KIIs) were conducted at 9 sites with 7 site-based VMMC program officers and 9 ZAZIC roving team members. Confidentiality was ensured to encourage candid conversation on adherence to VMMC standards, methods to increase productivity, challenges to target achievement, and suggestions for program modification. Interviews were recorded, transcribed and analyzed using Atlas.ti 6. RESULTS: VMMC teams work long hours in diverse community settings to reach ambitious targets. Rotating, large teams of trained VMMC providers ensures meeting demand. Service providers prioritize VMMC safety procedures and implement additional QA measures to prevent AEs among all clients, especially minors. However, KIs noted three areas where pressure for increased numbers of clients diminished adherence to VMMC safety standards. For pre- and post-operative counselling, MC teams may combine individual and group sessions to reach more people, potentially reducing client understanding of critical wound care instructions. Second, key infection control practices may be compromised (handwashing, scrubbing techniques, and preoperative client preparation) to speed MC procedures. Lastly, pressure for client numbers may reduce prioritization of patient follow-up, while client-perceived stigma may reduce care-seeking. Although AEs appear well managed, delays in AE identification and lack of consistent AE reporting compromise program quality. CONCLUSION: In pursuit of ambitious targets, healthcare workers may compromise quality of MC services. Although risk to patients may appear minimal, careful consideration of the realities and risks of ambitious target setting by donors, ministries, and implementing partners could help to ensure that client safety and program quality is consistently prioritized over productivity.

Linkage of voluntary medical male circumcision clients to adolescent sexual and reproductive health (ASRH) services through Smart-LyncAges project in Zimbabwe: a cohort study.

OBJECTIVES: WHO recommended strengthening the linkages between various HIV prevention programmes and adolescent sexual reproductive health (ASRH) services. The Smart-LyncAges project piloted in Bulawayo city and Mt Darwin district of Zimbabwe established a referral system to link the voluntary medical male circumcision (VMMC) clients to ASRH services provided at youth centres. Since its inception in 2016, there has been no assessment of the performance of the referral system. Thus, we aimed to assess the proportion of young (10-24 years) VMMC clients getting 'successfully linked' to ASRH services and factors associated with 'not being linked'. DESIGN: This was a cohort study using routinely collected secondary data. SETTING: All three VMMC clinics of Mt Darwin district and Bulawayo province. PRIMARY OUTCOME MEASURES: The proportion of 'successfully linked' was summarised as the percentage with a 95% CI. Adjusted relative risks (aRR) using a generalised linear model was calculated as a measure of association between client characteristics and 'not being linked'. RESULTS: Of 1773 young people registered for VMMC services, 1478 (83%) were referred for ASRH services as they had not registered for ASRH previously. Of those referred for ASRH services, the mean (SD) age of study participants was 13.7 (4.3) years and 427 (28.9%) were out of school. Of the referred, 463 (31.3%, 95% CI: 30.0 to 33.8) were 'successfully linked' to ASRH services and the median (IQR) duration for linkage was 6 (0-56) days. On adjusted analysis, receiving referral from Bulawayo circumcision clinic (aRR: 1.5 (95% CI: 1.3 to 1.7)) and undergoing circumcision at outreach sites (aRR: 1.2 (95% CI: 1.1 to 1.3)) were associated with 'not being linked' to ASRH services. CONCLUSION: Linkage to ASRH services from VMMC is feasible as one-third VMMC clients were successfully linked. However, there is need to explore reasons for not accessing ASRH services and take corrective actions to improve the linkages.

Reducing Provider Workload While Preserving Patient Safety: A Randomized Control Trial Using 2-Way Texting for Postoperative Follow-up in Zimbabwe's Voluntary Medical Male Circumcision Program.

BACKGROUND: Voluntary medical male circumcisions (MCs) are safe: the majority of men heal without complication. However, guidelines require multiple follow-up visits. In Zimbabwe, where there is high mobile phone ownership, severe health care worker shortages, and rapid MC scale up intersect, we tested a 2-way texting (2wT) intervention to reduce provider workload while safeguarding patient safety. SETTING: Two high-volume facilities providing MC near Harare, Zimbabwe. METHODS: A prospective, unblinded, noninferiority, randomized control trial of 722 adult MC clients with cell phones randomized 1:1. 2wT clients (n = 362) responded to a daily text with in-person follow-up only if desired or an adverse event (AE) was suspected. The control group (n = 359) received routine in-person visits. All men were asked to return on postoperative day 14 for review. AEs at ≤day 14 visit and the number of in-person visits were compared between the groups. RESULTS: Cumulative AEs were identified in 0.84% [95% confidence interval (CI): 0.28 to 2.43] among routine care men as compared with 1.88% (95% CI: 0.86 to 4.03) of 2wT participants. Noninferiority cannot be ruled out (95% CI: -∞ to +2.72); however, AE rates did not differ between the groups (P = 0.32). 2wT men attended an average of 0.30 visits as compared with 1.69 visits among routine care men, a significant reduction (P < 0.001). CONCLUSIONS: Although noninferiority cannot be demonstrated, increased AEs in the 2wT arm likely reflect improved AE ascertainment. 2wT serves as a proxy for active surveillance, improving the quality of MC patient care. 2wT also reduced provider workload. 2wT provides an option for men to heal safely at home, returning to care when desired or if complications arise. 2wT should be further tested to enable widespread scale-up.

Does peer education go beyond giving reproductive health information? Cohort study in Bulawayo and Mount Darwin, Zimbabwe.

OBJECTIVE: Peer education is an intervention within the voluntary medical male circumcision (VMMC)-adolescent sexual reproductive health (ASRH) linkages project in Bulawayo and Mount Darwin, Zimbabwe since 2016. Little is known if results extend beyond increasing knowledge. We therefore assessed the extent of and factors affecting referral by peer educators and receipt of HIV testing services (HTS), contraception, management of sexually transmitted infections (STIs) and VMMC services by young people (10-24 years) counselled. DESIGN: A cohort study involving all young people counselled by 95 peer educators during October-December 2018, through secondary analysis of routinely collected data. SETTING: All ASRH and VMMC sites in Mt Darwin and Bulawayo. PARTICIPANTS: All young people counselled by 95 peer educators. OUTCOME MEASURES: Censor date for assessing receipt of services was 31 January 2019. Factors (clients' age, gender, marital and schooling status, counselling type, location, and peer educators' age and gender) affecting non-referral and non-receipt of services (dependent variables) were assessed by log-binomial regression. Adjusted relative risks (aRRs) were calculated. RESULTS: Of the 3370 counselled (66% men), 65% were referred for at least one service. 58% of men were referred for VMMC. Other services had 5%-13% referrals. Non-referral for HTS decreased with clients' age (aRR: ~0.9) but was higher among group-counselled (aRR: 1.16). Counselling by men (aRR: 0.77) and rural location (aRR: 0.61) reduced risks of non-referral for VMMC, while age increased it (aRR ≥1.59). Receipt of services was high (64%-80%) except for STI referrals (39%). Group counselling and rural location (aRR: ~0.52) and male peer educators (aRR: 0.76) reduced the risk of non-receipt of VMMC. Rural location increased the risk of non-receipt of contraception (aRR: 3.18) while marriage reduced it (aRR: 0.20). CONCLUSION: We found varying levels of referral ranging from 5.1% (STIs) to 58.3% (VMMC) but high levels of receipt of services. Type of counselling, peer educators' gender and location affected receipt of services. We recommend qualitative approaches to further understand reasons for non-referrals and non-receipt of services.