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Reducing provider workload while preserving patient safety via a two-way texting intervention in Zimbabwe's voluntary medical male circumcision program: study protocol for an un-blinded, prospective, non-inferiority, randomized controlled trial.

ABSTRACT: BACKGROUND:Surgical male circumcision (MC) safely reduces risk of female-to-male HIV-1 transmission by up to 60%. The average rate of global moderate and severe adverse events (AEs) is 0.8%: 99% of men heal from MC without incident. To reach the 2016 global MC target of 20 million, productivity must double in countries plagued by severe healthcare worker shortages like Zimbabwe. The ZAZIC consortium partners with the Zimbabwe Ministry of Health and Child Care and has performed over 120,000 MCs. MC care in Zimbabwe requires in-person, follow-up visits at post-operative days 2,7, and 42. The ZAZIC program AE rate is 0.4%; therefore, overstretched clinic have staff conducted more than 200,000 unnecessary reviews of MC clients without complications. METHODS:Through an un-blinded, prospective, randomized, controlled trial in two high-volume MC facilities, we will compare two groups of adult MC clients with cell phones, randomized 1:1 into two groups: (1) routine care (control group, N?=?361) and (2) clients who receive and respond to a daily text with in-person follow up only if desired or if a complication is suspected (intervention group, N?=?361). If an intervention client responds affirmatively to any automated daily text with a suspected AE, an MC nurse will exchange manual, modifiable, scripted texts with the client to determine symptoms and severity, requesting an in-person visit if desired or warranted. Both arms will complete a study-specific, day 14, in-person, follow-up review for verification of self-reports (intervention) and comparison (control). Data collection includes extraction of routine client MC records, study-specific database reports, and participant usability surveys. Intent-to-treat (ITT) analysis will be used to explore differences between groups to determine if two-way texting (2wT) can safely reduce MC follow-up visits, estimate the cost savings associated with 2wT over routine MC follow up, and assess the acceptability and feasibility of 2wT for scale up. DISCUSSION:It is expected that this mobile health intervention will be as safe as routine care while providing distinct advantages in efficiency, costs, and reduced healthcare worker burden. The success of this intervention could lead to adaptation and adoption of this intervention at the national level, increasing the efficiency of MC scale up, and reducing burdens on providers and patients. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03119337 . Registered on 18 April 2017.

SUBMITTER: Feldacker C

PROVIDER: S-EPMC6651991 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Reducing provider workload while preserving patient safety via a two-way texting intervention in Zimbabwe's voluntary medical male circumcision program: study protocol for an un-blinded, prospective, non-inferiority, randomized controlled trial.

Feldacker Caryl C Murenje Vernon V Barnhart Scott S Xaba Sinokuthemba S Makunike-Chikwinya Batsirai B Holeman Isaac I Tshimanga Mufuta M

Trials 20190723 1

<h4>Background</h4>Surgical male circumcision (MC) safely reduces risk of female-to-male HIV-1 transmission by up to 60%. The average rate of global moderate and severe adverse events (AEs) is 0.8%: 99% of men heal from MC without incident. To reach the 2016 global MC target of 20 million, productivity must double in countries plagued by severe healthcare worker shortages like Zimbabwe. The ZAZIC consortium partners with the Zimbabwe Ministry of Health and Child Care and has performed over 120,0 ...[more]

PMID: 31337414

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Project description:ObjectiveAlthough 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 methodsWe 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.Results2wT 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.Conclusions2wT 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.

Project description:BackgroundVoluntary 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.MethodsThe 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.ResultsClients 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.ConclusionResults 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.

Project description: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.

Project description:BackgroundIn 2013, Zimbabwe's voluntary medical male circumcision (VMMC) program adopted performance-based financing (PBF) to speed progress towards ambitious VMMC targets. The $25 USD PBF intended to encourage low-paid healthcare workers to remain in the public sector and to strengthen the public healthcare system. The majority of the incentive supports healthcare workers (HCWs) who perform VMMC alongside other routine services; a small portion supports province, district, and facility levels.MethodsThis qualitative study assessed the effect of the PBF on HCW motivation, satisfaction, and professional relationships. The study objectives were to: 1) Gain understanding of the advantages and disadvantages of PBF at the HCW level; 2) Gain understanding of the advantages and disadvantages of PBF at the site level; and 3) Inform scale up, modification, or discontinuation of PBF for the national VMMC program. Sixteen focus groups were conducted: eight with HCWs who received PBF for VMMC and eight with HCWs in the same clinics who did not work in VMMC and, therefore, did not receive PBF. Fourteen key informant interviews ascertained administrator opinion.ResultsFindings suggest that PBF appreciably increased motivation among VMMC teams and helped improve facilities where VMMC services are provided. However, PBF appears to contribute to antagonism at the workplace, creating divisiveness that may reach beyond VMMC. PBF may also cause distortion in the healthcare system: HCWs prioritized incentivized VMMC services over other routine duties. To reduce workplace tension and improve the VMMC program, participants suggested increasing HCW training in VMMC to expand PBF beneficiaries and strengthening integration of VMMC services into routine care.ConclusionIn the low-resource, short-staffed context of Zimbabwe, PBF enabled rapid VMMC scale up and achievement of ambitious targets; however, side effects make PBF less advantageous and sustainable than envisioned. Careful consideration is warranted in choosing whether, and how, to implement PBF to prioritize a public health program.

Project description:As an HIV prevention strategy, the scale-up of voluntary medical male circumcision (VMMC) is underway in 14 countries in Africa. For prevention impact, these countries must perform millions of circumcisions in adolescent and adult men before 2015. Although acceptability of VMMC in the region is well documented and service delivery efforts have proven successful, countries remain behind in meeting circumcision targets. A better understanding of men's VMMC-seeking behaviors and experiences is needed to improve communication and interventions to accelerate uptake. To this end, we conducted semi-structured interviews with 40 clients waiting for surgical circumcision at clinics in Zambia. Based on Stages of Change behavioral theory, men were asked to recount how they learned about adult circumcision, why they decided it was right for them, what they feared most, how they overcame their fears, and the steps they took to make it to the clinic that day. Thematic analysis across all cases allowed us to identify key behavior change triggers while within-case analysis elucidated variants of one predominant behavior change pattern. Major stages included: awareness and critical belief adjustment, norming pressures and personalization of advantages, a period of fear management and finally VMMC-seeking. Qualitative comparative analysis of ever-married and never-married men revealed important similarities and differences between the two groups. Unprompted, 17 of the men described one to four failed prior attempts to become circumcised. Experienced more frequently by older men, failed VMMC attempts were often due to service-side barriers. Findings highlight intervention opportunities to increase VMMC uptake. Reaching uncircumcised men via close male friends and female sex partners and tailoring messages to stage-specific concerns and needs would help accelerate men's movement through the behavior change process. Expanding service access is also needed to meet current demand. Improving clinic efficiencies and introducing time-saving procedures and advance scheduling options should be considered.

Project description:BackgroundThe epidemiological and programmatic implications of inclusivity of HIV-positive males in voluntary medical male circumcision (VMMC) programs are uncertain. We modeled these implications using Zambia as an illustrative example.Methods and findingsWe used the Age-Structured Mathematical (ASM) model to evaluate, over an intermediate horizon (2010-2025), the effectiveness (number of VMMCs needed to avert one HIV infection) of VMMC scale-up scenarios with varying proportions of HIV-positive males. The model was calibrated by fitting to HIV prevalence time trend data from 1990 to 2014. We assumed that inclusivity of HIV positive males may benefit VMMC programs by increasing VMMC uptake among higher risk males, or by circumcision reducing HIV male-to-female transmission risk. All analyses were generated assuming no further antiretroviral therapy (ART) scale-up. The number of VMMCs needed to avert one HIV infection was projected to increase from 12.2 VMMCs per HIV infection averted, in a program that circumcises only HIV-negative males, to 14.0, in a program that includes HIV-positive males. The proportion of HIV-positive males was based on their representation in the population (e.g. 12.6% of those circumcised in 2010 would be HIV-positive based on HIV prevalence among males of 12.6% in 2010). However, if a program that only reaches out to HIV-negative males is associated with 20% lower uptake among higher-risk males, the effectiveness would be 13.2 VMMCs per infection averted. If improved inclusivity of HIV-positive males is associated with 20% higher uptake among higher-risk males, the effectiveness would be 12.4. As the assumed VMMC efficacy against male-to-female HIV transmission was increased from 0% to 20% and 46%, the effectiveness of circumcising regardless of HIV status improved from 14.0 to 11.5 and 9.1, respectively. The reduction in the HIV incidence rate among females increased accordingly, from 24.7% to 34.8% and 50.4%, respectively.ConclusionImproving inclusivity of males in VMMC programs regardless of HIV status increases VMMC effectiveness, if there is moderate increase in VMMC uptake among higher-risk males and/or if there is moderate efficacy for VMMC against male-to-female transmission. In these circumstances, VMMC programs can reduce the HIV incidence rate in males by nearly as much as expected by some ART programs, and additionally, females can benefit from the intervention nearly as much as males.

Project description:BackgroundOverwhelming evidence, including three clinical trials, shows that male circumcision (MC) reduces the risk of HIV infection among men. However, data from recent Lesotho Demographic and Health Surveys do not demonstrate MC to be protective against HIV. These contradictory findings could partially be due to inaccurate self-reported MC status used to estimate MC prevalence. This study describes MC characteristics among men applying for Lesotho Defence Force recruitment and seeks to assess MC self-reported accuracy through comparison with physical-examination-based data.Methods and findingsDuring Lesotho Defence Force applicant screening in 2009, 241 (77%) of 312 men, aged 18-25 y, consented to a self-administered demographic and MC characteristic survey and physician-performed genital examination. The extent of foreskin removal was graded on a scale of 1 (no evidence of MC) to 4 (complete MC). MC was self-reported by 27% (n?=?64/239) of participants. Of the 64 men self-reporting being circumcised, physical exam showed that 23% had no evidence of circumcision, 27% had partial circumcision, and 50% had complete circumcision. Of the MCs reportedly performed by a medical provider, 3% were Grade 1 and 73% were Grade 4. Of the MCs reportedly performed by traditional circumcisers, 41% were Grade 1, while 28% were Grade 4. Among participants self-reporting being circumcised, the odds of MC status misclassification were seven times higher among those reportedly circumcised by initiation school personnel (odds ratio?=?7.22; 95% CI?=?2.29-22.75).ConclusionsApproximately 27% of participants self-reported being circumcised. However, only 50% of these men had complete MC as determined by a physical exam. Given this low MC self-report accuracy, countries scaling up voluntary medical MC (VMMC) should obtain physical-exam-based MC data to guide service delivery and cost estimates. HIV prevention messages promoting VMMC should provide comprehensive education regarding the definition of VMMC.

Dataset Information

Reducing provider workload while preserving patient safety via a two-way texting intervention in Zimbabwe's voluntary medical male circumcision program: study protocol for an un-blinded, prospective, non-inferiority, randomized controlled trial.

Publications

Reducing provider workload while preserving patient safety via a two-way texting intervention in Zimbabwe's voluntary medical male circumcision program: study protocol for an un-blinded, prospective, non-inferiority, randomized controlled trial.

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