Text-based Follow-up in Zimbabwe's Voluntary Medical Male Circumcision Program
Condition: Voluntary Medical Male Circumcision
Study type: Interventional

Summary: 
      Voluntary medical male circumcision (VMMC) in sub-Saharan Africa is safe: the average rate of
      moderate and severe adverse events (AEs) at the country level is 0.8%, corresponding to 99%
      of men healing without incident. To reach the global target of 20 million by 2018, VMMC
      productivity needs to double in countries already plagued by severe healthcare worker
      shortages like Zimbabwe. The ZAZIC consortium partners with the Zimbabwe Ministry of Health
      and Child Care (MoHCC) and performed over 120,000 VMMCs. Current VMMC care in Zimbabwe
      requires in-person, follow-up visits at post-operative days 2,7, and 42. Over 95% adhere to
      multiple follow-up visits within 14 days of VMMC. ZAZIC's program has an overall AE rate of
      0.4%; therefore, overstretched clinic staff conducted more than 200,000 unnecessary reviews
      for VMMC clients without complications. High mobile phone ownership, severe healthcare worker
      shortages, and rapid VMMC scale up make ZAZIC's VMMC program an ideal setting to test a
      mobile health (mHealth) intervention to reduce provider workload while safeguarding patient
      safety. Through an un-blinded, prospective, randomized, control trial (RCT) in high-volume
      facilities providing VMMC, ZAZIC will implement an interactive, two-way texting (2wT)
      intervention to identify men healing without complication, allowing them to decline routine
      in-person follow up visits. 2wT will simultaneously identify men with any sign of an adverse
      event, encouraging rapid in-person follow-up when an AE is suspected on any day, reducing
      unnecessary visits while maintaining quality care. We aim to 1) determine if 2wT can safely
      reduce VMMC follow-up visits; 2) estimate the cost savings associated with 2wT over routine
      VMMC follow-up; and 3) assess the acceptability and feasibility of 2wT for further scale-up.
      It is expected that this intervention with be as safe as routine care while providing
      distinct advantages in terms of efficiency, costs, and reduced healthcare worker burden. This
      approach is innovative as it focuses on using a low-cost mHealth intervention to reduce
      provider workload without deterioration in quality care. The success of this intervention
      could lead to adoption of this intervention at the national level, increasing efficiency of
      VMMC scale up and reducing burdens on providers and patients
    

Detailed description: 
      The investigators propose to maintain patient safety while reducing the substantial VMMC
      follow-up workload burden by using two-way mobile phone texts to provide in-person review
      only for men who indicate a desire or need for follow-up. This tailored approach to
      post-procedure VMMC care could reduce unnecessary visits and remove barriers for VMMC clients
      without deterioration of quality care. ZAZIC's diverse, expert team of researchers from the
      University of Washington, Seattle, USA; the University of Zimbabwe; Medic Mobile, Nairobi,
      Kenya; and Zimbabwean partner organizations will test this mHealth intervention. The
      investigators believe that bi-directional, interactive, text-based short message service
      (SMS) during the most critical 14 days after circumcision will help men identify and act on
      any sign of an adverse event, thereby seeking in-person follow-up only when an AE is
      suspected and reducing unnecessary visits. Reduced in-person follow-up could also free
      healthcare workers to perform additional VMMC surgeries. Using a prospective, randomized
      control trial (RCT), our intervention compares two groups of clients with cell phones: 1)
      standard care (control group) and 2) clients who receive and respond to a daily text with
      in-person follow-up only if desired or if an AE is suspected (intervention). Both arms
      complete a study-specific, Day 14, in-person, follow-up review for verification of
      self-reports (intervention) and comparison (control). Our specific aims are to:

      Aim 1: Determine if 2-way texting can safely reduce VMMC follow-up visits Approach:
      Un-blinded, prospective, non-inferiority, RCT in high-volume facilities providing VMMC.
      Two-way texting (2wT) will provide interactive, text-based follow-up. 2wT men healing without
      complication could decline in-person follow-up; those with suspected AEs will be referred to
      in-person care. The investigators will compare the safety outcome of combined moderate or
      severe AE rate ≤ Day 14 post-VMMC and the workload outcome of average number of in-person
      follow-up visits between control and intervention arms.

      Aim 2: Estimate the cost savings associated with 2wT over routine VMMC follow-up Approach:
      The investigators will determine the programmatic costs of 2wT from a systems perspective,
      including the technology [24], healthcare worker costs, and client perspective. The
      investigators will estimate the incremental intervention costs relative to standard practice
      to quantify gains in healthcare efficiency for scale-up and adoption.

      Aim 3: Assess the acceptability and feasibility of 2wT for further scale-up Approach:
      Qualitative interviews with VMMC healthcare workers and brief quantitative interviews with
      2wT clients inform intervention acceptance. Meetings with local researchers and collaborators
      will further assess feasibility, adaptation, open-source collaborative development, and
      system integration for replication and sustainability in Zimbabwe and the region.

      APPROACH Study overview: Following usability testing with both healthcare workers and 2wT
      VMMC clients, The investigators will test if two-way texting (2wT) reduces unnecessary
      follow-up visits without compromising patient safety (Aim 1) using a randomized control trial
      in large, urban VMMC clinics. The investigators will assess the costs of 2wT from technology,
      healthcare worker, and client perspectives to determine the costs incurred by MoHCC if
      adopted for scale-up (Aim 2). The investigators will assess acceptability and feasibility
      working towards system integration and sustainability in Zimbabwe and beyond (Aim 3).

      Aim 1: Technology overview: Studies that demonstrate the impacts of mHealth interventions too
      often have evaluated technologies that are made 'from scratch' and as a result are not robust
      enough to merit widespread replication [48, 74]. By partnering with a well-established
      non-profit mHealth organization, Medic Mobile (http://medicmobile.org/), and integrating with
      their existing software platform, open-source community and current efforts to integrate with
      existing health information systems (HIS) throughout sub-Saharan Africa, our team and
      proposed intervention are well positioned to scale up and sustain any promising results.
      Since 2008, Medic Mobile has been a leader in the global mHealth community [75-77], equipping
      more than 13,500 health workers serving over 8 million people across 23 countries. The Mobile
      Medic Toolkit is an Android-based application that supports texting in any language and works
      with or without internet connectivity on basic phones, smartphones, tablets, and computers
      [78]. The existing, well-proven, app-based Toolkit that will be the basis for 2wT provides an
      automated and prioritized list of upcoming tasks, guiding health worker through actions
      (e.g., response waiting, referral). The Toolkit provides real-time progress indicators such
      as texting delivery rates and response rates. Data from mobile users are replicated to Medic
      Mobile web app and analytics tools for real-time response. The platform is highly
      configurable, currently supporting evidence-backed workflows and program implementation
      related to ensuring safe deliveries [79], tracking tuberculosis patients [80], boosting
      immunization rates [81] and monitoring stocks of essential medicines [82]. These adaptable
      tools are free, open-source, and developed using human-centered design with input from people
      delivering care in the hardest-to-reach communities. While this technology has never been
      used in a VMMC program and requires adaptation of the clinical content, the existing 2wT
      software toolkit already contains the robust messaging features discussed in this proposal
      (Figure 2). The software adaptation process to alter and test alternative clinical content
      and the local specifications requires little additional software development. The adaptation
      process will be completed by co-investigator, Holeman, with additional technical and training
      support provided by Nairobi-based technical experts.

      Study sites and population: In Zimbabwe, 81% of people already had mobile phone subscriptions
      in 2014 [83], indicating that the technology infrastructure exists and uptake is high. 2wT
      will be implemented in existing VMMC sites in the Chitungwiza District, a district
      purposefully selected for its high VMMC volume clinic locations. Chitungwiza District, a
      suburb of Harare, has an estimated 300,000 eligible, HIV-negative men ages 15-29; only 14% of
      eligible men have been circumcised to date. The investigators will implement 2wT in up to 5
      ZAZIC VMMC sites in Chitungwiza, sites averaging 50-200 VMMC/month. About 80% of VMMC clients
      are surgical, rather than PrePex device-based, clients.

      Study preparation: The investigators will conduct a rapid situation analysis with healthcare
      workers, VMMC clients, and stakeholders to assess suitable responses to VMMC client texts,
      setting standards for text responses and in-person follow-up. The investigators will modify
      existing usability surveys for this public health context. A small pilot with 50 VMMC clients
      will include usability testing with both 2wT clients and nurses implementing the 2wT system,
      illuminating system experiences from both perspectives. Usability results will inform in-box
      modification, message format preferences (SMS or WhatsApp) and optimal message delivery
      (timing, frequency, language preferences). Experience from study coordinator and other team
      members will add detail to inform 2wT adaptation and modification of Standard Operating
      Procedures before implementation. The investigators will examine local infrastructure (e.g.
      electricity and cell network), and explore 2wT cost reduction options (e.g., text bundling,
      free-call back numbers) and adapt accordingly

      Standard VMMC care (Control arm): ZAZIC follows all MoHCC protocols based on WHO guidelines
      [20] including routine surgical VMMC follow-up on post-surgery days 2, 7 and 42 (Table 1).
      Patients may seek care outside scheduled visits for suspicion of AEs at any healthcare
      facility at any time but most often return to their VMMC site. Referral cards for VMMC
      clients provide local numbers for patients to text, call, or request a call back for
      emergencies. A standardized approach is used to assess, identify, and record the severity of
      AEs [51]. All VMMC care, from assessment of all AEs through complete healing, is provided
      free to clients from MoHCC. Clients who do not return to the clinic for follow-up on Day 2 or
      Day 7 are traced: 3 attempts by phone and then up to 3 attempts at in-person tracking after
      which they are considered lost to follow-up (LTFU) [52]. There is no tracing for Day 42
      visits. For the purposes of this study, control arm VMMC clients will be asked to come in on
      Day 14 for an additional follow-up visit. No active follow-up is provided at Day 14.

      VMMC care procedures (2wT arm): The investigators will conduct a prospective, un-blinded,
      randomized control trial (RCT) among VMMC clients in a 1:1 ratio of control to intervention.
      Study participants and clinic staff are not masked to treatment. Men in the 2wT will receive
      routine VMMC surgical care and counseling, including referral cards for emergencies. 2wT
      clients will receive automated daily texts from days 1-14 (Table 1 and Figure 3). It is free
      to receive call and texts; it costs $0.05 to send a SMS in Zimbabwe [84]. If they respond
      that they suspect no adverse event, no immediate follow-up action will be taken. If a 2wT
      VMMC client responds affirmatively to any daily text that he suspects an AE, a VMMC nurse
      will exchange modifiable, scripted texts with the client to determine the symptoms,
      frequency, and severity. Then, if deemed necessary, the client will be asked to return to
      clinic the following day or earlier if an emergency is suspected. AE management will adhere
      to MoHCC standard care. If 2wT patients do not respond to texts on Day 2 or Day 7, the same
      MoHCC tracing process will be activated, after which they will be considered LTFU. All study
      participants will be asked to come to the clinic for study-specific, Day 14 follow-up to
      review healing and verify adverse event reporting. Day 14 was chosen for verification because
      95% of all AEs within the ZAZIC VMMC program are reported Day 14 or earlier [50], suggesting
      that most AEs have occurred by this time point. In a previous field study of AEs, the most
      common AEs of bleeding and infection were found a mean of 6.7 and 9.0 days, respectively,
      after VMMC [29], further supporting the 14 day period used in this and a previous study[5].
      The Day 14 review will be conducted by routine VMMC providers according to MoHCC review
      guidelines. At Day 42, The investigators will implement a brief text-based survey with 2wT
      clients to ascertain complete healing, providing stronger inferences at study completion.
    

Intervention name(s): Text-based follow-up
Intervention type(s): Other
Intervention description(s): 2wT clients will receive automated daily texts from days 1-14. If a 2wT VMMC client responds that he suspects an AE, a VMMC nurse will exchange modifiable, scripted texts with clients to determine symptoms, frequency, and severity. Then, if deemed necessary, the client will be asked to return to clinic the following day or earlier. If 2wT patients do not respond to texts on Day 2 or Day 7, the same MoHCC tracing process will be activated, after which they will be considered LTFU. All study participants will be asked to come to the clinic for study-specific, Day 14 follow-up to review healing and verify adverse event reporting. At Day 42, we will implement a brief text-based survey with 2wT clients to ascertain complete healing, providing stronger inferences at study completion.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigators will conduct a prospective, un-blinded, randomized control trial (RCT) among VMMC clients in a 1:1 ratio of control to intervention. Study participants and clinic staff are not masked to treatment.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: male circumcision, text-based follow-up, Zimbabwe,