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Text-based Follow-up in Zimbabwe's Voluntary Medical Male Circumcision Program (2WT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119337
Recruitment Status : Active, not recruiting
First Posted : April 18, 2017
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
Medic Mobile
International Training and Education Center for Health
ZICHIRe
University of Zimbabwe
Information provided by (Responsible Party):
Caryl Feldacker, University of Washington

Brief 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

Condition or disease Intervention/treatment Phase
Voluntary Medical Male Circumcision Other: Text-based follow-up Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 780 participants
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
Official Title: Reducing Provider Workload While Preserving Patient Safety: A 2-Way Texting Intervention in Zimbabwe's Voluntary Medical Male Circumcision Program
Actual Study Start Date : June 18, 2018
Actual Primary Completion Date : February 28, 2019
Estimated Study Completion Date : August 30, 2019

Arm Intervention/treatment
Experimental: Text-based VMMC follow-up
Follow-up conducted via daily text not through mandatory in person visits. Men may elect to come to the clinic if concerned about any complications but have no routine, scheduled follow-up visits.
Other: Text-based follow-up
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.

No Intervention: Routine VMMC follow-up care
Routine VMMC follow up care with in person visits according to national guidelines.



Primary Outcome Measures :
  1. Cumulative adverse event (AE) rate (moderate or severe) [ Time Frame: ≤ Day 14 for each participant with analysis completed in year 1. ]
    Incidence of AEs before Day 14 will be extracted from routine VMMC data for both 2wT and control. Incident AEs on Day 14 will be identified, classified, and graded for severity using routine MoHCC protocols [26] and recorded on routine VMMC AE forms. The investigators will compare cumulative rates of any moderate or severe AE ≤ Day 14 between groups using Fisher's exact test as the expected number of AEs is low. The rates will be calculated per arm as: (# moderate + severe AEs)/(total # VMMC clients who attend 2, 7 or 14 Day follow-up visit). Multivariate logistic regression models (any AE v none) will quantify the magnitude of difference, adjusting for any potential confounders.

  2. Mean number of in-person visits [ Time Frame: Before 42 day visit for each participant with analysis completed in year 1. ]
    To determine follow-up visit reduction, the investigators will compare the mean number of in-person visits for intervention and control using a t-test. A multivariate linear regression model will further quantify the effect of intervention on visit reduction, adjusting for potential confounders.

  3. 2wT costs [ Time Frame: The costing data collection will be completed by April 2018 at the completion of all study participant follow-up. Analysis will conclude in year 1 ]
    The investigators will calculate the relative costs and outcomes (effects) of intervention versus control, including costs for technology, healthcare worker time, and client considerations (travel, text costs, missed work). The investigators will conduct both activity-based costing from the implementation perspective and from the technology perspective to extrapolate results as costs that would be incurred by the MoHCC should they elect widespread scale up of 2wT.

  4. 2WT acceptability [ Time Frame: The acceptability activities will be completed by April 2018 at the completion of all study participant follow-up with analysis to commence after that point. Analysis will conclude in year 1. ]
    2wT acceptability, using study recruitment and enrollment logs in addition to the texting database, the investigators will describe levels of acceptance, participation, refusal and drop-out. The investigators will carry out key informant interviews (KIIs) with up to 8 health care workers to gauge acceptability, satisfaction, identify facilitators and barriers to program success, and ascertain suggestions for intervention improvement. KIIs will be audio recorded and transcribed. The investigators will also implement questionnaires at the Day 14 visit with a subset of 100 2wT VMMC clients to gauge satisfaction, estimate direct and indirect costs (time away from work, transportation costs), and ascertain suggestions for intervention improvement.

  5. 2WT feasibility [ Time Frame: The feasibility activities be completed by April 2018 at the completion of all study participant follow-up with analysis to commence after that point. Analysis will conclude in year 1. ]
    For feasibility, costing data will be combined with usability and acceptability information.


Secondary Outcome Measures :
  1. AE rates on Day 14 [ Time Frame: Day 14 data collection for each participant with analysis to be completed in year 1. ]
    AE rates on Day 14

  2. severity of AEs. [ Time Frame: Day 14 data collection for each participant with analysis to be completed in year 1. ]
    severity of AEs.

  3. time between 2wT AE text reporting and follow-up [ Time Frame: Day 14 data collection for each participant with analysis to be completed in year 1. ]
    time between 2wT AE text reporting and follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only men will be enrolled in the study on male circumcision. Health care workers may be male or female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion: For health care workers (Aim 3):

  1. are employees posted at the site;
  2. are at least 18 years of age or over;
  3. provide health care services to patients as part of the VMMC programs; and
  4. are able to provide written informed consent.

For VMMC clients (Aims 1): Eligibility criteria for VMMC clients are:

  1. 18 years or older;
  2. possession of own phone at enrollment;
  3. provides contact details (phone, physical location);
  4. receives surgical VMMC;
  5. willing to follow MoHCC VMMC protocols;
  6. willing to come in Day 14;
  7. Able and willing to respond to a questionnaire administered by phone 42 days after circumcision.

Exclusion for Healthcare workers:

  1. not willing to participate
  2. not willing to be recorded

Exclusion for VMMC clients:

  1. men without cell phones;
  2. those who chose PrePex as PrePex requires a device-removal visit 7 days after placement and has distinctly different follow-up protocols;
  3. men who have an inter-operative AE during routine VMMC will be withdrawn from the study as these men will have known, additional follow-up risks and mandatory in-person visits.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119337


Locations
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Zimbabwe
1. Chitungwiza Central Hospital
Chitungwiza, Stand Number 12096 Batanai ROAD Zengeza 4, Zimbabwe
2. South Medical Citimed Chitungwiza Hospital
Chitungwiza, Stand Number 14656 Zengeza 4, Zimbabwe
5. Seke North Clinic
Seke North, Stand Number: 16106 UNIT G, Zimbabwe
4. Seke South Clinic
Seke South, Stand Number: 19188 UNIT L, Zimbabwe
Zengeza 3 Clinic
Chitungwiza, Stand Number: 7723 Cheuka WAY Zengeza 3, Zimbabwe
Sponsors and Collaborators
University of Washington
Medic Mobile
International Training and Education Center for Health
ZICHIRe
University of Zimbabwe
Investigators
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Principal Investigator: Caryl Feldacker, PhD, MPH University of Washington

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Caryl Feldacker, Clinical Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03119337    
Other Study ID Numbers: STUDY00001839
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share IPD with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Caryl Feldacker, University of Washington:
male circumcision, text-based follow-up, Zimbabwe,