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
|Condition or disease||Intervention/treatment||Phase|
|Voluntary Medical Male Circumcision||Other: Text-based follow-up||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||780 participants|
|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|
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.
- 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  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.
- 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.
- 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.
- 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.
- 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.
- 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
- severity of AEs. [ Time Frame: Day 14 data collection for each participant with analysis to be completed in year 1. ]severity of AEs.
- 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
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
|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|
|Principal Investigator:||Caryl Feldacker, PhD, MPH||University of Washington|