Text-based Follow-up in Zimbabwe's Voluntary Medical Male Circumcision Program

NCT03119337 | Completed DMC

• 1 other identifier: STUDY00001839
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 5

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

Conditions

Voluntary Medical Male Circumcision

Keywords

male circumcision, text-based follow-up, Zimbabwe,

Outcome Measures

Primary Outcomes (5)

• Cumulative adverse event (AE) rate (moderate or severe)

  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.

  ≤ Day 14 for each participant with analysis completed in year 1.

• Mean number of in-person visits

  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.

  Before 42 day visit for each participant with analysis completed in year 1.

• 2wT costs

  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.

  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

• 2WT acceptability

  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.

  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 feasibility

  For feasibility, costing data will be combined with usability and acceptability information.

  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.

Secondary Outcomes (3)

• AE rates on Day 14

  Day 14 data collection for each participant with analysis to be completed in year 1.

• severity of AEs.

  Day 14 data collection for each participant with analysis to be completed in year 1.

• time between 2wT AE text reporting and follow-up

  Day 14 data collection for each participant with analysis to be completed in year 1.

Study Arms (2)

Text-based VMMC follow-up

EXPERIMENTAL

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

Routine VMMC follow-up care

NO INTERVENTION

Routine VMMC follow up care with in person visits according to national guidelines.

Interventions

Text-based follow-up OTHER

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.

Text-based VMMC follow-up

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Only men will be enrolled in the study on male circumcision. Health care workers may be male or female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are employees posted at the site;
• are at least 18 years of age or over;
• provide health care services to patients as part of the VMMC programs; and
• are able to provide written informed consent.
• For VMMC clients (Aims 1): Eligibility criteria for VMMC clients are:
• years or older;
• possession of own phone at enrollment;
• provides contact details (phone, physical location);
• receives surgical VMMC;
• willing to follow MoHCC VMMC protocols;
• willing to come in Day 14;
• Able and willing to respond to a questionnaire administered by phone 42 days after circumcision.
• not willing to participate
• not willing to be recorded
• men without cell phones;

Sponsors & Collaborators

• University of Washington: lead
• Medic Mobile: collaborator
• International Training and Education Center for Health: collaborator
• ZICHIRe: collaborator
• University of Zimbabwe: collaborator

Study Sites (5)

1. Chitungwiza Central Hospital

Chitungwiza, Stand Number 12096 Batanai ROAD Zengeza 4, Zimbabwe

Location

2. South Medical Citimed Chitungwiza Hospital

Chitungwiza, Stand Number 14656 Zengeza 4, Zimbabwe

Location

5. Seke North Clinic

Seke North, Stand Number: 16106 UNIT G, Zimbabwe

Location

4. Seke South Clinic

Seke South, Stand Number: 19188 UNIT L, Zimbabwe

Location

Zengeza 3 Clinic

Chitungwiza, Stand Number: 7723 Cheuka WAY Zengeza 3, Zimbabwe

Location

Related Publications (4)

• Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

  PMID: 32779730 DERIVED

• Feldacker C, Holeman I, Murenje V, Xaba S, Korir M, Wambua B, Makunike-Chikwinya B, Holec M, Barnhart S, Tshimanga M. Usability and acceptability of a two-way texting intervention for post-operative follow-up for voluntary medical male circumcision in Zimbabwe. PLoS One. 2020 Jun 16;15(6):e0233234. doi: 10.1371/journal.pone.0233234. eCollection 2020.

  PMID: 32544161 DERIVED

• Feldacker C, Murenje V, Holeman I, Xaba S, Makunike-Chikwinya B, Korir M, Gundidza PT, Holec M, Barnhart S, Tshimanga M. 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. J Acquir Immune Defic Syndr. 2020 Jan 1;83(1):16-23. doi: 10.1097/QAI.0000000000002198.

  PMID: 31809358 DERIVED

• Feldacker C, Murenje V, Barnhart S, Xaba S, Makunike-Chikwinya B, Holeman I, Tshimanga M. 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. Trials. 2019 Jul 23;20(1):451. doi: 10.1186/s13063-019-3470-9.

  PMID: 31337414 DERIVED

Study Officials

• Caryl Feldacker, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 18, 2017
• Study Start: June 18, 2018
• Primary Completion: February 28, 2019
• Study Completion: August 30, 2019
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ZI (5)