2wT_RSA: Two-way Texting for VMMC Follow-up in Republic of South Africa
Study Details
Study Description
Brief Summary
Male circumcision (MC) is a critical HIV prevention intervention with global support for expansion across sub-Saharan Africa (SSA). MC is safe: routine programs in SSA report adverse event (AE) rates well under 2%. Nevertheless, global MC guidelines require one or more follow-up visits within 14 days for AE detection. Our prior research in Zimbabwe employed two-way texting (2wT) between patients and providers to focus follow-up on men with potential AEs, allowing men healing without complication to opt-out of routine post-operative visits. 2wT safely reduced client visits by 85%, suggesting that 2wT can make MC services dramatically more efficient while maintaining safety. In the Republic of South Africa (RSA), high-volume urban clinics, remote service delivery, and low AE identification threaten quality at scale. Across more than 500,000 annual MCs performed, up to 1 million multi-stage, unnecessary MC reviews are likely conducted. RSA pressure for MC expansion and severe health system constraints, combined with good cell coverage, suggest 2wT's impact would be significant for MC care quality and efficiency, especially in rural areas. Therefore, the investigators seek to develop an adaptable 2wT dissemination and implementation model at scale (2wT-2-SCALE) delivered by routine MC teams, not research teams. First, a randomized control trial (RCT) (phase 1: test) will rigorously evaluate how 2wT improves AE ascertainment and follow-up efficiency in urban and rural clinics. Then (phase 2: intensive), the investigators scale (2wT-2-SCALE) via a one-year, quasi-experimental, step-wedge design with insights gained from one additional year of 2wT with routine MC teams (phase 3: maintain). Guided by implementation science, the investigators employ mixed-methods to evaluate 2wT-2-SCALE's impact on VMMC service quality. Our specific aims are to 1) conduct an RCT to determine how 2wT increases AE ascertainment while reducing workload in the RSA implementation context; 2) develop an effective dissemination and implementation strategy at scale (2WT-2-SCALE) using RE-AIM to evaluate program reach, effectiveness, adoption, implementation, and maintenance; and 3) use activity based micro-costing to estimate the payer-perspective budget and program impact from 2wT scale-up compared to routine care.
| Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
The goals and procedures overview of the proposed project are to:
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Aim 1: Generate SA evidence determining how 2wT increases AE ascertainment while reducing workload via an un-blinded, prospective, non-inferiority, RCT in urban and rural contexts comparing moderate or severe AE rate ≤ Day 14 post-MC and average number of in-person follow- ups control and intervention arms. For Aim 1, the investigators will enroll 50 and 1104 VMMC-seeking, healthy South African men ages 18 and older in a pilot and the trial, respectively, with cell phones who are seeking VMMC service at up to 5 health facilities/areas (1 urban and 4 rural) for participation in the randomized controlled study of the two-way texting (2wT) intervention. Men in the pilot will not be randomized and will be assigned texting. Men in the RCT will be randomly assigned 1:1 to intervention or control condition. The investigators will also conduct brief surveys with a subset up to 100 2wT study participants. Up to 10 key informant interviews will also be conducted with healthcare workers and NDoH workers. Only Aim 1 is a clinical trial.
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Aim 2: To develop an effective dissemination and implementation strategy at scale (2WT-2-SCALE), using RE-AIM-based evaluation of program Reach, Effectiveness, Adoption, Implementation, and Maintenance. For aim 2, 800 new human subjects will be involved in prospective data collection for a 2wT intensive phase that is opt-in - clients will not be randomized. The investigators will also interview up to 25 new key informants with healthcare workers and NDoH workers.
Aim 2 sub aims include:
Aim 2a) Reach: Proportion of 2wT-2-SCALE outreach-based (rural) MC clients reached (target:70% of eligible men in 1 Limpopo district by year 4 (maintenance)).
Aim 2b) Effectiveness: Assess 2wT-2-SCALE effect on MC program process measures (AE rate,# in-person visits), and at the individual level (2wT response rate, AE severity) in rural Limpopo (intensive + maintenance); Aim 2c) Adoption: Apply Diffusion of Innovation 34 via mixed-methods assessment of 2wT-2- SCALE provider acceptability, appropriateness, and feasibility to predict individual level adoption (target: 95%); Aim 2d) Implementation: Measure fidelity to 2wT-2-SCALE intervention (protocol adherence); facilitators and barriers to implementation described using the Consolidated Framework for Implementation Research (CFIR); Aim 2e) Maintenance: % of target MC districts sustaining 2wT as designed in maintenance phase (target: >90% at 6 months, >80% at 12 months, and >70% at 18 months).
- Aim 3: Use activity based micro-costing to estimate the budget and program impact from the payer perspective to scale-up the 2wT intervention compared to the standard of care. For Aim 3, no human subjects will be involved.
Aim 1 STUDY DESIGN: Phase 1 RCT Study overview: Following usability testing with both healthcare workers and 2wT VMMC clients during a 50-man pilot, the investigators will test if two-way texting (2wT) reduces unnecessary follow-up visits without compromising patient safety using a randomized control trial of 1104 men randomized 1:1 in 1 large, urban VMMC clinic and 4 rural sites clustered within one implementation team. The investigators will assess acceptability and feasibility working towards system integration and sustainability in RSA and beyond. Qualitative interviews with 2wT teams help inform acceptability, feasibility, and usability.
Study Procedures:
PARTICIPANT OVERVIEW:
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Based on prior experience in Zimbabwe, up to 50 men (25 rural and 25 urban) assigned to texting intervention will be needed for the pilot depending to reach maximum system stability (after making adaptations) and to reach healthcare worker efficiency and comfort. This increases the quality of the full study. Not randomized. Enrolled into texting. Not included in outcome analysis.
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1104 men in the full study randomized in a 1:1 ratio of texting and control for 552 men in texting and 552 in control (routine care).
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Same recruitment, consent, and follow-up procedures in pilot and intervention as outlined, per group, below
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10 healthcare workers for qualitative interviews for the RCT
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Study preparation: PILOT 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 who will be enrolled in the texting intervention will include usability testing with both 2wT clients and nurses implementing the 2wT system, illuminating system experiences from both perspectives to inform full study implementation. Data from the pilot will not be included in the analysis.
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RECRUITMENT AND INFORMED CONSENT (PILOT AND FULL STUDY):
Each site will establish local recruitment and screening methods that operationalize protocol-specified requirements for eligibility determination in a manner that is tailored to and most efficient for the local study setting and target study population. In brief, information about the study will be disseminated at the selected sites. VMMC demand creation as part of routine program practice will support study recruitment. HCW recruited for participation in the study will be reached at their workplaces (the health care facilities) following communication between the study team and the site leadership. VMMC clients will be recruited in the VMMC clinic area. Recruitment will be managed by a specifically-trained study coordinator who will meet with VMMC patients to sensitize them about the opportunity to participate in a study of text-based follow-up; those meeting eligibility criteria will be individually informed by study staff about the opportunity to participate. Interested patients will be referred to the site 2WT study coordinator. This person will meet with patients in a private setting, further explain the study, confirm study eligibility, and seek informed consent. Participant enrollment may be made by teams/clinicians using the Medic Mobile phone/tablet app or the laptop-based system.
- RANDOMIZATION PROCESS:
The investigators will conduct randomization using a randomized block design, ensuring that each group of 20 envelopes has 10 intervention and 10 control per block, shuffling each block to ensure a near random order. The full set of 1104 will be numbered before distribution to sites. Each group assignment envelope will be selected by the coordinator and then opened by the participant and shown to the coordinator or 2WT enrollment coordinator. Security envelopes will be used to help prevent selection of assigned group. Subjects within each block are randomly assigned to treatment conditions. This design reduces variability within treatment conditions and potential confounding, allowing for more interim analysis with near equal size groups and more certain randomization within sites.
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Standard VMMC care (Control arm): For the 552 men randomized into the control arm, the investigators follow all NDOH protocols based on WHO guidelines 1 including routine surgical VMMC follow-up on post-surgery days 2, 7 and 21 (Table 1) 2. 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 3. All VMMC care, from assessment of all AEs through complete healing, is provided free to clients. Clients who do not return to the clinic for follow-up on Day 2 or Day 7 are considered lost to follow-up (LTFU). 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. Active follow-up by phone call is provided at Day 14.
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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. For the 552 men randomized into the intervention arm, 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 1-13. It is free to receive call and texts; it costs approximately $0.04 to send a SMS in RSA 4. 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 NDOH standard care. 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. If 2wT patients do not respond to texts or phone and do not return on Day 14, they will be traced by SMS, Phone and up to 2 visits to their home after which they will be considered LTFU. Day 14 was chosen for verification because 95% of all AEs within a similar VMMC program in Zimbabwe are reported Day 14 or earlier 5, 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, further supporting the 14 day period used in this and a previous study. The Day 14 review will be conducted by routine VMMC providers according to NDOH review guidelines. At Day 21, The investigators will implement a brief text-based survey with 2wT clients to ascertain complete healing, providing stronger inferences at study completion.
HCW: Brief Qualitative interviews with staff will occur on or after the study mid-point when the system will be optimal. Interviews are only to solicit feedback for 2WT implementation, acceptability, and feasibility. Up to Ten HCWs will be interviewed, selected by convenience. HCWs can decline without repercussion on their employment. Interviews will be conducted in a private location by a trained interviewer who has extensive experience conducting qualitative interviews and will be able to effectively sensitize HCWs to the interview process. The interviews are brief. They are likely to take 5-15 minutes, but the investigators allow for 30 in case there is sufficient interest in sharing. They have a separate informed consent.
Study Design
Arms and Interventions
| 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. |
Behavioral: Text-based VMMC follow-up
2wT clients will receive automated daily texts from days 1-13. 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 or return for any visit by day 14, they will be traced by SMS, phone or home visit. 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 21, we will implement a brief text-based survey with 2wT clients to ascertain complete healing, providing stronger inferences at study completion.
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| No Intervention: Routine VMMC follow-up care Routine VMMC follow up care with in person visits according to national guidelines. |
Outcome Measures
Primary Outcome Measures
- Cumulative adverse event (AE) rate (moderate or severe) [≤ Day 14]
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 NDoH 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 [≤ 42 day visit]
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 [By 12 months post RCT]
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 NDoH should they elect widespread scale up of 2wT.
Secondary Outcome Measures
- Acceptability of the 2wT system for clients assessed through response rates [By 12 months post RCT]
Acceptability is the usefulness of the system as evidenced by clients who employ the technology for the intended purposes. Acceptability will be determined by average client response rates = # daily responses per client/13 texts.
- 2WT feasibility ascertained from interviews with healthcare workers [By 12 months post RCT]
For feasibility, the investigators will collect qualitative data from key informant interviews (KIIs) with up to 10 health care workers. These interviews will help identify facilitators and barriers to program success and help assess feasibility for scale up. KIIs will be audio recorded and transcribed.
- AE rates on Day 14 [Day 14 visit]
AE rates on Day 14
- AE severity [≤ Day 14]
# severe AEs/all reported AEs
- Time between 2wT AE text reporting and follow-up [≤ Day 14]
Time between 2wT AE text reporting and follow-up
Eligibility Criteria
Criteria
Inclusion Criteria:
For VMMC clients:
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are at least 18 years of age or over
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Possession of own phone at enrollment
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Willing to respond to daily text
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Provides contact details (phone, address)
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Undergoes surgical MC
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Willing to follow NDoH VMMC protocols
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No interoperative AE
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Informed consent
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Receives confirmed 2wT enrollment text.
For healthcare workers/key informants:
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are employees at the site/MC providers at the site or NDoH VMMC district level KII targets
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are at least 18 years of age or over
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provide health care services to patients as part of the VMMC programs; and
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are able to provide written informed consent. -
Exclusion Criteria:
For VMMC clients:
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Not meeting above requirements
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Men without cell phones
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Men who chose PrePex device-based VMMC
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Inter-operative AE during VMMC
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No informed consent
For healthcare workers/key informants:
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not willing to participate
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not willing to be recorded
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no informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mogwase | Mogwase | Bojanala | South Africa | |
| 2 | Bafokeng | Phokeng | Bojanala | South Africa | |
| 3 | Tsakane Clinic | Brakpan | Gauteng | South Africa | |
| 4 | Katlehong North Clinic | Katlehong | Gauteng | South Africa | |
| 5 | Winnie Mandela Male Health Clinic | Tembisa | Gauteng | South Africa | 1632 |
| 6 | Nchabeleng Community Health Centre | Apel | Limpopo | South Africa | 0739 |
| 7 | Philadelphia Hospital | Dennilton | Limpopo | South Africa | 1030 |
| 8 | Dilokong Hospital | Driekop | Limpopo | South Africa | 1129 |
| 9 | Matlala Hospital | Marble Hall | Limpopo | South Africa | 0450 |
Sponsors and Collaborators
- University of Washington
- Aurum Institute
- National Institute of Nursing Research (NINR)
Investigators
- Principal Investigator: Caryl Feldacker, PhD, MPH, University of Washington
- Principal Investigator: Geoffrey Setswe, DrPH, MPH, Aurum Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- STUDY00009703
- 1R01NR019229-01