Voluntary Medical Male Circumcision Clinical Trial
Official title:
Expanding and Scaling Two-way Texting to Reduce Unnecessary Follow-Up and Improve Adverse Event Identification Among Voluntary Medical Male Circumcision (VMMC) Clients in the Republic of South Africa
Voluntary medical male circumcision (alternatively abbreviated in the literature as VMMC or 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. A randomized control trial (RCT) will rigorously evaluate how 2wT improves AE ascertainment and follow-up efficiency in urban and rural clinics. We aim to conduct an RCT to determine how 2wT increases AE ascertainment while reducing workload in the RSA implementation context. While the overall protocol covers multiple components over a 5-year study, this registration is specific to the RCT, aim 1.
The goals and procedures overview of the randomized control trial (RCT) are to: 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 on or before the Day 14 post-MC visit and average number of in-person follow- ups control and intervention arms. For the RCT, the investigators will enroll 1104 VMMC-seeking, healthy South African men ages 18 and older in 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 RCT will be randomly assigned 1:1 to intervention or control condition. STUDY DESIGN RCT Study overview: 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. Study Procedures: PARTICIPANT OVERVIEW: • 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). 1. Technology optimization 2. RECRUITMENT AND INFORMED CONSENT (RCT): 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. 3. 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. 4. Standard VMMC care (Control arm): For the 552 men randomized into the control arm, the investigators follow all NDOH protocols based on World Health Organization (WHO) guidelines including routine surgical VMMC follow-up on post-surgery days 2, 7 and 21. 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. 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. 5. 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. 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, 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. Day 14 visit may take place between days 13 and 22, depending on logistics, including patient transportation or delays. ;
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