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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,093
- 试验地点
- 14
- 主要终点
- Cumulative Percentage of Patients With an Adverse Event (AE) (Moderate or Severe) on or Before Day 14 Visit
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For VMMC clients:
- •are at least 18 years of age or over
- •Possession of own phone at enrollment
- •Willing to respond to daily text
- •Provides contact details (phone, address)
- •Undergoes surgical MC
- •Willing to follow NDoH VMMC protocols
- •No interoperative AE
- •Informed consent
- •Receives confirmed 2wT enrollment text.
排除标准
- •For VMMC clients:
- •Not meeting above requirements
- •Men without cell phones
- •Men who chose PrePex device-based VMMC
- •Inter-operative AE during VMMC
- •No informed consent
结局指标
主要结局
Cumulative Percentage of Patients With an Adverse Event (AE) (Moderate or Severe) on or Before Day 14 Visit
时间窗: Any AE before, and including, up to 22 days post VMMC to allow for logistical issues delaying attendance of the Day 14 visit
AE rates are a global indicator of VMMC quality. This is a standard WHO and US PEPFAR government indicator as indicated in the attached reference material: PEPFAR's Best Practices for Voluntary Medical Male Circumcision Site Operations. 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 Ministry of Health protocols and recorded on routine VMMC AE forms. The investigators will compare cumulative rates of any moderate or severe AE on or before 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: (num moderate plus severe AEs)/(total num VMMC clients who attend 2, 7 or 14 Day follow-up visit). Multivariate logistic regression models (any AE versus none) will quantify the magnitude of difference, adjusting for any potential confounders
Number of Non-study In-person Visits
时间窗: Less than or equal to 42 days post-operative
To determine follow-up visit reduction, the investigators will compare the number of in- person visits for intervention and control using a t-test.
次要结局
- Percent of Adverse Events (AE) Identified /on/ Day 14 Visit(AEs identified during Day 14 visits that occurred only in the window between post-operative days 13-22)
- Number VMMC-related Severe Adverse Events Over 22 Post-operative Days(Within 22 days post operative)
研究者
Caryl Feldacker
Assistant Professor, School of Public Health, Global Health
University of Washington