I-TECH, in close partnership with voluntary medical male circumcision (VMMC) implementing partner, the Aurum Institute and technology partner, Medic, is conducting a five-year study funded by the National Institutes of Health to further evidence on the efficiency, safety, and scalability of two-way text-based (2wT) follow-up for VMMC services.
2wT is SMS-based telehealth, providing direct patient to provider communication that improves the quality of post-operative VMMC care. A daily educational message is sent to each participant, requesting a response to report potential complications. 2wT allows the nurse to triage men to care when needed or desired while supporting most men to heal independently at home. 2wT-based follow-up dramatically reduces unnecessary post-operative visits, saving patient and provider costs, while improving patient care quality through swift identification and referral for potential adverse events. In South Africa, the 2wT intervention benefits were similar across routine VMMC programs in both rural and urban settings.
The International AIDS Society (IAS) virtually hosted their 23rd International AIDS conference (AIDS 2020: Virtual) on 6-10 July 2020. The AIDS 2020: Virtual theme was resilience, to celebrate and acknowledge the strength of the HIV community and the significant advances in treatment, while also addressing gaps in treatment, prevention, and care.
Representatives from the International Training and Education Center for Health (I-TECH) virtually presented the following posters with accompanying audio recordings:
Malango Msukwa, BSc, MPHc, I-TECH Malawi Monitoring, Evaluation, and Data Manager, received a scholarship from IAS to attend AIDS 2020: Virtual and presented a late-breaker e-poster on a study that evaluated the uptake of a new HIV surveillance system and described which populations have continued HIV transmission titled, “Characterizing recent infections among persons with new HIV-1 diagnoses in Malawi.”
In addition to the I-TECH representatives presenting their posters, representatives from the Centers for Disease Control and Prevention (CDC) and Health Alliance International (HAI) also presented data from I-TECH programs in Malawi and Mozambique.
A new five-year research project will study two-way texting as a means of communication between healthcare providers and male circumcision (MC) patients in South Africa. It will build on previous research conducted in Zimbabwe.
Caryl Feldacker is the Principal Investigator (PI) on this RO1, which will support research through 2025. The multi-stage implementation science study is based out of the International Training and Education Center for Health (I-TECH), and will be implemented with Dr. Geoffrey Setswe, PI for South Africa partner, Aurum Institute, and with technology partner, Medic Mobile.
“Previous research shows that healthcare workers waste a lot of time and money reviewing MC clients without complications,” Feldacker said. “So, in partnership with Medic Mobile, we developed a two-way texting (2wT) system to identify and refer men with potential medical issues to in-person care while allowing the vast majority to opt-out of routine post-operative visits.”
Programs providing voluntary medical male circumcision (MC) in sub-Saharan Africa are struggling to meet the annual goal of 5 million MCs. However, chronic human and financial resource shortages threaten achievement of MC targets, reducing impact of this effective HIV prevention intervention. Although MC is safe with an adverse event (AE) rate of less than 2% , global MC guidelines require one or more in-person, post-operative visits within 14 days of MC for timely AE identification. With low AE rates, overstretched clinic staff likely waste invaluable resources conducting unnecessary routine reviews for MC clients without complications while men healing well needlessly pay for transport, miss work, and wait for reviews, discouraging MC uptake.
The International Training and Education Center for Health (I-TECH) has transitioned another office to an autonomous entity. The Zimbabwe Technical Assistance, Training and Education Center for Health (Zim-TTECH) was officially launched on April 1, 2020, as a locally registered health trust. Zim-TTECH is the administrative and managing partner for the two existing I-TECH CDC/PEPFAR funded grants in Zimbabwe, each grant having a consortium of local partners:
ZimPAAC (Zimbabwe Partnership to Accelerate AIDS Control) is a partnership between Zim-TTECH, Africaid, Pangaea Zimbabwe AIDS Trust, and I-TECH. ZimPAAC collaborates with the Ministry of Health and Child Care (MoHCC) on context-appropriate health interventions to improve access to, as well as strengthen the quality of HIV prevention, treatment, care, and support services. ZimPAAC provides services at 373 facilities in 17 districts.
ZAZIC is a partnership between Zim-TTECH, I-TECH, and two local implementing partners—Zimbabwe Association of Church Related Hospitals (ZACH) and Zimbabwe Community Health Intervention Research Project (ZiCHIRe). ZAZIC supports voluntary medical male circumcision (VMMC) services at 38 static facilities in 13 districts.
“The transition from an I-TECH country office to a fully fledged independent local organization is exciting,” states Dr. Batsirai Makunike-Chikwinya, Zim-TTECH’s Executive Director. “Zim-TTECH is committed to continue to provide high-quality support to the MoHCC and to the health sector as a whole. Special thanks go to management and staff of both I-TECH/UW [University of Washington] and UZCHS-CTRC [University of Zimbabwe College of Health Sciences Clinical Trials Research Centre], who played pivotal roles during this transition.”
I-TECH has worked in Zimbabwe since 2003, collaborating with the MoHCC and other partners to improve clinical services and strengthen health systems. “It is a pleasure to support the launch of Zim-TTECH, which is the right next step toward country ownership and, importantly, recognizes the high level of skill and professionalism of the prior I-TECH country office and now Zim-TTECH team,” remarks Dr. Scott Barnhart.
Since 2013, the ZAZIC Consortium has been implementing Voluntary Medical Male Circumcision (VMMC) as part of a combination HIV prevention package approved by the Ministry of Health and Child Care (MoHCC) in Zimbabwe. Unlike other VMMC programs in the region, the ZAZIC model uses an integrated approach, blending local clinic staff supported by MOHCC with partner staff. The ZAZIC consortium supports:
Training using MoHCC approved curricula, health workers in the supported districts are trained on the surgical technique as well as on demand creation
Development and implementation of age appropriate demand creation strategies
Support service delivery in 13 districts from consent procedures to post-surgical care and linkage to other services
Comprehensive monitoring and evaluation including continuous quality improvement and operations research
From 2013-2018, ZAZIC performed over 300,000 VMMCs with a reported moderate and severe adverse event rate of 0.3%. The safety, flexibility, and pace of scale-up associated with the integrated VMMC model appears similar to vertical delivery with potential benefits of capacity building, sustainability and health system strengthening. Although more complicated than traditional approaches to program implementation, attention should be given to this country-led approach for its potential to spur positive health system changes, including building local ownership, capacity, and infrastructure for future public health programming. Over 80% of the circumcisions occur in outreach settings, an approach that ensures wide coverage and expanded services in hard-to-reach locations.
Voluntary medical male circumcision (VMMC) is considered safe and the vast majority of men heal without complication. However, guidelines require multiple follow-up visits, which can burden staff and facilities with clients who are typically healing well. With funding from the National Institutes of Health (NIH), ZAZIC recently conducted a prospective randomized control trial (RCT) to determine if two-way texting (2wT) was as safe as routine post-operative visits and if it reduced workload in two high-volume VMMC sites near Harare, Zimbabwe.
Both clients and providers felt satisfied with the 2wT system and felt it could be ready for scale. Many clients reported feeling confident, comfortable, satisfied, and safe with text follow-up. Importantly, clients felt that 2wT saved them time and money. Providers also noted 2wT saved them time, empowered their clients to engage in the healing process, and addressed gaps in MC service quality.
It was recommended in the study that 2wT between providers and patients should be considered for future adaptation in other short-term care contexts. 2wT also appears far less expensive than active follow-up to improve patient safety: on average, post-VMMC follow-up under 2wT was $0.098 compared to $0.955 under routine care. 2wT was both less costly and more effective in identifying AEs relative to the expected rate of AEs. As such, I-TECH aims to scale 2wT in further testing among rural clients and guardians to improve patient care at lower cost.
The trial is registered on ClinicalTrials.gov, trial NCT03119337, and activated on April 18, 2017. https://clinicaltrials.gov/ct2/show/NCT03119337. This RCT was supported by the Fogarty International Center of the National Institutes of Health under Award Number R21TW010583.
Employing modern medical male circumcision within traditional settings may increase patient safety and further male circumcision scale up efforts in Sub-Saharan Africa. ZAZIC established a successful, culturally sensitive, partnership with the VaRemba, an ethnic group in Zimbabwe that practices traditional male circumcision. The VaRemba Camp Collaborative (VCC) was created to provide safe, standardized male circumcisions and reduce adverse events (AEs) during traditional male circumcisions. ZAZIC supported the VCC by providing key MC commodities and transport to help ensure patient safety. In 2017, the VaRemba granted permission to ZAZIC doctors to provide oversight of MC procedures and post-operative treatment for all moderate and severe AEs within the Camp setting. Of the Camp residents, 98% chose medical male circumcision.
The multi-year, iterative cycle of meetings and trust building ultimately resulted in the successful VCC, a model that may be replicable for others trying to combine modern male circumcision and traditional practice.
ZAZIC employs an innovative performance-based financing (PBF) system to speed progress towards ambitious voluntary medical male circumcision (VMMC) targets. The PBF schedule, which started at $25 USD and now varies from $6.50-$14 USD depending on the location and the circumcision team, is continually refined to set the program up for sustainable transition. The PBF is an incentive that is intended to encourage underpaid healthcare workers (HCWs) to remain in the public sector and to strengthen the public healthcare system. The majority of the incentive supports HCWs who perform VMMC alongside other routine services; a small portion supports province, district, and facility levels.
I-TECH conducted a qualitative study to assess the effect of the PBF on HCW motivation, satisfaction, and professional relationships. The study found that the PBF appreciably increased motivation among VMMC teams and helped improve facilities where VMMC services are provided. However, PBF appears to contribute to antagonism at the workplace and create divisiveness. To reduce workplace tension and improve the VMMC program, ZAZIC increased training of additional HCWs to share the PBF incentive more widely and strengthened integration of VMMC services into routine care.
Describing Adverse Events within VMMC Programs at Scale
I-TECH works diligently to review and revise procedures to identify, manage, and report adverse events (AEs). I-TECH’s previous publications on AEs reveal efforts to maintain high quality programming and emphasize patient safety alongside achievement of targets.
Increasing Understanding on the Timing and Type of AEs in Routine VMMC Programs at Scale
As VMMC expands in Sub-Saharan Africa, I-TECH works to ensure program quality matches efforts to increase program productivity. I-TECH ensures patient safety through patient follow-up to identify and treat AEs. The timing of routine follow-up visits in MC programs is designed to ensure patient safety by identifying, treating, and managing complications. Although routine follow-up timing may differ by country, in Zimbabwe, three follow-up visits are scheduled to ensure quality service provision and patient care: Visit 1 (Day 2); Visit 2 (Day 7); and, Visit 3 (Day 42).
I-TECH’s implementation science efforts use routine data collected from clients with AEs and has found that AEs followed distinct patterns over time. Using these findings, ZAZIC has been improving VMMC care by 1) improving counseling about MC complications following initial visits for clinicians, clients, and caregivers ; 2) distributing wound care pamphlets to clients and caregivers; and 3) emphasizing follow-up tracing for younger boys, ages 10-14, and their caregivers to provide additional targeted, post-operative counseling on AE prevention.
Increasing AE Ascertainment through Routine Quality Assurance Efforts
The QI data suggested that AEs may be higher and follow-up lower than reported and ZAZIC’s Quality Assurance Task Force is replicating this QA study in other sites; increasing training in AE identification, management, and documentation for clinical and data teams; and improving post-operative counseling for younger clients. Additional nurses and vehicles, especially in rural health clinics, are currently being trained and leveraged to further improve client follow-up and AE ascertainment.
Improving Data Quality
ZAZIC undertakes weekly, monthly, and quarterly data quality audits (DQA) to ensure data correctness and completeness. Intensive DQA processes were documented and availability and completeness of data collected before and after DQAs in several specific sites was assessed with the aim to determine the effect of this process on data quality. ZAZIC found that after the DQA, high record availability of over 98% was maintained and record availability increased. After the DQA, most sites improved significantly in data completeness and ZAZIC continues to emphasize data completeness to support high-quality program implementation and availability of reliable data for decision-making.
Voluntary medical male circumcision (VMMC) safely reduces the risk of female-to-male HIV transmission by up to 60%. Few men have any post-operative VMMC complication. However, current practice in Zimbabwe and throughout most of sub-Saharan Africa requires VMMC patients to return for multiple, in-person post-operative visits. With low complication rates, and severe healthcare worker shortages, these required visits are a burden for providers and patients — threatening achievement of critical HIV prevention targets. A two-way texting model studied by University of Washington researchers in Zimbabwe offers a new way to address this barrier by reducing provider workload while also safeguarding patient safety.
“These visits can be a barrier to male circumcision uptake and expansion in countries with severe health care worker shortages, as well as negatively impacting patients who needlessly pay for transport, miss work, and wait for unnecessary reviews,” said Principal Investigator Caryl Feldacker, PhD, MPH, at the International Training and Education Center for Health (I-TECH) in the University of Washington Department of Global Health.
The study included 721 VMMC patients in two locations in urban Zimbabwe. In the study, patients communicated directly with a health care worker through interactive text messaging for the critical 13 days post-VMMC, rather than returning for required in-person visits. By giving men the option to heal safely at home, or return to care when desired or if complications arose, the method dramatically reduced in-person visits by 85%. Texting also reduced follow-up costs by about one-third while improving the quality of care.
As compared to routine in-person care, the study yielded twice the number of reported complications. “This increased identification and reporting is a positive result that is likely attributable to improved counseling and men’s engagement in care. Through texting, men were empowered to observe their healing and report potential issues promptly, before they worsened,” said Feldacker.
Currently, most text-based health care efforts blast pre-defined messages to many people simultaneously, removing patients’ ability to communicate back with health care workers. In contrast, two-way texting between providers and patients provides interactive care, and the short time frame heightened participation: in the study, 93% of men responded to texts. Both providers and clients reported confidence in the texting option, feeling safe and highly recommending it for scale.
“With the current system, Zimbabwe could perform millions of unnecessary follow-up visits over the coming five years. The workload burden for health care workers and time lost for patients who are healing without complication is a significant burden for health care workers and clients alike,” said Feldacker. “Potential gains in efficiency and reduced costs through using two-way messaging are large.”
With funding from the U.S. Centers for Disease Control and Prevention (CDC), and in partnership with the Society for Family Health, the model will soon be tested in urban South Africa. The new, field-based research will further test two-way texting in a different geographical and patient context to better inform the model for adaptation and widespread scale-up.
Feldacker added that “while our findings are grounded in studies on male circumcision, our results are largely attributable to the methods rather than to a specific disease or condition.
“With minimal adaptation,” she continued, “two-way texting could streamline other post-operative care contexts or be re-configured for other similarly acute, episodic conditions where continuity of care within a short period is critical for patients, such as short-course TB treatment, post-operative healing, post-natal care or early childhood illnesses — diarrhea, pneumonia, malaria — laying the foundation for generalizing to other diseases and contexts.”
For more on the study, see the paper pre-published in the Journal of Acquired Immune Deficiency Syndromes (JAIDS):
The study was led by Caryl Feldacker, and co-investigators are Vernon Murenje (International Training and Education Center for Health (I-TECH), Harare, Zimbabwe); Mufuta Tshimanga (Zimbabwe Community Health Intervention Project (ZiCHIRE), Harare, Zimbabwe); Scott Barnhart, Isaac Holeman, and Joseph B. Babigumira (Department of Global Health, University of Washington); Sinokuthemba Xaba (Ministry of Health and Child Care, Harare, Zimbabwe); and technology partner Medic Mobile (Nairobi, Kenya).
The Zimbabwe 2wT study was supported by the Fogarty International Center of the National Institutes of Health under Award Number R21TW010583.