"Endless opportunities": A qualitative exploration of facilitators and barriers to scale-up of two-way texting follow-up after voluntary medical male circumcision in Zimbabwe.

In Zimbabwe, the ZAZIC consortium employs two-way, text-based (2wT) follow-up to strengthen post-operative care for voluntary medical male circumcision (VMMC). 2wT scaled nationally with evidence of client support and strengthened follow-up. However, 2wT uptake among healthcare providers remains suboptimal. Understanding the gap between mobile health (mHealth) potential for innovation expansion and scale-up realization is critical for 2wT and other mHealth innovations. Therefore, we conducted an exploratory qualitative study with the objective of identifying 2wT program strengths, challenges, and suggestions for scale up as part of routine VMMC services. A total of 16 in-depth interviews (IDIs) with diverse 2wT stakeholders were conducted, including nurses, monitoring & evaluation teams, and technology partners-a combination of perspectives that provide new insights. We used both inductive and deductive coding for thematic analysis. Among 2wT drivers of expansion success, interviewees noted: 2wT care benefits for clients; effective hands-on 2wT training; ease of app use for providers; 2wT saved time and money; and 2wT strengthened client/provider interaction. For 2wT scale-up challenges, staff shortages; network infrastructure constraints; client costs; duplication of paper and electronic reporting; and complexity of digital tools integration. To improve 2wT robustness, respondents suggested: more staff training to offset turnover; making 2wT free for clients; using 2wT to replace paper VMMC reporting; integrating with routine VMMC reporting systems; and expanding 2wT to other health areas. High stakeholder participation in app design, implementation strengthening, and evaluation were appreciated. Several 2wT improvements stemmed from this study, including enrollment of multiple people on one number to account for phone sharing; 2wT inclusion of minors ages 15+; clients provided with $1 to offset SMS costs; and reduced SMS messages to clients. Continued 2wT mentoring for staff, harmonization of 2wT with Ministry e-health data systems, and increased awareness of 2wT's client and provider benefits will help ensure successful 2wT scale-up.

Implementing quality management strategies improves clinical quality as a voluntary medical male circumcision program in Namibia matures: a process analysis.

BACKGROUND: Surgical voluntary medical male circumcision (VMMC) is a safe procedure; however, maintaining quality standards at scale, particularly during scale-up, is a challenge making ongoing quality management (QM) efforts essential. This study describes program quality measured by rates of adverse events (AEs) over four years of VMMC implementation in Namibia, compares AE rates over time, and discusses QM processes that contextualize AE trends and illustrate improvements in quality as the program matured. The International Training and Education Center for Health (I-TECH) assisted the Namibian Ministry of Health and Social Services (MoHSS) in expanding VMMC in three regions among boys and men over 10 years of age between January 2015 and September 2019. METHODS: A comprehensive package of QM strategies was implemented by multi-disciplinary onsite teams with support from national and international technical advisors. Retrospective routine MoHSS data from the VMMC register, client forms, and monthly AE reports were collected during implementation in the three regions to assess the impact of QM interventions on AEs and to calculate the proportion of clients who experienced AEs over time. The proportion of clients who experienced an AE over time was compared using a Cochran-Armitage test for trend. RESULTS: Between January 2015 and September 2019, 40,336 clients underwent VMMC and 593 (1.5%) clients experienced a post-operative AE in the three supported regions. The AE rate was highest in the first quarter of clinical service delivery in each region (January-March 2015 in Oshana and Zambezi, October-December 2017 in //Kharas) but declined over the implementation period as the program matured. This observed trend between program maturity and declining AE rates over time was significant (p < 0.001) when compared using a Cochran-Armitage test for trend. CONCLUSIONS: As the I-TECH-supported VMMC program matured, QM measures were introduced and routinized, and clinical quality improved over time with the rate of AEs decreasing significantly over the implementation period. Applying systematic and continuous QM processes and approaches across the continuum of VMMC services and considering local context can contribute to increased clinical safety. QM measures that are established in more mature program sites can be quickly adopted to respond to quality issues in program expansion sites.

Depression and HIV Care-seeking Behaviors in a Population-based Sample in North West Province, South Africa.

Depression is associated with key HIV-related prevention and treatment behaviors in sub-Saharan Africa. We aimed to identify the association of depressive symptoms with HIV testing, linkage to care, and ART adherence among a representative sample of 18-49 year-olds in a high prevalence, rural area of South Africa. Utilizing logistic regression models (N = 1044), depressive symptoms were inversely associated with reported ever HIV testing (AOR 0.92, 95% CI 0.85-0.99; p = 0.04) and ART adherence (AOR 0.82, 95% CI: 0.73-0.91; p < 0.01) among women. For men, depressive symptoms were positively associated with linkage to care (AOR: 1.21, 95% CI: 1.09-1.34; p < 0.01). Depression may adversely impact ART adherence for HIV-positive women and reduce the likelihood of HIV testing for women not aware of their HIV status which, in settings with high HIV prevalence, carries severe consequences. For HIV-positive men, findings suggest that depression may encourage help-seeking behavior, thereby impacting their health system interactions. These findings underscore the need for health-care settings to factor mental health, such as depression, into their programs to address health-related outcomes, particularly for women.

RESUMEN: La depresión está asociada con conductas clave de prevención y tratamiento relacionadas con el VIH en África subsahariana. Nuestro objetivo fue identificar la asociación de los síntomas depresivos con los resultados relacionados con el VIH entre una muestra representativa de personas de 18 a 49 años en Sudáfrica. Utilizando modelos de regresión logística (N = 1044), los síntomas depresivos se asociaron inversamente con los que se informaron que habían probado de VIH alguna vez (AOR 0,92, IC del 95%: 0,85 a 0,99; p = 0,04) y la adherencia al TAR (AOR 0,82, IC del 95%: 0,73 a 0,91; p < 0,01) entre las mujeres. Para los hombres, los síntomas depresivos se asociaron positivamente con la vinculación con cuidado (AOR: 1,21, IC del 95%: 1,09­1,34; p < 0,01). La depresión puede tener un impacto adverso en la adherencia al TAR para las mujeres VIH-positivas y reducir la probabilidad de que las mujeres se hagan la prueba del VIH. Para los hombres VIH-positivos, los resultados sugieren que la depresión fomente una conducta de búsqueda de ayuda, afectando así sus interacciones con el sistema de salud. Estos resultados subrayan la necesidad de que los que proveen servicios médicos tengan en cuenta la salud mental en sus programas que abordan los resultados relacionados con la salud.

Impact of short message service and peer navigation on linkage to care and antiretroviral therapy initiation in South Africa.

OBJECTIVE: We examine the efficacy of short message service (SMS) and SMS with peer navigation (SMS + PN) in improving linkage to HIV care and initiation of antiretroviral therapy (ART). DESIGN: I-Care was a cluster randomized trial conducted in primary care facilities in North West Province, South Africa. The primary study outcome was retention in HIV care; this analysis includes secondary outcomes: linkage to care and ART initiation. METHODS: Eighteen primary care clinics were randomized to automated SMS ( n  = 7), automated and tailored SMS + PN ( n  = 7), or standard of care (SOC; n  = 4). Recently HIV diagnosed adults ( n  = 752) were recruited from October 2014 to April 2015. Those not previously linked to care ( n  = 352) contributed data to this analysis. Data extracted from clinical records were used to assess the days that elapsed between diagnosis and linkage to care and ART initiation. Cox proportional hazards models and generalized estimating equations were employed to compare outcomes between trial arms, overall and stratified by sex and pregnancy status. RESULTS: Overall, SMS ( n  = 132) and SMS + PN ( n  = 133) participants linked at 1.28 [95% confidence interval (CI): 1.01-1.61] and 1.60 (95% CI: 1.29-1.99) times the rate of SOC participants ( n  = 87), respectively. SMS + PN significantly improved time to ART initiation among non-pregnant women (hazards ratio: 1.68; 95% CI: 1.25-2.25) and men (hazards ratio: 1.83; 95% CI: 1.03-3.26) as compared with SOC. CONCLUSION: Results suggest SMS and peer navigation services significantly reduce time to linkage to HIV care in sub-Saharan Africa and that SMS + PN reduced time to ART initiation among men and non-pregnant women. Both should be considered candidates for integration into national programs. TRIAL REGISTRATION: NCT02417233, registered 12 December 2014; closed to accrual 17 April 2015.

Prevalence, motivation, and outcomes of clinic transfer in a clinical cohort of people living with HIV in North West Province, South Africa.

INTRODUCTION: Continuity of care is an attribute of high-quality health systems and a necessary component of chronic disease management. Assessment of health information systems for HIV care in South Africa has identified substantial rates of clinic transfer, much of it undocumented. Understanding the reasons for changing sources of care and the implications for patient outcomes is important in informing policy responses. METHODS: In this secondary analysis of the 2014 - 2016 I-Care trial, we examined self-reported changes in source of HIV care among a cohort of individuals living with HIV and in care in North West Province, South Africa. Individuals were enrolled in the study within 1 year of diagnosis; participants completed surveys at 6 and 12 months including items on sources of care. Clinical data were extracted from records at participants' original clinic for 12 months following enrollment. We assessed frequency and reason for changing clinics and compared the demographics and care outcomes of those changing and not changing source of care. RESULTS: Six hundred seventy-five (89.8%) of 752 study participants completed follow-up surveys with information on sources of HIV care; 101 (15%) reported receiving care at a different facility by month 12 of follow-up. The primary reason for changing was mobility (N=78, 77%). Those who changed clinics were more likely to be young adults, non-citizens, and pregnant at time of diagnosis. Self-reported clinic attendance and ART adherence did not differ based on changing clinics. Those on ART not changing clinics reported 0.66 visits more on average than were documented in clinic records. CONCLUSION: At least 1 in 6 participants in HIV care changed clinics within 2 years of diagnosis, mainly driven by mobility; while most appeared lost to follow-up based on records from the original clinic, self-reported visits and adherence were equivalent to those not changing clinics. Routine clinic visits could incorporate questions about care at other locations as well as potential relocation, particularly for younger, pregnant, and non-citizen patients, to support existing efforts to make HIV care records portable and facilitate continuity of care across clinics. TRIAL REGISTRATION: The original trial was registered with ClinicalTrials.gov , NCT02417233, on 12 December 2014.

Working toward sustainability: Transitioning HIV programs from a USA-based organization to a local partner in Zimbabwe.

BACKGROUND: Despite the history of United States of America (USA)-based partners implementing global health programs in low- and middle-income countries (LMIC), future models for sustainable healthcare rely on local country ownership and leadership. Transition is the process of shifting programs towards country ownership, where local stakeholders plan, manage, and deliver health programs. Transition is not a singular event but a process which may include a phase where health programs are led and managed by local entities but still reliant on awards from international partners. This phase is scarcely described yet can impact long-term program sustainability if navigated poorly. This qualitative study examines the transition of Zimbabwe's voluntary medical male circumcision and HIV care and treatment services from management by a USA-based organization, the International Training and Education Center for Health (I-TECH), to management under a new Zimbabwean organization, the Zimbabwe Technical Assistance, Training and Education Centre for Health (Zim-TTECH). The primary objective of this paper is to explore challenges, successes, and lessons learned during this transition to inform other non-governmental organizations. METHODS: We conducted sixteen virtual, key informant interviews using purposeful sampling, identifying potential participants based on their role in the transition team (leadership, administrative, financial, or human resources) and willingness to consent to the study. We aimed for equal representation from USA-based, I-TECH headquarters staff and Zimbabwe-based, Zim-TTECH staff involved in the transition team. Data were analyzed in Atlas.Ti using deductive and inductive methods, followed by a thematic analysis guided by several frameworks for program transition and organizational change. RESULTS: Findings suggest five themes to guide transition: 1) Develop a vision and empower leadership for change by delegating clear roles and supporting local ownership; 2) Plan and strategize for transition in a manner that accounts for historical context; 3) Communicate with and inform stakeholders to understand transition perceptions, understand barriers to transition, and enable open communications related to risks and benefits; 4) Engage and mobilize staff by constructing necessary infrastructure and providing technical assistance as needed; and 5) Define short-term and long-term success. CONCLUSION: Transition processes were challenged by the local country context, compressed transition timelines, and all-or-nothing measures of transition success. Facilitators included strong staff capacity and a synergistic partnership model between Zim-TTECH and I-TECH. Global funders and international organizations should support local LMIC partners in their pathway to independence by removing restrictions on funding awards, including transitioning ownership mid-stream, and positioning leadership of international awards for in-country entities.

REDCap mobile data collection: Using implementation science to explore the potential and pitfalls of a digital health tool in routine voluntary medical male circumcision outreach settings in Zimbabwe.

Background: Digital data collection tools improve data quality but are limited by connectivity. ZAZIC, a Zimbabwean consortium focused on scaling up male circumcision (MC) services, provides MC in outreach settings where both data quality and connectivity is poor. ZAZIC implemented REDCap Mobile app for data collection among roving ZAZIC MC nurses. To inform continued scale-up or discontinuation, this paper details if, how, and for whom REDCap improved data quality using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Methods: Data were collected for this retrospective, cross-sectional study for nine months, from July 2019 to March 2020, before COVID-19 paused MC services. Data completeness was compared between paper- and REDCap-based tools and between two ZAZIC partners using two sample, one-tailed t-tests. Results: REDCap reached all roving nurses who reported 26,904 MCs from 1773 submissions. REDCap effectiveness, as measured by data completeness, decreased from 89.2% in paper to 76.6% in REDCap app for Partner 1 (p < 0.001, 95% CI: -0.24, -0.12) but increased modestly from 86.2% to 90.3% in REDCap for Partner 2 (p = 0.05, 95% CI: -.007, 0.12). Adoption of REDCap was 100%; paper-based reporting concluded in October 2019. Implementation varied by partner and user. Maintenance appeared high. Conclusion: Although initial transition from paper to REDCap showed mixed effectiveness, post-hoc analysis from service resumption found increased REDCap data completeness across partners, suggesting locally-led momentum for REDCap-based data collection. Staff training, consistent mentoring, and continued technical support appear critical for continued use of digital health tools for quality data collection in rural Zimbabwe and similar low connectivity settings.

Urethrocutaneous fistula following VMMC: a case series from March 2013 to October 2019 in ZAZIC's voluntary medical male circumcision program in Zimbabwe.

BACKGROUND: Urethrocutaneous fistula (subsequently, fistula) is a rare adverse event (AE) in voluntary medical male circumcision (VMMC) programs. Global fistula rates of 0.19 and 0.28 per 100,000 VMMCs were reported. Management of fistula can be complex and requires expert skills. We describe seven cases of fistula in our large-scale VMMC program in Zimbabwe. We present fistula rates; provide an overview of initial management, surgical interventions, and patient outcomes; discuss causes; and suggest future prevention efforts. RESULTS: Case details are presented on fistulas identified between March 2013 and October 2019. Among the seven fistula clients, ages ranged from 10 to 22 years; 6 cases were among boys under 15 years of age. All clients received surgical VMMC by trained providers in an outreach setting. Clients presented with fistulae 2-42 days after VMMC. Secondary infection was identified in 6 of 7 cases. Six cases were managed through surgical repair. The number of repair attempts ranged from 1 to 10. One case healed spontaneously with conservative management. Fistula rates are presented as cases/100,000 VMMCs. CONCLUSION: Fistula is an uncommon but severe AE that requires clinical expertise for successful management and repair. High-quality AE surveillance should identify fistula promptly and include consultation with experienced urologists. Strengthening provider surgical skills and establishment of standard protocols for fistula management would aid future prevention efforts in VMMC programs.

Transitioning a digital health innovation from research to routine practice: Two-way texting for male circumcision follow-up in Zimbabwe.

Adult medical male circumcision (MC) is safe: global notifiable adverse event (AE) rates average below 2.0%. With Zimbabwe's shortage of health care workers (HCWs) compounded by COVID-19 constraints, two-way text-based (2wT) MC follow-up may be advantageous over routinely scheduled in-person reviews. A 2019 randomized control trial (RCT) found 2wT to be safe and efficient for MC follow-up. As few digital health interventions successfully transition from RCT to scale, we detail the 2wT scale-up approach from RCT to routine MC practice comparing MC safety and efficiency outcomes. After the RCT, 2wT transitioned from a site-based (centralized) system to hub-and-spoke model for scale-up where one nurse triaged all 2wT patients, referring patients in need to their local clinic. No post-operative visits were required with 2wT. Routine patients were expected to attend at least one post-operative review. We compare 1) AEs and in-person visits between 2wT men from RCT and routine MC service delivery; and 2) 2wT-based and routine follow-up among adults during the 2wT scale-up period, January to October 2021. During scale-up period, 5084 of 17417 adult MC patients (29%) opted into 2wT. Of the 5084, 0.08% (95% CI: 0.03, 2.0) had an AE and 71.0% (95% CI: 69.7, 72.2) responded to ≥1 daily SMS, a significant decrease from the 1.9% AE rate (95% CI: 0.7, 3.6; p<0.001) and 92.5% response rate (95% CI: 89.0, 94.6; p<0.001) from 2wT RCT men. During scale-up, AE rates did not differ between routine (0.03%; 95% CI: 0.02, 0.08) and 2wT (p = 0.248) groups. Of 5084 2wT men, 630 (12.4%) received telehealth reassurance, wound care reminders, and hygiene advice via 2wT; 64 (19.7%) were referred for care of which 50% had visits. Similar to RCT outcomes, routine 2wT was safe and provided clear efficiency advantages over in-person follow-up. 2wT reduced unnecessary patient-provider contact for COVID-19 infection prevention. Rural network coverage, provider hesitancy, and the slow pace of MC guideline changes slowed 2wT expansion. However, immediate 2wT benefits for MC programs and potential benefits of 2wT-based telehealth for other health contexts outweigh limitations.

Adverse event profile and associated factors following surgical voluntary medical male circumcision in two regions of Namibia, 2015-2018.

INTRODUCTION: Monitoring clinical safety of voluntary medical male circumcision (VMMC) is critical to minimize risk as VMMC programs for HIV prevention are scaled. This cross-sectional analysis describes the adverse event (AE) profile of a large-scale, routine VMMC program and identifies factors associated with the development, severity, and timing of AEs to provide recommendations for program quality improvement. MATERIALS AND METHODS: From 2015-2018 there were 28,990 circumcisions performed in International Training and Education Center for Health (I-TECH) supported regions of Namibia in collaboration with the Ministry of Health and Social Services. Two routine follow-up visits after VMMC were scheduled to identify clients with AEs. Summary statistics were used to describe characteristics of all VMMC clients and the subset who experienced an AE. We used chi-square tests to evaluate associations between AE timing, patient age, and other patient and AE characteristics. We used a logistic regression model to explore associations between patient characteristics and AE severity. RESULTS: Of the 498 clients with AEs (AE rate of 1.7%), 40 (8%) occurred ≤2 days, 262 (53%) occurred 3-7 days, 161 (32%) between day 8 and 14, and 35 (7%) were ≥15 days post-VMMC. Early AEs (on or before day 2) tended to be severe and categorized as bleeding, while infections were the most common AEs occurring later (p<0.001). Younger clients (aged 10-14 years) experienced more infections, whereas older clients experienced more bleeding (p<0.001). CONCLUSIONS: Almost 40% of AEs occurred after the second follow-up visit, of which 179 (91%) were infections. Improvements in pre-surgical and post-surgical counselling and post-operative educational materials encouraging clients to seek care at any time, adoption of alternative follow-up methods, and the addition of a third follow-up visit may improve outcomes for patients. Enhancing post-surgical counselling and emphasizing wound care for younger VMMC clients and their caregivers could help mitigate elevated risk of infection.

Impact of SMS and peer navigation on retention in HIV care among adults in South Africa: results of a three-arm cluster randomized controlled trial.

INTRODUCTION: Few interventions have demonstrated improved retention in care for people living with HIV (PLHIV) in sub-Saharan Africa. We tested the efficacy of two personal support interventions - one using text messaging (SMS-only) and the second pairing SMS with peer navigation (SMS+PN) - to improve HIV care retention over one year. METHODS: In a cluster randomized control trial (NCT# 02417233) in North West Province, South Africa, we randomized 17 government clinics to three conditions: SMS-only (6), SMS+PN (7) or standard of care (SOC; 4). Participants at SMS-only clinics received appointment reminders, biweekly healthy living messages and twice monthly SMS check-ins. Participants at SMS+PN clinics received SMS appointment reminders and healthy living messages and spoke at least twice monthly with peer navigators (PLHIV receiving care) to address barriers to care. Outcomes were collected through biweekly clinical record extraction and surveys at baseline, six and 12 months. Retention in HIV care over one year was defined as clinic visits every three months for participants on antiretroviral therapy (ART) and CD4 screening every six months for pre-ART participants. We used generalized estimating equations, adjusting for clustering by clinic, to test for differences across conditions. RESULTS: Between October 2014 and April 2015, we enrolled 752 adult clients recently diagnosed with HIV (SOC: 167; SMS-only: 289; SMS+PN: 296). Individuals in the SMS+PN arm had approximately two more clinic visits over a year than those in other arms (p < 0.01) and were more likely to be retained in care over one year than those in SOC clinics (54% vs. 38%; OR: 1.77, CI: 1.02, 3.10). Differences between SMS+PN and SOC conditions remained significant when restricting analyses to the 628 participants on ART (61% vs. 45% retained; OR: 1.78, CI: 1.08, 2.93). The SMS-only intervention did not improve retention relative to SOC (40% vs. 38%, OR: 1.12, CI: 0.63, 1.98). CONCLUSIONS: A combination of SMS appointment reminders with personalized, peer-delivered support proved effective at enhancing retention in HIV care over one year. While some clients may only require appointment reminders, the SMS+PN approach offers increased flexibility and tailored, one-on-one support for patients struggling with more substantive challenges.

Short-Term Effects of the COVID-19 Pandemic on HIV Care Utilization, Service Delivery, and Continuity of HIV Antiretroviral Treatment (ART) in Haiti.

INTRODUCTION: Our study describes changes in HIV care service delivery and continuity of HIV antiretroviral therapy (ART) for people living with HIV (PLHIV) during the 8 weeks before and after diagnosis of the first coronavirus disease 2019 (COVID-19) cases in Haiti on March 19, 2020. METHODS: Using data from 96 out of 167 health facilities offering ART services, we compared four ART program indicators: (1) count of HIV visits; (2) proportion of ART dispenses in community-based settings (DAC); (3) proportion of multi-month dispensing of ART medications > 6 months (> 6 m MMD); and (4) proportion of timely ART refills. We used uncontrolled interrupted time series (ITS) models to estimate slope and level changes in each indicator with the arrival of COVID-19. RESULTS AND DISCUSSION: From week 1 to week 16, the average number of HIV visits fell from 121.5 to 92.5 visits, the proportion of DAC rose from 22.7% to 36.7%, the proportion of > 6 m MMD rose from 29.4% to 48.4%, and the proportion of timely ART refills fell from 51.9% to 43.8%. The ITS models estimated abrupt increases of 36% in > 6 m MMD (p < 0.001) and 37% in DAC (p < 0.001) at the time of COVID-19 arrival, and no change after arrival of COVID-19. The was an abrupt decline of 18% in timely ART refills with the arrival of COVID-19 and a decline of 1% per week thereafter, both non-statistically significant changes. CONCLUSIONS: The sudden changes in HIV service utilization represent dramatic adaptations needed to mitigate primary and secondary effects of the COVID-19 pandemic on PLHIV. This study underscores the urgency of optimizing ART delivery models in Haiti and beyond, in order to maintain progress toward HIV epidemic control.

Sexual and Physical Violence in Childhood Is Associated With Adult Intimate Partner Violence and Nonpartner Sexual Violence in a Representative Sample of Rural South African Men and Women.

Intimate partner violence, nonpartner sexual violence, and physical and sexual violence against children are significant public health issues in South Africa. Theory suggests that experiencing violence in childhood plays a role in propensity to perpetrate violence or vulnerability to violence in adulthood. Most research to date on this topic has been conducted in high-resource countries or within urban or high-risk populations. We explore the relationship between violence in childhood and violence in adulthood in a community-based sample of 18- to 49-year-old adults in rural South Africa using data from a population-based survey (N = 1,044) in North West province in 2014. We measured childhood violence before age 15 years, experience of nonpartner sexual violence in adulthood, and IPV victimization and perpetration in the last 12 months. We conducted multivariate logistic regression; gender was tested as an effect modifier. All estimates are weighted to the subdistrict population. More women (2.7%) than men (0.8%) reported childhood forced sex, whereas fewer women (2.0%) than men (7.9%) reported childhood physical violence. Women and men reported similar rates of IPV victimization (6.8% vs. 5.4%), IPV perpetration (3.3% vs. 4.8%), and forced sex by a nonpartner (1.6% vs. 1.2%). We found that men and women who experienced childhood violence (combined physical and/or sexual) were significantly more likely to experience forced sex by a nonpartner (men: adjusted odds ratio [aOR] = 5.53, 95% confidence interval [CI] = [1.27, 24.0], p < .05; women: aOR = 51.1, 95% CI = [10.58, 246.3], p < .01) compared with those who did not experience childhood violence. They were also 2.5 times as likely to perpetrate recent IPV (aOR = 2.5, 95% CI = [0.97, 6.7], p = .06) or experience recent IPV (aOR = 2.5, 95% CI = [0.9, 6.9], p = .07), although this finding was marginally significant. These results align with the literature from other settings and population groups.

Balancing competing priorities: Quantity versus quality within a routine, voluntary medical male circumcision program operating at scale in Zimbabwe.

BACKGROUND: Since 2013, the ZAZIC consortium supported the Zimbabwe Ministry of Health and Child Care (MOHCC) to implement a high quality, integrated voluntary medical male circumcision (VMMC) program in 13 districts. With the aim of significantly lowering global HIV rates, prevention programs like VMMC make every effort to achieve ambitious targets at an increasingly reduced cost. This has the potential to threaten VMMC program quality. Two measures of program quality are follow-up and adverse event (AE) rates. To inform further VMMC program improvement, ZAZIC conducted a quality assurance (QA) activity to assess if pressure to do more with less influenced program quality. METHODS: Key informant interviews (KIIs) were conducted at 9 sites with 7 site-based VMMC program officers and 9 ZAZIC roving team members. Confidentiality was ensured to encourage candid conversation on adherence to VMMC standards, methods to increase productivity, challenges to target achievement, and suggestions for program modification. Interviews were recorded, transcribed and analyzed using Atlas.ti 6. RESULTS: VMMC teams work long hours in diverse community settings to reach ambitious targets. Rotating, large teams of trained VMMC providers ensures meeting demand. Service providers prioritize VMMC safety procedures and implement additional QA measures to prevent AEs among all clients, especially minors. However, KIs noted three areas where pressure for increased numbers of clients diminished adherence to VMMC safety standards. For pre- and post-operative counselling, MC teams may combine individual and group sessions to reach more people, potentially reducing client understanding of critical wound care instructions. Second, key infection control practices may be compromised (handwashing, scrubbing techniques, and preoperative client preparation) to speed MC procedures. Lastly, pressure for client numbers may reduce prioritization of patient follow-up, while client-perceived stigma may reduce care-seeking. Although AEs appear well managed, delays in AE identification and lack of consistent AE reporting compromise program quality. CONCLUSION: In pursuit of ambitious targets, healthcare workers may compromise quality of MC services. Although risk to patients may appear minimal, careful consideration of the realities and risks of ambitious target setting by donors, ministries, and implementing partners could help to ensure that client safety and program quality is consistently prioritized over productivity.

Cost-effectiveness analysis of two-way texting for post-operative follow-up in Zimbabwe's voluntary medical male circumcision program.

OBJECTIVE: Although adverse events (AEs) following voluntary medical male circumcision (VMMC) are rare, their prompt ascertainment and management is a marker of quality care. The use of two-way text messaging (2wT) for client follow-up after VMMC reduces the need for clinic visits (standard of care (SoC)) without compromising safety. We compared the cost-effectiveness of 2wT to SoC for post-VMMC follow-up in two, high-volume, public VMMC sites in Zimbabwe. MATERIALS AND METHODS: We developed a decision-analytic (decision tree) model of post-VMMC client follow-up at two high-volume sites. We parameterized the model using data from both a randomized controlled study of 2wT vs. SoC and from the routine VMMC program. The perspective of analysis was the Zimbabwe government (payer). The time horizon covered the time from VMMC to wound healing. Costs included text messaging; both in-person and outreach follow-up; and AE management. Costs were estimated in 2018 U.S. dollars. The outcome of analysis was AE yield relative to the globally accepted safety standard of a 2% AE rate. We estimated the incremental cost per percentage increase in AE ascertainment and the incremental cost per additional AE identified. We conducted univariate and probabilistic sensitivity analyses. RESULTS: 2wT increased the costs due to text messaging by $4.42 but reduced clinic visit costs by $2.92 and outreach costs by $3.61 -a net savings of $2.10. 2wT also increased AE ascertainment by 50% (92% AE yield in 2wT compared to 42% AE yield in SoC). Therefore, 2wT dominated SoC in the incremental analysis: 2wT was less costly and more effective. Results were generally robust to univariate and probabilistic sensitivity analysis. CONCLUSIONS: 2wT is cost-effective for post-VMMC follow-up in Zimbabwe. Countries in which VMMC is a high-priority HIV prevention intervention should consider this mHealth intervention to reduce overall cost per VMMC, increasing the likelihood of current and future VMMC program sustainability.

Usability and acceptability of a two-way texting intervention for post-operative follow-up for voluntary medical male circumcision in Zimbabwe.

BACKGROUND: Voluntary medical male circumcision (MC) is safe and effective. Nevertheless, MC programs require multiple post-operative visits. In Zimbabwe, a randomized control trial (RCT) found that post-operative two-way texting (2wT) between clients and MC providers instead of in-person reviews reduced provider workload and safeguarded patient safety. A critical component of the RCT assessed usability and acceptability of 2wT among providers and clients. These findings inform scale-up of the 2wT approach to post-operative follow-up. METHODS: The RCT assigned 362 adult MC clients with cell phones into 2wT; these men responded to 13 automated daily texts supported by interactive texting or in-person follow-up, when needed. A subset of 100 texting clients filled a self-administered usability survey on day 14. 2wT acceptability was ascertained via 2wT response rates. Among 2wT providers, eight key informant interviews focused on 2wT acceptability and usability. Influences of wage and age on response rates and client-reported potential AEs were explored using linear and logistic regression models, respectively. RESULTS: Clients felt confident, comfortable, satisfied, and well-supported with 2wT-based follow-up; few noted texting challenges or concerns about healing. Clients felt 2wT saved them time and money. Response rates (92%) suggested 2wT acceptability. Both clients and providers felt 2wT was highly usable. Providers noted 2wT saved them time, empowered clients to engage in their healing, and closed gaps in MC service quality. For scale, providers reinforced good post-operative counseling on AEs and texting instructions. Wage and age did not influence text response rates or potential AE texts. CONCLUSION: Results strongly suggest that 2wT is highly usable and acceptable for providers and patients. Men with concerns solicited provider guidance and reassurance offered via text. Providers noted that men engaged proactively in their healing. 2wT between providers and patients should be expanded for MC and considered for other short-term care contexts. The trial is registered on ClinicalTrials.gov, trial NCT03119337, and was activated on April 18, 2017. https://clinicaltrials.gov/ct2/show/NCT03119337.

Expanded access to viral load testing and use of second line regimens in Haiti: time trends from 2010-2017.

BACKGROUND: Haiti initiated the scale-up of HIV viral load (VL) testing in 2015-2016, with plans to achieve 100% coverage for all patients on antiretroviral therapy (ART) for treatment of HIV/AIDS. In the absence of HIV drug susceptibility testing, VL testing is a key tool for monitoring response to ART and optimizing treatment results. This study describes trends in expanded use of VL testing, VL results, and use of second-line ART regimens, and explores the association between VL testing and second-line regimen switching in Haiti from 2010 to 2017. METHODS: We conducted a retrospective cohort study with 66,042 patients drawn from 88 of Haiti's 160 national ART clinics. Longitudinal data from the iSanté electronic data system was used to analyze the trends of interest. We described patients' VL testing status in five categories based on up to two most recent VL test results: no test; suppressed; unsuppressed followed by no test; re-suppressed; and confirmed failure. Among those with confirmed failure, we described ART adherence level. Finally, we used Cox proportional hazards regression to estimate the risk of second-line regimen switching by VL testing status, after adjusting for other individual characteristics. RESULTS: The number of patients who had tests done increased annually from 11 in 2010 to 18,828 in the first 9 months of 2017, while the number of second-line regimen switches rose from 21 to 279 during this same period. Compared with patients with no VL test, the hazard ratio (HR) for switching to a second-line regimen was 22.2 for patients with confirmed VL failure (95% confidence interval [CI] for HR: 18.8-26.3; p < 0.005) after adjustment for individual characteristics. Among patients with confirmed VL failure, 44.7% had strong adherence, and fewer than 20% of patients switched to a second-line regimen within 365 days of VL failure. CONCLUSIONS: Haiti has significantly expanded access to VL testing since 2016. In order to promote optimal patient health outcomes, it is essential for Haiti to continue broadening access to confirmatory VL testing, to expand evidence-based initiatives to promote strong ART adherence, and to embrace timely switching for patients with confirmed ART failure despite strong ART adherence.

The role of drug resistance in poor viral suppression in rural South Africa: findings from a population-based study.

BACKGROUND: Understanding factors driving virological failure, including the contribution of HIV drug resistance mutations (DRM), is critical to ensuring HIV treatment remains effective. We examine the contribution of drug resistance mutations for low viral suppression in HIV-positive participants in a population-based sero-prevalence survey in rural South Africa. METHODS: We conducted HIV drug resistance genotyping and ART analyte testing on dried blood spots (DBS) from HIV-positive adults participating in a 2014 survey in North West Province. Among those with virologic failure (> 5000 copies/mL), we describe frequency of DRM to protease inhibitors (PI), nucleoside reverse transcriptase inhibitors (NRTI), and non-nucleoside reverse transcriptase inhibitors (NNRTI), report association of resistance with antiretroviral therapy (ART) status, and assess resistance to first and second line therapy. Analyses are weighted to account for sampling design. RESULTS: Overall 170 DBS samples were assayed for viral load and ART analytes; 78.4% of men and 50.0% of women had evidence of virologic failure and were assessed for drug resistance, with successful sequencing of 76/107 samples. We found ≥1 DRM in 22% of participants; 47% were from samples with detectable analyte (efavirenz, nevirapine or lopinavir). Of those with DRM and detectable analyte, 60% showed high-level resistance and reduced predicted virologic response to ≥1 NRTI/NNRTI typically used in first and second-line regimens. CONCLUSIONS: DRM and predicted reduced susceptibility to first and second-line regimens were common among adults with ART exposure in a rural South African population-based sample. Results underscore the importance of ongoing virologic monitoring, regimen optimization and adherence counseling to optimize durable virologic suppression.

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.

BACKGROUND: Voluntary medical male circumcisions (MCs) are safe: the majority of men heal without complication. However, guidelines require multiple follow-up visits. In Zimbabwe, where there is high mobile phone ownership, severe health care worker shortages, and rapid MC scale up intersect, we tested a 2-way texting (2wT) intervention to reduce provider workload while safeguarding patient safety. SETTING: Two high-volume facilities providing MC near Harare, Zimbabwe. METHODS: A prospective, unblinded, noninferiority, randomized control trial of 722 adult MC clients with cell phones randomized 1:1. 2wT clients (n = 362) responded to a daily text with in-person follow-up only if desired or an adverse event (AE) was suspected. The control group (n = 359) received routine in-person visits. All men were asked to return on postoperative day 14 for review. AEs at ≤day 14 visit and the number of in-person visits were compared between the groups. RESULTS: Cumulative AEs were identified in 0.84% [95% confidence interval (CI): 0.28 to 2.43] among routine care men as compared with 1.88% (95% CI: 0.86 to 4.03) of 2wT participants. Noninferiority cannot be ruled out (95% CI: -∞ to +2.72); however, AE rates did not differ between the groups (P = 0.32). 2wT men attended an average of 0.30 visits as compared with 1.69 visits among routine care men, a significant reduction (P < 0.001). CONCLUSIONS: Although noninferiority cannot be demonstrated, increased AEs in the 2wT arm likely reflect improved AE ascertainment. 2wT serves as a proxy for active surveillance, improving the quality of MC patient care. 2wT also reduced provider workload. 2wT provides an option for men to heal safely at home, returning to care when desired or if complications arise. 2wT should be further tested to enable widespread scale-up.

Need for improved detection of voluntary medical male circumcision adverse events in Mozambique: a mixed-methods assessment.

BACKGROUND: Adverse events (AE) resulting from voluntary medical male circumcision (VMMC) are commonly used to measure program quality. Mozambique's VMMC program data reports a combined moderate and severe AE rate of 0.2% through passive surveillance. With active surveillance, similar programs report AE rates ranging from 1.0 to 17.0%. The objective of this activity was to assess potential underreporting of AEs via the passive surveillance system in Mozambique. METHODS: This mixed-methods assessment randomly selected one third (16) of all 46 VMMC clinics through stratified sampling, based on volume. A retrospective record review was conducted including patient clinical files, stock records of Amoxicillin/Clavulanic Acid (the choice antibiotic for VMMC-related infections), and clinic-level AE rates from the national database. Records from the month of April 21 to May 20, 2017 were analyzed to identify both reported and potentially unreported AEs. In addition, external, expert clinicians observed post-operative visits (n = 167). Descriptive statistics were calculated, including difference between reported and identified AEs, an adjusted retrospective AE rate, and an observed prospective AE rate in each clinic. RESULTS: A total of 5352 circumcisions were performed in the 16 clinics: 8 (0.15%) AEs were reported. Retrospective clinical record reviews identified 36 AEs (0.67%); AE severity or type was unknown. Using Amoxicillin/Clavulanic Acid dispensation as a proxy for VMMC-related infections, 39 additional AEs infections were identified, resulting in an adjusted AE rate of 1.4%, an 8.3 fold increase from the reported AE rate. Prospective, post-operative visit observations of 167 clients found 10 AEs (5.9%); infection was common and boys 10-14 years old represented 80% of AE clients. CONCLUSIONS: Evidence suggests underreporting of AEs in the Mozambican VMMC program. Quality improvement efforts should be implemented in all VMMC sites to improve AE identification, documentation and prevention efforts.