Time spent at health facility is a key driver of patient satisfaction, but did not influence retention to HIV care: A serial cross-sectional study in Mozambique.

INTRODUCTION: Patient satisfaction with clinical services can have an effect on retention in HIV care and adherence to antiretroviral therapy. This study assessed patient satisfaction and its association with retention and viral suppression in Zambézia Province, Mozambique. METHODS: Monthly exit interviews with persons living with HIV were completed from August 2017-January 2019 in 20 health facilities; clinical data were extracted from medical records. Regression analyses assessed the effect of satisfaction scores on retention and viral suppression, adjusting for age, sex, education, civil status, time on treatment, and site. Satisfaction scores were correlated with time spent at health facilities using generalized linear regression models. RESULTS: Data from 4388 patients were analyzed. Overall median satisfaction score was 75% (IQR 53%-84%); median time spent at facilities (from arrival until completion of clinical services) was 2h54min (IQR 1h48min-4h). Overall satisfaction score was not associated with higher odds of retention or viral suppression, but association was seen between satisfaction regarding attention given to patient and respect and higher odds of viral suppression. Patient satisfaction was negatively associated with time spent in facility (Spearman's correlation -0.63). Increased time spent at facility (from 1 to 3 hours) was not associated with lower retention in care (OR 0.72 [95%CI:0.52-1.01] and 0.83 [95%CI: 0.63-1.09] at 6- and 12-months, respectively), nor with a lower odds of viral suppression (OR 0.96 [95%CI: 0.71-1.32]). CONCLUSIONS: Strategies to reduce patient wait times at the health facility warrant continued prioritization. Differentiated models of care have helped considerably, but novel approaches are still needed to further decongest crowded health facilities. In addition, a good client-provider communication and positive attitude can improve patient satisfaction with health services, with an overall improved retention.

The V-BRCH Project: Strengthening HIV Research Capacity in Nigeria through Intensive Workshops in Implementation Science and Grant Writing.

As persons with HIV live longer as the result of antiretroviral therapy, morbidity from HIV-associated noncommunicable diseases (NCDs) is increasing. The Vanderbilt-Nigeria Building Research Capacity in HIV and Noncommunicable Diseases program is a training platform created with the goal of training a cohort of successful Nigerian investigators to become leaders in HIV-associated NCD research. We describe survey findings from two week-long workshops in Kano, Nigeria, where trainees received instruction in implementation science and grant writing. Surveys assessed participants' self-perceived knowledge and confidence in topics taught during these workshops. Thirty-seven participants (all assistant professors) attended the implementation science workshop; 30 attended the grant-writing workshop. Response rates for the implementation science workshop were 89.2% for the preworkshop survey and 91.9% for the postworkshop survey. For the grant-writing workshop, these values were 88.2% and 85.3%, respectively. Improvement in participant knowledge and confidence was observed in every domain measured for both workshops. On average, a 101.4% increase in knowledge and a 118.0% increase in confidence was observed across measured domains among participants in the implementation science workshop. For the grant-writing workshop, there was a 68.8% increase in knowledge and a 70.3% increase in confidence observed. Participants rated the workshops and instructors as effective for both workshops. These workshops improved participants' knowledge and competence in implementation science and grant writing, and provide a model for training programs that aim to provide physician scientists with the skills needed to compete for independent funding, conduct locally relevant research, and disseminate research findings.

Availability of substance use screening and treatment within HIV clinical sites across seven geographic regions within the IeDEA consortium.

BACKGROUND: Overwhelming evidence highlights the negative impact of substance use on HIV care and treatment outcomes. Yet, the extent to which alcohol use disorder (AUD) and other substance use disorders (SUD) services have been integrated within HIV clinical settings is limited. We describe AUD/SUD screening and treatment availability in HIV clinical sites participating in the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium. METHODS: In 2020, 223 IeDEA HIV clinical sites from 41 countries across seven geographic regions completed a survey on capacity and practices related to management of AUD/ SUD. Sites provided information on AUD and other SUD screening and treatment practices. RESULTS: Sites were from low-income countries (23%), lower-middle-income countries (38%), upper-middle income countries (17%) and high-income counties (23%). AUD and SUD screening using validated instruments were reported at 32% (n=71 located in 12 countries) and 12% (n=27 located in 6 countries) of the 223 sites from 41 countries, respectively. The North American region had the highest proportion of clinics that reported AUD screening (76%), followed by East Africa (46%); none of the sites in West or Central Africa reported AUD screening. 31% (n=69) reported both AUD screening and counseling, brief intervention, psychotherapy, or Screening, Brief Intervention, and Referral to Treatment; 8% (n=18) reported AUD screening and detox hospitalization; and 10% (n=24) reported both AUD screening and medication. While the proportion of clinics providing treatment for SUD was lower than those treating AUD, the prevalence estimates of treatment availability were similar. CONCLUSIONS: Availability of screening and treatment for AUD/SUD in HIV care settings is limited, leaving a substantial gap for integration into ongoing HIV care. A critical understanding is needed of the multilevel implementation factors or feasible implementation strategies for integrating screening and treatment of AUD/SUD into HIV care settings, particularly for resource-constrained regions.

Risk factors and outcomes associated with pregnancy-related acute kidney injury in a high-risk cohort of women in Nigeria.

INTRODUCTION: Despite a decline in developed countries, pregnancy-related acute kidney injury (PRAKI) remains a significant contributor to maternal mortality and adverse fetal outcomes in resource-constrained settings. Little is known about the impact of pregnancy-related acute kidney injury in Nigeria. Therefore, this study aimed to assess the incidence and maternal-fetal outcomes associated with pregnancy-related acute kidney injury among a cohort of high-risk women in Nigeria. METHODS: This prospective multicenter study included women at high risk of acute kidney injury, who were more than 20 weeks pregnant or within 6 weeks postpartum and admitted to the Obstetrics and Gynecology units of two large public hospitals between September 1, 2019, and July 31, 2022. Acute kidney injury was defined and classified using the Kidney Disease Improving Global Outcomes (KDIGO) criteria. RESULTS: A total of 433 women, with mean age (± standard deviation) of 28 ± 6 years, were included in the evaluation. Pregnancy-related acute kidney injury occurred in 113 women (26.1%; 95% confidence interval [CI]: 21.1%-30.2%). The leading cause was preeclampsia (n = 57; 50.1%); 19 women died (4.4%), with 17 deaths (15%) occurring in the PRAKI group. Increasing severity of pregnancy-related acute kidney injury was independently associated with maternal mortality: adjusted odds ratio (aOR) for KDIGO stage 2 = 4.40; 95% CI 0.66-29.34, p = 0.13, and KDIGO stage 3 aOR = 6.12; 95% CI 1.09-34.34, p = 0.04. The overall perinatal mortality was 15% (n = 65), with 28 deaths (24.8%) occurring in the PRAKI group. Pregnancy-related acute kidney injury was also associated with an increased risk of perinatal mortality, aOR = 2.23; 95 CI 1.17-4.23, p = 0.02. CONCLUSIONS: The incidence of pregnancy-related acute kidney injury was high, and significantly associated with maternal and perinatal mortality. The leading causes were hypertensive disorders of pregnancy.

Training the next generation of Biostatisticians in West Africa: The Vanderbilt Nigeria Biostatistics Training Program (VN-BioStat).

Biomedical HIV research is growing in West Africa, but biostatistical expertise is lagging. The Vanderbilt-Nigeria Biostatistics Training Program (VN-BioStat) seeks to establish a research and training platform for biostatisticians doing HIV-related research in Nigeria. The objectives of the program are: 1) Host two Nigerian data scientists per year (a total of 10 over 5 years) at Vanderbilt University Medical Center to gain hands-on biostatistics training and experience via one-year fellowships. Eligible trainees will be junior investigators with PhDs or nearing completion of their PhDs in statistics or related fields, including mathematics and computer science. 2) Conduct annual workshops in Nigeria to provide biostatistics training. Trainees will undertake biostatistics coursework and hands-on training and participate in mentorship as biostatisticians involved in HIV research. Trainees will be at Vanderbilt for a full year and be part of an active biostatistics department. They will be immersed in a dry-lab HIV biostatistics project in collaboration with a Nigerian HIV research project and lead a methodologically focused research project. They will also participate in a one-month research training/grant writing program in Nashville. The VN-BioStat program will build on the existing momentum of ongoing initiatives to enhance research capacity in Nigeria by developing biostatistics leadership. VN-BioStat trainees will interact with investigators from Nigeria to provide collaborative biostatistical assistance with study design and data analysis, thus gaining real-world experience that will benefit the trainees and the broader research community in Nigeria.

Prevalence and Determinants of Endothelial Dysfunction among Adults Living with HIV in Northwest Nigeria.

Background: Endothelial dysfunction constitutes an early pathophysiological event in atherogenesis and cardiovascular disease. This study aimed to assess the prevalence, determinants, and degree of endothelial dysfunction in antiretroviral therapy (ART)-treated people living with HIV (PLWH) in northwestern Nigeria using brachial flow-mediated dilatation (FMD). Methods: This was a comparative, cross-sectional study. A total of 200 ART-treated adults living with HIV with no evidence of kidney disease were compared with 200 HIV-negative participants attending a tertiary hospital in Kano, Nigeria, between September 2020 and May 2021. Endothelial function was evaluated by measuring FMD with a high-resolution vascular ultrasound transducer. FMD was calculated as the ratio of the brachial artery diameter after reactive hyperemia to baseline diameter and expressed as a percentage of change. Blood and urine samples were obtained from participants in both arms. Urine albumin-to-creatinine ratio (uACR) was calculated using the 2021 CKD-EPI estimated glomerular filtration rate (eGFR) creatinine-cystatin C equation without the race variable, and low-density lipoprotein (LDL) cholesterol was measured using enzymatic method. Results: The overall mean age (± standard deviation) of the study participants was 42 ± 11 years. Participants in the comparison arm were younger than PLWH (38 ± 11 versus 46 ± 10 years, respectively). The median (interquartile range) uACR was 41.6 (23.2-162.9) mg/g for the ART-treated PLWH versus 14.5 (7.4-27.0) mg/g for healthy controls. PLWH had a significantly lower mean percent FMD when compared to HIV-negative participants (9.8% ± 5.4 versus 12.1% ± 9.2, respectively). Reduced FMD was independently associated with HIV infection (ß = -2.83%, 95% CI, -4.44% to -1.21%, p = 0.001), estimated glomerular filtration rate (ß = -0.04%, 95% CI, -0.07% to -0.01%, p = 0.004) and LDL cholesterol (ß = -1.12%, 95% CI, -2.13% to -0.11%, p = 0.029). Conclusion: HIV-positive status, lower estimated GFR, and higher LDL cholesterol levels were independently associated with endothelial dysfunction. Future prospective studies with larger cohorts of persons living with HIV (and age- and sex-matched HIV-negative controls) are needed to gain further insight into these important findings. In the interim, aggressive management of modifiable risk factors is warranted.

Availability of screening and treatment for common mental disorders in HIV clinic settings: data from the global International epidemiology Databases to Evaluate AIDS (IeDEA) Consortium, 2016-2017 and 2020.

INTRODUCTION: Common mental disorders (CMDs) are highly prevalent among people with HIV. Integrating mental healthcare into HIV care may improve mental health and HIV treatment outcomes. We describe the reported availability of screening and treatment for depression, anxiety and post-traumatic stress disorder (PTSD) at global HIV treatment centres participating in the International epidemiology Databases to Evaluate AIDS (IeDEA) Consortium in 2020 and changes in availability at sites in low- or middle-income countries (LMICs) between 2016/2017 and 2020. METHODS: In 2020, 238 sites contributing individual-level data to the IeDEA Consortium and in 2016/2017 a stratified random sample of IeDEA sites in LMICs were eligible to participate in site surveys on the availability of screening and treatment for CMDs. We assessed trends over time for 68 sites across 27 LMICs that participated in both surveys. RESULTS: Among the 238 sites eligible to participate in the 2020 site survey, 227 (95%) participated, and mental health screening and treatment data were available for 223 (98%) sites across 41 countries. A total of 95 sites across 29 LMICs completed the 2016/2017 survey. In 2020, 68% of sites were in urban settings, and 77% were in LMICs. Overall, 50%, 14% and 12% of sites reported screening with a validated instrument for depression, anxiety and PTSD, respectively. Screening plus treatment in the form of counselling was available for depression, anxiety and PTSD at 46%, 13% and 11% of sites, respectively. Screening plus treatment in the form of medication was available for depression, anxiety and PTSD at 36%, 11% and 8% of sites, respectively. Among sites that participated in both surveys, screening for depression was more commonly available in 2020 than 2016/2017 (75% vs. 59%, respectively, p = 0.048). CONCLUSIONS: Reported availability of screening for depression increased among this group of IeDEA sites in LMICs between 2016/2017 and 2020. However, substantial gaps persist in the availability of mental healthcare at HIV treatment sites across global settings, particularly in resource-constrained settings. Implementation of sustainable strategies to integrate mental health services into HIV care is needed.

Design and implementation of a global site assessment survey among HIV clinics participating in the International epidemiology Databases to Evaluate AIDS (IeDEA) research consortium.

INTRODUCTION: Timely descriptions of HIV service characteristics and their evolution over time across diverse settings are important for monitoring the scale-up of evidence-based program strategies, understanding the implementation landscape, and examining service delivery factors that influence HIV care outcomes. METHODS: The International epidemiology Databases to Evaluate AIDS (IeDEA) consortium undertakes periodic cross-sectional surveys on service availability and care at participating HIV treatment sites to characterize trends and inform the scientific agenda for HIV care and implementation science communities. IeDEA's 2020 general site assessment survey was developed through a consultative, 18-month process that engaged diverse researchers in identifying content from previous surveys that should be retained for longitudinal analyses and in developing expanded and new content to address gaps in the literature. An iterative review process was undertaken to standardize the format of new survey questions and align them with best practices in survey design and measurement and lessons learned through prior IeDEA site assessment surveys. RESULTS: The survey questionnaire developed through this process included eight content domains covered in prior surveys (patient population, staffing and community linkages, HIV testing and diagnosis, new patient care, treatment monitoring and retention, routine HIV care and screening, pharmacy, record-keeping and patient tracing), along with expanded content related to antiretroviral therapy (differentiated service delivery and roll-out of dolutegravir-based regimens); mental health and substance use disorders; care for pregnant/postpartum women and HIV-exposed infants; tuberculosis preventive therapy; and pediatric/adolescent tuberculosis care; and new content related to Kaposi's sarcoma diagnostics, the impact of COVID-19 on service delivery, and structural barriers to HIV care. The survey was distributed to 238 HIV treatment sites in late 2020, with a 95% response rate. CONCLUSION: IeDEA's approach for site survey development has broad relevance for HIV research networks and other priority health conditions.

Global HIV prevention, care and treatment services for children: a cross-sectional survey from the International Epidemiology Databases to Evaluate AIDS (IeDEA) consortium.

OBJECTIVES: To assess access children with HIV have to comprehensive HIV care services, to longitudinally evaluate the implementation and scale-up of services, and to use site services and clinical cohort data to explore whether access to these services influences retention in care. METHODS: A cross-sectional standardised survey was completed in 2014-2015 by sites providing paediatric HIV care across regions of the International Epidemiology Databases to Evaluate AIDS (IeDEA) consortium. We developed a comprehensiveness score based on the WHO's nine categories of essential services to categorise sites as 'low' (0-5), 'medium', (6-7) or 'high' (8-9). When available, comprehensiveness scores were compared with scores from a 2009 survey. We used patient-level data with site services to investigate the relationship between the comprehensiveness of services and retention. RESULTS: Survey data from 174 IeDEA sites in 32 countries were analysed. Of the WHO essential services, sites were most likely to offer antiretroviral therapy (ART) provision and counselling (n=173; 99%), co-trimoxazole prophylaxis (168; 97%), prevention of perinatal transmission services (167; 96%), outreach for patient engagement and follow-up (166; 95%), CD4 cell count testing (126; 88%), tuberculosis screening (151; 87%) and select immunisation services (126; 72%). Sites were less likely to offer nutrition/food support (97; 56%), viral load testing (99; 69%) and HIV counselling and testing (69; 40%). 10% of sites rated 'low', 59% 'medium' and 31% 'high' in the comprehensiveness score. The mean comprehensiveness of services score increased significantly from 5.6 in 2009 to 7.3 in 2014 (p<0.001; n=30). Patient-level analysis of lost to follow-up after ART initiation estimated the hazard was highest in sites rated 'low' and lowest in sites rated 'high'. CONCLUSION: This global assessment suggests the potential care impact of scaling-up and sustaining comprehensive paediatric HIV services. Meeting recommendations for comprehensive HIV services should remain a global priority.

Favorable Impact of Community Adherence Support Groups on Retention in Care and Viral Suppression Rates Among Persons with HIV Receiving Antiretroviral Therapy in Mozambique.

The community adherence support group (CASG) was one of the first differentiated service delivery (DSD) models introduced in Mozambique. This study assessed the impact of this model on retention in care, loss to follow-up (LTFU), and viral suppression among antiretroviral therapy (ART)-treated adults in Mozambique. A retrospective cohort study included CASG-eligible adults enrolled between April 2012 and October 2017 at 123 health facilities in Zambézia Province. Propensity score matching (1:1 ratio) was used to allocate CASG members and those who never enrolled in a CASG. Logistic regressions were performed to estimate the impact of CASG membership on 6- and 12-month retention and viral load (VL) suppression. Cox proportional regression was used to model differences in LTFU. Data from 26,858 patients were included. The median age at CASG eligibility was 32 years and 75% were female, with 84% residing in rural areas. A total of 93% and 90% of CASG members were retained in care at 6 and 12 months, respectively, while 77% and 66% non-CASG members were retained during the same periods. The odds of being retained in care at 6 and 12 months were significantly higher among patients receiving ART through CASG support (adjusted odds ratio [aOR] = 4.19 [95% confidence interval; CI: 3.79-4.63], p < .001, and aOR = 4.43 [95% CI: 4.01-4.90], p < .001, respectively). Among 7,674 patients with available VL measurements, the odds of being virally suppressed were higher among CASG members (aOR = 1.14 [95% CI: 1.02-1.28], p < .001). Non-CASG members had a significantly higher likelihood of being LTFU (adjusted hazard ratio = 3.45 [95% CI: 3.20-3.73], p < .001). While Mozambique rapidly scales up multi-month drug dispensation as the preferred DSD model, this study emphasizes the continued importance of CASG as an efficacious DSD alternative, especially among patients residing in rural areas, where CASG acceptability is higher.

The Vanderbilt Nigeria Biostatistics Training Program (VN-BioStat): Results from a Skills Workshop.

The Vanderbilt-Nigeria Biostatistics Training Program (VN-BioStat) aims to establish a research and training platform for biostatisticians doing HIV-related research in Nigeria, including enhancing mid-level biostatistics capacity through annual workshops. This paper describes findings from the inaugural workshop in Kano, Nigeria. Participants were surveyed before and after the workshop to assess their self-perceived familiarity with and confidence in their abilities to use statistical software and apply specific statistical techniques, as well as to gather feedback regarding the conduct of the workshop and future topic areas. Of the 23 participants enrolled in the workshop, 22 (96%) completed both pre- and post-workshop assessments. In both pre-workshop and post-workshop surveys, participants ranked their confidence in statistical skills using Likert scales. Scores were transformed to a 0-100 scale, and averages computed. Participants also shared open-ended feedback about the workshop and suggested future topic areas. Before the training, the average participant reported having either a "beginner" (30% of participants) or "moderate" (43%) level of familiarity with R. Many participants (65%) rated themselves as having "moderate" or "expert" familiarity with SPSS. Pre-workshop averages for confidence ranged from 26 to 64, with lowest confidence in "expanding continuous covariates in regression models and interpret results" and highest confidence in "fitting and interpreting results from a linear regression model". Post-workshop averages for confidence were all above 70. The lowest post-workshop score (74) was for "fit and interpret results from a semiparametric linear transformation model". The greatest increase in confidence was observed in "expanding continuous covariates in regression models using splines and interpreting results" and the lowest increase was in "fitting and interpreting results from a linear regression model." Participants offered positive feedback on instructor effectiveness (4.9/5) and overall course quality (4.9/5). While the overall course was rated on a 0-100 scale as "moderately difficult" (mean ± SD: 40.5 ± 17.5), the participants felt the course was highly organized (87.7 ± 17.8), and the information was moderately easy to learn (81.9 ± 15.9). Suggestions for future workshops included providing supplementary resources for out-of-classroom learning and releasing codes in advance to enhance participants' preparation. Among suggestions for future workshop topics, 80% of respondents listed survival analysis. Lessons learned provide insight into how short-term training opportunities can be leveraged to build biostatistics capacity in similar settings.

Service delivery challenges in HIV care during the first year of the COVID-19 pandemic: results from a site assessment survey across the global IeDEA consortium.

INTRODUCTION: Interruptions in treatment pose risks for people with HIV (PWH) and threaten progress in ending the HIV epidemic; however, the COVID-19 pandemic's impact on HIV service delivery across diverse settings is not broadly documented. METHODS: From September 2020 to March 2021, the International epidemiology Databases to Evaluate AIDS (IeDEA) research consortium surveyed 238 HIV care sites across seven geographic regions to document constraints in HIV service delivery during the first year of the pandemic and strategies for ensuring care continuity for PWH. Descriptive statistics were stratified by national HIV prevalence (<1%, 1-4.9% and ≥5%) and country income levels. RESULTS: Questions about pandemic-related consequences for HIV care were completed by 225 (95%) sites in 42 countries with low (n = 82), medium (n = 86) and high (n = 57) HIV prevalence, including low- (n = 57), lower-middle (n = 79), upper-middle (n = 39) and high- (n = 50) income countries. Most sites reported being subject to pandemic-related restrictions on travel, service provision or other operations (75%), and experiencing negative impacts (76%) on clinic operations, including decreased hours/days, reduced provider availability, clinic reconfiguration for COVID-19 services, record-keeping interruptions and suspension of partner support. Almost all sites in low-prevalence and high-income countries reported increased use of telemedicine (85% and 100%, respectively), compared with less than half of sites in high-prevalence and lower-income settings. Few sites in high-prevalence settings (2%) reported suspending antiretroviral therapy (ART) clinic services, and many reported adopting mitigation strategies to support adherence, including multi-month dispensing of ART (95%) and designating community ART pick-up points (44%). While few sites (5%) reported stockouts of first-line ART regimens, 10-11% reported stockouts of second- and third-line regimens, respectively, primarily in high-prevalence and lower-income settings. Interruptions in HIV viral load (VL) testing included suspension of testing (22%), longer turnaround times (41%) and supply/reagent stockouts (22%), but did not differ across settings. CONCLUSIONS: While many sites in high HIV prevalence settings and lower-income countries reported introducing or expanding measures to support treatment adherence and continuity of care, the COVID-19 pandemic resulted in disruptions to VL testing and ART supply chains that may negatively affect the quality of HIV care in these settings.

Building Physician-Scientist Skills in R Programming:A Short Workshop Report.

Introduction: Statistical analysis programs require coding experience and a basic understanding of programming, skills which are not taught as part of medical school or residency curricula. Methods: We conducted a five-day course for early-career Nigerian physician-scientists interested in learning common statistical tests and acquiring R programming skills. The workshop included didactic presentations, small group learning activities, and interactive discussions. A baseline questionnaire captured participant demographics and solicited participants' level of confidence in understanding/performing common statistical tests. REDCap questionnaires were emailed to obtain feedback on educational format and content. A post-workshop assessment covered participants' overall impression of the program. Results: A total of 23 participants attended the program. Most participants were male (n=14, 60.9%) and at an early stage in their career (assistant professor, n=20, 87.0%). Approximately 70% of respondents indicated having received some prior training in statistics. The proportion of participants without experience using R and SAS software (90% and 85%, respectively) was greater than the corresponding proportions for Stata (55%) and SPSS (20%). Prior to the workshop, most respondents expressed being "not at all confident" in performing one-way ANOVA (60%), logistic regression (68%), simple linear regression (60%), and McNemar's test (80%). There was a statistically significant post-workshop improvement in the level of confidence in understanding and performing common statistical tests. The course was rated on a 0-100 scale as "moderately difficult" (mean ± SD: 51.7 ± 19.5). Most participants felt comfortable in putting the knowledge learned into practice (82.2 ± 17.1). Conclusion and Public Health Implications: Introductory R can be taught to junior physician-scientists in resource-limited settings and can inform the development and implementation of similar training initiatives in analogous settings.

Etiology of Persistent Microalbuminuria in Nigeria (P_MICRO study): protocol and study design.

BACKGROUND: Microalbuminuria is an independent risk factor for cardiovascular and kidney disease and a predictor of end organ damage, both in the general population and in persons with HIV (PWH). Microalbuminuria is also an important risk factor for mortality in PWH treated with antiretroviral therapy (ART). In the ongoing Renal Risk Reduction (R3) study in Nigeria, we identified a high prevalence of microalbuminuria confirmed by two measurements 4-8 weeks apart in ART-experienced, virologically suppressed PWH. Although Stage 1 or 2 hypertension and exposure to potentially nephrotoxic antiretroviral medications were common in R3 participants, other traditional risk factors for albuminuria and kidney disease, including diabetes, APOL1 high-risk genotype, and smoking were rare. Co-infection with endemic pathogens may also be significant contributors to albuminuria, but co-infections were not evaluated in the R3 study population. METHODS: In Aim 1, we will cross-sectionally compare the prevalence of albuminuria and established kidney disease risk factors in a cohort of PWH to age- and sex-matched HIV-negative adults presenting for routine care at the Aminu Kano Teaching Hospital in Kano, Nigeria. We will leverage stored specimens from 2500 R3 participants and enroll an additional 500 PLWH recently initiated on ART (≤ 24 months) and 750 age- and sex-matched HIV-negative adults to determine the contribution of HIV, hypertension, and other comorbid medical conditions to prevalent albuminuria. In Aim 2, we will follow a cohort of 1000 HIV-positive, ART-treated and 500 HIV-negative normoalbuminuric adults for 30 months to evaluate the incidence and predictors of albuminuria. DISCUSSION: The findings from this study will support the development of interventions to prevent or address microalbuminuria in PWH to reduce kidney and cardiovascular morbidity and mortality. Such interventions might include more intensive monitoring and treatment of traditional risk factors, the provision of renin-angiotensin aldosterone system or sodium-glucose cotransporter-2 inhibitors, consideration of changes in ART regimen, and screening and treatment for relevant co-infections.

The effect of a Mentor Mothers program on prevention of vertical transmission of HIV outcomes in Zambézia Province, Mozambique: a retrospective interrupted time series analysis.

INTRODUCTION: Mentor Mothers (MM) provide peer support to pregnant and postpartum women living with HIV (PPWH) and their infants with perinatal HIV exposure (IPE) throughout the cascade of prevention of vertical transmission (PVT) services. MM were implemented in Zambézia Province, Mozambique starting in August 2017. This evaluation aimed to determine the effect of MM on PVT outcomes. METHODS: A retrospective interrupted time series analysis was done using routinely collected aggregate data from 85 public health facilities providing HIV services in nine districts of Zambézia. All PPWH (and their IPE) who initiated antiretroviral therapy (ART) from August 2016 through April 2019 were included. Outcomes included the proportion per month per district of: PPWH retained in care 12 months after ART initiation, PPWH with viral suppression and IPE with HIV DNA PCR test positivity by 9 months of age. The effect of MM on outcomes was assessed using logistic regression. RESULTS: The odds of 12-month retention increased 1.5% per month in the pre-MM period, compared to a monthly increase of 7.6% with-MM (35-61% pre-MM, 56-72% with-MM; p < 0.001). The odds of being virally suppressed decreased by 0.9% per month in the pre-MM period, compared to a monthly increase of 3.9% with-MM (49-85% pre-MM, 59-80% with-MM; p < 0.001). The odds of DNA PCR positivity by 9 months of age decreased 8.9% per month in the pre-MM period, compared to a monthly decrease of 0.4% with-MM (0-14% pre-MM, 4-10% with-MM; p < 0.001). The odds of DNA PCR uptake (the proportion of IPE who received DNA PCR testing) by 9 months of age were significantly higher in the with-MM period compared to the pre-MM period (48-100% pre-MM, 87-100% with-MM; p < 0.001). CONCLUSIONS: MM services were associated with improved retention in PVT services and higher viral suppression rates among PPWH. While there was ongoing but diminishing improvement in DNA PCR positivity rates among IPE following MM implementation, this might be explained by increased uptake of HIV testing among high-risk IPE who were previously not getting tested. Additional efforts are needed to further optimize PVT outcomes, and MM should be one part of a comprehensive strategy to address this critical need.

Reaching Men and Young Adults in a Pharmacy-Based HIV Self-Testing Strategy: Results from an Acceptability Study in Mozambique.

HIV self-testing (HIVST) is a WHO-recommended strategy to increase testing, especially among key populations, men, and young adults. Between May and December 2019, a pilot was implemented in Zambézia province, Mozambique, allowing clients to purchase HIV self-tests in 14 public/private pharmacies. The study assessed the strategy's acceptability and uptake. Pharmacy-based exit surveys were conducted among a random sample of clients, during the first three months of the pilot, independent of HIVST purchase. Another random sample of clients who bought an HIVST completed a survey 1-12 weeks after purchase. Chi-square and Mann-Whitney tests were used for the analysis, comparing clients who purchased an HIVST versus not. A total of 1,139 adults purchased 1,344 tests. Buyers were predominantly male (70%) and younger (52% between 15 and 34 years of age). Surveys were completed by 280 exiting pharmacy clients and 82 clients who purchased an HIVST. Main advantages were confidentiality and lack of need of a health provider visit, with main disadvantages being absence of nearby counseling and fear of results. No differences were seen between buyers and non-buyers for these factors. Among all undergoing HIVST, 71 (92%) perceived the instructions to be clear, however, 29 (38%) stated they would have benefitted from additional pre-test information or counseling. Ten (13%) reported following up at a nearby health facility to confirm results and/or receive care. Offering HIVST at public/private pharmacies was acceptable among people who traditionally tend to have a lower HIV testing coverage, such as men and young adults. However, additional resources and/or enhanced educational materials to address the lack of counseling, and linkage-to-care systems need to be put into place before scaling up this strategy.

Magnetic Bead Processing Enables Sensitive Ligation-Based Detection of HIV Drug Resistance Mutations.

HIV develops single nucleotide polymorphisms (SNPs), some of which lead to drug resistance mutations (DRMs) that prevent therapeutic viral suppression. Genomic sequencing enables healthcare professionals to select effective combination antiretroviral therapy (ART) to achieve and maintain viral suppression. However, sequencing technologies, which are resource-intensive, are limited in their availability. This report describes the first step toward a highly specific ligation-based SNP discrimination method with endpoint PCR detection, which is more suitable for resource-limited clinics. The approach is based on magnetic bead processing to maximize reaction product transfer and minimize the carryover of incompatible buffer for three consecutive enzymatic reactions─reverse transcription (RT), oligonucleotide ligation assay (OLA), and PCR. The method improved PCR detection following RT → OLA by 8.06 cycles (∼250-fold) compared to direct pipette processing and detected between 103 and 104 RNA copies per reaction. In studies with synthesized nucleic acids based on the well-studied HIV mutation, K103N, the assay successfully differentiated between wild-type and mutant for RNA targets with high specificity. With further development, this design provides a pathway for SNP detection with more accessible PCR instrumentation and is a step toward a self-contained processing approach that incorporates the SNP specificity of the ligation reaction for more effective clinical management of DRMs in resource-constrained settings.

CD4 Trends With Evolving Treatment Initiation Policies Among Children Living With HIV in Zambézia Province, Mozambique, 2012-2018.

BACKGROUND: Historically, antiretroviral therapy (ART) initiation was based on CD4 criteria, but this has been replaced with "Test and Start" wherein all people living with HIV are offered ART. We describe the baseline immunologic status among children relative to evolving ART policies in Mozambique. METHODS: This retrospective evaluation was performed using routinely collected data. Children living with HIV (CL aged 5-14 years) with CD4 data in the period of 2012-2018 were included. ART initiation "policy periods" corresponded to implementation of evolving guidelines: in period 1 (2012-2016), ART was recommended for CD4 <350 cells/mm3; during period 2 (2016-2017), the CD4 threshold increased to <500 cells/mm3; Test and Start was implemented in period 3 (2017-2018). We described temporal trends in the proportion of children with severe immunodeficiency (CD4 <200 cells/mm3) at enrollment and at ART initiation. Multivariable regression models were used to estimate associations with severe immunodeficiency. RESULTS: The cohort included 1815 children with CD4 data at enrollment and 1922 at ART initiation. The proportion of children with severe immunodeficiency decreased over time: 20% at enrollment into care in period 1 vs. 16% in period 3 (P = 0.113) and 21% at ART initiation in period 1 vs. 15% in period 3 (P = 0.004). Children initiating ART in period 3 had lower odds of severe immunodeficiency at ART initiation compared with those in period 1 [adjusted odds ratio (aOR) = 0.67; 95% CI: 0.51 to 0.88]. Older age was associated with severe immunodeficiency at enrollment (aOR = 1.13; 95% CI: 1.06 to 1.20) and at ART initiation (aOR = 1.14; 95% CI: 1.08 to 1.21). CONCLUSIONS: The proportion of children with severe immunodeficiency at ART initiation decreased alongside more inclusive ART initiation guidelines. Earlier treatment of children living with HIV is imperative.

Building Research Capacity in HIV and Noncommunicable Diseases in Africa: A Mentorship and Leadership Workshop Report.

INTRODUCTION: Few structured mentoring programs target early-stage investigators in Africa, creating a gap in mentorship skills where HIV burden is greatest. We describe findings from a Nigeria-based workshop for early-career physician scientists to build mentoring and leadership capacity in HIV and noncommunicable disease research. METHODS: Baseline surveys captured participant demographics, confidence in implementing mentoring competencies, and perceived importance of workshop training domains. The workshop included didactic presentations, small group activities, and interactive discussions. Daily surveys evaluated sessions, and postworkshop surveys solicited overall course impressions. RESULTS: Of the 33 participants, most were male (n = 21, 63.6%) and from medicine, laboratory sciences, and surgical specialties. "Building mentees' confidence" and "setting mentees' research goals" were ranked as areas where participants most believed they needed training. Sessions were rated favorably across five areas. Greatest improvements in mean scores were for confidence in identifying personal temperament styles, describing mentoring and leadership theories/frameworks, and developing mentoring plans. Additional identified workshop strengths were content relevance, leadership case series, interactive nature, and collegial atmosphere. All respondents indicated learning something new/useful/helpful in each session. At 6-month postworkshop, most respondents (25 of 26, 96%) had replicated or plan to replicate parts of the workshop in their departments/institutions. DISCUSSION: Effective mentoring training initiatives targeting future academic leaders have the potential to create skilled academicians who can impart mentoring skills and competencies to their mentees.