Effects of Maternal HIV Infection and Alcohol Use in Pregnancy on Birth Outcomes in Uganda.

Alcohol use and HIV infection are prevalent in sub-Saharan Africa (sSA), and both are associated with low birth weight. Yet, few studies have evaluated the combined effects of maternal HIV infection and alcohol use on birth outcomes. We analyzed data from a prospective cohort study of HIV-related placental changes in Ugandan women. We defined alcohol use as self-reported alcohol use within the last year, using the AUDIT questionnaire and used linear and logistic regression to measure associations between maternal alcohol use, HIV serostatus, and birth weight. In a subsample, we measured alcohol exposure using phosphatidylethanol (PEth) in neonatal heelstick dried blood spots to confirm maternal alcohol use. Of 352 participants, 176 (50%) were women with HIV (WHIV). Three of 176 (2%) HIVuninfected women and 17/176 (10%) of WHIV self-reported alcohol use (P = 0.002). Maternal HIV infection was associated with lower birth weight (ß = -0.12, 95% CI [-0.20, -0.02], P = 0.02), but self-reported alcohol use was not (ß = 0.06, 95% CI [-0.15, 0.26], P = 0.54), and the interaction between HIV serostatus and alcohol use was not significant (P = 0.13). Among the PEth subsample, neither HIV status nor PEthconfirmed alcohol use were associated with low birth weight. Maternal HIV infection was associated with lower birth weight, but alcohol use was not, and there was no significant interaction between maternal HIV infection and alcohol use. Alcohol use was more prevalent in WHIV and under-reporting was common. A larger study of the effects of laboratory-confirmed alcohol and HIV exposure on birth outcomes is warranted.

Acceptability, feasibility and preliminary effectiveness of the mHealth intervention, InTSHA, on retention in care and viral suppression among adolescents with HIV in South Africa: a pilot randomized clinical trial.

We describe the results of a pilot randomized clinical trial of a mobile phone-based intervention, InTSHA: Interactive Transition Support for Adolescents with HIV, compared to standard care. Encrypted, closed group chats delivered via WhatsApp provided peer support and improved communication between adolescents with HIV, their caregivers, and healthcare providers. We randomized 80 South African adolescents ages 15 to 19 years with perinatally-acquired HIV to receive either the intervention (n=40) or standard of care (n=40). We measured acceptability (Acceptability of Intervention Measure [AIM]) and feasibility (Feasibility of Intervention Measure [FIM]) as primary outcomes. We evaluated impact on retention in care and viral suppression six months after randomization as secondary endpoints. We performed bivariable and multivariable analyses using logistic regression models to assess the effect of the InTSHA intervention compared to standard of care. Among the adolescents randomized to the InTSHA intervention, the median AIM was 4.1/5.0 (82%) and median FIM was 3.9/5.0 (78%). We found no difference in retention in care or in viral suppression comparing intervention and control groups. Among adolescents who attended three or more sessions, retention in care was 100% at 6 months. InTSHA is an acceptable and feasible mHealth intervention warranting further study in a larger population.

Multicenter Analysis of Attrition from the Pediatric Tuberculosis Infection Care Cascade in Boston.

OBJECTIVE: To characterize losses from the pediatric tuberculosis (TB) infection care cascade to identify ways to improve TB infection care delivery. STUDY DESIGN: We conducted a retrospective cohort study of children (age <18 years) screened for TB within 2 Boston-area health systems between January 2017 and May 2019. Patients who received a tuberculin skin test (TST) and/or an interferon gamma release assay (IGRA) were included. RESULTS: We included 13 353 tests among 11 622 patients; 93.9% of the tests were completed. Of 199 patients with positive tests for whom TB infection evaluation was clinically appropriate, 59.3% completed treatment or were recommended to not start treatment. Age 12-17 years (vs < 5 years; aOR 1.59; 95% CI, 1.32-1.92), non-English/non-Spanish language preference (vs English; aOR, 1.34; 95% CI, 1.02-1.76), and receipt of an IGRA (vs TST, aOR, 30.82; 95% CI, 21.92-43.34) were associated with increased odds of testing completion. Odds of testing completion decreased as census tract social vulnerability index quartile increased (ie, social vulnerability worsened; most vulnerable quartile vs least vulnerable quartile, aOR, 0.77; 95% CI, 0.60-0.99). Odds of completing treatment after starting treatment were higher in females (vs males; aOR, 2.35; 95% CI, 1.14-4.85) and were lower in patients starting treatment in a primary care clinic (vs TB/infectious diseases clinic; aOR, 0.44; 95% CI, 0.27-0.71). CONCLUSIONS: Among children with a high proportion of negative TB infection tests, completion of testing was high, but completion of evaluation and treatment was moderate. Transitions toward IGRA testing will improve testing completion; interventions addressing social determinants of health are important to improve treatment completion.

Trajectories of Oral PrEP Adherence Among Young Kenyan Women: Implications for Promoting Effective PrEP Use.

Using data from a 2-year study of young women at high HIV risk in Thika and Kisumu, Kenya, we identified group-based trajectories of PrEP adherence based on electronic pillcap-monitoring and assessed potentially associated demographic and socio-behavioral factors. Among 348 women, we selected a three-trajectory adherence model: low and declining (N = 211, 61%), moderate but declining (N = 119, 34%) and steady high adherers (N = 18, 5%). We also identified a two-trajectory HIV risk model based on self-perceived risk in the past week: high and increasing (N = 28, 8%) and steady low (N = 320, 92%) risk. The Kisumu site was associated with the moderate but declining and steady high adherence trajectories, while increasing VOICE risk score was associated with the low and declining adherence trajectory. We found no association between the adherence and risk trajectories. Our findings suggest adherence support may need tailoring by setting. Early, sustained support may also help those at highest risk of non-adherence.

RESUMEN: Utilizando datos de un estudio de dos años de duración en mujeres jóvenes con alto riesgo de VIH en Thika y Kisumu, Kenia, identificamos trayectorias grupales de adherencia a la PrEP basadas en el monitoreo electrónico de pillcap y evaluamos los factores demográficos, sociales y de comportamiento potencialmente asociados con la adherencia. En un grupo de 348 mujeres, seleccionamos un modelo de adherencia de tres trayectorias: baja y decreciente (N = 211, 61%), moderada pero decreciente (N = 119, 34%) y altas constantes (N = 18, 5%). También identificamos un modelo de riesgo de VIH de dos trayectorias basado en el riesgo autopercibido en la última semana: riesgo alto y creciente (N = 28, 8%) y riesgo bajo constante (N = 320, 92%). El sitio de Kisumu estuvo asociado con las trayectorias de adherencia alta moderadas pero decrecientes y constantes, mientras que el aumento de la puntuación de riesgo de VOICE se asoció con la trayectoria de adherencia baja y decreciente. No se encontró asociación entre la adherencia y las trayectorias de riesgo. Nuestros hallazgos sugieren que el apoyo a la adherencia podría individualizarse de acuerdo con el entorno. El apoyo temprano y sostenido a la adherencia también puede ayudar a las personas con mayor riesgo de no adherencia.

Performance of Multiple Adherence Measures for pre-exposure Prophylaxis (PrEP) Among Young Women in Kenya.

Understanding PrEP adherence is key in the formulation of HIV prevention strategies; however, measurement of adherence can be challenging. We compared multiple adherence measures in a two-year study of young Kenyan women at high risk of HIV acquisition. Among 289 participants, concordance between electronic adherence monitoring (EAM) and tenofovir diphosphate (TFV-DP) in dried blood spots ranged from 57 to 72% depending on selected thresholds. Using area under the receiver operating curve, discrimination of quantifiable TFV-DP was high at 0.85 with EAM and low at 0.49-0.54 for multiple self-reported measures. Correlation between EAM and self-reported measures was low (r < 0.11) although correlation within self-reported measures was moderate (r > 0.69). These findings indicate that both TFV-DP and EAM are useful PrEP adherence tools. Adherence would benefit from better availability of less expensive versions of both measurement tools. Additionally, further research on TFV-DP thresholds is needed to inform interpretation and use in understanding PrEP adherence in this population.

RESUMEN: Comprender la adherencia a la PrEP es importante en la formulación de estrategias de prevención del VIH; sin embargo, la medición de la adherencia puede ser difícil. Comparamos múltiples medidas de adherencia en un estudio de dos años de mujeres jóvenes kenianas con alto riesgo de contraer el VIH. Entre 289 participantes, la concordancia entre la monitorización electrónica de la adherencia (EAM) y el tenofovir difosfato (TFV-DP) en las manchas de sangre seca varió del 57% al 72% dependiendo de los umbrales seleccionados. Utilizando el área bajo la curva operativa del receptor, la discriminación de TFV-DP cuantificable fue alta en 0.85 con EAM y baja en 0.49­0.54 para múltiples medidas autoinformadas. La correlación entre la EAM y las medidas autoinformadas fue baja (r < 0,11), aunque la correlación entre de las medidas autoinformadas fue moderada (r > 0,69). Estos resultados indican que tanto TFV-DP como EAM son herramientas útiles de adherencia a la PrEP. La adherencia se beneficiaría de una mejor disponibilidad de versiones menos costosas de ambas herramientas de medición. Además, se necesita más investigación sobre los umbrales TFV-DP para informar la interpretación y el uso en la comprensión de la adherencia a la PrEP en esta población.

Determinants of health-related quality of life in people with Human Immunodeficiency Virus, failing first-line treatment in Africa.

BACKGROUND: Antiretroviral treatment improves health related quality of life (HRQoL) of people with human immunodeficiency virus (PWH). However, one third initiating first-line treatment experience virological failure and the determinants of HRQoL in this key population are unknown. Our study aims to identify determinants of among PWH failing antiretroviral treatment in sub-Saharan Africa. METHODS: We analysed data from a cohort of PWH having virological failure (> 1,000 copies/mL) on first-line ART in South Africa and Uganda. We measured HRQoL using the EuroQOL EQ-5D-3L and used a two-part regression model to obtain by-country analyses for South Africa and Uganda. The first part identifies risk factors that were associated with the likelihood of participants reporting perfect health (utility = 1) versus non-perfect health (utility < 1). The second part identifies risk factors that were associated with the EQ-5 L-3L utility scores for participants reporting non-perfect health. We performed sensitivity analyses to compare the results between the two-part model using tobit models and ordinary least squares regression. RESULTS: In both countries, males were more likely to report perfect health and participants with at least one comorbidity were less likely to report perfect health. In South Africa, participants with side effects and in Uganda those with opportunistic infections were also less likely to report perfect health. In Uganda, participants with 100% ART adherence were more likely to report perfect health. In South Africa, high HIV viral load, experiencing ART side effects, and the presence of opportunistic infections were each associated with lower HRQoL, whereas participants with 100% ART adherence reported higher HRQoL. In Uganda participants with lower CD4 count had lower HRQoL. CONCLUSION: Markers of advanced disease (opportunistic infection, high viral load, low CD4), side effects, comorbidities and lack of ART adherence negatively impacted HRQoL for PWH experiencing virological failure. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02787499.

High residual inflammation despite HIV viral suppression: Lessons learned from real-time adherence monitoring among people with HIV in Africa.

BACKGROUND: Lower antiretroviral therapy (ART) adherence is associated with higher systemic inflammation in virally suppressed people with HIV (PWH); however, previous studies have mostly relied on subjective adherence measures and have not assessed this association by disease stage upon ART initiation. METHODS: In the Monitoring Early Treatment Adherence study, adherence was monitored electronically in real time among adult, treatment-naïve PWH in Uganda and South Africa who initiated tenofovir disoproxil fumarate/emtricitabine/efavirenz during early-stage (CD4 > 350 cells/µL) or late-stage (CD4 < 200 cells/µL) disease. Participants who achieved viral suppression (< 400 copies/mL) at 6 months and remained suppressed after 12 months were analysed. The association between average ART adherence and plasma concentrations of interleukin 6 (IL-6), soluble CD14 (sCD14) and D-dimer was evaluated using adjusted multivariable linear regression, stratified by disease stage. RESULTS: In all, 488 PWH (61% women, mean age 35 years) were included in the analysis. Median ART adherence overall was 87%. In adjusted models, every 10% increase in average adherence was associated with a 3.0% decrease in IL-6 [95% confidence interval (CI): -5.9 to -0.01, p = 0.05] at 12 months. This relationship was observed in PWH with both early-stage (5.9%, 95% CI: -10.1 to -1.6, p = 0.009) and late-stage disease (3.7%, 95% CI: -7.2 to -0.2, p = 0.039). No significant associations were found with sCD14 or D-dimer. CONCLUSIONS: Objective ART adherence measurement was inversely associated with systemic inflammation in PWH who achieved viral suppression after ART initiation in sub-Saharan Africa, with a greater association in those with early-stage HIV. This finding underscores the importance of ART adherence beyond establishing viral suppression.

Who's slipping through the cracks? A comprehensive individual, clinical and health system characterization of people with virological failure on first-line HIV treatment in Uganda and South Africa.

OBJECTIVES: HIV virological failure remains a major threat to programme success in sub-Saharan Africa. While HIV drug resistance (HIVDR) and inadequate adherence are the main drivers of virological failure, the individual, clinical and health system characteristics that lead to poor outcomes are not well understood. The objective of this paper is to identify those characteristics among people failing first-line antiretroviral therapy (ART). METHODS: We enrolled a cohort of adults in HIV care experiencing virological failure on first-line ART at five sites and used standard statistical methods to characterize them with a focus on three domains: individual/demographic, clinical, and health system, and compared each by country of enrolment. RESULTS: Of 840 participants, 51% were women, the median duration on ART was 3.2 years [interquartile range (IQR) 1.1, 6.4 years] and the median CD4 cell count prior to failure was 281 cells/µL (IQR 121, 457 cells/µL). More than half of participants [53%; 95% confidence interval (CI) 49-56%] stated that they had > 90% adherence and 75% (95% CI 72-77%) took their ART on time all or most of the time. Conversely, the vast majority (90%; 95% CI 86-92%) with a completed genotypic drug resistance test had any HIV drug resistance. This population had high health system use, reporting a median of 3 (IQR 2.6) health care visits and a median of 1 (IQR 1.1) hospitalization in the preceding 6 months. CONCLUSIONS: Patients failing first-line ART in sub-Saharan Africa generally report high rates of adherence to ART, have extremely high rates of HIV drug resistance and utilize significant health care resources. Health systems interventions to promptly detect and manage treatment failure will be a prerequisite to establishing control of the HIV epidemic.

Development of a transition readiness score for adolescents living with perinatally-acquired HIV and transitioning to adult care.

We created a transition readiness score for adolescents with perinatally-acquired HIV as they transition from pediatric to adult care. Of the 199 adolescents who transitioned to adult care, 84 (42%) had viral suppression (< 200 copies/ml) one year after transition. Adolescents on first-line ART, with documented HIV status disclosure, and higher rating on the HIV Adolescent Readiness to Transition Scale had significantly higher odds of viral suppression after transition. Conversely, females, those with older age at ART initiation, and those with prior alcohol use had significantly lower odds of viral suppression after transition. Using these data, we created a transition readiness score organized into low, intermediate, and high levels of transition readiness. This transition readiness score can be used to identify adolescents who are likely ready to transition to adult care and identify additional areas for intervention to improve the likelihood of successful transition for those with lower transition readiness scores.

Resistance Testing for Management of HIV Virologic Failure in Sub-Saharan Africa : An Unblinded Randomized Controlled Trial.

BACKGROUND: Virologic failure in HIV predicts the development of drug resistance and mortality. Genotypic resistance testing (GRT), which is the standard of care after virologic failure in high-income settings, is rarely implemented in sub-Saharan Africa. OBJECTIVE: To estimate the effectiveness of GRT for improving virologic suppression rates among people with HIV in sub-Saharan Africa for whom first-line therapy fails. DESIGN: Pragmatic, unblinded, randomized controlled trial. (ClinicalTrials.gov: NCT02787499). SETTING: Ambulatory HIV clinics in the public sector in Uganda and South Africa. PATIENTS: Adults receiving first-line antiretroviral therapy with a recent HIV RNA viral load of 1000 copies/mL or higher. INTERVENTION: Participants were randomly assigned to receive standard of care (SOC), including adherence counseling sessions and repeated viral load testing, or immediate GRT. MEASUREMENTS: The primary outcome of interest was achievement of an HIV RNA viral load below 200 copies/mL 9 months after enrollment. RESULTS: The trial enrolled 840 persons, divided equally between countries. Approximately half (51%) were women. Most (72%) were receiving a regimen of tenofovir, emtricitabine, and efavirenz at enrollment. The rate of virologic suppression did not differ 9 months after enrollment between the GRT group (63% [263 of 417]) and SOC group (61% [256 of 423]; odds ratio [OR], 1.11 [95% CI, 0.83 to 1.49]; P = 0.46). Among participants with persistent failure (HIV RNA viral load ≥1000 copies/mL) at 9 months, the prevalence of drug resistance was higher in the SOC group (76% [78 of 103] vs. 59% [48 of 82]; OR, 2.30 [CI, 1.22 to 4.35]; P = 0.014). Other secondary outcomes, including 9-month survival and retention in care, were similar between groups. LIMITATION: Participants were receiving nonnucleoside reverse transcriptase inhibitor-based therapy at enrollment, limiting the generalizability of the findings. CONCLUSION: The addition of GRT to routine care after first-line virologic failure in Uganda and South Africa did not improve rates of resuppression. PRIMARY FUNDING SOURCE: The President's Emergency Plan for AIDS Relief and the National Institute of Allergy and Infectious Diseases.

Association between obesity and combination antiretroviral therapy (cART) adherence among persons with early-stage HIV infection initiating cART.

BACKGROUND: Obesity is common among people living with HIV (PLWH) and early-stage infection, yet associations with combination antiretroviral (cART) adherence are unclear. METHODS: Among PLWH initiating cART in Uganda and South Africa, body mass index (BMI) was assessed at cART initiation, and cART adherence was monitored in real-time over 12 months. The association of obesity (BMI ≥ 30 kg/m2) with adherence was assessed among nonpregnant participants with CD4 > 350 cells/mm3 using fractional regression modeling. RESULTS: Among 322 participants, median age was 32 years, 70% were female, and 54% were from Uganda. Prevalence of obesity was 12% in Uganda and 28% in South Africa. Mean overall cART adherence was 83% in Uganda and 66% in South Africa. Participants with obesity had higher adherence than those without obesity: +3.6% (p = 0.44) in Uganda and +11.4% (p = 0.02) in South Africa. CONCLUSION: Obesity at cART initiation was common and associated with higher adherence, although only significantly in South Africa.

Surgical, Obstetric, and Anesthetic Mortality Measurement at a Ugandan Secondary Referral Hospital.

BACKGROUND: The health care systems of low-income countries have severely limited capacity to treat surgical diseases and conditions. There is limited information about which hospital mortality outcomes are suitable metrics in these settings. METHODS: We did a 1-year observational cohort study of patient admissions to the Surgery and the Obstetrics and Gynecology departments and of newborns delivered at a Ugandan secondary referral hospital. We examined the proportion of deaths captured by standardized metrics of mortality. RESULTS: There were 17,015 admissions and 9612 deliveries. A total of 847 deaths were documented: 385 (45.5%) admission deaths and 462 (54.5%) perinatal deaths. Less than one-third of admission deaths occurred during or after an operation (n = 126/385, 32.7%). Trauma and maternal mortality combined with perioperative mortality produced 79.2% (n = 305/385) of admission deaths. Of 462 perinatal deaths, 412 (90.1%) were stillborn, and 50 (10.9%) were early neonatal deaths. The combined metrics of the trauma mortality rate, maternal mortality ratio, thirty-day perioperative mortality rate, and perinatal mortality rate captured 89.8% (n = 761/847) of all deaths documented at the hospital. CONCLUSIONS: The combination of perinatal, maternal, trauma, and perioperative mortality metrics captured most deaths documented at a Ugandan referral hospital.

Wireless versus routine physiologic monitoring after cesarean delivery to reduce maternal morbidity and mortality in a resource-limited setting: protocol of type 2 hybrid effectiveness-implementation study.

BACKGROUND: Women in sub-Saharan Africa have the highest rates of morbidity and mortality during childbirth globally. Despite increases in facility-based childbirth, gaps in quality of care at facilities have limited reductions in maternal deaths. Infrequent physiologic monitoring of women around childbirth is a major gap in care that leads to delays in life-saving interventions for women experiencing complications. METHODS: We will conduct a type-2 hybrid effectiveness-implementation study over 12 months to evaluate using a wireless physiologic monitoring system to detect and alert clinicians of abnormal vital signs in women for 24 h after undergoing emergency cesarean delivery at a tertiary care facility in Uganda. We will provide physiologic data (heart rate, respiratory rate, temperature and blood pressure) to clinicians via a smartphone-based application with alert notifications if monitored women develop predefined abnormalities in monitored physiologic signs. We will alternate two-week intervention and control time periods where women and clinicians use the wireless monitoring system during intervention periods and current standard of care (i.e., manual vital sign measurement when clinically indicated) during control periods. Our primary outcome for effectiveness is a composite of severe maternal outcomes per World Health Organization criteria (e.g. death, cardiac arrest, jaundice, shock, prolonged unconsciousness, paralysis, hysterectomy). Secondary outcomes include maternal mortality rate, and case fatality rates for postpartum hemorrhage, hypertensive disorders, and sepsis. We will use the RE-AIM implementation framework to measure implementation metrics of the wireless physiologic system including Reach (proportion of eligible women monitored, length of time women monitored), Efficacy (proportion of women with monitoring according to Uganda Ministry of Health guidelines, number of appropriate alerts sent), Adoption (proportion of clinicians utilizing physiologic data per shift, clinical actions in response to alerts), Implementation (fidelity to monitoring protocol), Maintenance (sustainability of implementation over time). We will also perform in-depth qualitative interviews with up to 30 women and 30 clinicians participating in the study. DISCUSSION: This is the first hybrid-effectiveness study of wireless physiologic monitoring in an obstetric population. This study offers insights into use of wireless monitoring systems in low resource-settings, as well as normal and abnormal physiologic parameters among women delivering by cesarean. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04060667 . Registered on 08/01/2019.

Sexually Transmitted Infection Prevalence Among Women at Risk for HIV Exposure Initiating Safer Conception Care in Rural, Southwestern Uganda.

BACKGROUND: Knowledge of sexually transmitted infection (STI) prevalence and risk factors is important to the development of tenofovir-based preexposure prophylaxis (PrEP) and safer conception programming. We introduced STI screening among women at risk for HIV exposure who were participating in a safer conception study in southwestern Uganda. METHODS: We enrolled 131 HIV-uninfected women, planning for pregnancy with a partner living with HIV or of unknown HIV serostatus (2018-2019). Women were offered comprehensive safer conception counseling, including PrEP. Participants completed interviewer-administered questionnaires detailing sociodemographics and sexual history. We integrated laboratory screening for chlamydia, gonorrhea, trichomoniasis, and syphilis as a substudy to assess STI prevalence. Multivariable logistic regression was used to determine correlates. RESULTS: Ninety-four women completed STI screening (72% of enrolled). Median age was 30 (interquartile range, 26-34) years, and 94% chose PrEP as part of safer conception care. Overall, 24% had STIs: 13% chlamydia, 2% gonorrhea, 6% trichomoniasis, 6% syphilis, and 3% ≥2 STI. Sexually transmitted infection prevalence was associated with younger age (adjusted odds ratio [AOR], 0.87; 95% confidence interval [CI], 0.77-0.99), prior stillbirth (AOR, 5.04; 95% CI, 1.12-22.54), and not feeling vulnerable to HIV (AOR, 16.33; 95% CI, 1.12-237.94). CONCLUSIONS: We describe a 24% curable STI prevalence among women at risk for HIV exposure who were planning for pregnancy. These data highlight the importance of integrating laboratory-based STI screening into safer conception programs to maximize the health of HIV-affected women, children, and families.

Correction to: Ugandan Study Participants Experience Electronic Monitoring of Antiretroviral Therapy Adherence as Welcomed Pressure to Adhere.

The original version of this article unfortunately contained an error. The authors would like to correct the error with this erratum.

Influences on Adherence to Antiretroviral Therapy (ART) in Early-Stage HIV Disease: Qualitative Study from Uganda and South Africa.

Realization of optimal treatment and prevention benefits in the era of universal antiretroviral therapy (ART) and "U=U" (undetectable = untransmittable) requires high adherence at all stages of HIV disease. This article draws upon qualitative interview data to characterize two types of influences on ART adherence for 100 Ugandans and South Africans initiating ART during early-stage HIV infection. Positive influences are: (a) behavioral strategies supporting adherence; (b) preserving health through adherence; (c) support from others; and (d) motivating effect of adherence monitoring. "De-stabilizing experiences" (mobility, loss, pregnancy) as barriers are posited to impact adherence indirectly through intervening consequences (e.g. exacerbation of poverty). Positive influences overlap substantially with adherence facilitators described for later-stage adherers in previous research. Adherence support strategies and interventions effective for persons initiating ART later in HIV disease are likely also to be helpful to individuals beginning treatment immediately upon confirmation of infection. De-stabilizing experiences merit additional investigation across varying populations.

Outcome Measurement at a Ugandan Referral Hospital: Validation of the Mbarara Surgical Services Quality Assurance Database.

BACKGROUND: Five billion people lack access to surgery. Accurate and complete data have been identified as essential to the global scale-up of perioperative care. This study retrospectively validates the Mbarara Surgical Services Quality Assurance Database (SQUAD), an electronic outcomes database at a Ugandan secondary referral hospital. METHODS: SQUAD data were compared to paper records from August 2013 to January 2017. To assess data entry accuracy, two researchers independently extracted 24 patient variables from 170 charts. To assess completeness of patient capture, SQUAD entries were compared to a sample of charts returned to the Medical Records Department, and to a sample of entries in ward and operating room logbooks. Two-tailed binomial proportions with 95% CI were calculated from the comparative results of patient observations, against a predefined accuracy of 0.85-0.95. RESULTS: Agreement between completed validation observations from charts and SQUAD data was 91.5% (n = 3734/4080 data points). Binomial tests indicated that 15 variables had higher than 95% accuracy. A total 19 of 24 variables had ≥ 85% accuracy. The completeness of SQUAD patient capture was 98.2% (n = 167/170) of charts returned to the Medical Records Department, 97.5% (n = 198/203) of operating logbook entries, and 100% (n = 111/111) of ward logbook entries, respectively. CONCLUSION: SQUAD closely reflects the primary surgical and anaesthetic data at a Ugandan secondary hospital. Data accuracy of key variables and completeness of population capture were comparable to those of databases in high-income countries and outperformed those of other low- and middle-income countries.

Adherence to recommendations for ART and targeted PrEP use among HIV serodiscordant couples in East Africa: the "PrEP as a bridge to ART" strategy.

BACKGROUND: PrEP use should be aligned with periods of risk for HIV acquisition. For HIV serodiscordant couples, PrEP can be used as a bridge until the partner living with HIV takes antiretroviral therapy (ART) long enough to achieve viral suppression (the "PrEP as a Bridge to ART" strategy). However, adherence to this strategy is unknown. METHODS: In a demonstration project in Kenya and Uganda, HIV-uninfected partners of serodiscordant couples were advised to take PrEP until the partner living with HIV took ART for ≥ 6 months. PrEP discontinuation was then recommended unless there were concerns about ART adherence, immediate fertility intentions, or outside partners with unknown HIV/ART status. Electronic adherence monitoring and socio-behavioral questionnaire data were used in logistic regression models to explore completion of this strategy and continuation of PrEP beyond recommendations to stop its use. RESULTS: Among 833 serodiscordant couples, 436 (52%) HIV-uninfected partners completed ≥ 6 months of PrEP as a bridge to ART. Strategy completion was associated with older age (aOR per 5 years = 1.1; p = 0.008) and having fewer children (aOR = 0.9; p = 0.019). Of the 230 participants encouraged to stop PrEP according to strategy recommendations, 170 (74%) did so. PrEP continuation among the remaining 60 participants was associated with more education (aOR = 1.1; p = 0.029), a preference for PrEP over ART (aOR = 3.6; p = 0.026), comfort with managing their serodiscordant relationship (aOR = 0.6; p = 0.046), and believing PrEP makes sex safe (aOR = 0.5; p = 0.026). CONCLUSION: Half of participants completed the PrEP as a bridge to ART strategy and the majority stopped PrEP as recommended. These findings suggest that targeting PrEP to periods of risk is a promising approach; however, tailoring counseling around aligning PrEP use and HIV risk will be important for optimal strategy implementation.

Timing of Antiretroviral Therapy and Systemic Inflammation in Sub-Saharan Africa: Results From the META Longitudinal Cohort Study.

Chronic inflammation predicts complications in persons with human immunodeficiency virus infection. We compared D-dimer, soluble CD14, and interleukin 6 levels before and 12 months after antiretroviral therapy (ART) initiation, among individuals starting ART during earlier-stage (CD4 T-cell count >350/µL) or late-stage disease (CD4 T-cell count <200/µL). Female sex, older age, viral load, and late-stage disease were associated with pre-ART biomarkers (n = 661; P < .05). However, there were no differences in biomarkers by disease stage after 12 months of ART (n = 438; P > .05), owing to loss from observation and greater declines in biomarkers in late-stage initiators (P < .001). Earlier initiation of ART is associated with decreased inflammation, but levels seem to converge between earlier and later initiators surviving to 12 months.

Short Message Service (SMS) Surveys Assessing Pre-exposure Prophylaxis (PrEP) Adherence and Sexual Behavior are Highly Acceptable Among HIV-Uninfected Members of Serodiscordant Couples in East Africa: A Mixed Methods Study.

Short message service (SMS) surveys are a promising data collection method and were used to measure sexual behavior and adherence to HIV pre-exposure prophylaxis (PrEP) among HIV-uninfected partners of serodiscordant couples enrolled in a sub-study of the Partners Demonstration Project (an open-label study of integrated antiretroviral therapy and PrEP for HIV prevention in Kenya and Uganda). Questionnaires were completed by 142 participants after study exit. Median age was 29 years; 69% were male. Ninety-five percent (95%) felt SMS surveys were "easy" or "very easy", 74% reported no challenges, and 72% preferred SMS surveys over in-person study visits. Qualitative interviews involving 32 participants confirmed the ease of responding to SMS surveys. Participants also indicated that surveys acted as reminders for adherence to PrEP and condom use and were experienced as support from the study. SMS surveys were generally found to be acceptable in this population and provided real-time context of PrEP use.