True and false positive HIV point of care test results in a prospective multinational study of at-risk African women: implications for large-scale repeat HIV testing in HIV prevention programs.

BACKGROUND: Accurate HIV point of care testing is the cornerstone of prevention and treatment efforts globally, though false (both negative and positive) results are expected to occur. SETTING: We assessed the spectrum of true and false positive HIV results in a large prospective study of HIV incidence in African women using three contraceptive methods tested longitudinally in Eswatini, Kenya, South Africa, and Zambia. METHODS: HIV serologic testing was conducted quarterly using two parallel rapid HIV tests. When one or both tests were positive, additional confirmatory testing was conducted, including HIV enzyme immunoassay (EIA) and ribonucleic acid (RNA). RESULTS: 7730 women contributed 48,234 visits: true positive results occurred at 412 visits (0.9%) and false positives at 96 visits (0.2%). Of 412 women with HIV seroconversion, 10 had discordant (i.e., one negative and one positive) rapid tests and 13 had undetectable HIV RNA levels. Of 62 women with false positive rapid HIV results, most had discordant rapid testing but six (9.7%) had dually-positive rapid results and four (6.5%) had false positive or indeterminate EIA results. The positive predictive value of dual positive rapid results was 98.3%. CONCLUSION: Although the majority of rapid test results were accurate, false positive results were expected and occurred in this population of initially HIV seronegative individuals tested repeatedly and prospectively. When HIV infection occurred, not all cases had textbook laboratory results. Our findings highlight the importance of confirmatory testing, particularly for individuals undergoing repeat testing and in settings where the point prevalence is expected to be low.

Clinical outcomes of intrauterine device insertions by newly trained providers: The ECHO trial experience.

Objectives: To assess the rates of failed insertion, expulsion, and perforation when intrauterine device (IUD) insertions were done by newly trained clinicians, and to examine factors that may affect these outcomes. Study design: We evaluated skill-based outcomes following IUD insertion at 12 African sites in a secondary analysis of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) randomized trial. Before trial initiation, we provided competency-based IUD training to clinicians and offered ongoing clinical support. We used Cox proportional hazards regression to examine factors associated with expulsion. Results: Among 2582 IUD acceptors who underwent first attempted IUD insertion, 141 experienced insertion failure (5.46%) and seven had uterine perforation (0.27%). Perforation was more common among breastfeeding women within three months postpartum (0.65%) compared with non-breastfeeding women (0.22%). We recorded 493 expulsions (15.5 per 100 person-years, 95% confidence interval [CI] 14.1─16.9): 383 partial and 110 complete. The risk of IUD expulsion was lower among women older than 24 years (aHR 0.63, 95% CI 0.50─0.78) and may be higher among nulliparous women. (aHR 1.65, 95% CI 0.97─2.82). Breastfeeding (aHR 0.94, 95% CI 0.72─1.22) had no significant effect on expulsion. IUD expulsion rate was highest during the first three months of the trial. Conclusions: IUD insertion failure and uterine perforation rates in our study were comparable to those reported in the literature. These results suggest that training, ongoing support, and opportunities to apply new skills were effective in ensuring good clinical outcomes for women receiving IUD insertion by newly trained providers. Implications: Data from this study support recommendations to program managers, policymakers, and clinicians that IUDs can be inserted safely in resource-constrained settings when providers receive appropriate training and support.

Post-COVID conditions and healthcare utilization among adults with and without disabilities-2021 Porter Novelli FallStyles survey.

BACKGROUND: Adults with disabilities are at increased risk for SARS-CoV-2 infection and severe disease; whether adults with disabilities are at an increased risk for ongoing symptoms after acute SARS-CoV-2 infection is unknown. OBJECTIVES: To estimate the frequency and duration of long-term symptoms (>4 weeks) and health care utilization among adults with and without disabilities who self-report positive or negative SARS-CoV-2 test results. METHODS: Data from a nationwide survey of 4510 U.S. adults administered from September 24, 2021-October 7, 2021, were analyzed for 3251 (79%) participants who self-reported disability status, symptom(s), and SARS-CoV-2 test results (a positive test or only negative tests). Multivariable models were used to estimate the odds of having ≥1 COVID-19-like symptom(s) lasting >4 weeks by test result and disability status, weighted and adjusted for socio-demographics. RESULTS: Respondents who tested positive for SARS-CoV-2 had higher odds of reporting ≥1 long-term symptom (with disability: aOR = 4.50 [95% CI: 2.37, 8.54] and without disability: aOR = 9.88 [95% CI: 7.13, 13.71]) compared to respondents testing negative. Among respondents who tested positive, those with disabilities were not significantly more likely to experience long-term symptoms compared to respondents without disabilities (aOR = 1.65 [95% CI: 0.78, 3.50]). Health care utilization for reported symptoms was higher among respondents with disabilities who tested positive (40%) than among respondents without disabilities who tested positive (18%). CONCLUSIONS: Ongoing symptoms among adults with and without disabilities who also test positive for SARS-CoV-2 are common; however, the frequency of health care utilization for ongoing symptoms is two-fold among adults with disabilities.

Surveillance of ADHD Among Children in the United States: Validity and Reliability of Parent Report of Provider Diagnosis.

OBJECTIVE: To evaluate the appropriateness of parent-reported diagnosis of ADHD as a surveillance tool. METHOD: We assessed agreement over time and concordance of parent-reported diagnosis against Diagnostic and Statistical Manual (DSM)-based criteria. We compared concordance of diagnosis and DSM-based criteria by child characteristics, including treatment. RESULTS: Among parents who reported their child had ADHD, 95.7% reported it again 2 years later. Comparing diagnosis with DSM-based criteria, specificity and negative predictive value were high, sensitivity was moderate, and positive predictive value was low. Most children with an ADHD diagnosis who did not meet DSM-based criteria met sub-threshold criteria or took medication for ADHD. Concordance differed by child characteristics and treatment. CONCLUSION: Parent-reported diagnosed ADHD is reliable over time. Although differences in parent-reported diagnosis and DSM-based criteria were noted, these may reflect children with milder symptoms or treated ADHD. Parent-report of child ADHD ever diagnosis may be a good single-item indicator for prevalence.

Children, adolescents, and young adults hospitalized with COVID-19 and diabetes in summer 2021.

INTRODUCTION: More information is needed to understand the clinical epidemiology of children and young adults hospitalized with diabetes and COVID-19. We describe the demographic and clinical characteristics of patients <21 years old hospitalized with COVID-19 and either Type 1 or Type 2 Diabetes Mellitus (T1DM or T2DM) during peak incidence of SARS-CoV-2 infection with the B.1.617.2 (Delta) variant. METHODS: This is a descriptive sub-analysis of a retrospective chart review of patients aged <21 years hospitalized with COVID-19 in six US children's hospitals during July-August 2021. Patients with COVID-19 and either newly diagnosed or known T1DM or T2DM were described using originally collected data and diabetes-related data specifically collected on these patients. RESULTS: Of the 58 patients hospitalized with COVID-19 and diabetes, 34 had T1DM and 24 had T2DM. Of those with T1DM and T2DM, 26% (9/34) and 33% (8/24), respectively, were newly diagnosed. Among those >12 years old and eligible for COVID-19 vaccination, 93% were unvaccinated (42/45). Among patients with T1DM, 88% had diabetic ketoacidosis (DKA) and 6% had COVID-19 pneumonia; of those with T2DM, 46% had DKA and 58% had COVID-19 pneumonia. Of those with T1DM or T2DM, 59% and 46%, respectively, required ICU admission. CONCLUSION: Our findings highlight the importance of considering diabetes in the evaluation of children and young adults presenting with COVID-19; the challenges of managing young patients who present with both COVID-19 and diabetes, particularly T2DM; and the importance of preventive actions like COVID-19 vaccination to prevent severe illness among those eligible with both COVID-19 and diabetes.

Factors Associated With Severe Illness in Patients Aged <21 Years Hospitalized for COVID-19.

OBJECTIVES: To describe coronavirus disease 2019 (COVID-19)-related pediatric hospitalizations during a period of B.1.617.2 (Δ) variant predominance and to determine age-specific factors associated with severe illness. METHODS: We abstracted data from medical charts to conduct a cross-sectional study of patients aged <21 years hospitalized at 6 United States children's hospitals from July to August 2021 for COVID-19 or with an incidental positive severe acute respiratory syndrome coronavirus 2 test. Among patients with COVID-19, we assessed factors associated with severe illness by calculating age-stratified prevalence ratios (PR). We defined severe illness as receiving high-flow nasal cannula, positive airway pressure, or invasive mechanical ventilation. RESULTS: Of 947 hospitalized patients, 759 (80.1%) had COVID-19, of whom 287 (37.8%) had severe illness. Factors associated with severe illness included coinfection with respiratory syncytial virus (RSV) (PR 3.64) and bacteria (PR 1.88) in infants; RSV coinfection in patients aged 1 to 4 years (PR 1.96); and obesity in patients aged 5 to 11 (PR 2.20) and 12 to 17 years (PR 2.48). Having ≥2 underlying medical conditions was associated with severe illness in patients aged <1 (PR 1.82), 5 to 11 (PR 3.72), and 12 to 17 years (PR 3.19). CONCLUSIONS: Among patients hospitalized for COVID-19, factors associated with severe illness included RSV coinfection in those aged <5 years, obesity in those aged 5 to 17 years, and other underlying conditions for all age groups <18 years. These findings can inform pediatric practice, risk communication, and prevention strategies, including vaccination against COVID-19.

Stability of mental disorder prevalence estimates among school-aged children and adolescents: findings from the community-based project to learn about youth-mental health (PLAY-MH) and replication-PLAY-MH (Re-PLAY-MH), 2014-2017.

PURPOSE: This study evaluated the stability over time of prevalence estimates of mental disorders among school-aged children from the same community. METHODS: We compared screening status and weighted prevalence of selected mental disorders from the two-stage school-based South Carolina Project to Learn About Youth-Mental Health (Time 1) and its replication study (Time 2) conducted between 2014 and 2017. During stage 1, two teacher screeners were used to group students into high or low risk for a mental disorder. During stage 2, parents of selected students completed a structured diagnostic interview to assess whether their child met criteria for specific disorders. RESULTS: For stage 1, 19.9% of students screened as high risk for a mental disorder at Time 2 compared to 17.8% at Time 1. Among students included at both timepoints, 9.1% screened as high risk at both timepoints while screening status changed for 20.7%. The overall prevalence of included mental disorders was approximately 18% at both time points There were no differences (P-values >.05) in prevalence of individual mental disorders between Time 1 (range:0.3%-6.7%) and Time 2 (range:1.2%-7.7%). CONCLUSIONS: Study findings demonstrate that similar methodology yielded similar prevalence estimates of mental disorders and can inform community-level planning for improving mental health in children.

Prevalence of Select New Symptoms and Conditions Among Persons Aged Younger Than 20 Years and 20 Years or Older at 31 to 150 Days After Testing Positive or Negative for SARS-CoV-2.

Importance: New symptoms and conditions can develop following SARS-CoV-2 infection. Whether they occur more frequently among persons with SARS-CoV-2 infection compared with those without is unclear. Objective: To compare the prevalence of new diagnoses of select symptoms and conditions between 31 and 150 days after testing among persons who tested positive vs negative for SARS-CoV-2. Design, Setting, and Participants: This cohort study analyzed aggregated electronic health record data from 40 health care systems, including 338 024 persons younger than 20 years and 1 790 886 persons aged 20 years or older who were tested for SARS-CoV-2 during March to December 2020 and who had medical encounters between 31 and 150 days after testing. Main Outcomes and Measures: International Statistical Classification of Diseases, Tenth Revision, Clinical Modification codes were used to capture new symptoms and conditions that were recorded 31 to 150 days after a SARS-CoV-2 test but absent in the 18 months to 7 days prior to testing. The prevalence of new symptoms and conditions was compared between persons with positive and negative SARS-CoV-2 tests stratified by age (20 years or older and young than 20 years) and care setting (nonhospitalized, hospitalized, or hospitalized and ventilated). Results: A total of 168 701 persons aged 20 years or older and 26 665 younger than 20 years tested positive for SARS-CoV-2, and 1 622 185 persons aged 20 years or older and 311 359 younger than 20 years tested negative. Shortness of breath was more common among persons with a positive vs negative test result among hospitalized patients (≥20 years: prevalence ratio [PR], 1.89 [99% CI, 1.79-2.01]; <20 years: PR, 1.72 [99% CI, 1.17-2.51]). Shortness of breath was also more common among nonhospitalized patients aged 20 years or older with a positive vs negative test result (PR, 1.09 [99% CI, 1.05-1.13]). Among hospitalized persons aged 20 years or older, the prevalence of new fatigue (PR, 1.35 [99% CI, 1.27-1.44]) and type 2 diabetes (PR, 2.03 [99% CI, 1.87-2.19]) was higher among those with a positive vs a negative test result. Among hospitalized persons younger than 20 years, the prevalence of type 2 diabetes (PR, 2.14 [99% CI, 1.13-4.06]) was higher among those with a positive vs a negative test result; however, the prevalence difference was less than 1%. Conclusions and Relevance: In this cohort study, among persons hospitalized after a positive SARS-CoV-2 test result, diagnoses of certain symptoms and conditions were higher than among those with a negative test result. Health care professionals should be aware of symptoms and conditions that may develop after SARS-CoV-2 infection, particularly among those hospitalized after diagnosis.

Perceived Racial/Ethnic Discrimination, Physical and Mental Health Conditions in Childhood, and the Relative Role of Other Adverse Experiences.

Adverse childhood experiences (ACEs) are associated with poor health. Childhood experiences of racial/ethnic discrimination and other forms of racism may underlie or exacerbate other ACEs. We explored health-related associations with perceived racial/ethnic discrimination relative to other ACEs, using data from 2016-2019 National Survey of Children's Health, an annual cross-sectional, nationally representative survey. Parent responses for 88,183 children ages 6-17 years with complete data for ACEs (including racial/ethnic discrimination) were analyzed for associations between racial/ethnic discrimination, other ACEs, demographics, and physical and mental health conditions with weighted prevalence estimates and Wald chi-square tests. To assess associations between racial/ethnic discrimination and health conditions relative to other ACEs, we used weighted Poisson regressions, adjusted for exposure to other ACEs, age, and sex. We assessed effect modification by race/ethnicity. Prevalence of other ACEs was highest among children with racial/ethnic discrimination, and both racial/ethnic discrimination and other ACEs were associated with having one or more health conditions. Adjusted associations between racial/ethnic discrimination and health conditions differed by race/ethnicity (interaction P-values < 0.001) and were strongest for mental health conditions among Hispanic/Latino (adjusted prevalence ratio (aPR)=1.62, 95% confidence interval (CI): 1.24-2.10) and non-Hispanic/Latino Asian American (aPR=2.25, 95% CI: 1.37-3.71) children. Results suggest racial/ethnic discrimination and other ACEs are associated with child health conditions, with differences in relative associations by race/ethnicity. Public health efforts to prevent childhood adversity, including racial/ethnic discrimination and other forms of racism could be associated with improvements in child health.

Characteristics and Clinical Outcomes of Children and Adolescents Aged <18 Years Hospitalized with COVID-19 - Six Hospitals, United States, July-August 2021.

During June 2021, the highly transmissible† B.1.617.2 (Delta) variant of SARS-CoV-2, the virus that causes COVID-19, became the predominant circulating strain in the United States. U.S. pediatric COVID-19-related hospitalizations increased during July-August 2021 following emergence of the Delta variant and peaked in September 2021.§ As of May 12, 2021, CDC recommended COVID-19 vaccinations for persons aged ≥12 years,¶ and on November 2, 2021, COVID-19 vaccinations were recommended for persons aged 5-11 years.** To date, clinical signs and symptoms, illness course, and factors contributing to hospitalizations during the period of Delta predominance have not been well described in pediatric patients. CDC partnered with six children's hospitals to review medical record data for patients aged <18 years with COVID-19-related hospitalizations during July-August 2021.†† Among 915 patients identified, 713 (77.9%) were hospitalized for COVID-19 (acute COVID-19 as the primary or contributing reason for hospitalization), 177 (19.3%) had incidental positive SARS-CoV-2 test results (asymptomatic or mild infection unrelated to the reason for hospitalization), and 25 (2.7%) had multisystem inflammatory syndrome in children (MIS-C), a rare but serious inflammatory condition associated with COVID-19.§§ Among the 713 patients hospitalized for COVID-19, 24.7% were aged <1 year, 17.1% were aged 1-4 years, 20.1% were aged 5-11 years, and 38.1% were aged 12-17 years. Approximately two thirds of patients (67.5%) had one or more underlying medical conditions, with obesity being the most common (32.4%); among patients aged 12-17 years, 61.4% had obesity. Among patients hospitalized for COVID-19, 15.8% had a viral coinfection¶¶ (66.4% of whom had respiratory syncytial virus [RSV] infection). Approximately one third (33.9%) of patients aged <5 years hospitalized for COVID-19 had a viral coinfection. Among 272 vaccine-eligible (aged 12-17 years) patients hospitalized for COVID-19, one (0.4%) was fully vaccinated.*** Approximately one half (54.0%) of patients hospitalized for COVID-19 received oxygen support, 29.5% were admitted to the intensive care unit (ICU), and 1.5% died; of those requiring respiratory support, 14.5% required invasive mechanical ventilation (IMV). Among pediatric patients with COVID-19-related hospitalizations, many had severe illness and viral coinfections, and few vaccine-eligible patients hospitalized for COVID-19 were vaccinated, highlighting the importance of vaccination for those aged ≥5 years and other prevention strategies to protect children and adolescents from COVID-19, particularly those with underlying medical conditions.

Long-Term Symptoms Among Adults Tested for SARS-CoV-2 - United States, January 2020-April 2021.

Long-term symptoms often associated with COVID-19 (post-COVID conditions or long COVID) are an emerging public health concern that is not well understood. Prevalence of post-COVID conditions has been reported among persons who have had COVID-19 (range = 5%-80%), with differences possibly related to different study populations, case definitions, and data sources (1). Few studies of post-COVID conditions have comparisons with the general population of adults with negative test results for SARS-CoV-2, the virus that causes COVID-19, limiting ability to assess background symptom prevalence (1). CDC used a nonprobability-based Internet panel established by Porter Novelli Public Services* to administer a survey to a nationwide sample of U.S. adults aged ≥18 years to compare the prevalence of long-term symptoms (those lasting >4 weeks since onset) among persons who self-reported ever receiving a positive SARS-CoV-2 test result with the prevalence of similar symptoms among persons who reported always receiving a negative test result. The weighted prevalence of ever testing positive for SARS-CoV-2 was 22.2% (95% confidence interval [CI] = 20.6%-23.8%). Approximately two thirds of respondents who had received a positive test result experienced long-term symptoms often associated with SARS-CoV-2 infection. Compared with respondents who received a negative test result, those who received a positive test result reported a significantly higher prevalence of any long-term symptom (65.9% versus 42.9%), fatigue (22.5% versus 12.0%), change in sense of smell or taste (17.3% versus 1.7%), shortness of breath (15.5% versus 5.2%), cough (14.5% versus 4.9%), headache (13.8% versus 9.9%), and persistence (>4 weeks) of at least one initially occurring symptom (76.2% versus 69.6%). Compared with respondents who received a negative test result, a larger proportion of those who received a positive test result reported believing that receiving a COVID-19 vaccine made their long-term symptoms better (28.7% versus 15.7%). Efforts to address post-COVID conditions should include helping health care professionals recognize the most common post-COVID conditions and optimize care for patients with persisting symptoms, including messaging on potential benefits of COVID-19 vaccination.

Outcomes Among Patients Referred to Outpatient Rehabilitation Clinics After COVID-19 diagnosis - United States, January 2020-March 2021.

As of June 30, 2021, 33.5 million persons in the United States had received a diagnosis of COVID-19 (1). Although most patients infected with SARS-CoV-2, the virus that causes COVID-19, recover within a few weeks, some experience post-COVID-19 conditions. These range from new or returning to ongoing health problems that can continue beyond 4 weeks. Persons who were asymptomatic at the time of infection can also experience post-COVID-19 conditions. Data on post-COVID-19 conditions are emerging and information on rehabilitation needs among persons recovering from COVID-19 is limited. Using data acquired during January 2020-March 2021 from Select Medical* outpatient rehabilitation clinics, CDC compared patient-reported measures of health, physical endurance, and health care use between patients who had recovered from COVID-19 (post-COVID-19 patients) and patients needing rehabilitation because of a current or previous diagnosis of a neoplasm (cancer) who had not experienced COVID-19 (control patients). All patients had been referred to outpatient rehabilitation. Compared with control patients, post-COVID-19 patients had higher age- and sex-adjusted odds of reporting worse physical health (adjusted odds ratio [aOR] = 1.8), pain (aOR = 2.3), and difficulty with physical activities (aOR = 1.6). Post-COVID-19 patients also had worse physical endurance, measured by the 6-minute walk test† (6MWT) (p<0.001) compared with control patients. Among patients referred to outpatient rehabilitation, those recovering from COVID-19 had poorer physical health and functional status than those who had cancer, or were recovering from cancer but not COVID-19. Patients recovering from COVID-19 might need additional clinical support, including tailored physical and mental health rehabilitation services.

Cost of pre-exposure prophylaxis delivery in family planning clinics to prevent HIV acquisition among adolescent girls and young women in Kisumu, Kenya.

INTRODUCTION: Oral pre-exposure prophylaxis (PrEP) is increasingly being implemented in sub-Saharan Africa. Adolescent girls and young women (AGYW) in Kenya contribute more than half of all new infections among young people aged 15-24 years, highlighting the need for evidence on the cost of PrEP in real-world implementation to inform the budget impact, cost-effectiveness, and financial sustainability of PrEP programs. METHODS: We estimated the cost of delivering PrEP to AGYW enrolled in a PrEP implementation study in two family planning clinics in Kisumu county, located in western Kenya. We derived total annual costs and the average cost per client-month of PrEP by input type (variable or fixed) and visit type (initiation or follow-up). We estimated all costs as implemented in the study, and under implementation by the Kenyan Ministry of Health (MoH), both at the program volume observed and if the facilities were delivering PrEP at full capacity (scaled-MoH). RESULTS: For the costing period between March 2018 and March 2019, 615 HIV-negative women contributed 1,128 (502 initiation and 626 follow-up) visits. The average cost per client-month of PrEP dispensed per study protocol and per the MoH scenario was $28.92 and $14.52, respectively. If the MoH scaled the program so that facilities could see PrEP clients at capacity, the average cost per client-month of PrEP was $10.88. Medication costs accounted for the largest proportion of the total annual costs (48% in MoH scenario and 65% in the scaled-MoH scenario). CONCLUSIONS: Using data from a PrEP implementation program, we found that the cost per client-month of PrEP dispensed is reduced by 62% if PrEP delivery at the two clinics is scaled up by the MoH. Our findings are valuable for informing local resource allocation and budgetary cost projections for scale-up of PrEP delivery to AGYW. Additionally, previous cost-effectiveness studies have been limited by the use of fixed assumptions of the cost of PrEP per person-month. Our study provides cost estimates from practical data which will better inform cost-effectiveness and budget impact analyses.

Kidney injury biomarkers during exposure to tenofovir-based preexposure prophylaxis.

We previously reported a higher incidence of non-albumin proteinuria and a small but significant decline in estimated glomerular filtration rate (eGFR) among HIV-negative adults randomized to emtricitabine/tenofovir disoproxil fumarate preexposure prophylaxis (FTC/TDF PrEP) versus placebo. In a nested case--control study among participants randomized to FTC/TDF PrEP, established kidney injury biomarkers measured at 12 months were not significantly different between participants who subsequently experienced one of these kidney endpoints and randomly selected controls who did not.

Brief Report: Bacterial Vaginosis and Risk of HIV Infection in the Context of CD101 Gene Variation.

BACKGROUND: Whether bacterial vaginosis (BV) and CD101 immunoglobulin-like (Ig-like) variants independently increase HIV risk through mucosal inflammation is not well understood. We evaluated whether the impact of BV on HIV acquisition in women differs by the presence or absence of candidate CD101 Ig-like variants. METHODS: We used data from 2 studies of HIV serodiscordant couples in east (Kenya, Tanzania, and Uganda) and southern (Botswana, South Africa, and Zambia) Africa, which longitudinally assessed HIV acquisition (by ELISA) and BV (by Nugent score ≥7). We used previously generated CD101 sequence data for each case and control participant to create a binary variable indicating the presence/absence of any of 5 CD101 Ig-like variants. RESULTS: Confirming previously shown results in this cohort, Ig-like variants increased HIV-infection risk (adjusted hazard ratio [aHR], = 2.63; 95% confidence interval [CI], 1.41 to 4.89). BV was associated with 2.5-fold higher HIV-infection risk only in the absence of Ig-like variants (aHR = 2.47; 95% CI, 0.99 to 6.15; P = 0.052), whereas in the presence of Ig-like variants, BV was not associated with higher HIV-infection risk (aHR = 0.87; 95% CI, 0.35 to 2.15; P = 0.765); however, a test for interaction was nonsignificant (P = 0.116). CONCLUSIONS: We hypothesized that both BV and CD101 Ig-like variants facilitate HIV acquisition by augmenting similar genital inflammation pathways. Our findings indicate that inflammatory mucosal effects of Ig-like variants may influence the impact of BV on HIV risk. Host-defined inflammatory pathways may be useful targets for HIV prevention.

Uptake and impact of facility-based HIV self-testing on PrEP delivery: a pilot study among young women in Kisumu, Kenya.

INTRODUCTION: HIV testing is a required part of delivery of pre-exposure prophylaxis (PrEP) for HIV prevention. However, repeat testing can be challenging in busy, under-staffed clinical settings, which could negatively impact PrEP uptake and continuation. We prospectively evaluated optional facility-based HIV self-testing (HIVST) among young women using PrEP in an implementation programme. METHODS: Between February and November 2019, we collected data from young women receiving PrEP at two family planning facilities in Kisumu, Kenya. At each PrEP follow-up visit, women were given the option to choose between provider-initiated testing and HIVST. We assessed factors associated with HIVST uptake and compared satisfaction with HIV testing and clinic experience between acceptors and decliners of HIVST. RESULTS: A total of 172 women were offered HIVST at 202 PrEP follow-up visits. The median age was 21 years, 27% had multiple partners and 15% reported previously using HIVST. HIVST was accepted at 34.7% (70/202) of visits. Age (adjusted relative risk (aRR) 1.09 per year, 95% CI (confidence interval) 1.01 to 1.18), never being married (aRR 1.81, 95% CI 1.11 to 2.95) and having more PrEP follow-up visits (aRR 1.13 per visit, 95% CI 1.04 to 1.23) were associated with HIVST uptake. Compared to HIVST decliners, HIVST acceptors were more likely to be very happy with their overall testing experience (73% vs. 47% of visits, p = 0.003) and were more likely to say they would use HIVST in the future (96% vs. 76%, p < 0.001). Women who accepted HIVST had shorter visits than those choosing standard provider-initiated HIV testing (median [IQR]: 33 [32, 38] vs. 54 [41.5, 81] minutes, p = 0.003). CONCLUSIONS: In this pilot evaluation in Kenya, about one-third of women using PrEP opted for HIVST over provider-initiated testing, and those choosing HIVST spent less time in the clinic and were generally satisfied with their experience. HIVST in PrEP delivery is feasible and has the potential to simplify PrEP delivery and give clients testing autonomy. Additional studies are needed to explore optimal HIV retesting strategies in PrEP delivery, including the use of HIVST in PrEP at a larger scale and in different settings.

Sexual Behavior and Perceived HIV Risk Among HIV-Negative Members of Serodiscordant Couples in East Africa.

HIV risk perception may influence the use of HIV prevention interventions. Using data from HIV-negative adults enrolled in a study of pre-exposure prophylaxis (PrEP) and antiretroviral therapy for HIV-serodiscordant couples in Kenya and Uganda, we examined associations between: (1) condom use and risk perception and (2) risk perception and PrEP adherence. Two-thirds of HIV-negative partners reported condomless sex with their HIV-positive partner or another partner in the month prior to study enrollment. Compared to those who reported no condomless sex, participants who reported condomless sex during the month prior to study visit had fivefold higher odds of reporting "high risk" vs "no risk" perception (36.3 versus 10.9%: aOR 4.9, 95% CI 3.4-6.9). Reporting condomless sex in the most recent sex act was associated with increased odds of perceiving some HIV risk (aOR for high risk = 7.3, 95% CI 4.9-10.8; aOR for moderate risk = 4.8, 95% CI 3.5-6.7; aOR for low risk = 3.5, 95% CI 2.7-4.6). We found no significant association between risk perception and PrEP adherence. Sexual behavior aligned with perceived HIV risk, which can facilitate an HIV-negative individual's decisions about PrEP use.

Impact of Tenofovir-Based Pre-exposure Prophylaxis on Biomarkers of Bone Formation, Bone Resorption, and Bone Mineral Metabolism in HIV-Negative Adults.

BACKGROUND: Pre-exposure prophylaxis (PrEP) with emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) reduces the risk of HIV seroconversion but may promote bone mineral density (BMD) decline. The mechanisms of BMD decline with FTC/TDF remain unclear, and studies in HIV-positive individuals have been confounded by the effects of HIV and concomitant antiretroviral medications. We evaluated the impact of FTC/TDF on biomarkers of bone remodeling and bone mineral metabolism in HIV-negative men and women enrolled in the Partners PrEP Study. METHODS: In a random sample of HIV-negative participants randomized to FTC/TDF PrEP (n = 50) or placebo (n = 50), serum parathyroid hormone (PTH), bone biomarkers (C-telopeptide, procollagen 1 intact N-terminal propeptide, and sclerostin), and plasma fibroblast growth factor 23 were measured at baseline and month 24, and the percentage change was compared between groups. In a complementary analysis, we compared the change in biomarkers between participants with and without a 25% decline in glomerular filtration rate (GFR) on FTC/TDF. RESULTS: Baseline characteristics were similar between the groups (median age, 38 years; 40% women). Vitamin D insufficiency was common, but baseline GFR and PTH were in the normal range. We observed a significantly greater percent increase in serum C-telopeptide in participants randomized to FTC/TDF vs placebo (P = .03), suggesting an increase in bone remodeling. We observed no differences in the other biomarkers, or in a separate analysis comparing participants with and without a decline in GFR. CONCLUSIONS: Increased bone remodeling may mediate the BMD decline observed with tenofovir-containing PrEP and antiretroviral therapy, independent of a TDF-mediated decrease in kidney function.

Demographic, psychosocial and clinical factors associated with postpartum depression in Kenyan women.

BACKGROUND: Few longitudinal studies have examined associations between risk factors during pregnancy and mental health outcomes during the postpartum period. We used a cohort study design to estimate the prevalence, incidence and correlates of significant postpartum depressive symptoms in Kenyan women. METHODS: We recruited adult women residing in an urban, resource-poor setting and attending maternal and child health clinics in two public hospitals in Nairobi, Kenya. A translated Kiswahili Edinburgh Postpartum Depression Scale was used to screen for depressive symptoms at baseline assessment in the 3rd trimester and follow up assessment at 6-10 weeks postpartum. Information was collected on potential demographic, psychosocial and clinical risk variables. Potential risk factors for postpartum depression were evaluated using multivariate logistic regression analysis. RESULTS: Out of the 171 women who were followed up at 6-10 weeks postpartum, 18.7% (95% CI: 13.3-25.5) were found to have postpartum depression using an EPDS cut off of 10. In multivariate analyses, the odds of having postpartum depression was increased more than seven-fold in the presence of conflict with partner (OR = 7.52, 95% CI: 2.65-23.13). The association between antepartum and postpartum depression was quite strong but did not reach statistical significance (OR = 3.37, 95% CI: 0.98-11.64). CONCLUSIONS: The high prevalence of significant postnatal depressive symptoms among Kenyan women underscores the need for addressing this public health burden. Depression screening and psychosocial support interventions that address partner conflict resolution should be offered as part of maternal health care.