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Adolescent girls and young women aged 13-24 years are disproportionately affected by HIV in sub-Saharan Africa (1), resulting from biologic, behavioral, and structural* factors, including violence. Girls in sub-Saharan Africa also experience sexual violence at higher rates than do boys (2), and women who experience intimate partner violence have 1.3-2.0 times the odds of acquiring HIV infection, compared with those who do not (3). Violence Against Children and Youth Survey (VACS) data during 2007-2018 from nine countries funded by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) were analyzed to estimate prevalence and assess factors associated with early sexual debut and forced sexual initiation.† Among adolescent girls and young women aged 13-24 years who ever had sex, the prevalence of lifetime sexual violence ranged from 12.5% to 49.3%, and forced sexual initiation ranged from 14.7% to 38.9%; early sexual debut among adolescent girls and young women aged 16-24 years ranged from 14.4% to 40.1%. In multiple logistic regression models, forced sexual initiation was associated with being unmarried, violence victimization, risky sexual behaviors, sexually transmitted infections (STIs), and poor mental health. Early sexual debut was associated with lower education, marriage, ever witnessing parental intimate partner violence during childhood, risky sexual behaviors, poor mental health, and less HIV testing. Comprehensive violence and HIV prevention programming is needed to delay sexual debut and protect adolescent girls and young women from forced sex.

Background: People living with advanced HIV disease are at high risk of morbidity and mortality. We assessed the prevalence of cryptococcal antigenemia (CrAg) and clinical outcomes among patients newly presenting with CD4 ≤100 cells/μL in Vietnam. Setting: Twenty-two public HIV clinics in Vietnam. Methods: During August 2015–March 2017, antiretroviral therapy (ART)-naïve adults presenting for care with CD4 ≤100 cells/μL were screened for CrAg. Those who consented to study enrollment were followed up for up to 12 months and assessed for clinical outcomes. Results: Of 3504 patients with CD4 results, 1354 (38.6%) had CD4 ≤100 cells/μL, of whom 1177 (86.9%) enrolled in the study. The median age was 35 years (interquartile range 30–40); 872 (74.1%) of them were men, and 892 (75.8%) had CD4

Male circumcision is an important preventive strategy that confers lifelong partial protection (approximately 60% reduced risk) against heterosexually acquired HIV infection among males (1). In Mozambique, the prevalence of male circumcision was 51% when the voluntary medical male circumcision (VMMC) program began in 2009. The Mozambique Ministry of Health set a goal of 80% circumcision prevalence among males aged 10-49 years by 2019 (2). CDC analyzed data from five cross-sectional surveys of the Chokwe Health and Demographic Surveillance System (CHDSS) to evaluate progress toward the goal and guide ongoing needs for VMMC in Mozambique. During 2014-2019, circumcision prevalence among males aged 15-59 years increased 42%, from 50.1% to 73.5% (adjusted prevalence ratio [aPR] = 1.42). By 2019, circumcision prevalence among males aged 15-24 years was 90.2%, exceeding the national goal (2). However, circumcision prevalence among males in older age groups remained below 80%; prevalence was 62.7%, 54.5%, and 55.7% among males aged 25-34, 35-44, and 45-59 years, respectively. A multifaceted strategy addressing concerns about the safety of the procedure, cultural norms, and competing priorities that lead to lack of time could help overcome barriers to circumcision among males aged ≥25 years.

BACKGROUND Early antiretroviral therapy (ART) is necessary for HIV epidemic control and depends on early diagnosis and successful linkage to care. Since 2014, annual household-based HIV testing and counseling and linkage services have been provided through the Chokwe Health and Demographic Surveillance System for residents testing HIV positive in this high HIV-burden district. METHODS District-wide Test and Start [T&S, ART for all people living with HIV (PLHIV)] began in August 2016, supported by systematic interventions to improve linkage to care and treatment. Annual rounds (R) of random household surveys were conducted to assess trends in population prevalence of ART use and viral load suppression (

Dolutegravir-based regimens are now standard of care for human immunodeficiency virus treatment for millions of people around sub-Saharan Africa. To ensure its continued efficacy, monitoring of emerging drug resistance that inform a treatment strategy among those failing is crucial. In this report, we outline the US President’s Emergency Plan for AIDS Relief to leverage viral load infrastructure to implement effective drug resistance surveillance in the countries it supports.

BackgroundClinical scores to determine early (6-month) antiretroviral therapy (ART) mortality risk have not been developed for sub-Saharan Africa (SSA), home to 70% of people living with HIV. In the absence of validated scores, WHO eligibility criteria (EC) for ART care intensification are CD4 MethodsWe used Botswana XPRES trial data for adult ART enrollees to develop CD4-independent and CD4-dependent multivariable prognostic models for 6-month mortality. Scores were derived by rescaling coefficients. Scores were developed using the first 50% of XPRES ART enrollees, and their accuracy validated internally and externally using South African TB Fast Track (TBFT) trial data. Predictive accuracy was compared between scores and WHO EC.ResultsAmong 5553 XPRES enrollees, 2838 were included in the derivation dataset; 68% were female and 83 (3%) died by 6 months. Among 1077 TBFT ART enrollees, 55% were female and 6% died by 6 months. Factors predictive of 6-month mortality in the derivation dataset atp 37.5 °C (2 points). The same variables plus CD4 ConclusionsSensitivity of the CD4-independent score was nearly twice that of WHO stage in predicting 6-month mortality and could be used in settings lacking CD4 testing to inform ART care intensification. The CD4-dependent score improved specificity versus WHO EC. Both scores should be considered for scale-up in SSA.

Background Children living with human immunodeficiency virus (HIV) (CLHIV) receiving antiretroviral therapy (ART) in resource-limited settings are susceptible to high rates of acquired HIV drug resistance (HIVDR), but few studies include children initiating age-appropriate World Health Organization (WHO)-recommended first-line regimens. We report data from a cohort of ART-naive South African children who initiated first-line ART. Methods ART-eligible CLHIV aged 0–12 years were enrolled from 2012 to 2014 at 5 public South African facilities and were followed for up to 24 months. Enrolled CLHIV received standard-of-care WHO-recommended first-line ART. At the final study visit, a dried blood spot sample was obtained for viral load and genotypic resistance testing. Results Among 72 successfully genotyped CLHIV, 49 (68.1%) received ABC/3TC/LPV/r, and 23 (31.9%) received ABC/3TC/EFV. All but 2 children on ABC/3TC/LPV/r were Conclusions High levels of NNRTI and NRTI DRMs among CLHIV receiving ABC/3TC/LPV/r suggests a lasting impact of failed mother-to-child transmission interventions on DRMs. However, drug susceptibility analysis reveals that CLHIV with detectable viremia on ABC/3TC/LPV/r are more likely to have maintained at least 2 effective agents on their current HIV regimen than those on ABC/3TC/EFV.

Twenty-two clinics providing HIV care and treatment in Botswana where tuberculosis (TB) and HIV comorbidity is as high as 49%.To assess eligibility of TB preventive treatment (TPT) at antiretroviral therapy (ART) initiation and at four follow-up visits (FUVs), and to describe the TB prevalence and associated factors at baseline and yield of TB diagnoses at each FUV.A prospective study of routinely collected data on people living with HIV (PLHIV) enrolled into care for the XpertOf 6041 PLHIV initiating ART, eligibility for TPT was 69% (4177/6041) at baseline and 93% (5408/5815); 95% (5234/5514); 96% (4869/5079); and 97% (3925/4055) at FUV1, FUV2, FUV3, and FUV4, respectively. TB prevalence at baseline was 11% and 2%, 3%, 3% and 6% at each subsequent FUV. At baseline, independent risk factors for prevalent TB were CD4200 cells/mmEligibility for TPT initiation is higher at visits post-ART initiation, while most cases of active TB were identified at ART initiation. Missed opportunities for TB further compromises TB control effort among PLHIV in Botswana.Veintidós consultorios que prestan atención y tratamiento relacionados con la infección por el virus de la inmunodeficiencia humana (VIH) en Botswana, donde la comorbilidad por tuberculosis (TB) e infección por el VIH puede alcanzar 49%.Evaluar los criterios para recibir el tratamiento preventivo de la TB (TPT) durante las consultas de iniciación y seguimiento del tratamiento antirretrovírico (TAR) y describir la prevalencia de TB y los factores asociados en el momento del inicio y el rendimiento del diagnóstico de TB en cada cita de seguimiento del TAR.Fue este un estudio prospectivo de los datos obtenidos sistemáticamente en las personas con infección por el VIH (PLHIV), inscritas en la atención para el estudio de evaluación del despliegue de la prueba XpertDe los 6041 PLHIV que iniciaron el TAR, 69% (4177/6041) cumplía los criterios para recibir el TPT al comienzo; 93% (5408/5815) en la primera consulta de seguimiento; 95% (5234/5514) en la segunda; 96% (4869/5079) en la tercera; y 97% (3925/4075) en la cuarta cita de seguimiento. La prevalencia inicial de TB fue 11% y durante el seguimiento fue 2%, 3%, 3% y 6%, respectivamente. Al comienzo del TAR, los factores de riesgo independientes de diagnóstico de TB fueron una cifra de linfocitos CD4200 células/mmLos pacientes cumplen las condiciones para recibir el TPT con mayor frecuencia en las consultas posteriores al comienzo del TAR, pero la mayoría de los casos de TB activa se detecta al iniciarlo. Las oportunidades desaprovechadas para detectar casos de TB dificultan aún más el control de esta enfermedad en las PLHIV en Botswana.

Background Undiagnosed tuberculosis (TB) remains the most common cause of HIV-related mortality. Xpert MTB/RIF (Xpert) is being rolled out globally to improve TB diagnostic capacity. However, previous Xpert impact trials have reported that health system weaknesses blunted impact of this improved diagnostic tool. During phased Xpert rollout in Botswana, we evaluated the impact of a package of interventions comprising (1) additional support for intensified TB case finding (ICF), (2) active tracing for patients missing clinic appointments to support retention, and (3) Xpert replacing sputum-smear microscopy, on early (6-month) antiretroviral therapy (ART) mortality. Methods At 22 clinics, ART enrollees > 12 years old were eligible for inclusion in three phases: a retrospective standard of care (SOC), prospective enhanced care (EC), and prospective EC plus Xpert (EC+X) phase. EC and EC+X phases were implemented as a stepped-wedge trial. Participants in the EC phase received SOC plus components 1 (strengthened ICF) and 2 (active tracing) of the intervention package, and participants in the EC+X phase received SOC plus all three intervention package components. Primary and secondary objectives were to compare all-cause 6-month ART mortality between SOC and EC+X and between EC and EC+X phases, respectively. We used adjusted analyses, appropriate for study design, to control for baseline differences in individual-level factors and intra-facility correlation. Results We enrolled 14,963 eligible patients: 8980 in SOC, 1768 in EC, and 4215 in EC+X phases. Median age of ART enrollees was 35 and 64% were female. Median CD4 cell count was lower in SOC than subsequent phases (184/μL in SOC, 246/μL in EC, and 241/μL in EC+X). By 6 months of ART, 461 (5.3%) of SOC, 54 (3.2%) of EC, and 121 (3.0%) of EC+X enrollees had died. Compared with SOC, 6-month mortality was lower in the EC+X phase (adjusted hazard ratio, 0.77; 95% confidence interval, 0.61–0.97, p = 0.029). Compared with EC enrollees, 6-month mortality was similar among EC+X enrollees. Conclusions Interventions to strengthen ICF and retention were associated with lower early ART mortality. This new evidence highlights the need to strengthen ICF and retention in many similar settings. Similar to other trials, no additional mortality benefit of replacing sputum-smear microscopy with Xpert was observed. Trial registration Retrospectively registered: ClinicalTrials.gov (NCT02538952)

Introduction WHO recommends implementing a mix of community and facility testing strategies to diagnose 95% of persons living with HIV (PLHIV). In Mozambique, a country with an estimated 506,000 undiagnosed PLHIV, use of home‐based HIV testing services (HBHTS) to help achieve the 95% target has not been evaluated. Methods HBHTS was provided at 20,000 households in the Chókwè Health Demographic Surveillance System (CHDSS), Mozambique, in annual rounds (R) during 2014 to 2019. Trends in prevalence of HIV infection, prior HIV diagnosis among PLHIV (diagnostic coverage), and undiagnosed HIV infection were assessed with three population‐based surveys conducted in R1 (04/2014 to 04/2015), R3 (03/2016 to 12/2016), and R5 (04/2018 to 03/2019) of residents aged 15 to 59 years. Counts of patients aged ≥15 years tested for HIV in CHDSS healthcare facilities were obtained from routine reports. Results During 2014 to 2019, counsellors conducted 92,512 home‐based HIV tests and newly diagnosed 3711 residents aged 15 to 59 years. Prevalence of HIV infection was stable (R1, 25.1%; R3 23.6%; R5 22.9%; p‐value, 0.19). After the first two rounds (44,825 home‐based tests; 31,717 facility‐based tests), diagnostic coverage increased from 73.8% (95% CI 70.3 to 77.2) in R1 to 93.0% (95% CI 91.3 to 94.7) in R3, and prevalence of undiagnosed HIV infection decreased from 6.6% (95% CI 5.6 to 7.5) in R1 to 1.7% (95% CI 1.2 to 2.1) in R3. After two more rounds (32,226 home‐based tests; 46,003 facility‐based tests), diagnostic coverage was 95.4% (95% CI 93.7 to 97.1) and prevalence of undiagnosed HIV infection was 1.1% (95% CI 0.7 to 1.5) in R5. Prevalence of having last tested at home was 12.7% (95% CI 11.3 to 14.0) in R1, 45.2% (95% CI 43.4 to 47.0) in R3, and 41.4% (95% CI 39.5 to 43.2) in R5, and prevalence of having last tested at a healthcare facility was 45.3% (95% CI 43.3 to 47.3) in R1, 40.1% (95% CI 38.4 to 41.8) in R3, and 45.2% (95% CI 43.3 to 47.0) in R5. Conclusions HBHTS successfully augmented facility‐based testing to achieve HIV diagnostic coverage in a high‐burden community of Mozambique. HBHTS should be considered in sub‐Saharan Africa communities striving to diagnose 95% of persons living with HIV.

Ten selected healthcare facilities in Tanzania, March-April 2016.To assess the implementation of screening among pediatric contacts of adults with tuberculosis (TB) disease.Using a mixed-methods approach, we conducted a questionnaire study among sputum smear-positive adult TB patients and abstracted data from their patient cards to assess the implementation of a child contact management (CCM) intervention. We also conducted in-depth interviews with healthcare workers (HCWs) to solicit their views on clinical practices and challenges in CCM.A total of 141 adult smear-positive TB patients reported 396 children living in households; detailed information on 346 (87.4%) was available. Only 37 (10.7%) children were clinically assessed for TB, 5 (13.5%) were diagnosed with TB, and 22 started on isoniazid preventive therapy (IPT) (59.0%). Of the 320 children whose caregivers responded to whether their children had undergone human immunodeficiency virus (HIV) testing, 55 (17.2%) had been tested and one (1.8%) was HIV-positive. Forty-one HCWs described passive CCM without use of contact or IPT registers.We identified gaps in the implementation of TB screening, IPT provision, and HIV testing in pediatric contacts of adults with sputum smear-positive TB. Systematic efforts, including increasing HCW training and educating the community, may improve implementation.Dix structures de santé en Tanzanie (mars–avril 2016).Evaluer la mise en œuvre du dépistage des contacts pédiatriques d'adultes atteints de tuberculose (TB) maladie.Grâce à une approche à méthodes mixtes, nous avons soumis à un questionnaire des patients TB adultes ayant un frottis de crachats positif et extrait des données de leurs cartes de patients afin d'évaluer la mise en œuvre de la prise en charge des contacts d'enfants (CCM). Nous avons également réalisé des entretiens approfondis avec des travailleurs de santé (HCW) pour solliciter leurs opinions sur les pratiques cliniques et les difficultés rencontrées en matière de CCM.Un total de 141 patients TB adultes à frottis positif ont désigné 396 enfants vivant dans leurs foyers, avec des informations détaillées pour 346 patients (87,4%). Seulement 37 (10,7%) enfants ont eu un examen clinique à la recherche de TB, 5 (13,5%) ont eu un diagnostic de TB et 22 ont démarré le traitement préventif à l'isoniazide (TPI) (59,0%). Sur 320 enfants dont les responsables savaient si ces enfants avaient eu un test virus de l'immunodéficience humaine (VIH), 55 (17,2%) avaient été testés et un (1,8%) était VIH positif ; 41 HCW ont décrit une CCM passive sans utilisation de registres de contact ou de TPI.Nous avons identifié des failles dans la mise en œuvre du dépistage de la TB, de la fourniture du TPI et du test VIH pour les contacts pédiatriques des adultes atteints de TB à frottis positif. Des efforts systématiques, notamment davantage de formation des HCW et d'éducation de la communauté pourraient améliorer la mise en œuvre.Diez establecimientos de atención de salud escogidos en Tanzanía (marzo y abril del 2016).Evaluar la ejecución de la investigación de los contactos pediátricos de pacientes adultos con enfermedad tuberculosa.Con un enfoque de métodos mixtos, se entregó un cuestionario a pacientes adultos con tuberculosis (TB) y baciloscopia positiva del esputo y se extrajeron datos de la tarjeta de atención de los pacientes con el objeto de evaluar la gestión de los contactos pediátricos (CCM). Se realizaron además entrevistas exhaustivas a los profesionales de salud (HCW), a fin de describir las prácticas clínicas y las dificultades en la gestión de los contactos pediátricos.Los 141 adultos con TB y baciloscopia positiva refirieron 396 niños que vivían en sus domicilios y existía información detallada sobre 346 de ellos (87,4%). Solo se realizó la investigación clínica de la TB en 37 niños (10,7%) y en cinco se diagnosticó TB (13,5%) y 22 iniciaron el tratamiento preventivo con isoniazida (TPI) (59,0%). De los 320 niños cuyos cuidadores informaron si el niño había recibido la prueba del virus de la inmunodeficiencia humana (VIH), en 55 se había practicado la prueba (17,2%) y uno era positivo frente al VIH (1,8%). Cuarenta y un HCW refirieron la práctica de una CCM pasiva, sin utilización de los registros de contactos ni del TPI.El estudio puso de manifiesto deficiencias en la ejecución de la detección sistemática de la TB, la provisión del TPI y la prueba del VIH en los contactos pediátricos de adultos con TB y baciloscopia positiva del esputo. La adopción de medidas sistemáticas como una mejor capacitación de los HCW y la educación de la comunidad podría mejorar la investigación de los contactos pediátricos.

Reducing HIV-related morbidity and mortality, and effectively eliminating HIV transmission risk, depends on use of antiretroviral therapy (ART) to achieve and maintain viral load suppression (VLS)* (1,2). By 2020, sub-Saharan African countries are working to achieve VLS among 90% of persons using ART and 73% of all persons living with HIV infection (1). In Tanzania, a country with 1.4 million persons with HIV infection, 49.6% of HIV-positive persons aged 15-49 years had achieved VLS in 2017, including only 21.5% of men and 44.6% of women aged 25-29 years (3). To identify interventions that might increase VLS in Tanzania, and reduce VLS-associated sex and age-group disparities, the Bukoba Combination Prevention Evaluation (BCPE) scaled up new HIV testing, linkage to care, and retention on ART interventions throughout Bukoba Municipal Council (Bukoba), Tanzania, during October 2014-March 2017 (4,5). Located on the western shore of Lake Victoria, Bukoba is a mixed urban and rural municipality of 150,000 persons and capital of Kagera Region. Of the 31 regions of Tanzania, Kagera has the fourth highest prevalence of HIV infection (6.8%) among residents aged 15-49 years (3). CDC analyzed data from BCPE preintervention and postintervention surveys and found that VLS prevalence among HIV-positive Bukoba residents aged 18-49 years increased approximately twofold overall (from 28.6% to 64.8%) and among women (33.3% to 67.8%) and approximately threefold among men (20.5% to 59.1%) and young adults aged 18-29 years (15.6% to 56.7%). During 2017, BCPE facility-based testing and linkage interventions were approved as new service delivery models by the Tanzania Ministry of Health, Community Development, Gender, Elderly and Children (4,5). After a successful rollout to 208 facilities in 11 regions in 2018, BCPE interventions are being scaled up in all regions of Tanzania in 2019 with support from the United States President's Emergency Plan for AIDS Relief (PEPFAR).†.

Background The feasibility of reducing the population-level incidence of human immunodeficiency virus (HIV) infection by increasing community coverage of antiretroviral therapy (ART) and m...

BACKGROUND Male circumcision (MC) offers men lifelong partial protection from heterosexually acquired HIV infection. The impact of MC on HIV incidence has not been quantified in nationally representative samples. Data from the population-based HIV impact assessments were used to compare HIV incidence by MC status in countries implementing voluntary medical MC (VMMC) programs. METHODS Data were pooled from population-based HIV impact assessments conducted in Eswatini, Lesotho, Malawi, Namibia, Tanzania, Uganda, Zambia, and Zimbabwe from 2015 to 2017. Incidence was measured using a recent infection testing algorithm and analyzed by self-reported MC status distinguishing between medical and nonmedical MC. Country, marital status, urban setting, sexual risk behaviors, and mean population HIV viral load among women as an indicator of treatment scale-up were included in a random-effects logistic regression model using pooled survey weights. Analyses were age stratified (15-34 and 35-59 years). Annualized incidence rates and 95% confidence intervals (CIs) and incidence differences were calculated between medically circumcised and uncircumcised men. RESULTS Men 15-34 years reporting medical MC had lower HIV incidence than uncircumcised men [0.04% (95% CI: 0.00% to 0.10%) versus 0.34% (95% CI: 0.10% to 0.57%), respectively; P value = 0.01]; whereas among men 35-59 years, there was no significant incidence difference [1.36% (95% CI: 0.32% to 2.39%) versus 0.55% (95% CI: 0.14% to 0.67%), respectively; P value = 0.14]. DISCUSSION Medical MC was associated with lower HIV incidence in men aged 15-34 years in nationally representative surveys in Africa. These findings are consistent with the expected ongoing VMMC program impact and highlight the importance of VMMC for the HIV response in Africa.

Summary Background Community randomised trials have had mixed success in implementing combination prevention strategies that diagnose 90% of people living with HIV, initiate and retain on antiretroviral therapy (ART) 90% of those diagnosed, and achieve viral load suppression in 90% of those on ART (90-90-90). The Bukoba Combination Prevention Evaluation (BCPE) aimed to achieve 90-90-90 in Bukoba Municipal Council, Tanzania, by scaling up new HIV testing, linkage, and retention interventions. Method We did population-based, cross-sectional surveys before and after our community-wide intervention in Bukoba—a mixed urban and rural council of approximately 150 000 residents located on the western shore of Lake Victoria in Tanzania. BCPE interventions were implemented in 11 government-supported health-care facilities throughout Bukoba from Oct 1, 2014, to March 31, 2017, when national ART-eligibility guidelines expanded from CD4 counts of less than 350 cells per μL (Oct 1, 2014–Dec 31, 2015) and 500 or less cells per μL (Jan 1, 2016–Sept 30, 2016) to any CD4 cell count (test and treat, Oct 1, 2016–March 31, 2017). We used pre-intervention (Nov 4, 2013–Jan 25, 2014) and post-intervention (June 21, 2017–Sept 20, 2017) population-based household surveys to assess population prevalence of undiagnosed HIV infection and ART coverage, and progress towards 90-90-90, among residents aged 18–49 years. Findings During the 2·5-year intervention, BCPE did 133 695 HIV tests, diagnosed and linked 3918 people living with HIV to HIV care at 11 Bukoba facilities, and returned to HIV care 604 patients who had stopped care. 4795 and 5067 residents aged 18–49 years participated in pre-intervention and post-intervention surveys. HIV prevalence before and after the intervention was similar: pre-intervention 8·9% (95% CI 7·5–10·4); post-intervention 8·4% (6·9–9·9). Prevalence of undiagnosed HIV infection decreased from 4·7% to 2·0% (prevalence ratio 0·42, 95% CI 0·31–0·57), and current ART use among all people living with HIV increased from 32·2% to 70·9% (2·20, 1·82–2·66) overall, 23·0% to 62·1% among men (2·70, 1·84–3·96), and 16·7% to 64·4% among people aged 18–29 years (3·87, 2·54–5·89). Of 436 and 435 people living with HIV aged 18–49 years who participated in pre-intervention and post-intervention surveys, previous HIV diagnosis increased from 47·4% (41·3–53·4) to 76·2% (71·8–80·6), ART use among diagnosed people living with HIV increased from 68·0% (60·9–75·2) to 93·1% (90·2–96·0), and viral load suppression of those on ART increased from 88·7% (83·6–93·8) to 91·3% (88·6–94·1). Interpretation BCPE findings suggest scaling up recommended HIV testing, linkage, and retention interventions can help reduce prevalence of undiagnosed HIV infection, increase ART use among all people living with HIV, and make substantial progress towards achieving 90-90-90 in a relatively short period. BCPE facility-based testing and linkage interventions are undergoing national scale up to help achieve 90-90-90 in Tanzania. Funding US Presidents' Emergency Plan for AIDS Relief.

BackgroundPatients with non-tuberculous mycobacteria (NTM) or Mycobacterium tuberculosis (MTB) pulmonary disease may have similar clinical presentation. The potential for misdiagnosis and inappropriate treatment exists in settings with limited testing capacity for Xpert® MTB/RIF (Xpert), phenotypic culture and NTM speciation. We describe treatment outcomes among people living with HIV (PLHIV) who received anti-tuberculosis treatment and were found to have NTM or MTB positive sputum cultures.MethodsPLHIV attending one of the 22 participating HIV clinics, who screened positive for ≥1 tuberculosis (TB) symptoms (cough, fever, night sweats, or weight loss) were asked to submit sputa for culture and speciation from August 2012 to November 2014. The national intensified TB case finding algorithms were followed: initially symptomatic patients were evaluated by testing sputum samples using a smear (smear-based TB diagnostic algorithm) and, after GeneXpert instruments were installed, by testing with Xpert (Xpert-based TB diagnostic algorithm). Within the study period, TB diagnostic algorithms used for MTB did not include screening, diagnosis, and management of NTM. Despite MTB negative culture, some symptomatic patients, including those with NTM positive culture, received empirical anti-TB treatment at the discretion of treating clinicians. Per the World Health Organization treatment outcomes classification: died, treatment failure or loss-to-follow-up were classified as unfavorable (unsuccessful) outcome; cured and treatment completed were classified as favorable (successful) outcome. Empiric treatment was defined as initiating treatment without or before receiving a test result indicating MTB. We compare treatment outcomes and characteristics among patients with NTM or MTB positive culture who received anti-TB treatment.ResultsAmong 314 PLHIV, who were found co-infected with TB, 146 cases had microbiological evidence; and for 131/146 MTB positive cultures were reported. One-hundred fifty-two of the 314 were clinically diagnosed with TB and treated empirically. Among those empirically treated for TB, 36/152 had culture results positive for NTM, and another 43/152 had culture results positive for MTB, reported after patients received empirical anti-TB treatment. Overall, MTB positive culture results were reported for 174 (131 plus 43) patients. Treatment outcomes were available for 32/36 NTM and 139/174 MTB; unfavorable outcomes were 12.5% and 8.7% for NTM and MTB, respectively, p = 0.514, respectively. For 34/36 tested NTM patients, all Xpert results indicated 'no MTB'. Among patients who initially received empiric anti-TB treatment and ultimately were found to have MTB positive culture, the unfavorable outcome was 11.8% (4/34), compared to 12.5% (4/32) of patients with NTM positive culture, Fisher's exact test p = 1.00.ConclusionsWhile the higher unfavorable outcome was non statistically significant, the impact of inappropriate treatment among NTM patients should not be overlooked. Our findings suggest that Xpert has the potential to rapidly rule-out NTM and avoid sub-optimal treatment; further research is needed to evaluate such potential.

Twenty-two human immunodeficiency virus (HIV) clinics in Botswana.To compare sputum collection rates, sputum quality and volume, and tuberculosis (TB) diagnosis rates before and after field efforts to improve sputum collection among individuals newly diagnosed with HIV with TB symptoms.Newly diagnosed individuals living with HIV attending 22 HIV clinics in Botswana were screened for TB from August 2012 to March 2014. Starting in May 2013, a field intervention composed of the introduction of a tracking log for presumed TB patients, and patient instructions and sputum induction to improve sputum collection rates was implemented.Prior to the intervention, sputum collection rates were 44.1% (384/870). Subsequently, sputum collection increased to 58.3% (579/993) (Sputum collection rates among presumptive TB cases, as well as sputum quality and volume improved after implementation of the field intervention. To improve sputum collection rates, efforts at the program level should be ongoing.Vingt-deux dispensaires pour l’infection par le virus de l’immunodéficience humaine (VIH) au Botswana.Examiner les niveaux de qualité des crachats, leur volume, et le diagnostic de TB avant et après les efforts sur le terrain d’amélioration du recueil des crachats parmi les individus ayant récemment eu un diagnostic de VIH avec des symptômes de TB.Les personnes nouvellement diagnostiquées, vivant avec le VIH (PLHIV) fréquentant 22 dispensaires VIH au Botswana ont eu un dépistage de TB entre août 2012 et mars 2014. Les patients ayant des symptômes de TB ont été invités à fournir des échantillons de crachats. A partir de mai 2013, a été mise en œuvre une intervention de terrain composée de l’introduction d’un registre de suivi des patients présumés atteints de TB, de l’instruction du patient et de l’induction de crachats afin d’améliorer les taux de recueil de crachats. Les taux de recueil de crachats, leur qualité, leur volume et le rendement ont été comparés avant et après l’intervention.Avant l’intervention, les taux de recueil des crachats ont été de 44,1% (384/870). Le recueil de crachats a ensuite augmenté à 58,3% (579/993) (Les taux de recueil de crachats parmi les cas de TB présumés ainsi que la qualité et le volume des crachats se sont améliorés après la mise en œuvre de l’intervention sur le terrain. Des efforts continus sont cependant requis au niveau du programme afin d’améliorer les taux de recueil des crachats.Veintidós consultorios de atención de la infección por el virus de la inmunodeficiencia humana (VIH) en Botswana.Examinar la calidad y el volumen de las muestras de esputo y el diagnóstico de tuberculosis (TB) antes y después de ejecutar iniciativas sobre el terreno encaminadas a mejorar la recolección de esputo, en personas con diagnóstico reciente de infección por el VIH que presentan síntomas indicativos de TB.Se realizó el tamizaje de la TB en las personas con diagnóstico reciente de infección por el VIH que acudieron a 22 consultorios de atención de la infección por el VIH en Botswana, de agosto del 2012 a marzo del 2014. Se solicitaron muestras de esputo a los pacientes con síntomas de TB. A partir de mayo del 2013, se llevó a cabo una intervención sobre el terreno que comportaba la introducción de un registro de rastreo de los pacientes con presunción de tuberculosis, instrucciones a los pacientes y la inducción del esputo con el fin de mejorar las tasas de recolección de muestras de esputo. Se compararon las tasas de obtención de muestras, su calidad y su volumen antes y después de la intervención.La tasa de recolección de esputo fue 44,1% (384/870) antes de la intervención y 58,3% (579/993) después de la misma (Tras la introducción de una intervención sobre el terreno se mejoró la tasa de obtención de muestras de esputo, su calidad y su volumen en los casos con presunción de TB. Se precisan no obstante esfuerzos permanentes a escala programática que mejoren las tasas de recolección.

In 2017, rapid human immunodeficiency virus (HIV) testing services enabled the HIV diagnosis and treatment of approximately 15.3 million persons with HIV infection in sub-Saharan Africa with life-saving antiretroviral therapy (ART) (1). Although suboptimal testing practices and misdiagnoses have been reported in sub-Saharan Africa and elsewhere, trends in population burden and rate of false positive HIV diagnosis (false diagnosis) have not been reported (2,3). Understanding the population prevalence and trends of false diagnosis is fundamental for guiding rapid HIV testing policies and practices. To help address this need, CDC analyzed data from 57,655 residents aged 15–59 years in the Chókwè Health and Demographic Surveillance System (CHDSS) in Mozambique to evaluate trends in the rate (the percentage of false diagnoses among retested persons reporting a prior HIV diagnosis) and population prevalence of false diagnosis. From 2014 to 2017, the observed rate of false diagnosis in CHDSS decreased from 0.66% to 0.00% (p

Couples HIV testing for tuberculosis (TB) patients and their partners may be an effective means to identify HIV-positive persons and strengthen linkage to HIV care. We evaluated an intervention to increase HIV testing and linkage to care (LTC) of newly diagnosed persons and re-linkage for TB/HIV patients in Pwani, Tanzania. In 2014, 12 TB settings within two regional clusters participated; each cluster included ≥1 referral hospital, health center, and directly observed therapy center. Three months after introducing tools to record HIV service delivery, TB clinic staff and peer education volunteers in Cluster 1 received training on HIV partner testing and linkage/re-linkage, and staff in the second cluster received training 3 months thereafter. Twelve months after tools were introduced, clinic records were abstracted to assess changes in couples HIV testing, LTC, and re-linkage. Staff interviews assessed the feasibility and acceptability of the service delivery model. HIV prevalence was high among TB patients during the study period (44.9%; 508/1132), as well as among others who received HIV testing (19.8%; 253/1288). Compared to pre-implementation, couples HIV testing increased in both clusters from 1.8% to 35.2%. Documented LTC increased (from 5.7% to 50.0%) following the introduction of the tools. Additional increases in LTC (from 57.9% to 79.3%) and re-linkage (from 32.9% to 53.7%) followed Cluster 1 training, but no additional increases after Cluster 2 training. Staff perceived little burden associated with service delivery. This study demonstrated a feasible, low-burden approach to expand couples HIV testing and linkage of HIV-positive persons to care. TB settings in sub-Saharan Africa serve populations at disproportionate risk for HIV infection and should be considered key venues to expand access to effective HIV prevention strategies for both patients and their partners. HIV services in TB settings should include HIV testing, condom distribution, and linkage to appropriate additional services.

The purpose of this paper is to summarize current practices for the design and analysis of group-randomized trials involving cancer-related risk factors or outcomes and to offer recommendations to improve future trials. We searched for group-randomized trials involving cancer-related risk factors or outcomes that were published or online in peer-reviewed journals in 2011-15. During 2016-17, in Bethesda MD, we reviewed 123 articles from 76 journals to characterize their design and their methods for sample size estimation and data analysis. Only 66 (53.7%) of the articles reported appropriate methods for sample size estimation. Only 63 (51.2%) reported exclusively appropriate methods for analysis. These findings suggest that many investigators do not adequately attend to the methodological challenges inherent in group-randomized trials. These practices can lead to underpowered studies, to an inflated type 1 error rate, and to inferences that mislead readers. Investigators should work with biostatisticians or other methodologists familiar with these issues. Funders and editors should ensure careful methodological review of applications and manuscripts. Reviewers should ensure that studies are properly planned and analyzed. These steps are needed to improve the rigor and reproducibility of group-randomized trials. The Office of Disease Prevention (ODP) at the National Institutes of Health (NIH) has taken several steps to address these issues. ODP offers an online course on the design and analysis of group-randomized trials. ODP is working to increase the number of methodologists who serve on grant review panels. ODP has developed standard language for the Application Guide and the Review Criteria to draw investigators' attention to these issues. Finally, ODP has created a new Research Methods Resources website to help investigators, reviewers, and NIH staff better understand these issues.

Background Xpert® MTB/RIF (Xpert) has high sensitivity for diagnosing tuberculosis (TB) compared to sputum-smear microscopy (smear) and can reduce time-to-diagnosis, time-to-treatment and potentially unfavorable patient-level treatment outcome. Methods People living with HIV (PLHIV) initiating antiretroviral therapy at 22 HIV clinics were enrolled and underwent systematic screening for TB (August 2012–November 2014). GeneXpert instruments were deployed following a stepped-wedge design at 13 centers from October 2012–June 2013. Treatment outcomes classified as an unfavorable outcome (died, treatment failure or loss-to-follow-up) or favorable outcome (cured and treatment completed). To determine outcome, smear was performed at month 5 or 6. Empiric treatment was defined as initiating treatment without/before receiving TB-positive results. Adjusting for intra-facility correlation, we compared patient-level treatment outcomes between patients screened using smear (smear arm)- and Xpert-based algorithms (Xpert arm). Results Among 6041 patients enrolled (smear arm, 1816; Xpert arm, 4225), 256 (199 per 2985 and 57 per 1582 person-years of follow-up in Xpert and smear arms, respectively; adjusted incidence rate ratio, 9.07; 95% confidence interval [CI]: 4.70–17.48; p p = 0.268). Compared to smear, in Xpert arm median days from sputum collection to TB treatment was 6 days (interquartile range [IQR] 2–17 versus 22 days [IQR] 3–51), p = 0.005; patients with available sputum test result had microbiologically confirmed TB in 59.0% (102/173) versus 41.9% (18/43), adjusted Odds Ratio [aOR], 2.00, 95% CI: 1.01–3.96, p = 0.048). In smear arm empiric treatment was 68.4% (39/57) versus 48.7% (97/199), aOR, 2.28, 95% CI: 1.24–4.20, p = 0.011), compared to Xpert arm. Conclusions TB treatment outcomes were similar between the smear and Xpert arms. However, compared to the smear arm, more patients in the Xpert arm received a TB diagnosis, had a microbiologically confirmed TB, and had a shorter time-to-treatment, and had a lower empiric treatment. Further research is recommended to identify potential gaps in the Botswana health system and similar settings. Trial registration ClinicalTrials.gov Identifier: NCT02538952. Retrospectively registered on 2 September 2015.

Summary Background In settings with high HIV prevalence and treatment coverage, such as Botswana, it is unknown whether uptake of HIV prevention and treatment interventions can be increased further. We sought to determine whether a community-based intervention to identify and rapidly treat people living with HIV, and support male circumcision could increase population levels of HIV diagnosis, treatment, viral suppression, and male circumcision in Botswana. Methods The Ya Tsie Botswana Combination Prevention Project study was a pair-matched cluster-randomised trial done in 30 communities across Botswana done from Oct 30, 2013, to June 30, 2018. 15 communities were randomly assigned to receive HIV prevention and treatment interventions, including enhanced HIV testing, earlier antiretroviral therapy (ART), and strengthened male circumcision services, and 15 received standard of care. The first primary endpoint of HIV incidence has already been reported. In this Article, we report findings for the second primary endpoint of population uptake of HIV prevention services, as measured by proportion of people known to be HIV-positive or tested HIV-negative in the preceding 12 months; proportion of people living with HIV diagnosed and on ART; proportion of people living with HIV on ART with viral suppression; and proportion of HIV-negative men circumcised. A longitudinal cohort of residents aged 16–64 years from a random, approximately 20% sample of households across the 15 communities was enrolled to assess baseline uptake of study outcomes; we also administered an end-of-study survey to all residents not previously enrolled in the longitudinal cohort to provide study end coverage estimates. Differences in intervention uptake over time by randomisation group were tested via paired Student's t test. The study has been completed and is registered with ClinicalTrials.gov ( NCT01965470 ). Findings In the six communities participating in the end-of-study survey, 2625 residents (n=1304 from standard-of-care communities, n=1321 from intervention communities) were enrolled into the 20% longitudinal cohort at baseline from Oct 30, 2013, to Nov 24, 2015. In the same communities, 10 791 (86%) of 12 489 eligible enumerated residents not previously enrolled in the longitudinal cohort participated in the end-of-study survey from March 30, 2017, to Feb 25, 2018 (5896 in intervention and 4895 in standard-of-care communities). At study end, in intervention communities, 1228 people living with HIV (91% of 1353) were on ART; 1166 people living with HIV (88% of 1321 with available viral load) were virally suppressed, and 673 HIV-negative men (40% of 1673) were circumcised in intervention communities. After accounting for baseline differences, at study end the proportion of people living with HIV who were diagnosed was significantly higher in intervention communities (absolute increase of 9% to 93%) compared with standard-of-care communities (absolute increase of 2% to 88%; prevalence ratio [PR] 1·08 [95% CI 1·02–1·14], p=0·032). Population levels of ART, viral suppression, and male circumcision increased from baseline in both groups, with greater increases in intervention communities (ART PR 1·12 [95% CI 1·07–1·17], p=0·018; viral suppression 1·13 [1·09–1·17], p=0·017; male circumcision 1·26 [1·17–1·35], p=0·029). Interpretation It is possible to achieve very high population levels of HIV testing and treatment in a high-prevalence setting. Maintaining these coverage levels over the next decade could substantially reduce HIV transmission and potentially eliminate the epidemic in these areas. Funding US President's Emergency Plan for AIDS Relief through the Centers for Disease Control and Prevention.

In Botswana, 85% of persons living with HIV are aware of their status. We performed an economic analysis of HIV testing activities implemented during intensive campaigns, in 11 communities, between April 2015 and March 2016, through the Botswana Combination Prevention Project. The total cost was $1,098,312, or $99,847 per community, with 60% attributable to home-based testing and 40% attributable to mobile testing. The cost per person tested was $44, and $671 per person testing positive (2017 USD). Labor costs comprised 64% of total costs. In areas of high HIV prevalence and treatment coverage, the cost of untargeted home-based testing may be inflated by the efforts required to assess the testing eligibility of clients who are HIV-positive and on ART. Home-based and mobile testing delivered though an intensive community-based campaign allowed the identification of HIV positive persons, who may not access health facilities, at a cost comparable to other studies.

Introduction The scale-up of Universal Test and Treat has resulted in reductions in HIV morbidity, mortality and incidence. However, healthcare system and personal challenges have impacted the levels of treatment coverage achieved. We implemented interventions to improve linkage to care, retention, viral load (VL) coverage and service delivery, and describe the HIV care cascade over the course of the Botswana Combination Prevention Project (BCPP) study. Methods BCPP was designed to evaluate the impact of prevention interventions on HIV incidence in 30 communities in Botswana. We followed a longitudinal cohort of newly identified and known HIV-positive persons not on antiretroviral therapy (ART) identified through community-based testing activities through BCPP and referred with appointments to local HIV clinics in 15 intervention communities. Those who did not keep the first or follow-up appointments were tracked and traced through phone and home contacts. Improvements to service delivery models in the intervention clinics were also implemented. Results A total of 3,657 newly identified or HIV-positive persons not on ART were identified and referred to their local HIV clinic; 90% (3,282/3,657) linked to care and of those, 93% (3,066/3,282) initiated treatment. Near the end of the study, 221 persons remained >90 days late for appointments or missing. Tracing efforts identified 54/3,066 (2%) persons who initiated treatment but died, and 106/3,066 (3%) persons were located and returned to treatment. At study end, 61/3,066 (2%) persons remained missing and were never reached. Overall, 2,951 (98%) persons living with HIV (PLHIV) who initiated treatment were still alive, retained in care and still receiving ART out of the 3,001 persons alive at the end of the study. Of those on ART, 2,854 (97%) had current VL results and 2,784 (98%) of those were virally suppressed at study end. Conclusions This study achieved high rates of linkage, treatment initiation, retention and VL coverage and suppression in a cohort of newly identified and known PLHIV not on ART. Tracking and tracing interventions effectively identified those persons who needed more resource intensive follow-up. The interventions implemented to improve service delivery and data quality may have also contributed to high linkage and retention rates. Clinical trial number: NCT01965470.

We conducted a group randomized trial to assess the feasibility and effectiveness of a multi-component, clinic-based HIV prevention intervention for HIV-positive patients attending clinical care in Namibia, Kenya, and Tanzania. Eighteen HIV care and treatment clinics (six per country) were randomly assigned to intervention or control arms. Approximately 200 sexually active clients from each clinic were enrolled and interviewed at baseline and 6- and 12-months post-intervention. Mixed model logistic regression with random effects for clinic and participant was used to assess the effectiveness of the intervention. Of 3522 HIV-positive patients enrolled, 3034 (86 %) completed a 12-month follow-up interview. Intervention participants were significantly more likely to report receiving provider-delivered messages on disclosure, partner testing, family planning, alcohol reduction, and consistent condom use compared to participants in comparison clinics. Participants in intervention clinics were less likely to report unprotected sex in the past 2 weeks (OR = 0.56, 95 % CI 0.32, 0.99) compared to participants in comparison clinics. In Tanzania, a higher percentage of participants in intervention clinics (17 %) reported using a highly effective method of contraception compared to participants in comparison clinics (10 %, OR = 2.25, 95 % CI 1.24, 4.10). This effect was not observed in Kenya or Namibia. HIV prevention services are feasible to implement as part of routine care and are associated with a self-reported decrease in unprotected sex. Further operational research is needed to identify strategies to address common operational challenges including staff turnover and large patient volumes.

Male circumcision provides men with approximately 60% protection from acquiring HIV infection via heterosexual sex, and has become a key component of HIV prevention efforts in sub-Saharan Africa. Possible mechanisms for this protection include removal of the inflammatory anaerobic sub-preputial environment and the high concentration of Langerhans cells on the inside of the foreskin, both believed to promote local vulnerability to HIV infection. In people who do acquire HIV, viral load is partially determined by infecting partner viral load, potentially mediated by size of infecting inoculum. By removing a portal for virion entry, prior male circumcision could decrease infecting inoculum and thus viral load in men who become HIV-infected, conferring the known associated benefits of slower progression to disease and decreased infectiousness. We performed an as-treated analysis of plasma samples collected under a randomized controlled trial of male circumcision for HIV prevention, comparing men based on their circumcision status at the time of HIV acquisition, to determine whether circumcision is associated with lower viral load. Eligible men were seroconverters who had at least one plasma sample available drawn at least 6 months after infection, reported no potential exposures other than vaginal sex and, for those who were circumcised, were infected more than 6 weeks after circumcision, to eliminate the open wound as a confounder. Initial viral load testing indicated that quality of pre-2007 samples might have been compromised during storage and they were excluded, as were those with undetectable or unquantifiable results. Log viral loads were compared between groups using univariable and multivariable linear regression, adjusting for sample age and sexually transmitted infection diagnosis with 3.5 months of seroconversion, with a random effect for intra-individual clustering for samples from the same man. A per-protocol analysis was also performed. There were no viral load differences between men who were circumcised and uncircumcised at the time of HIV infection (means 4.00 and 4.03 log10 copies/mL respectively, p = .88) in any analysis. Circumcision status at the time of HIV infection does not affect viral load in men. The original RCT which provided the samples was ClinicalTrials.gov trial NCT00059371 .

INTRODUCTION: The World Health Organization endorsed (2010) the use of Xpert MTB/RIF and countries are shifting from smear microscopy (smear)-based to Xpert MTB/RIF-based tuberculosis (TB) diagnostic algorithms. As with smear, sputum quality may predict the likelihood of obtaining a bacteriologically-confirmed TB when using Xpert MTB/RIF. METHODS: From 08/12-11/2014, all people living with HIV were recruited at 22 clinics. For patients screened positive using the four TB symptoms their sputa were tested by Xpert MTB/RIF and smear. Laboratorians assessed and recorded sputum appearance and volume. The yield of bacteriologically-positive sputum evaluated using Xpert MTB/RIF and smear, likelihood-ratios were calculated. RESULTS: Among 6,041 patients enrolled 2,296 were presumptive TB, 1,305 (56.8%) had > 1 sputa collected and 644/1,305 (49.3%) had both Xpert MTB/RIF and smear results. Since >1 sputa collected from 644 patients 954 sputa were tested by Xpert MTB/RIF and smear. Bacteriologically-positive sputum was two-fold higher with Xpert MTB/RIF 11.4% versus smear 5.3%, p < 0.001. Sputum appearance and quantity were not predictive of bacteriologically-positive results, except volume of 2ml to < 3ml, tested by Xpert MTB/RIF LR+=1.26 (95% CI, 1.05–1.50). CONCLUSION: Xpert MTB/RIF test yield to bacteriologically-positive sputum was superior to smear. Sputum quality and quantity, however, were not consistently predictive of bacteriologically-positive results by Xpert MTB/RIF or smear.

This is a protocol for a Cochrane Review (Diagnostic test accuracy). The objectives are as follows:\ud To assess the accuracy of the four-symptom screen (cough, fever, night sweats, or weight loss) for identifying active TB in pregnant PLHIV who are screened in an outpatient or community setting.\ud To investigate potential sources of heterogeneity of the accuracy of the four-symptom screen between studies including: ART status, CD4 cell count, gestational age, pregnancy stage (pregnancy vs. postpartum), screening test definition of cough (any cough vs. cough greater than 2 weeks).\ud To describe the accuracy of single symptoms included within the four-symptom screen, additional symptoms or symptom combinations, for identifying active TB in pregnant PLHIV. For example, additional symptoms may include failure to gain weight or fatigue

Although several studies have evaluated one or more linkage services to improve early enrollment in HIV care in Tanzania, none have evaluated the package of linkage services recommended by the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). We describe the uptake of each component of the CDC/WHO recommended package of linkage services, and early enrollment in HIV care and antiretroviral therapy (ART) initiation among persons with HIV who participated in a peer-delivered, linkage case management (LCM) program implemented in Bukoba, Tanzania, October 2014 –May 2017. Of 4206 participants (88% newly HIV diagnosed), most received recommended services including counseling on the importance of early enrollment in care and ART (100%); escort by foot or car to an HIV care and treatment clinic (CTC) (83%); treatment navigation at a CTC (94%); telephone support and appointment reminders (77% among clients with cellphones); and counseling on HIV-status disclosure and partner/family testing (77%), and on barriers to care (69%). During three periods with different ART-eligibility thresholds [CD4

Background Swaziland has the highest adult HIV prevalence and second highest rate of TB/HIV coinfection globally. Recently, the Ministry of Health and partners have increased integration and co-location of TB/HIV services, but the timing of antiretroviral therapy (ART) relative to TB treatment—a marker of program quality and predictor of outcomes—is unknown. Methods We conducted a retrospective analysis of programmatic data from 11 purposefully-sampled facilities to evaluate timely ART provision for HIV-positive TB patients enrolled on TB treatment between July-November 2014. Timely ART was defined as within two weeks of TB treatment initiation for patients with CD4

Objective To incorporate preexposure prophylaxis and other biomedical or intensive behavioral interventions into the care of injection drug users (IDUs), health care providers need validated, rapid, risk screening tools for identifying persons at highest risk of incident HIV infection. Methods To develop and validate a brief screening tool for assessing the risk of contracting HIV (ARCH), we included behavioral and HIV test data from 1904 initially HIV-uninfected men and women enrolled and followed in the AIDS Linked to the Intravenous Experience prospective cohort study between 1988 and 2008. Using logistic regression analyses with generalized estimating equations, we identified significant predictors of incident HIV infection, then rescaled and summed their regression coefficients to create a risk score. Results The final logistic regression model included age, engagement in a methadone maintenance program, and a composite injection risk score obtained by counting the number of the following 5 behaviors reported during the past 6 months: injection of heroin, injection of cocaine, sharing a cooker, sharing needles, or visiting a shooting gallery. The area under the receiver operating characteristic curve was 0.720; possible scores on the index ranged from 0 to 100 and a score 46 or greater had a sensitivity of 86.2% and a specificity of 42.5%, appropriate for a screening tool. Discussion We developed an easy to administer 7-question screening tool with a cutoff that is predictive of incident HIV infection in a large prospective cohort of IDUs in Baltimore. The ARCH-IDUs screening tool can be used to prioritize persons who are injecting illicit drugs for consideration of preexposure prophylaxis and other intensive HIV prevention efforts.

Summary Background Male circumcision reduces men's risk of acquiring HIV and some sexually transmitted infections from heterosexual exposure, and is essential for HIV prevention in sub-Saharan Africa. Studies have also investigated associations between male circumcision and risk of acquisition of HIV and sexually transmitted infections in women. We aimed to review all evidence on associations between male circumcision and women's health outcomes to benefit women's health programmes. Methods In this systematic review we searched for peer-reviewed and grey literature publications reporting associations between male circumcision and women's health outcomes up to April 11, 2016. All biomedical (not psychological or social) outcomes in all study types were included. Searches were not restricted by year of publication, or to sub-Saharan Africa. Publications without primary data and not in English were excluded. We extracted data and assessed evidence on each outcome as high, medium, or low consistency on the basis of agreement between publications; outcomes found in fewer than three publications were indeterminate consistency. Findings 60 publications were included in our assessment. High-consistency evidence was found for five outcomes, with male circumcision protecting against cervical cancer, cervical dysplasia, herpes simplex virus type 2, chlamydia, and syphilis. Medium-consistency evidence was found for male circumcision protecting against human papillomavirus and low-risk human papillomavirus. Although the evidence shows a protective association with HIV, it was categorised as low consistency, because one trial showed an increased risk to female partners of HIV-infected men resuming sex early after male circumcision. Seven outcomes including HIV had low-consistency evidence and six were indeterminate. Interpretation Scale-up of male circumcision in sub-Saharan Africa has public health implications for several outcomes in women. Evidence that female partners are at decreased risk of several diseases is highly consistent. Synergies between male circumcision and women's health programmes should be explored. Funding US Centers for Disease Control and Prevention and Jhpiego.

Background In 2011, the Botswana National Tuberculosis Program adopted World Health Organization guidelines and introduced Xpert MTB/RIF (Xpert) assay to support intensified case finding among people living with HIV enrolling in care. An evaluation was designed to assess performance under operational conditions to inform the national Xpert scale-up. Methods Xpert was implemented from August 2012 through November 2014 with 13 GeneXpert instruments (GeneXpert) deployed in a phased approach over nine months: nine centralized laboratory and four point-of-care (POC) peripheral clinics. Clinicians and laboratorians were trained on the four-symptom tuberculosis screening algorithm and Xpert testing. We documented our experience with staff training and GeneXpert performance. Test results were extracted from GeneXpert software; unsuccessful tests were analysed in relation to testing sites and trends over time. Results During 276 instrument-months of operation a total of 3,630 tests were performed, of which 3,102 (85%) were successful with interpretable results. Mycobacterium tuberculosis complex was detected for 447 (14%); of these, 36 (8%) were rifampicin resistant. Of all 3,630 Xpert tests, 528 (15%) were unsuccessful; of these 361 (68%) were classified as “error”, 119 (23%) as “invalid” and 48 (9%) as “no result”. The total number of recorded error codes was 385 and the most common reasons were related to sample processing (211; 55%) followed by power supply (77; 20%) and cartridge/module related (54; 14%). Cumulative incidence of unsuccessful test was similar between POC (17%, 95% CI: 11–25%) and centralized laboratory-based GeneXpert instruments (14%, 95% CI: 11–17%; p = 0.140). Conclusions Xpert introduction was successful in the Botswana setting. The incidence of unsuccessful test was similar by GeneXpert location (POC vs. centralized laboratory). However, unsuccessful test incidence (15%) in our settings was higher than previously reported and was mostly related to improper sample processing. Ensuring adequate training among Xpert testing staff is essential to minimize errors.

Background Non-tuberculous mycobacteria (NTM) can cause pulmonary infection and disease especially among people living with HIV (PLHIV). PLHIV with NTM disease may clinically present with one of the four symptoms consistent with tuberculosis (TB). We describe the prevalence of NTM and Mycobacterium tuberculosis complex (MTBC) isolated among PLHIV who presented for HIV care and treatment. Methods All PLHIV patients presenting for HIV care and treatment services at 22 clinical sites in Botswana were offered screening for TB and were recruited. Patients who had ≥1 TB symptom were asked to submit sputa for Xpert MTB/RIF and culture. Culture growth was identified as NTM and MTBC using the SD-Bioline TB Ag MPT64 Kit and Ziehl Neelsen microscopy. NTM and MTBC isolates underwent species identification by the Hain GenoType CM and AS line probe assays. Results Among 16, 259 PLHIV enrolled 3068 screened positive for at least one TB symptom. Of these, 1940 submitted ≥1 sputum specimen, 427 (22%) patients had ≥1 positive-culture result identified phenotypically for mycobacterial growth. Of these 247 and 180 patients were identified as having isolates were NTM and MTBC, respectively. Of the 247 patients identified with isolates containing NTM; 19 were later excluded as not having NTM based on additional genotypic testing. Among the remaining 408 patients 228 (56%, 95% confidence interval, 46–66%) with NTM. M. intracellulare was the most common isolated (47.8%). Other NTMs commonly associated with pulmonary disease included M. malmoense (3.9%), M. avium (2.2%), M. abscessus (0.9%) and M. kansasii (0.4%). After excluding NTM isolates that were non-speciated and M. gordonae 154 (67.5%) of the NTM isolates were potential pathogens. Conclusions In the setting of HIV care and treatment, over-half (56%) of a positive sputum culture among PLHIV with TB symptoms was NTM. Though we were not able to distinguish in our study NTM disease and colonization, the study suggests culture and species identification for PLHIV presenting with TB symptoms remains important to facilitate NTM diagnosis and hasten time to appropriate treatment.

We estimated HIV prevalence and identified correlates of HIV infection among 1106 men and women aged 16–34 years residing in Kisumu, Kenya. Demographic, sexual, and other behavioural data were collected using audio computer-assisted self-interview in conjunction with a medical examination, real-time parallel rapid HIV testing, and laboratory testing for pregnancy, gonorrhoea, chlamydia, syphilis, and herpes simplex virus type 2. Multivariate logistic regression was used to identify variables associated with prevalent HIV infection by gender. Overall HIV prevalence was 12.1%. HIV prevalence among women (17.1%) was approximately two-and-one-half times the prevalence among men (6.6%). Odds of HIV infection in men increased with age (aOR associated with one-year increase in age = 1.21, CI = 1.07–1.35) and were greater among those who were uncircumcised (aOR = 4.42, CI = 1.41–13.89) and those who had an herpes simplex virus type 2-positive (aOR = 3.13, CI = 1.12–8.73) test result. Odds of prevalent HIV infection among women also increased with age (aOR associated with one-year increase in age = 1.16, CI = 1.04–1.29). Women who tested herpes simplex virus type 2 positive had more than three times the odds (aOR = 3.85, CI = 1.38–10.46) of prevalent HIV infection compared with those who tested herpes simplex virus type 2 negative. Tailored sexual health interventions and programs may help mitigate HIV age and gender disparities.

Background: We determined the prevalence of four sexually transmitted infections and the demographic and behav- ioural correlates associated with having one or more sexually transmitted infections among participants in an HIV incidence cohort study in Kisumu, western Kenya. Methods: Participants were enrolled from a convenience sample and underwent aetiologic sexually transmitted infec- tion investigation. Demographic and behavioural information were collected and basic clinical evaluation performed. Multiple regression analysis was done to determine variables associated with having one or more sexually transmitted infections. Results: We screened 846, 18- to 34-year-olds. One-third had at least one sexually transmitted infection with specific prevalence being, syphilis; 1.6%, gonorrhoea; 2.4%, herpes simplex virus type-2; 29.1%, chlamydia; 2.8%, and HIV; 14.8%. Odds of having any sexually transmitted infection were higher among participants who were women, were aged 20-24 or 30-34 years compared to 18-19 years, had secondary or lower education compared to tertiary education, were divorced, widowed or separated compared to singles, reported having unprotected sex compared to those who did not, reported previous sexually transmitted infection treatment, and tested HIV-positive. Conclusion: Multiple strategies are needed to address the overall high prevalence of sexually transmitted infections as well as the gender disparity found in this Kenyan population. Structural interventions may be beneficial in addressing educational and socio-economic barriers, and increasing the uptake of health-promoting practices.

Violence exposure among HIV-infected adolescents was estimated using Poisson regression and adjusted event rate ratios (ERR). Of 166 urban adolescents (99 perinatally infected youth [PIY]; 67 behaviorally infected youth [BIY]) 52.5% (n = 85) experienced violence; 79% (n = 131) witnessed violence. Sexual violence was experienced by 18% (6 PIY, 24 BIY) before age 13 years and by 15% (6 PIY, 19 BIY) during adolescence. BIY were significantly more likely than PIY to have experienced and witnessed violence. Controlling for transmission, ever-bartered sex (ERR = 1.92, CI [1.31 to 2.81], p = .009) and family disruptions (ERR = 1.19, CI [1.03 to 1.39], p = .022) were associated with violence victimization. Family disruptions (ERR = 1.17, CI [1.05 to 1.30], p = .004), female gender (ERR = 1.32, CI [1.05 to 1.66], p = .017), and heterosexual orientation (ERR = 1.48, CI = [1.11 to 1.97], p = .006) were associated with witnessing violence.

To diagnose ≥90% HIV-infected residents (diagnostic coverage), the Bukoba Combination Prevention Evaluation (BCPE) implemented provider-initiated (PITC), home- (HBHTC), and venue-based (VBHTC) HIV testing and counseling (HTC) intervention in Bukoba Municipal Council, a mixed urban and rural lake zone community of 150,000 residents in Tanzania. This paper describes the methods, outcomes, and incremental costs of these HTC interventions. PITC was implemented in outpatient department clinics in all eight public and three faith-based health facilities. In clinics, lay counselors routinely screened and referred eligible patients for HIV testing conducted by HTC-dedicated healthcare workers. In all 14 wards, community teams offered HTC to eligible persons encountered at 31,293 home visits and at 79 male- and youth-frequented venues. HTC was recommended for persons who were not in HIV care or had not tested in the prior 90 days. BCPE conducted 133,695 HIV tests during the 2.5 year intervention (PITC: 88,813, 66%; HBHTC: 27,407, 21%; VBHTC: 17,475, 13%). Compared with other strategies, PITC conducted proportionally more tests among females (65%), and VBHTC conducted proportionally more tests among males (69%) and young-adults aged 15-24 years (42%). Of 5,550 (4.2% of all tests) HIV-positive tests, 4,143 (75%) clients were newly HIV diagnosed, including 1,583 males and 881 young adults aged 15-24 years. Of HIV tests conducted 3.7%, 1.8%, and 2.1% of PITC, HBHTC, and VBHTC clients, respectively, were newly HIV diagnosed; PITC accounted for 79% of all new diagnoses. Cost per test (per new diagnosis) was $4.55 ($123.66), $6.45 ($354.44), and $7.98 ($372.67) for PITC, HBHTC, and VBHTC, respectively. In a task-shifting analysis in which lay counselors replaced healthcare workers, estimated costs per test (per new diagnosis) would have been $3.06 ($83.15), $ 4.81 ($264.04), and $5.45 ($254.52), for PITC, HBHTC, and VBHTC, respectively. BCPE models reached different target groups, including men and young adults, two groups with consistently low coverage. Implementation of multiple models is likely necessary to achieve ≥90% diagnostic coverage.

There is increased emphasis on physician attention to the overall health and wellness of homosexual and bisexual men, though little is known about the health-related attitudes of these groups. This study determined factors associated with the health attitudes of homosexual and bisexual men and identified preferred sources of health information. For this study, the 2008 ConsumerStyles panel survey was used to create three health attitude scales and to determine factors associated with each scale. The three scales were labeled: (1) health motivation; (2) relationship with health care provider; and (3) self-perception of health literacy. In addition to other factors, higher scores for health motivation and relationship with health care provider were associated with black compared with white men. In contrast, lower scores for self-perception of health literacy were associated with black compared with white men. For information on an unfamiliar health condition, most homosexual and bisexual men chose the Internet. Black homosexual and bisexual men reported being motivated to be healthy and working well with their health care provider to manage their health. However, their perception of their own health motivation was low compared with the white men. Attempts to improve health literacy through Internet sites may be helpful in improving health attitudes and reducing negative health outcomes.

Background To implement biomedical and other intensive HIV prevention interventions cost-effectively, busy care providers need validated, rapid, risk screening tools for identifying persons at highest risk of incident infection. Methods To develop and validate an index, we included behavioral and HIV test data from initially HIV-uninfected men who have sex with men who reported no injection drug use during semiannual interviews in the VaxGen VAX004 study and Project Explore HIV prevention trials. Using generalized estimating equations and logistic regression analyses, we identified significant predictors of incident HIV infection, then weighted and summed their regression coefficients to create a risk index score. Results The final logistic regression model included age, and the following behaviors reported during the past 6 months: total number of male sex partners, total number of HIV-positive male sex partners, number of times the participant had unprotected receptive anal sex with a male partner of any HIV status, number of times the participant had insertive anal sex with an HIV-positive male partner, whether the participant reported using poppers, and whether they reported using amphetamines. The area under the receiver operating characteristic curve was 0.74, possible scores on index range from 0 to 47 and a score ≥10 had as sensitivity of 84% and a specificity of 45%, levels appropriate for a screening tool. Conclusions We developed an easily administered and scored 7-item screening index with a cutoff that is predictive of HIV seroconversion in 2 large prospective cohorts of US men who have sex with men. The index can be used to prioritize patients for intensive HIV prevention efforts (eg, preexposure prophylaxis).

We present a cost-utility analysis based on data from the Housing and Health (H&H) Study of rental assistance for homeless and unstably housed persons living with HIV in Baltimore, Chicago and Los Angeles. As-treated analyses found favorable associations of housing with HIV viral load, emergency room use, and perceived stress (an outcome that can be quantitatively linked to quality of life). We combined these outcome data with information on intervention costs to estimate the cost-per-quality-adjusted-life-year (QALY) saved. We estimate that the cost-per-QALY-saved by the HIV-related housing services is $62,493. These services compare favorably (in terms of cost-effectiveness) to other well-accepted medical and public health services.

Audio computer-assisted self-interview (ACASI) has been shown to reduce interviewer and social desirability bias related to sensitive questions, which can be especially important for studies of sexual behavior and HIV risk. Baseline demographic and HIV risk data were collected using ACASI for 849 adults aged 18–34 (423 males and 426 females) of unknown or HIV-negative status as part of an HIV-incidence cohort study in Kisumu, Kenya. ACASI questionnaires and possible responses were recorded being read either by a male or female voice in the three most commonly used languages (English, Kiswahili, and Dholuo). Participants were randomly assigned to hear either male or female voice. Dependent variables, including 12 sexual behavior questions, were evaluated using logistic regression. No significant differences in responses to the 12 sensitive questions were found for gender of the recorded voice on ACASI or for the interaction between gender of recorded ACASI voice and respondent gender.

A combination of in-depth interviews ( n = 38) and surveys ( n = 203) were used to (1) identify strategies to recruit persons at high risk for HIV infection; (2) determine whether one strategy was more successful than others; and (3) describe motivators and barriers to participation in HIV-prevention studies. From in-depth interviews, four main recruitment strategies were identified: (1) use of a person with specific knowledge of a target population (link person mobilization); (2) use of co-workers or contemporaries (peer mobilization); (3) use of group or association leaders (leader mobilization); and (4) contacting persons by study staff directly (staff contact mobilization). The odds of inconsistently using condoms during sex were greater among those recruited using the peer mobilization (adjusted odds ratio [AOR] = 3.59; 95% confidence interval [CI] = 1.35–9.54) and the leader mobilization strategies (AOR = 2.76; 95% CI = 1.04–7.38) compared with the link person mobilization strategy. The main motivators for taking part in an HIV research study were receiving HIV-prevention education, HIV information or counselling, and receiving compensation for study participation. The main barriers were fear of lack of confidentiality and HIV testing concerns. Using evaluated strategies to recruit persons at high risk for HIV infection and addressing barriers to participation will improve the conduct and outcome of HIV-prevention studies.

(See the editorial commentary by Yin and Stein, on pages 406–408.)Background. We explored serum 25-hydroxyvitamin D (25[OH]D) levels and associated factors forinsufficiency or deficiency in an adult human immunodeficiency virus (HIV) cohort and compared 25(OH)Dlevels with those in the general US population.Methods. Usingbaseline datafrom theStudytoUnderstandtheNaturalHistory ofHIVandAIDSintheEraofEffective Therapy (SUN), a prospective, observational cohort study of HIV-infected adults enrolled at 7 HIVspecialtyclinicsin4UScitiesfromMarch2004toJune2006,weestimatedtheprevalenceofvitaminDinsufficiencyor deficiency (defined as 25(OH)D levels ,30 ng/mL), standardized by age, race, and sex. Using multiple logisticregression, we examined risk factors for vitamin D insufficiency or deficiency.Results. Among672SUNparticipantswithbaselineserum25(OH)DdeterminationswhowerenotreceivingvitaminD supplements, 70.3% (95% confidence interval [CI], 68.1%– 74.9%) were vitamin D insuffi cient or deficient, comparedwith79.1%(95%CI,76.7–81.3)ofUSadults.Factorsassociat edwithvitaminDinsufficiencyordeficiencyincludedblackrace(adjustedoddsratio[aOR],4.51;95%CI,2.59–7.85),Hispanicethnicity(aOR,2.78;95%CI,1.31–5.90),higherbodymassindex(aOR,1.04;95%CI,1.00–1.09),hypertension(aOR,1.88;95%CI,1.10–3.22),lackofexercise(aOR,3.14;95%CI,1.80–5.47),exposuretoefavirenz(aOR,1.98;95%CI,1.18–3.34),higherexposuretoultravioletlight(aOR,.78;95%CI,.71–.86),renalinsufficiency(aOR,.55;95%CI,.36–.83),andexposuretoritonavir(aOR,.56;95%CI,.35–0.89).Conclusions. SimilartofindingsinUSadultsgenerally,vitaminDinsufficiencyordeficiencyishighlyprevalentamongHIV-infectedadultsandisassociatedwithknownriskfactors.ObservedassociationsofvitaminDlevelswithrenal insufficiency and with use of ritonavir- and efavirenz-containing regimens are consistent with both HIV-relatedandtherapy-mediatedalterationsin vitaminDmetabolism. Cliniciansshouldconsiderscreening allpatientsfor vitamin D insufficiency or deficiency.Vitamin D is essential for calcium homeostasis and bonemetabolism [1]. Vitamin D deficiency is associated witha number of comorbidities, including hypertension,cardiovascular disease, insulin resistance, diabetes, dysli-pidemia, impaired immune function, decreased neuro-cognitive function, and malignancies [2–6]. The primarydeterminant of vitamin D status is exposure to sunlight.With increasing urbanizationand sunscreen use, vitaminD deficiency has become highly prevalent among thegeneral population [7, 8].Currently, serum concentration of 25-hydrox-yvitamin D (25[OH]D) is considered the best indicatorof vitamin D status, because it represents cumulative