Search

BackgroundDigital health interventions (DHI) have been used to enhance the uptake of postpartum contraception and reduce unmet contraception needs. We conducted a systematic review of the effectiveness of DHI on postpartum contraceptive use and repeated pregnancy.MethodWe searched MEDLINE, Embase, Global Health, CINAHL and Cochrane CENTRAL (January 1990–July 2020). Randomised controlled trials (RCTs) of DHI promoting contraception among pregnant or postpartum women were included. Two researchers screened articles and extracted data. We assessed the risk of bias, certainty of evidence (CoE) and conducted meta-analyses following Cochrane guidance.ResultsTwelve trials with 5527 women were included. Interventions were delivered by video (four trials), mobile phone counselling (three trials), short message services (SMS) (four trials) and computer (one trial). During pregnancy or the postpartum period, mobile phone counselling had an uncertain effect on the use of postpartum contraception (risk ratio (RR) 1.37, 95% CI 0.82 to 2.29, very low CoE); video-based education may moderately improve contraception use (RR 1.48, 95% CI 1.01 to 2.17, low CoE); while SMS education probably modestly increased contraception use (RR 1.12, 95% CI 1.01 to 1.23, moderate CoE). Mobile phone counselling probably increased long-acting reversible contraception (LARC) use (RR 4.23, 95% CI 3.01 to 5.93, moderate CoE). Both mobile phone counselling (RR 0.27, 95% CI 0.01 to 5.77, very low CoE) and videos (RR 1.25, 95% CI 0.24 to 6.53, very low CoE) had uncertain effects on repeated pregnancy.ConclusionsDuring pregnancy or in the postpartum period, videos may moderately increase postpartum contraception use and SMS probably modestly increase postpartum contraception use. The effects of DHI on repeated pregnancy are uncertain. Further well-conducted RCTs of DHI would strengthen the evidence of effects on contraception use and pregnancy.

Objective To quantify the effects of a series of text messages (safetxt) delivered in the community on incidence of chlamydia and gonorrhoea reinfection at one year in people aged 16-24 years. Design Parallel group randomised controlled trial. Setting 92 sexual health clinics in the United Kingdom. Participants People aged 16-24 years with a diagnosis of, or treatment for, chlamydia, gonorrhoea, or non-specific urethritis in the past two weeks who owned a mobile phone. Interventions 3123 participants assigned to the safetxt intervention received a series of text messages to improve sex behaviours: four texts daily for days 1-3, one or two daily for days 4-28, two or three weekly for month 2, and 2-5 monthly for months 3-12. 3125 control participants received a monthly text message for one year asking for any change to postal or email address. It was hypothesised that safetxt would reduce the risk of chlamydia and gonorrhoea reinfection at one year by improving three key safer sex behaviours: partner notification at one month, condom use, and sexually transmitted infection testing before unprotected sex with a new partner. Care providers and outcome assessors were blind to allocation. Main outcome measures The primary outcome was the cumulative incidence of chlamydia or gonorrhoea reinfection at one year, assessed by nucleic acid amplification tests. Safety outcomes were self-reported road traffic incidents and partner violence. All analyses were by intention to treat. Results 6248 of 20 476 people assessed for eligibility between 1 April 2016 and 23 November 2018 were randomised. Primary outcome data were available for 4675/6248 (74.8%). At one year, the cumulative incidence of chlamydia or gonorrhoea reinfection was 22.2% (693/3123) in the safetxt arm versus 20.3% (633/3125) in the control arm (odds ratio 1.13, 95% confidence interval 0.98 to 1.31). The number needed to harm was 64 (95% confidence interval number needed to benefit 334 to ∞ to number needed to harm 24) The risk of road traffic incidents and partner violence was similar between the groups. Conclusions The safetxt intervention did not reduce chlamydia and gonorrhoea reinfections at one year in people aged 16-24 years. More reinfections occurred in the safetxt group. The results highlight the need for rigorous evaluation of health communication interventions. Trial registration ISRCTN registry ISRCTN64390461 .

BackgroundThe use of mobile technologies to prevent STIs is recognised as a promising approach worldwide; however, evidence has been inconclusive, and the field has developed rapidly. With about 1 million new STIs a day globally, up-to-date evidence is urgently needed.ObjectiveTo assess the effectiveness of mobile health interventions delivered to participants for preventing STIs and promoting preventive behaviour.MethodsWe searched seven databases and reference lists of 49 related reviews (January 1990–February 2020) and contacted experts in the field. We included randomised controlled trials of mobile interventions delivered to adolescents and adults to prevent sexual transmission of STIs. We conducted meta-analyses and assessed risk of bias and certainty of evidence following Cochrane guidance.ResultsAfter double screening 6683 records, we included 22 trials into the systematic review and 20 into meta-analyses; 18 trials used text messages, 3 used smartphone applications and 1 used Facebook messages as delivery modes. The certainty of evidence regarding intervention effects on STI/HIV occurrence and adverse events was low or very low. There was moderate certainty of evidence that in the short/medium-term text messaging interventions had little or no effect on condom use (standardised mean differences (SMD) 0.02, 95% CI −0.09 to 0.14, nine trials), but increased STI/HIV testing (OR 1.83, 95% CI 1.41 to 2.36, seven trials), although not if the standard-of-care control already contained an active text messaging component (OR 1.00, 95% CI 0.68 to 1.47, two trials). Smartphone application messages also increased STI/HIV testing (risk ratio 1.40, 95% CI 1.22 to 1.60, subgroup analysis, two trials). The effects on other outcomes or of social media or blended interventions is uncertain due to low or very low certainty evidence.ConclusionsText messaging interventions probably increase STI/HIV testing but not condom use in the short/medium term. Ongoing trials will report the effects on biological and other outcomes.

Background Most people around the world do not have access to facility-based diagnostic testing, and the gap in availability of diagnostic tests is a major public health challenge. Self-testing, self-sampling, and institutional testing outside conventional clinical settings are transforming infectious disease diagnostic testing in a wide range of low- and middle-income countries (LMICs). We examined the delivery models of infectious disease diagnostic testing outside clinics to assess the impact on test uptake and linkage to care. Methods We conducted a systematic review and meta-analysis, searching 6 databases and including original research manuscripts comparing testing outside clinics with conventional testing. The main outcomes were test uptake and linkage to care, delivery models, and adverse outcomes. Data from studies with similar interventions and outcomes within thematic areas of interest were pooled, and the quality of evidence was assessed using GRADE. This study was registered in PROSPERO (CRD42019140828). We identified 10 386 de-duplicated citations, and 76 studies were included. Data from 18 studies were pooled in meta-analyses. Studies focused on HIV (48 studies), chlamydia (8 studies), and multiple diseases (20 studies). HIV self-testing increased test uptake compared with facility-based testing (9 studies: pooled odds ratio [OR], 2.59; 95% CI, 1.06–6.29; moderate quality). Self-sampling for sexually transmitted infections increased test uptake compared with facility-based testing (7 studies: pooled OR, 1.74; 95% CI, 0.97–3.12; moderate quality). Conclusions. Testing outside of clinics increased test uptake without significant adverse outcomes. These testing approaches provide an opportunity to expand access and empower patients. Further implementation research, scale-up of effective service delivery models, and policies in LMIC settings are needed.

Background: Most people around the world do not have access to facility-based diagnostic testing and the gap in availability of diagnostic tests is a major public health challenge. Self-testing, self-sampling, and institutional testing outside conventional clinical settings are transforming infectious disease diagnostic testing in a wide range of low- and middle-income countries (LMICs). We examined the delivery models of infectious disease diagnostic testing outside clinics to assess impact on test uptake and linkage to care. Methods: We conducted a systematic review and meta-analysis, searching six databases and including original research manuscripts comparing testing outside clinics with conventional testing. Main outcomes were test uptake and linkage to care, delivery models and adverse outcomes. Data from studies with similar interventions and outcomes were pooled and the quality of evidence was assessed using GRADE. Findings: We identified 10,386 de-duplicated citations and 76 studies were included. Studies focused on HIV (48 studies), chlamydia (eight studies), and multiple diseases (20 studies). HIV self-testing increased test uptake compared with facility-based testing (11 studies, pooled OR 1·4, 95% CI 1·36 – 1·46, moderate quality). STI self-sampling increased test uptake compared with facility-based testing (six studies in five countries, pooled OR 3·60, 95% CI 3·28 – 3·96, moderate quality). Interpretation: Testing outside of clinics increased test uptake without significant adverse outcomes. These testing approaches provide an opportunity to expand access and empower patients. Further implementation research, scale-up of effective service delivery models, and policies in LMIC settings are needed. Funding Statement: Foundation for Innovative New Diagnostics (FIND). Declaration of Interests: The authors declare that we have no conflict of interest. Ethics Approval Statement: This study was registered in PROSPERO (CRD42019140828).

HIV-infected adults have increased risk of several individual micronutrient deficiencies. However, the prevalence and risk factors of concurrent and multiple micronutrient deficiencies and whether micronutrient concentrations change after antiretroviral therapy (ART) initiation have not been well described. The objective of this study was to determine the prevalence and risk factors of individual, concurrent and multiple micronutrient deficiencies among ART-naïve HIV-infected adults from nine countries and assess change in micronutrient status 48 weeks post-ART initiation.A random sub-cohort (n = 270) stratified by country was selected from the multinational PEARLS clinical trial (n = 1571 ART-naïve, HIV-infected adults). We measured serum concentrations of vitamins A, D (25-hydroxyvitamin), E, carotenoids and selenium pre-ART and 48 weeks post-ART initiation, and measured vitamins B6, B12, ferritin and soluble transferrin receptor at baseline only. Prevalence of single micronutrient deficiencies, concurrent (2 coexisting) or conditional (a deficiency in one micronutrient given a deficiency in another) and multiple (≥3) were determined using defined serum concentration cutoffs. We assessed mean changes in micronutrient concentrations from pre-ART to week 48 post-ART initiation using multivariable random effects models.Of 270 participants, 13.9%, 29.2%, 24.5% and 32.4% had 0, 1, 2 and multiple deficiencies, respectively. Pre-ART prevalence was the highest for single deficiencies of selenium (53.2%), vitamin D (42.4%), and B6 (37.3%) with 12.1% having concurrent deficiencies of all three micronutrients. Deficiency prevalence varied widely by country. 48 weeks post-ART initiation, mean vitamin A concentration increased (p 0.001) corresponding to a 9% decrease in deficiency. Mean concentrations also increased for other micronutrients assessed 48 weeks post-ART (p 0.001) but with minimal change in deficiency status.Single and multiple micronutrient deficiencies are common among HIV-infected adults pre-ART initiation but vary between countries. Importantly, despite increases in micronutrient concentrations, prevalence of individual deficiencies remains largely unchanged after 48 weeks on ART. Our results suggest that ART alone is not sufficient to improve micronutrient deficiency.

A case-cohort analysis of human immunodeficiency virus (HIV)–infected individuals receiving antiretroviral therapy (ART) was performed within a multicountry randomized trial (PEARLS) to assess the prevalence of persistently elevated C-reactive protein (CRP) levels, based on serial measurements of CRP levels, and their association with HIV clinical failure. A persistently elevated CRP level in plasma (defined as ≥ 5 mg/L at both baseline and 24 weeks after ART initiation) was observed in 50 of 205 individuals (24%). A persistently elevated CRP level but not an elevated CRP level only at a single time point was independently associated with increased clinical failure, compared with a persistently low CRP level, despite achievement of virologic suppression. Serial monitoring of CRP levels could identify individuals who are at highest risk of HIV progression and may benefit from future adjunct antiinflammatory therapies.

IntroductionIs achievement of Sustainable Development Goal (SDG) 16 (building peaceful societies) a precondition for achieving SDG 3 (health and well-being in all societies, including conflict-affected countries)? Do health system investments in conflict-affected countries waste resources or benefit the public’s health? To answer these questions, we examine the maternal, newborn, child and reproductive health (MNCRH) service provision during protracted conflicts and economic shocks in the Republic of South Sudan between 2011 (at independence) and 2015.MethodsWe conducted two national cross-sectional probability surveys in 10 states (2011) and nine states (2015). Trained state-level health workers collected data from households randomly selected using probability proportional to size sampling of villages in each county. County data were weighted by their population sizes to measure state and national MNCRH services coverage. A two-sample, two-sided Z-test of proportions tested for changes in national health service coverage between 2011 (n=11 800) and 2015 (n=10 792).ResultsTwenty-two of 27 national indicator estimates (81.5%) of MNCRH service coverage improved significantly. Examples: malaria prophylaxis in pregnancy increased by 8.6% (pConclusionHealth system strengthening is not a uniform process and not necessarily deterred by conflict. Despite the conflict, health system investments were not wasted; health service coverage increased.

Mark W. Tenforde, MD, MPH,* Ashish Yadav, MBBS, MD, MPH,† David W. Dowdy, MD, PhD, Nikhil Gupte, PhD,§ Rupak Shivakoti, PhD, MSPH,§ Wei-Teng Yang, MD, MPH,k Noluthando Mwelase, MBChB, Cecilia Kanyama, MD,# Sandy Pillay, MBChB,** Wadzanai Samaneka, MBChB, MSc,†† Breno Santos, MD,‡‡ Selvamuthu Poongulali, MBBS,§§ Srikanth Tripathy, MBBS,kk Cynthia Riviere, MD, Sima Berendes, MD, MPH,##*** Javier R. Lama, MD, MPH,††† Sandra W. Cardoso, MD,‡‡‡ Patcharaphan Sugandhavesa, MD,§§§ Rarul Christian, DrPH, MSc,† Richard D. Semba, MD, MPH,kkk Thomas B. Campbell, MD, and Amita Gupta, MD, MHS,†§ the NWCS319 and ACTG 5175 study team From the *Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington School of Medicine, Seattle, WA; Departments of †International Health; ‡Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; §Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD; kDepartment of Medicine, Bridgeport Hospital, Yale New Haven Health, Bridgeport, CT; Department of Medicine, University of Witwatersrand, Johannesburg, South Africa; #UNC Lilongwe, Lilongwe, Malawi; **Durban International Clinical Research Site, Durban University of Technology, Durban, South Africa; ††University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe; ‡‡Hospital Nossa Senhora de Conceicao, Porto Alegre, Brazil; §§YR Gaitonde Centre for AIDS Research and Education, Chennai, India; kkNational AIDS Research Institute, Pune, India; Les Centres GHESKIO, Port-Au-Prince, Haiti; ##Malawi College of Medicine, Johns Hopkins University Research Project, Blantyre, Malawi; ***Liverpool School of Tropical Medicine, Liverpool, United Kingdom; †††Asociacion Civil Impacta Salud y Educacion, Lima, Peru; ‡‡‡STD/AIDS Clinical Research Laboratory, Instituto de Pesquisa Clinica Evandro Chagas, Fundacao Oswaldo Cruz, Rio de Janeiro, Brazil; §§§Research Institute for Health Sciences, Chiang Mai, Thailand; kkkDepartment of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, MD; and Division of Infectious Diseases, Department of Medicine, University of Colorado School of Medicine, Aurora, CO.

OBJECTIVES We adapted a rapid quality of care monitoring method to a fragile state with two aims: to assess the delivery of child health services in South Sudan at the time of independence and to strengthen local capacity to perform regular rapid health facility assessments. METHODS Using a two-stage lot quality assurance sampling (LQAS) design, we conducted a national cross-sectional survey among 156 randomly selected health facilities in 10 states. In each of these facilities, we obtained information on a range of access, input, process and performance indicators during structured interviews and observations. RESULTS Quality of care was poor with all states failing to achieve the 80% target for 14 of 19 indicators. For example, only 12% of facilities were classified as acceptable for their adequate utilisation by the population for sick-child consultations, 16% for staffing, 3% for having infection control supplies available and 0% for having all child care guidelines. Health worker performance was categorised as acceptable in only 6% of cases related to sick-child assessments, 38% related to medical treatment for the given diagnosis and 33% related to patient counselling on how to administer the prescribed drugs. Best performance was recorded for availability of in-service training and supervision, for seven and ten states, respectively. CONCLUSIONS Despite ongoing instability, the Ministry of Health developed capacity to use LQAS for measuring quality of care nationally and state-by-state, which will support efficient and equitable resource allocation. Overall, our data revealed a desperate need for improving the quality of care in all states.

Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. Background: Women progress to death at the same rate as men despite lower plasma HIV RNA (viral load). We investigated sexspecific differences in immune activation and inflammation as a potential explanation. Methods: Inflammatory and immune activation markers [interferon-γ, tumor necrosis factor (TNF) α, IL-6, IL-18, IFN-γ- induced protein 10, C-reactive protein (CRP), lipopolysaccharide, and sCD14] were measured at weeks 0, 24, and 48 after combination antiretroviral therapy (cART) in a random subcohort (n = 215) who achieved virologic suppression in ACTG A5175 (Prospective Evaluation of Antiretrovirals in Resource-Limited Settings). Association between sex and changes in markers postcART was examined using random effects models. Average marker differences and 95% confidence intervals were estimated using multivariable models. Results: At baseline, women had lower median log10viral load (4.93 vs 5.18 copies per milliliter, P = 0.01), CRP (2.32 vs 4.62 mg/L, P = 0.01), detectable lipopolysaccharide (39% vs 55%, P = 0.04), and sCD14 (1.9 vs 2.3 μg/mL, P = 0.06) vs men. By week 48, women had higher interferon -γ (22.4 vs 14.9 pg/mL, P = 0.05), TNF-α (11.5 vs 9.5 pg/mL, P = 0.02), and CD4 (373 vs 323 cells per cubic millimeter, P = 0.02). In multivariate analysis, women had greater increases in CD4 and TNF-α but less of a decrease in CRP and sCD14 compared with men. Conclusions: With cART-induced viral suppression, women have less reduction in key markers of inflammation and immune activation compared with men. Future studies should investigate the impact of these sex-specific differences on morbidity and mortality.

Background. Combination antiretroviral therapy (cART) reduces genital tract human immunodeficiency virus type 1 (HIV-1) load and reduces the risk of sexual transmission, but little is known about the efficacy of cART for decreasing genital tract viral load (GTVL) and differences in sex or HIV-1 subtype. Methods. HIV-1 RNA from blood plasma, seminal plasma, or cervical wicks was quantified at baseline and at weeks 48 and 96 after entry in a randomized clinical trial of 3 cART regimens. Results. One hundred fifty-eight men and 170 women from 7 countries were studied (men: 55% subtype B and 45% subtype C; women: 24% subtype B and 76% subtype C). Despite similar baseline CD4+ cell counts and blood plasma viral loads, women with subtype C had the highest GTVL (median, 5.1 log10 copies/mL) compared to women with subtype B and men with subtype C or B (4.0, 4.0, and 3.8 log10 copies/mL, respectively; P < .001). The proportion of participants with a GTVL below the lower limit of quantification (LLQ) at week 48 (90%) and week 96 (90%) was increased compared to baseline (16%; P < .001 at both times). Women were significantly less likely to have GTVL below the LLQ compared to men (84% vs 94% at week 48, P = .006; 84% vs 97% at week 96, P = .002), despite a more sensitive assay for seminal plasma than for cervical wicks. No difference in GTVL response across the 3 cART regimens was detected. Conclusions. The female genital tract may serve as a reservoir of persistent HIV-1 replication during cART and affect the use of cART to prevent sexual and perinatal transmission of HIV-1.

© 2016 The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. Background. Both wasting and obesity are associated with inflammation, but the extent to which body weight changes influence inflammation during human immunodeficiency virus infection is unknown. Methods. Among a random virologically suppressed participants of the Prospective Evaluation of Antiretrovirals in Resource-Limited Settings trial, inflammatory markers were measured at weeks 0, 24, and 48 after antiretroviral therapy (ART) initiation. Associations between both baseline and change in body mass index (BMI; calculated as the weight in kilograms divided by the height in meters squared) and changes in inflammation markers were assessed using random effects models. Results. Of 246 participants, 27% were overweight/obese (BMI, ≥ 25), and 8% were underweight (BMI < 18.5) at baseline. After 48 weeks, 37% were overweight/obese, and 3% were underweight. While level of many inflammatory markers decreased 48 weeks after ART initiation in the overall group, the decrease in C-reactive protein (CRP) level was smaller in overweight/obese participants (P =. 01), and the decreases in both CRP (P =. 01) and interleukin 18 (P =. 02) levels were smaller in underweight participants. Each 1-unit gain in BMI among overweight/obese participants was associated with a 0.02-log10increase in soluble CD14 level (P =. 05), while each 1-unit BMI gain among underweight participants was associated with a 9.32-mg/L decrease in CRP level (P =. 001). Conclusions. Being either overweight or underweight at ART initiation was associated with heightened systemic inflammation. While weight gain among overweight/obese persons predicted increased inflammation, weight gain among underweight persons predicted reduced inflammation.

Background. We assessed immune activation after antiretroviral therapy (ART) initiation to understand clinical failure in diverse settings. Methods. We performed a case-control study in ACTG Prospective Evaluation of Antiretrovirals in Resource-Limited Settings (PEARLS). Cases were defined as incident World Health Organization Stage 3 or 4 human immunodeficiency virus (HIV) disease or death, analyzed from ART weeks 24 (ART24) to 96. Controls were randomly selected. Interleukin (IL)-6, interferon (IFN)-γ-inducible protein-10, IL-18, tumor necrosis factor-α, IFN-γ, and soluble CD14 (sCD14) were measured pre-ART and at ART24 in plasma. Continued elevation was defined by thresholds set by highest pre-ART quartiles (>Q3). Incident risk ratios (IRRs) for clinical progression were estimated by Poisson regression, adjusting for age, sex, treatment, country, time-updated CD4+ T-cell count, HIV ribonucleic acid (RNA), and prevalent tuberculosis. Results. Among 99 cases and 234 controls, median baseline CD4+ T-cell count was 181 cells/µL, and HIV RNA was 5.05 log10 cp/mL. Clinical failure was independently associated with continued elevations of IL-18 (IRR, 3.03; 95% confidence interval [CI], 1.27–7.20), sCD14 (IRR, 2.17; 95% CI, 1.02–4.62), and IFN-γ (IRR, 0.08; 95% CI, 0.01–0.61). Among 276 of 333 (83%) who were virologically suppressed at ART24, IFN-γ was associated with protection from failure, but the association with sCD14 was attenuated. Conclusions. Continued IL-18 and sCD14 elevations were associated with clinical ART failure. Interferon-γ levels may reflect preserved immune function.

Objectives We adapted a rapid monitoring method to South Sudan, a new nation with one of the world's highest maternal and child mortality rates, aiming to assess coverage of maternal, neonatal and child health (MNCH) services at the time of independence, and introducing a monitoring and evaluation system (M&E) for equity-sensitive tracking of progress related to Millennium Development Goals (MDG) 4 and 5 at national, state and county levels to detect local variability. Methods We conducted a national cross-sectional household survey among women from six client populations in all, but six of South Sudan's 79 counties. We used lot quality assurance sampling (LQAS) to measure coverage with diverse MNCH indicators to obtain information for national-, state- and county-level health system management decision-making. Results National coverage of MNCH services was low for all maternal and neonatal care, child immunisation, and child care indicators. However, results varied across states and counties. Central Equatoria State (CES), where the capital is located, showed the highest coverage for most indicators (e.g. ≥4 antenatal care visits range: 4.5% in Jonglei to 40.1% in CES). Urban counties often outperformed rural ones. Conclusions This adaptation of LQAS to South Sudan demonstrates how it can be used in the future as an M&E system to track progress of MDGs at national, state and county levels to detect local disparities. Overall, our data reveal a desperate need for improving MNCH service coverage in all states.

BACKGROUND Anemia is a known risk factor for clinical failure following antiretroviral therapy (ART). Notably, anemia and inflammation are interrelated, and recent studies have associated elevated C-reactive protein (CRP), an inflammation marker, with adverse human immunodeficiency virus (HIV) treatment outcomes, yet their joint effect is not known. The objective of this study was to assess prevalence and risk factors of anemia in HIV infection and to determine whether anemia and elevated CRP jointly predict clinical failure post-ART. METHODS A case-cohort study (N = 470 [236 cases, 234 controls]) was nested within a multinational randomized trial of ART efficacy (Prospective Evaluation of Antiretrovirals in Resource Limited Settings [PEARLS]). Cases were incident World Health Organization stage 3, 4, or death by 96 weeks of ART treatment (clinical failure). Multivariable logistic regression was used to determine risk factors for pre-ART (baseline) anemia (females: hemoglobin

A case-cohort study, within a multi-country trial of antiretroviral therapy (ART) efficacy (Prospective Evaluation of Antiretrovirals in Resource Limited Settings (PEARLS)), was conducted to determine if pre-ART serum selenium deficiency is independently associated with human immunodeficiency virus (HIV) disease progression after ART initiation. Cases were HIV-1 infected adults with either clinical failure (incident World Health Organization (WHO) stage 3, 4 or death by 96 weeks) or virologic failure by 24 months. Risk factors for serum selenium deficiency (&lt, 85 μg/L) pre-ART and its association with outcomes were examined. Median serum selenium concentration was 82.04 μg/L (Interquartile range (IQR): 57.28–99.89) and serum selenium deficiency was 53%, varying widely by country from 0% to 100%. In multivariable models, risk factors for serum selenium deficiency were country, previous tuberculosis, anemia, and elevated C-reactive protein. Serum selenium deficiency was not associated with either clinical failure or virologic failure in multivariable models. However, relative to people in the third quartile (74.86–95.10 μg/L) of serum selenium, we observed increased hazards (adjusted hazards ratio (HR): 3.50, 95% confidence intervals (CI): 1.30–9.42) of clinical failure but not virologic failure for people in the highest quartile. If future studies confirm this relationship of high serum selenium with increased clinical failure, a cautious approach to selenium supplementation might be needed, especially in HIV-infected populations with sufficient or unknown levels of selenium.

STUDY BACKGROUND\ud Vitamin D has wide-ranging effects on the immune system, and studies suggest that low serum vitamin D levels are associated with worse clinical outcomes in HIV. Recent studies have identified an interaction between antiretrovirals used to treat HIV and reduced serum vitamin D levels, but these studies have been done in North American and European populations.\ud \ud METHODS\ud Using a prospective cohort study design nested in a multinational clinical trial, we examined the effect of three combination antiretroviral (cART) regimens on serum vitamin D levels in 270 cART-naïve, HIV-infected adults in nine diverse countries, (Brazil, Haiti, Peru, Thailand, India, Malawi, South Africa, Zimbabwe and the United States). We evaluated the change between baseline serum vitamin D levels and vitamin D levels 24 and 48 weeks after cART initiation.\ud \ud RESULTS\ud Serum vitamin D levels decreased significantly from baseline to 24 weeks among those randomized to efavirenz/lamivudine/zidovudine (mean change: -7.94 [95% Confidence Interval (CI) -10.42, -5.54] ng/ml) and efavirenz/emtricitabine/tenofovir-DF (mean change: -6.66 [95% CI -9.40, -3.92] ng/ml) when compared to those randomized to atazanavir/emtricitabine/didanosine-EC (mean change: -2.29 [95% CI -4.83, 0.25] ng/ml). Vitamin D levels did not change significantly between week 24 and 48. Other factors that significantly affected serum vitamin D change included country (p

BACKGROUND: Libya had one of the world's largest nosocomial HIV outbreaks in the late 1990s leading to the detention of six foreign medical workers. They were released in 2007 after the Libyan Government and the European Union agreed to humanitarian cooperation that included the development of Libya's first National HIV-Strategy and the research reported in this paper. Despite the absence of sound evidence on the status and dynamics of Libya's HIV-epidemic, some officials posited that injecting drug use (IDU) was a main mode of transmission. We therefore sought to assess HIV-prevalence and related risk factors among people who inject drugs (PWID) in Tripoli. METHODS: We conducted a cross-sectional survey among 328 PWID in Tripoli using respondent-driven sampling. We collected behavioural data and blood samples for HIV, hepatitis C virus (HCV) and hepatitis B virus (HBC) testing. RESULTS: We estimate an HIV-prevalence of 87%, HCV-prevalence of 94% and HBV-prevalence of 5%. We detected IDU-related, and sexual risk factors in the context of poor access to comprehensive services for HIV-prevention and mitigation. For example, most respondents (85%) reported having shared needles. CONCLUSION: In this first bio-behavioural survey among PWID in Libya we detected one of the highest (or even the highest) levels of HIV infection worldwide in the absence of a comprehensive harm-reduction programme. There is urgent need to implement an effective National HIV-Strategy informed by the results of this research, especially because recent military events, and related socio-political disruption and migration might lead to a further expansion of the epidemic.

Background\ud \ud In developing countries, the private sector provides a substantial proportion of primary health care to low income groups for communicable and non-communicable diseases. These providers are therefore central to improving health outcomes. We need to know how their services compare to those of the public sector to inform policy options.\ud \ud Methods and Findings\ud \ud We summarised reliable research comparing the quality of formal private versus public ambulatory health care in low and middle income countries. We selected studies against inclusion criteria following a comprehensive search, yielding 80 studies. We compared quality under standard categories, converted values to a linear 100% scale, calculated differences between providers within studies, and summarised median values of the differences across studies. As the results for for-profit and not-for-profit providers were similar, we combined them. Overall, median values indicated that many services, irrespective of whether public or private, scored low on infrastructure, clinical competence, and practice. Overall, the private sector performed better in relation to drug supply, responsiveness, and effort. No difference between provider groups was detected for patient satisfaction or competence. Synthesis of qualitative components indicates the private sector is more client centred.\ud \ud Conclusions\ud \ud Although data are limited, quality in both provider groups seems poor, with the private sector performing better in drug availability and aspects of delivery of care, including responsiveness and effort, and possibly being more client orientated. Strategies seeking to influence quality in both groups are needed to improve care delivery and outcomes for the poor, including managing the increasing burden of non-communicable diseases.

This study was carried out to test the hypothesis that HIV-related stigma would function as a barrier to uptake of HIV testing and that knowledge and self-efficacy would serve as facilitators. We also hypothesized that exposure to a behavior-change campaign would be associated with lower levels of stigma and higher levels of knowledge and self-efficacy. We conducted two separate cross-sectional surveys as part of the Malawi BRIDGE Project, including one at baseline in eight districts (n = 891), and another at mid-term in four districts in Malawi (n = 881). HIV-related knowledge, self-efficacy, and lack of stigma were positively associated with HIV testing. A positive association was also found between program exposure, on one hand, and knowledge, self-efficacy, and lack of stigma, on the other. These findings suggest that important psychosocial variables are linked with people’s likelihood of HIV testing, and that these variables may be influenced by behavior-change programs.\ud \ud Key words

Background There has been no sound evidence on the status and dynamics of Libya’s HIV-epidemic, which is urgently needed to inform near-term policy making while the window of opportunity to act is still open. With funding from the European Union we therefore aimed to assess HIV prevalence and related risk factors among populations most vulnerable to HIV. Methods Using respondent-driven sampling, we conducted a cross-sectional survey among 328 people who inject drugs (PWID), 227 men having sex with men (MSM), and 69 female sex workers (FSW) in Tripoli. We collected behavioural data and blood samples for HIV, hepatitis C and B testing. Results We estimated HIV-prevalence of 87% among PWID, 3% among MSM, and 16% among FSW. We detected high levels of IDU-related, and sexual risk factors, in the context of strong stigma and lack of prevention programmes. Of particular concern, 85% of PWID reported having shared needles, only 21% of MSM used a condom at last sex, and 28% of FSW experienced STI symptoms during the last year. Over a third of MSM had risky sex with men and women and nearly a third of FSW had 50 or more sexual partners in the past six months. Conclusion In this first bio-behavioural survey in Libya we detected among PWID one of the highest (or even the highest) levels of HIV-infection worldwide in the absence of a comprehensive harm-reduction programme. There is urgent need to implement an effective National HIV-Strategy informed by the results of this research, and designed to account for the overlap of high-risk sexual and drug-using networks. The risk of further transmission within different risk groups and to the general population is particularly high given the recent military events that led to increased violence, migration, and the disruption of essential HIV-related services and structures.

Background\ud \ud Publications on Libya’s HIV epidemic mostly examined the victims of the tragic nosocomial HIV outbreak in the 1990s and the related dispute about the detention of foreign medical workers. The dispute resolution in 2003 included an agreement with the European Union on humanitarian cooperation and the development of Libya’s first National HIV Strategy. As part of this we conducted Libya’s first bio-behavioural survey among men having sex with men (MSM) and female sex workers (FSW).\ud \ud Methods\ud \ud Using respondent-driven sampling, we conducted a cross-sectional study to estimate the prevalence of HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and related risk factors among 227 MSM and 69 FSW in Tripoli (FSW recruitment ended prematurely due to the political events in 2011).\ud \ud Results\ud \ud For MSM we estimated an HIV prevalence of 3.1%, HBV prevalence of 2.9%, and HCV prevalence of 7.3%, and for FSW an HIV prevalence of 15.7%, HBV prevalence of 0%, and HCV prevalence of 5.2%. We detected high levels of risk behaviours, poor HIV-related knowledge, high stigma and lack of prevention programmes. These results must be interpreted in the context of the political situation which prohibited reaching an ideal sample size for FSW.\ud \ud Conclusion\ud \ud There is urgent need to implement an effective National HIV Strategy informed by the results of this research. The risk of transmission within different risk groups and to the general population may be high given the recent military events that led to increased violence, migration, and the disruption of essential HIV-related services.

BackgroundAntiretroviral regimens with simplified dosing and better safety are needed to maximize the efficiency of antiretroviral delivery in resource-limited settings. We investigated the efficacy and safety of antiretroviral regimens with once-daily compared to twice-daily dosing in diverse areas of the world.Methods and findings1,571 HIV-1-infected persons (47% women) from nine countries in four continents were assigned with equal probability to open-label antiretroviral therapy with efavirenz plus lamivudine-zidovudine (EFV+3TC-ZDV), atazanavir plus didanosine-EC plus emtricitabine (ATV+DDI+FTC), or efavirenz plus emtricitabine-tenofovir-disoproxil fumarate (DF) (EFV+FTC-TDF). ATV+DDI+FTC and EFV+FTC-TDF were hypothesized to be non-inferior to EFV+3TC-ZDV if the upper one-sided 95% confidence bound for the hazard ratio (HR) was ≤1.35 when 30% of participants had treatment failure. An independent monitoring board recommended stopping study follow-up prior to accumulation of 472 treatment failures. Comparing EFV+FTC-TDF to EFV+3TC-ZDV, during a median 184 wk of follow-up there were 95 treatment failures (18%) among 526 participants versus 98 failures among 519 participants (19%; HR 0.95, 95% CI 0.72-1.27; p = 0.74). Safety endpoints occurred in 243 (46%) participants assigned to EFV+FTC-TDF versus 313 (60%) assigned to EFV+3TC-ZDV (HR 0.64, CI 0.54-0.76; pConclusionEFV+FTC-TDF had similar high efficacy compared to EFV+3TC-ZDV in this trial population, recruited in diverse multinational settings. Superior safety, especially in HIV-1-infected women, and once-daily dosing of EFV+FTC-TDF are advantageous for use of this regimen for initial treatment of HIV-1 infection in resource-limited countries. ATV+DDI+FTC had inferior efficacy and is not recommended as an initial antiretroviral regimen.Trial registrationwww.ClinicalTrials.gov NCT00084136. Please see later in the article for the Editors' Summary.