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Introduction: Implementation science (IS) offers methods to systematically achieve the Ending the HIV Epidemic goals in the United States, as well as the global UNAIDS targets. Federal funders such as the National Institutes of Mental Health (NIMH) have invested in implementation research to achieve these goals, including supporting the AIDS Research Centres (ARCs), which focus on high‐impact science in HIV and mental health (MH). To facilitate capacity building for the HIV/MH research workforce in IS, "grey areas," or areas of IS that are confusing, particularly for new investigators, should be addressed in the context of HIV/MH research. Discussion: A group of IS experts affiliated with NIMH‐funded ARCs convened to identify common and challenging grey areas. The group generated a preliminary list of 19 grey areas in HIV/MH‐related IS. From the list, the authors developed a survey which was distributed to all ARCs to prioritize grey areas to address in this paper. ARC members across the United States (N = 60) identified priority grey areas requiring clarification. This commentary discusses topics with 40% or more endorsement. The top grey areas that ARC members identified were: (1) Differentiating implementation strategies from interventions; (2) Determining when an intervention has sufficient evidence for adaptation; (3) Integrating recipient perspectives into HIV/MH implementation research; (4) Evaluating whether an implementation strategy is evidence‐based; (5) Identifying rigorous approaches for evaluating the impact of implementation strategies in the absence of a control group or randomization; and (6) Addressing innovation in HIV/MH IS grants. The commentary addresses each grey area by drawing from the existing literature (when available), providing expert guidance on addressing each in the context of HIV/MH research, and providing domestic and global HIV and HIV/MH case examples that address these grey areas. Conclusions: HIV/MH IS is key to achieving domestic and international goals for ending HIV transmission and mitigating its impact. Guidance offered in this paper can help to overcome challenges to rigorous and high‐impact HIV/MH implementation research. [ABSTRACT FROM AUTHOR]

Background Home delivery and late and infrequent attendance at antenatal care (ANC) are responsible for substantial avoidable maternal and pediatric morbidity and mortality in sub-Saharan Africa. This cluster-randomized trial aimed to determine the impact of a community health worker (CHW) intervention on the proportion of women who (i) visit ANC fewer than 4 times during their pregnancy and (ii) deliver at home. Methods and findings As part of a 2-by-2 factorial design, we conducted a cluster-randomized trial of a home-based CHW intervention in 2 of 3 districts of Dar es Salaam from 18 June 2012 to 15 January 2014. Thirty-six wards (geographical areas) in the 2 districts were randomized to the CHW intervention, and 24 wards to the standard of care. In the standard-of-care arm, CHWs visited women enrolled in prevention of mother-to-child HIV transmission (PMTCT) care and provided information and counseling. The intervention arm included additional CHW supervision and the following additional CHW tasks, which were targeted at all pregnant women regardless of HIV status: (i) conducting home visits to identify pregnant women and refer them to ANC, (ii) counseling pregnant women on maternal health, and (iii) providing home visits to women who missed an ANC or PMTCT appointment. The primary endpoints of this trial were the proportion of pregnant women (i) not making at least 4 ANC visits and (ii) delivering at home. The outcomes were assessed through a population-based household survey at the end of the trial period. We did not collect data on adverse events. A random sample of 2,329 pregnant women and new mothers living in the study area were interviewed during home visits. At the time of the survey, the mean age of participants was 27.3 years, and 34.5% (804/2,329) were pregnant. The proportion of women who reported having attended fewer than 4 ANC visits did not differ significantly between the intervention and standard-of-care arms (59.1% versus 60.7%, respectively; risk ratio [RR]: 0.97; 95% CI: 0.82-1.15; p = 0.754). Similarly, the proportion reporting that they had attended ANC in the first trimester did not differ significantly between study arms. However, women in intervention wards were significantly less likely to report having delivered at home (3.9% versus 7.3%; RR: 0.54; 95% CI: 0.30-0.95; p = 0.034). Mixed-methods analyses of additional data collected as part of this trial suggest that an important reason for the lack of effect on ANC outcomes was the perceived high economic burden and inconvenience of attending ANC. The main limitations of this trial were that (i) the outcomes were ascertained through self-report, (ii) the study was stopped 4 months early due to a change in the standard of care in the other trial that was part of the 2-by-2 factorial design, and (iii) the sample size of the household survey was not prespecified. Conclusions A home-based CHW intervention in urban Tanzania significantly reduced the proportion of women who reported having delivered at home, in an area that already has very high uptake of facility-based delivery. The intervention did not affect self-reported ANC attendance. Policy makers should consider piloting, evaluating, and scaling interventions to lessen the economic burden and inconvenience of ANC. Trial registration ClinicalTrials.gov NCT01932138, Author(s): Pascal Geldsetzer 1, Eric Mboggo 2,*, Elysia Larson 3, Irene Andrew Lema 2, Lucy Magesa 2, Lameck Machumi 2, Nzovu Ulenga 2, David Sando 1, Mary Mwanyika-Sando 4, Donna [...]

Background: Anaemia is common among HIV-infected children and iron supplementation is prescribed routinely for the prevention and management of anaemia among children. Limited evidence suggests iron supplementation may have adverse effects among HIV-infected populations. We aimed to estimate the effect of iron supplement use on mortality, disease progression and haematological outcomes among HIV-infected children in Dar es Salaam, Tanzania.Methods: A prospective cohort study was conducted among HIV-infected children (aged 0-14 years) receiving antiretroviral treatment or supportive care between October 2004 and September 2014. Clinical data were recorded on morbidity and vital status, haematological status and prescriptions at each clinical visit. Cox proportional hazards models adjusted for time-varying covariates were used to estimate the association of time-varying iron supplementation on the hazard rate of mortality, HIV disease stage progression, tuberculosis incidence and anaemia and microcytosis persistence.Results: In all, 4229 children were observed during 149 260 clinic visits for a mean follow-up of 2.9 years. After adjustment for time-varying clinical covariates, time-varying iron supplementation was associated with a 2.87 times higher hazard rate of mortality (95% CI: 1.70, 4.87) and a 1.48 times higher hazard rate of HIV disease stage progression (95% CI: 1.10, 1.98). Iron supplementation was also associated with a lower rate of anaemia persistence (HR = 0.47; 95% CI: 0.37, 0.61). No differences in the association between iron supplementation and clinical outcomes were observed by antiretroviral therapy or anaemia status.Conclusions: Iron supplementation may increase the risk of HIV disease stage progression and mortality among HIV-infected children, while reducing the risk of anaemia. [ABSTRACT FROM AUTHOR]

Background: Hematological status may predict HIV disease progression and mortality among adults initiating highly active antiretroviral therapy (HAART).Objectives: We aimed to examine the relation of anemia and iron status at HAART initiation with survival and morbidity outcomes.Methods: We conducted a case-cohort study of 570 HIV-infected adults initiating HAART who were enrolled in a trial of multivitamins in Tanzania. Hemoglobin, serum ferritin, and hepcidin concentrations were assessed at HAART initiation and participants were followed up monthly. We adjusted serum ferritin for inflammation using a regression correction method to characterize hematological status. Cox proportional hazards models were used to estimate HRs for mortality and incident clinical outcomes.Results: We found an 83% prevalence of anemia, 15% prevalence of iron deficiency anemia, and 66% prevalence of anemia of chronic diseases (ACD). The prevalence of elevated iron was 33% and 19% had iron deficiency (ID). After multivariate adjustment, severe anemia (HR: 2.57; 95% CI: 1.49, 4.45) and ACD (HR: 4.71; 95% CI: 2.91, 7.62) were associated with increased risk of mortality as compared with nonanemic participants. In addition, both ID (HR: 2.65; 95% CI: 1.08, 7.78) and elevated iron (HR: 2.83; 95% CI: 2.10, 3.82) were associated with increased risk of mortality as compared with normal iron concentrations. Severe anemia and elevated iron concentrations were associated with incident wasting and >10% weight loss (P values <0.05).Conclusions: Anemia and both ID and elevated iron were associated with increased mortality among HIV-infected adults initiating HAART. Safety and efficacy studies including anemia etiology, timing of HAART initiation, and dose of iron supplementation among HIV patients appear warranted.This trial was registered at clinicaltrials.gov as NCT00383669. [ABSTRACT FROM AUTHOR]

Background: Four of the largest HIV prevention trials have been conducted in sub-Saharan Africa, enrolling hundreds of thousands of participants in catchment areas of millions of people. The trials have focused on community-level interventions to increase diagnosis and initiation of antiretroviral therapy (ART) to improve health and reduce HIV transmission. Universal test-and-treat strategies are deployed to achieve viral suppression thereby reducing risk to uninfected persons, known as treatment as prevention (TasP). Purpose: We review the work that found HIV plasma load to correlate with transmission risk, demonstrated that ART could reduce genital tract viral expression, and showed early treatment to be beneficial for persons living with HIV, and that HIV-uninfected sexual partners were protected from infection. We review the seemingly inconsistent findings of the major TasP trials: the TasP [National Agency for AIDS Research (ANRS) 12249] study in South Africa, the SEARCH trial in Kenya and Uganda, the Botswana Combination Prevention Project Ya Tsie study, and the HIV Prevention Trials Network 071 (PopART) trial in Zambia and South Africa. Findings: All the trials reinforce the critical need to identify approaches to optimize programs and incentivize uptake and engagement in HIV testing and ART-based care in ways that consistently reduce HIV transmission. That other chronic conditions can be screened for and treated in the same infrastructures suggests added value of HIV investments. Conclusions: Implementation challenges are a principal frontier in the global struggle to reduce HIV transmission and mortality using TasP, complementing efforts to find a cure for HIV and an effective, deployable vaccine. [ABSTRACT FROM AUTHOR]

The first goal of the United Nations' 90-90-90 HIV/AIDS elimination strategy is to ensure that, by 2020, 90% of HIV-positive people know their HIV status. Estimating the prevalence of HIV among people eligible for screening allows assessment of the number of additional cases that might be diagnosed through continued screening efforts in this group. Here, we present methods for estimating prevalence when HIV status is verified by a gold standard only among those who test positive on an initial, imperfect screening test with known sensitivity and specificity. We develop maximum likelihood estimators and asymptotic confidence intervals for use in 2 scenarios: when the total number of test negatives is known (Scenario 1) and unknown (Scenario 2). We derive Bayesian prevalence estimators to account for non-negligible uncertainty in previous estimates of the sensitivity and specificity. The Scenario 1 estimator consistently outperformed the Scenario 2 estimator in simulations, demonstrating the use of recording the number of test negatives in public health screening programs. For less accurate tests (sensitivity and specificity < 90%), the performance of the 2 estimators was comparable, suggesting that, under these circumstances, prevalence can still be estimated with adequate precision when the number of test negatives is unknown. However, use of the Bayesian approach to account for uncertainty in the sensitivity and specificity is especially recommended for the Scenario 2 estimator, which was particularly sensitive to misspecification of these values. R code for implementing these methods is available at hsph.harvard.edu/donna-spiegelman/software. [ABSTRACT FROM AUTHOR]

Objectives: In a large cohort of HIV-infected Tanzanians, we assessed: (i) rates of first-line treatment failure and switches to second-line ART; (ii) the effect of switching to second-line ART on death and loss to follow-up; and (iii) treatment outcomes on second-line ART by regimen.Methods: HIV-1-infected adults (≥15 years) initiated on first-line ART between November 2004 and September 2012, and who remained on initial therapy for at least 24 weeks before switching, were studied. Survival analyses were conducted to examine the effect of second-line ART on mortality and loss to follow-up in: (i) the whole cohort; (ii) all patients eligible for second-line ART by immunological failure (IF) and/or virological failure (VF) criteria; and (iii) patients eligible by VF criteria.Results: In total, 47 296 HIV-infected patients [mean age 37.5 (SD 9.5) years, CD4 175 (SD 158) cells/mm 3 , 71% female] were included in the analyses. Of these, 1760 (3.7%) patients switched to second-line ART (incidence rate = 1.7/100 person-years). Higher rates of mortality were observed in switchers versus non-switchers in all patients and patients with ART failure using IF/VF criteria. Switching only protected against mortality in patients with ART failure defined virologically and with the highest level of adherence [switching versus non-switching; >95% adherence; adjusted HR = 0.50 (95% CI = 0.26-0.93); P  =   0.03].Conclusions: Switching patients to second-line ART may only be beneficial in a select group of patients who are virologically monitored and demonstrate good adherence. Our data emphasize the need for routine viral load monitoring and aggressive adherence interventions in HIV programmes in sub-Saharan Africa. [ABSTRACT FROM AUTHOR]

Background: Overweight and obesity are increasingly prevalent among HIV-infected populations. We describe their prevalence and associated risk factors among HIV-infected adults in Dar es Salaam, Tanzania.Methods: A cross-sectional study was conducted to determine the proportion of patients who were overweight or obese at enrollment to care and treatment centres from 2004 to 2011. Multivariate relative risk regression models were fit to identify risk factors.Results: A total of 53 825 patients were included in the analysis. In all, 16% of women and 8% of men were overweight, while 7% and 2% were obese, respectively. In multivariate analyses, older age, higher CD4 count, higher hemoglobin levels, female sex, and being married were associated with obesity and overweight. World Health Organization HIV disease stage, tuberculosis history, and previous antiretroviral therapy were inversely associated with obesity and overweight.Conclusion: Overweight and obesity were highly prevalent among HIV-infected patients. Screening for overweight and obesity and focused interventions should be integrated into HIV care. [ABSTRACT FROM AUTHOR]

Although the beneficial effects of antiretroviral (ARV) therapy for preventing mother-to-child transmission are indisputable, studies in developed and developing countries have reported conflicting findings on the association between ARV exposure and adverse birth outcomes. We conducted a prospective observational study at 10 human immunodeficiency virus (HIV) care and treatment centers in Dar es Salaam, Tanzania. Multivariate log-binomial regression was used to investigate the associations between ARV use and adverse birth outcomes among HIV-negative HIV-exposed infants. Our findings demonstrate an increased risk of adverse birth outcomes associated with the use of highly active antiretroviral therapy during pregnancy. Further studies are needed to investigate the underlying mechanisms and identify the safest ARV regimens for use during pregnancy. [ABSTRACT FROM AUTHOR]

To determine the prevalence and predictors of cervical squamous intraepithelial lesions (SIL) among HIV-infected women in Tanzania, a cross-sectional study was conducted among HIV-infected women at HIV care and treatment clinics. A Papanicolaou (Pap) smear was used as a screening tool for detection of cervical SIL. From December 2006 to August 2009, 1365 HIV-infected women received cervical screening. The median age was 35 (interquartile range [IQR]: 30-42) years, and the median CD4 + cell count was 164 (IQR: 80-257) cells/mm(3). The prevalence of cervical SIL was 8.7% (119/1365). In multivariate analysis, older age (≥50 versus 30-<40 years: prevalence ratio [PR], 2.36; 95% confidence interval [CI], 1.45-3.84, p for trend = 0.001), lower CD4 + cell counts (<100 versus ≥200 cells/mm(3): PR, 1.55; 95% CI, 1.01-2.36, p for trend = 0.03) and cervical inflammation (PR, 1.73; 95% CI, 1.16-2.60, p = 0.008) were associated with an increased risk of cervical SIL. Women with advanced WHO HIV disease stage (IV versus I/II: PR, 3.45; 95% CI, 1.35-8.85, p for trend = 0.01) had an increased risk for high-grade SIL. In resource-limited settings where it is not feasible to provide cervical cancer prevention services to all HIV-infected women, greater efforts should focus on scaling-up services among those who are older than 50 years, with lower CD4 cell counts and advanced HIV disease stage. [ABSTRACT FROM AUTHOR]

Human immunodeficiency virus (HIV)-infected males have poor treatment outcomes after initiation of antiretroviral therapy (ART) compared to HIV-infected women. Dietary factors might mediate the association between sex and disease progression. However, the gender difference in diet among HIV-infected individuals in sub-Saharan Africa is largely unknown. The objective of this study was to examine differences in dietary intake among HIV-infected men and women. We conducted a cross-sectional analysis of dietary questionnaire data from 2038 adults initiating ART in Dar es Salaam, Tanzania to assess whether nutrient adequacy differed by sex. We dichotomized participants' nutrient intakes by whether recommended dietary allowances (RDAs) were met and estimated the relative risk (RR) of meeting RDAs in males using binomial regression models. We also estimated the mean difference in intake of foods and food groups by gender. We found poorer dietary practices among men compared to women. Males were less likely to meet the RDAs for micronutrients critical for slowing disease progression among HIV patients: niacin (RR = 0.39, 95% confidence interval [CI]: 0.27 to 0.55), riboflavin (RR = 0.81, 95% CI: 0.73 to 0.91), vitamin C (RR = 0.94, 95% CI: 0.89 to 1.00), and zinc (RR = 0.06, 95% CI: 0.01 to 0.24). Intake of thiamine, pantothenate, vitamins B6, B12, and E did not vary by gender. Males were less likely to eat cereals (mean difference [servings per day] = −0.21, 95% CI: −0.44 to 0.001) and vegetables (mean difference = −0.47, 95% CI: −0.86 to −0.07) in their diet, but more likely to have meat (mean difference = 0.14, 95% CI: 0.06 to 0.21). We conclude that male HIV patients have poorer dietary practices than females, and this may contribute to faster progression of the disease in males. [ABSTRACT FROM AUTHOR]

Background: Few studies have described time-based trends of clinical and demographic characteristics of children enrolling in HIV and AIDS care and treatment services. We present findings of a study that explored time-based trends of baseline characteristics among children enrolling into 26 public HIV care facilities in Dar es Salaam, Tanzania. Methods: Children enrolled between October 2004 and September 2011 was included in these analyses. The year of enrollment was used as the primary predictor of interest, and log linear and linear regressions model were used to analyze dichotomous and continuous variables respectively. P-values under 0.05 were considered significant. Results: Among the 6,579 children enrolled, the proportion with advanced disease at enrollment increased from 35% to 58%, mean age increasing from 5.0 to 6.2 years (p < 0.0001), proportion of children less than 2 years decreased from 35% to 29%. While the median hemoglobin concentration rose from 9.1 g/dl to 10.3 g/dl (P <0.0001), proportion with a history of past TB dropped from 25% to 12.8% (P < 0.0001). Over time, health centers and dispensaries enrolled more children as compared to hospitals (P < 0.0001). Temeke district, which has the lowest socioeconomic status among the three districts in Dar es Salaam, had a significant increase in enrollment from 22% to 25% (P = 0.02). Conclusion: We found that as time progressed, children were enrolled in care and treatment services at an older age sicker status as evidenced by increase in mean age and more advanced disease stage at first contact with providers. We recommend more efforts be focused on scaling up early HIV infant diagnosis and enrollment to HIV care and treatment. [ABSTRACT FROM AUTHOR]

Background: We assembled a prospective cohort of 3144 children less than 15 years of age initiating antiretroviral therapy (ART) in Dar es Salaam, Tanzania.Methods: The relationships of nutritional status and other baseline characteristics in relation to mortality were examined using Cox proportional hazards model.Results: Compared with children with weight for age (WAZ) > -1, those with WAZ ≤ -2 to < -3 had a nearly double risk of death (relative risk [RR], 1.85; 95% confidence interval [CI], 1.10-3.11), and among those with WAZ ≤ -3, the risk more than tripled (RR, 3.36; 95% CI, 2.12-5.32). Other baseline risk factors for overall mortality included severe anemia (P < .001), severe immune suppression (P = .02), history of tuberculosis (P = .01), opportunistic infections (P < .001), living in the poorest district (P < .001), and advanced World Health Organization stage (P = .003).Conclusions: To sustain the obtained benefit of ART in this setting, interventions to improve nutritional status may be used as an adjunct to ART. [ABSTRACT FROM AUTHOR]

Background and Methods: This cross-sectional study aimed at determining the prevalence and risk factors for severe anemia, severe microcytic anemia, and severe normocytic anemia among HIV-infected individuals aged >15 years. Univariate and multivariate analyses were performed to identify the risk factors for anemia.Results: Data from 40 408 patients were analyzed, showing an overall prevalence of 22% for severe anemia. The risk of developing severe anemia increased by 49% among patients with a body mass index of <18.5 kg/m(2), by approximately 2-fold among patients with the World Health Organization (WHO) stage III, and by 3-fold among patients with WHO stage IV illness. Severe normocytic anemia was uniquely increased among patients aged ≥50 years, among those with chronic diarrhea and Kaposi's sarcoma, and those taking cotrimoxazole.Conclusion: There was a high prevalence of severe anemia among adults infected with HIV. Focused identification of anemia should be based on the hemoglobin and mean corpuscular volume measurements. [ABSTRACT FROM AUTHOR]

Background: Mother-to-child transmission of HIV remains an important public health problem in sub-Saharan Africa. As HIV testing and linkage to PMTCT occurs in antenatal care (ANC), major challenges for any PMTCT option in developing countries, including Tanzania, are delays in the first ANC visit and a low overall number of visits. Community health workers (CHWs) have been effective in various settings in increasing the uptake of clinical services and improving treatment retention and adherence. At the beginning of this trial in January 2013, the World Health Organization recommended either of two medication regimens, Option A or B, for prevention of mother-to-child transmission of HIV (PMTCT). It is still largely unclear which option is more effective when implemented in a public healthcare system. This study aims to determine the effectiveness, cost-effectiveness, acceptability, and feasibility of: (1) a community health worker (CWH) intervention and (2) PMTCT Option B in improving ANC and PMTCT outcomes. Methods/Design: This study is a cluster-randomized controlled health systems implementation trial with a two-by-two factorial design. All 60 administrative wards in the Kinondoni and Ilala districts in Dar es Salaam were first randomly allocated to either receiving the CHW intervention or not, and then to receiving either Option B or A. Under the standard of care, facility-based health workers follow up on patients who have missed scheduled appointments for PMTCT, first through a telephone call and then with a home visit. In the wards receiving the CHW intervention, the CHWs: (1) identify pregnant women through home visits and refer them to antenatal care; (2) provide education to pregnant women on antenatal care, PMTCT, birth, and postnatal care; (3) routinely follow up on all pregnant women to ascertain whether they have attended ANC; and (4) follow up on women who have missed ANC or PMTCT appointments. [ABSTRACT FROM AUTHOR]

Background: Cervical cancer is the third most common cancer among women worldwide, and in Nigeria it is the second most common female cancer. Cervical cancer is an AIDS-defining cancer; however, HIV only marginally increases the risk of cervical pre-cancer and cancer. In this study, we examine the risk factors for cervical pre-cancer and cancer among HIV-positive women screened for cervical cancer at two medical institutions in Abuja, Nigeria. Methods: A total of 2,501 HIV-positive women participating in the cervical cancer screen-and-treat program in Abuja, Nigeria consented to this study and provided socio-demographic and clinical information. Log-binomial models were used to calculate relative risk (RR) and 95% confidence intervals (95%CI) for the risk factors of cervical pre-cancer and cancer. Results: There was a 6% prevalence of cervical pre-cancer and cancer in the study population of HIV-positive women. The risk of screening positivity or invasive cancer diagnosis reduced with increasing age, with women aged 40 years and older having the lowest risk (RR=0.4; 95%CI=0.2-0.7). Women with a CD4 count of 650 per mm3 or more also had lower risk of screening positivity or invasive cancer diagnosis (RR=0.3, 95%CI=0.2-0.6). Other factors such as having had 5 or more abortions (RR=1.8, 95%CI=1.0-3.6) and the presence of other vaginal wall abnormalities (RR=1.9, 95%CI=1.3-2.8) were associated with screening positivity or invasive cancer diagnosis. Conclusion: The prevalence of screening positive lesions or cervical cancer was lower than most previous reports from Africa. HIV-positive Nigerian women were at a marginally increased risk of cervical pre-cancer and cancer. These findings highlight the need for more epidemiological studies of cervical cancer and pre-cancerous lesions among HIV-positive women in Africa and an improved understanding of incidence and risk factors. [ABSTRACT FROM AUTHOR]

In human immunodeficiency virus–infected Tanzanian adults, lipid abnormalities were improved temporarily then worsened gradually over a 3-year follow-up following antiretroviral therapy initiation, with more unfavorable changes in patients on stavudine- and efavirenz-based regimens compared to zidovudine- and nevirapine-based regimens, respectively.Background. With the rapid rollout of antiretroviral therapy (ART) in sub-Saharan Africa (SSA), there has been an increasing concern about cardiovascular risks related to ART. However, data from human immunodeficiency virus (HIV)–infected populations from this region are very limited.Methods. Among 6385 HIV-infected adults in Dar es Salaam, Tanzania, we investigated the nonfasting lipid changes over 3 years following ART initiation and their associations with different first-line ART agents that are commonly used in SSA.Results. In the first 6 months of ART, the prevalence of dyslipidemia decreased from 69% to 54%, with triglyceride (TG) decreasing from 127 mg/dL to 113 mg/dL and high-density lipoprotein (HDL) cholesterol increasing from 39 mg/dL to 52 mg/dL. After 6 months, TG returned to its baseline level and increased to 139 mg/dL at 3 years; total cholesterol and low-density lipoprotein cholesterol continued to increase whereas HDL cholesterol leveled off. The prevalence of dyslipidemia increased to 73% after a 3-year follow-up. In multivariate analyses, patients on zidovudine-containing regimens had a greater reduction in TG levels at 6 months (−16.0 vs −6.3 mg/dL), and a lower increase at 3 years compared to patients on stavudine-containing regimens (2.1 vs 11.7 mg/dL, P < .001); patients on nevirapine-based regimens had a higher increase in HDL cholesterol levels at 3 years compared to those on efavirenz-based regimens (13.6 vs 9.5 mg/dL, P = .01).Conclusions. Our findings support the latest World Health Organization guidelines on the substitution of stavudine in first-line ART in resource-limited settings, and provide further evidence for selection of lipid-friendly ART for patients in SSA. [ABSTRACT FROM AUTHOR]

Prenatal iron supplementation may improve pregnancy outcomes and decrease the risk of child mortality. However, little is known about the importance of post-natal maternal iron status for child health and survival, particularly in the context of HIV infection. We examined the association of maternal anaemia and hypochromic microcytosis, an erythrocyte morphology consistent with iron deficiency, with child health and survival in the first two to five years of life. Repeated measures of maternal anaemia and hypochromic microcytosis from 840 HIV-positive women enrolled in a clinical trial of vitamin supplementation were prospectively related to child mortality, HIV infection and CD4 T-cell count. Median duration of follow-up for the endpoints of child mortality, HIV infection and CD4 cell count was 58, 17 and 23 months, respectively. Maternal anaemia and hypochromic microcytosis were associated with greater risk of child mortality [hazard ratio (HR) for severe anaemia = 2.58, 95% confidence interval (CI): 1.66-4.01, P trend < 0.0001; HR for severe hypochromic microcytosis = 2.36, 95% CI: 1.27-4.38, P trend = 0.001]. Maternal anaemia was not significantly associated with greater risk of child HIV infection (HR for severe anaemia = 1.46, 95% CI: 0.91, 2.33, P trend = 0.08) but predicted lower CD4 T-cell counts among HIV-uninfected children (difference in CD4 T-cell count/ µL for severe anaemia: −93, 95% CI: −204-17, P trend = 0.02). The potential child health risks associated with maternal anaemia and iron deficiency may not be limited to the prenatal period. Efforts to reduce maternal anaemia and iron deficiency during pregnancy may need to be expanded to include the post-partum period. [ABSTRACT FROM AUTHOR]

Background: The clinical implications of lower body weight in drug using populations are uncertain given that lower mean weights may still fall within the healthy range. Objectives: To determine the effect of type, mode and frequency of drug use on underlying body composition after accounting for differences in body shape and size. Methods: We conducted a cross-sectional analysis of 511 participants from the Tufts Nutrition Collaborative (TNC) Study. Data included measures of body composition, a 24-hour dietary recall, and a detailed health history and lifestyle questionnaire. Multivariate regression analysis was used to determine the independent effect of drug use on percent body fat (BF) after adjusting for BMI and waist circumference. Results: Heavy injection drug users (IDUs) had a 2.6% lower percent BF than non-users after adjusting for BMI, waist circumference, and other confounders. (p = 0.0006). Differences in percent BF were predominantly due to higher lean mass, rather than lower fat mass. Cocaine and heroin had similar effects on body composition. Conclusions: In the U.S., where the general population is prone to over-nutrition, the average percent BF for heavy injectors does not fall into a range low enough to suggest harmful effects. However, in populations with substantial levels of under-nutrition, small differences in percent BF among drug users will have a greater impact on health status. Scientific Significance: Differences in BMI, weight and body composition are not always straightforward. Accounting for underlying nutritional status and relative differences in fat and FFM is critical when interpreting results. diagnosed patients and prevent them from returning to prison. [ABSTRACT FROM AUTHOR]

The article presents a study which examines the total body bone mineral density (total BMD) of HIV-infected men and women. It states that total BMD was measured using the whole-body dual-energy absorptiometry (DXA) while the medical and behavioral histories of the patients were collected. Findings show that low body weight and catabolic steroid use may accelerate bone loss while tenofovir and didanosine may cause a harmful effect on BMD.

Micronutrient status has been associated with shedding of human immunodeficiency virus type 1 (HIV-1) in the lower-genital tract in observational studies. We examined the effect of vitamin supplements on genital HIV-1 shedding and interleukin-1β (IL-1β), a cytokine marker of vaginal inflammation and promotion of HIV-1 infection. Consenting HIV-1-infected pregnant women were randomized to receive daily supplementation with vitamin A and/or multivitamins B-complex, C, and E with use of a factorial design. Cervicovaginal lavage (CVL) specimens were obtained shortly before delivery. Significantly more women who received vitamin A had detectable levels of HIV-1 in CVL (74.8%), compared with those who did not receive vitamin A (65.1%) (P = .04, by multivariate analysis). Multivitamin B-complex, C, and E had no effect on the risk of viral shedding. Our results raise concern about the use of vitamin A supplements by HIV-1-infected women. Use of prenatal multivitamin supplements (including vitamins B-complex, C, and E) should be continued despite the lack of effect on HIV-1 transmission because of previously reported positive effects on maternal health and pregnancy outcomes. [ABSTRACT FROM AUTHOR]

Background: Lipodystrophy has been described with increasing frequency in patients infected with HIV. This study focused on the identification of dietary components that may predispose HIVpositive patients to the development of fat deposition. Objective: We evaluated differences in past dietary intake between men with HIV who developed fat deposition and those who did not. Design: This nested case-control study consisted of 47 cases and 47 controls from the Nutrition for Healthy Living cohort. Food records from 6 to 24 mo before development of fat deposition in cases were analyzed and compared with food records from controls by using t tests for normally distributed nutrients and Wilcoxon rank-sum tests for nutrients with skewed distributions. Results: HIV-positive patients without fat deposition had greater overall energy intakes (kcal/kg; P = 0.03) and greater intakes of total protein (P = 0.01), total dietary fiber (P = 0.01), soluble dietary fiber (P = 0.01), insoluble dietary fiber (P = 0.03), and pectin (P = 0.02) than did HIV-positive patients with fat deposition. Those without fat deposition also tended to currently perform more resistance training (P = 0.05) and to not be current smokers (P = 0.05). Conclusion: Our results indicate that an overall high-quality diet, rich in fiber and adequate in energy and protein, may be beneficial in preventing the development of fat deposition in persons infected with HIV. The results of this study further emphasize that a healthy lifestyle, including exercise and avoidance of unhealthy behaviors such as smoking, may also be similarly beneficial. [ABSTRACT FROM AUTHOR]

Background: Dietary adequacy, as distinct from weight loss, has not been examined thoroughly in a diverse cohort of HIV-infected individuals. Objective: An analysis was undertaken to determine the correlates of inadequate dietary intake among HIV-infected adults. Design: In a cross-sectional study of 463 men and 170 women (aged 21-70 y) with HIV infection, dietary adequacy was evaluated by using 3-d diet records. Results: Among nondieting males, whites had higher energy intakes than did nonwhites. Injection drug users consumed less energy than did nonusers. Among nondieting females, only the absence of nausea and vomiting was marginally associated with higher energy intakes. Inadequate energy intake, which occurred in 38% of this population, was independently associated with female sex among nondieters. A significant proportion of the study cohort (52%) was consuming less than the recommended dietary allowance of vitamin A. Inadequate protein intake, found in 11% of the study population, occurred more often in females, those without a caregiving adult in the household, and individuals with reduced appetite. A considerable proportion of the participants (23%) reported that they were dieting to lose weight. Conclusions: Dietary inadequacy was strongly correlated with being in the sociodemographic groups that are at heightened risk of adverse clinical outcomes. It may be worthwhile to study dietary intake as a potential determinant of the clinical outcomes of HIV infection. [ABSTRACT FROM AUTHOR]

The objectives of this study were to evaluate the frequency and determinants of rectal bleeding and the association between rectal bleeding and risk of human immunodeficiency virus (HIV) infection among homosexual/bisexual men in Mexico City. Men who requested anonymous HIV testing at a public clinic in Mexico City and who reported engaging in any homosexual behavior were eligible to participate in this study. Trained staff collected information on demographic factors, sexual behavior, psychological states, and HIV serostatus from all consenting, eligible clients. Logistic regression modeling was used to investigate the independent effect of risk factors among 2, 758 men who were tested between June 1991 and December 1992. Bleeding during anal intercourse was a common occurrence: More than one third of the men in the study reported some bleeding, and 8% reported bleeding in half or more of their intercourse episodes. The prevalence of HIV infection among bleeders was 42% as compared with 28% in nonbleeders (p < 0.0001), and the adjusted odds ratio was 1.8 (95% confidence interval (CI) 1.1–2.8) for men who bled in more than half of their anal intercourse episodes relative to nonbleeders. There was a trend of increasing HIV seroprevalence with increasing frequency of rectal bleeding (p = 0.001). Nine percent of all HIV infections and 42% of infections among frequent bleeders were attributable to rectal bleeding. Men who reported both rectal bleeding and anal warts were 3.5 (95% Cl 2.1–5.8) times more likely to be HIV-infected in multivariate analysis than men reporting neither rectal bleeding nor anal warts. Determinants of rectal bleeding included older age, more education, more receptive anal intercourse than insertive intercourse, receptive digital-anal contact, anal warts, and genital ulcers. Among men reporting sex with men in Mexico City, rectal bleeding is common. It is an independent risk factor for HIV infection, and warrants attention in acquired immunodeficiency syndrome prevention efforts. Rectal bleeding that results from rupture of anal warts may be an especially effective portal of HIV transmission. Am J Epidemiol 1996; 144: 817–27. [ABSTRACT FROM AUTHOR]

BACKGROUND: We assembled a prospective cohort of 3144 children less than 15 years of age initiating antiretroviral therapy (ART) in Dar es Salaam, Tanzania. METHODS: The relationships of nutritional status and other baseline characteristics in relation to mortality were examined using Cox proportional hazards model. RESULTS: Compared with children with weight for age (WAZ) > -1, those with WAZ ≤ -2 to < -3 had a nearly double risk of death (relative risk [RR], 1.85; 95% confidence interval [CI], 1.10-3.11), and among those with WAZ ≤ -3, the risk more than tripled (RR, 3.36; 95% CI, 2.12-5.32). Other baseline risk factors for overall mortality included severe anemia (P < .001), severe immune suppression (P = .02), history of tuberculosis (P = .01), opportunistic infections (P < .001), living in the poorest district (P < .001), and advanced World Health Organization stage (P = .003). CONCLUSIONS: To sustain the obtained benefit of ART in this setting, interventions to improve nutritional status may be used as an adjunct to ART.

Background: Children born to HIV-infected women are susceptible to undernutrition, but modifiable risk factors and the time course of the development of undernutrition have not been well characterized. Objective: To identify maternal, socioeconomic, and child characteristics that are associated with stunting, wasting, and underweight among Tanzanian children born to HIV-infected mothers, followed from 6 weeks for 24 months. Methods: Maternal and socioeconomic characteristics were recorded during pregnancy, data pertaining to the infant’s birth were collected immediately after delivery, morbidity histories and anthropometric measurements were performed monthly. Multivariate Cox proportional hazards methods were used to assess the association between potential predictors and the time to first episode of stunting, wasting, and underweight. Results: 2387 infants (54.0% male) were enrolled and followed for a median duration of 21.2 months. The respective prevalence of prematurity (<37 weeks) and low birthweight (<2500g) was 15.2% and 7.0%; 11.3% of infants were HIV-positive at 6 weeks. Median time to first episode of stunting, wasting, and underweight was 8.7, 7.2, and 7.0 months, respectively. Low maternal education, few household possessions, low infant birthweight, child HIV infection and male sex were all independent predictors of stunting, wasting, and underweight. In addition, preterm infants were more likely to become wasted and underweight, whereas those with a low Apgar score at birth were more likely to become stunted. Conclusion: Interventions to improve maternal education and nutritional status, reduce mother-to-child transmission of HIV, and increase birth weight may lower the risk of undernutrition among children born to HIV-infected women.

Background: Experimental data suggest a role for iron in the course of tuberculosis (TB) infection, but there is limited evidence on the potential effects of iron deficiency or iron overload on the progression of TB disease in humans. The aim of the present analysis was to examine the association of iron status with the risk of TB progression and death. Methodology/Principal Findings: We analyzed plasma samples and data collected as part a randomized micronutrient supplementation trial (not including iron) among HIV-infected and HIV-uninfected TB patients in Dar es Salaam, Tanzania. We prospectively related baseline plasma ferritin concentrations from 705 subjects (362 HIV-infected and 343 HIV-uninfected) to the risk of treatment failure at one month after initiation, TB recurrence and death using binomial and Cox regression analyses. Overall, low (plasma ferritin<30 \(\mu\)g/L) and high (plasma ferritin>150 \(\mu\)g/L for women and>200 \(\mu\)g/L for men) iron status were seen in 9% and 48% of patients, respectively. Compared with normal levels, low plasma ferritin predicted an independent increased risk of treatment failure overall (adjusted RR = 1.95, 95% CI: 1.07 to 3.52) and of TB recurrence among HIV-infected patients (adjusted RR = 4.21, 95% CI: 1.22 to 14.55). High plasma ferritin, independent of C-reactive protein concentrations, was associated with an increased risk of overall mortality (adjusted RR = 3.02, 95% CI: 1.95 to 4.67). Conclusions/Significance: Both iron deficiency and overload exist in TB patients and may contribute to disease progression and poor clinical outcomes. Strategies to maintain normal iron status in TB patients could be helpful to reduce TB morbidity and mortality.

BACKGROUND Patients with tuberculosis (TB) often suffer from profound malnutrition. OBJECTIVE To examine the patterns and predictors of change in nutritional and hemoglobin status during and after TB treatment. METHODS A total of 471 HIV-positive and 416 HIV-negative adults with pulmonary TB were prospectively followed in Dar es Salaam, Tanzania. All patients received 8 months TB treatment following enrollment. RESULTS About 40% of HIV-positive and 47% of HIV-negative TB patients had BMI <18.5 kg/m2 at baseline. About 94% of HIV-positive and 84% of HIV-negative participants were anemic at baseline. Both HIV-positive and HIV-negative patients experienced increases in BMI and hemoglobin concentrations over the course of TB treatment. Among HIV-positive patients, older age, low CD4 cell counts, and high viral load were independently associated with a smaller increase in BMI from baseline to 8 months. Female sex, older age, low CD4 cell counts, previous TB infection, and less money spent on food were independently associated with a smaller improvement in hemoglobin among HIV-positive patients during treatment. CONCLUSION HIV- positive TB patients, especially those with low CD4 cell counts, showed poor nutritional recovery during TB treatment. Adequate nutritional support should be considered during TB treatment.

This paper examines predictors of breastfeeding cessation among a cohort of human immunodeficiency virus (HIV)-infected women. This was a prospective follow-up study of HIV-infected women who participated in a randomized micronutrient supplementation trial conducted in Dar es Salaam, Tanzania. 795 HIV-infected Tanzanian women with singleton newborns were utilized from the cohort for this analysis. The proportion of women breastfeeding declined from 95% at 12 months to 11% at 24 months. The multivariate analysis showed breastfeeding cessation was significantly associated with increasing calendar year of delivery from 1995 to 1997 [risk ratio (RR), 1.36; 95% confidence interval (CI) 1.13–1.63], having a new pregnancy (RR 1.33; 95% CI 1.10–1.61), overweight [body mass index (BMI) ≥25 kg m−2; RR 1.37; 95% CI 1.07–1.75], underweight (BMI <18.5 kg m−2; RR 1.29; 95% CI 1.00–1.65), introduction of cow’s milk at infant’s age of 4 months (RR 1.30; 95% CI 1.04–1.63). Material and social support was associated with decreased likelihood of cessation (RR 0.83; 95% CI 0.68–1.02). Demographic, health and nutritional factors among women and infants are associated with decisions by HIV-infected women to cease breastfeeding. The impact of breastfeeding counselling programs for HIV-infected African women should consider individual maternal, social and health contexts.

Objective: To determine the demographic, socio-economic and psycho-social factors associated with condom use amongst antenatal clinic attendees in Dar es Salaam. Methods: A cross sectional study design was employed in four antenatal clinics in Dar es Salaam. Pregnant women were interviewed between April 1995 and July 1997 to find out if they have ever used a condom and if so whether they had used them consistently for all coital acts in the previous year. Results: Of 1,585 women interviewed, 41% had their first sexual experience before age of 18 years and 82% had a history of having more than two sexual partners during their lifetime. Sixty two percent of women had never used a condom. Although 40% had used a condom in the previous year only 12% used them consistently. Ever use of a condom increased significantly with the number of years of education of the respondent and her partner also with the respondent's financial independence. Women with >9 years of education were twice as likely as women with < 5 years of education to be condom users (prevalence ratio (PR) = 2.1, 95% confidence interval (CI) = 1.6 - 2.7). Professional women were almost twice as likely as housewives to have ever used a condom (PR = 1.8, 95% CI = 1.3 - 2.3). Women who reported that they have had more than four sexual partners during their lifetime were associated with nearly a four-fold higher lifetime rate of having ever used a condom, compared with a single lifetime partnership (PR = 3.9, 95% CI = 2.8-5.4). Conclusion: The reported prevalence of ever use of a condom amongst antenatal clinic attendees is low and inconsistent especially among HIV positive women. Deliberate effort should be used to ensure condom access, availability and correct and consistent use of condoms by women in all sexual acts. [ABSTRACT FROM AUTHOR]

Presents a study on the decline in the incidence of HIV-related wasting syndrome since the introduction of highly active antiretroviral therapy (HAART) in the U.S. Characteristics of weight loss in the later HAART use; Details on the clinical diagnosis of HIV wasting syndrome; Risk of weight loss.

Examines the association of HIV-1 disease progression with pregnancy and live birth incidence in a cohort of HIV-1-positive women in Dar es Salaam, Tanzania. Determinants of fertility; Use of Cox proportional hazards models; Multivariate pregnancy rate ratio.

Examines the timing and correlates of HIV-1 transmission through breastfeeding among HIV-infected pregnant women from Dar es Salaam, Tanzania. Mean duration of breastfeeding; Number of infections observed; Infection risk by age.

Abstract: Malnutrition is associated with morbidity and mortality in HIV-infected individuals. Little research has been conducted to identify the roles that clinical, illicit drug use and socioeconomic characteristics play in the nutritional status of HIV-infected patients. This cross-sectional analysis included 562 HIV-infected participants enrolled in the Nutrition for Healthy Living study conducted in Boston, MA and Providence, RI. The relationship between body mass index (BMI) and several covariates (type of drug use, demographic, and clinical characteristics) were examined using linear regression. Overall, drug users had a lower BMI than non-drug users. The BMI of cocaine users was 1.4kg/m2 less than that of patients who did not use any drugs, after adjusting for other covariates (p =0.02). The BMI of participants who were over the age of 55 years was 2.0kg/m2 less than that of patients under the age of 35, and BMI increased by 0.3kg/m2 with each 100cells/mm3 increase in CD4 count. HAART use, adherence to HAART, energy intake, AIDS status, hepatitis B and hepatitis C co-infections, cigarette smoking and depression were not associated with BMI in the final model. In conclusion, BMI was lower in drug users than non-drug users, and was lowest in cocaine users. BMI was also directly associated with CD4 count and inversely related to age more than 55 years old. HIV-infected cocaine users may be at higher risk of developing malnutrition, suggesting the need for anticipatory nutritional support. [Copyright &y& Elsevier]

Cites a study regarding the insulin resistance in an HIV-infected cohort. Evaluation of the insulin resistance in an HIV-infected cohort; Comparison of the evaluation results with the National Health and Nutrition Examination Survey III; Association of protease inhibitor highly active antiretroviral therapy and nonnucleoside reverse transcriptase inhibitor with worse insulin resistance in men.

Examines the role of selenium status in pregnancy outcomes of HIV-infected pregnant women in Tanzania. Benefits of adequate selenium status; Effect of maternal selenium status on preterm birth; Ability of selenium supplementation to reduce the risk of intrapartum HIV transmission among women who do not receive antiretroviral therapy.