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1.  Factors Associated With Adherence Amongst 5295 People Receiving Antiretroviral Therapy as Part of an International Trial 
Background. We assessed factors associated with antiretroviral therapy (ART) adherence, including specific ART medications.
Methods. The Strategies for Management of Antiretroviral Therapy study was an international antiretroviral therapy (ART) strategy trial that compared intermittent ART, using CD4+ T-cell count as a guide, to continuous ART. Adherence during the 7 days before each visit was measured using self-report. We defined high adherence as self-report of taking “all” pills for each prescribed ART medication; all other reports were defined as suboptimal adherence. Factors associated with adherence were assessed using logistic regression with generalized estimating equations.
Results. Participants reported suboptimal adherence at 6016 of 35 695 study visits (17%). Factors independently associated with suboptimal adherence were black race, protease inhibitor–containing regimens, greater pill burden, higher maximum number of doses per day, and smoking. Factors independently associated with higher adherence were older age, higher education, region of residence, episodic treatment, higher latest (at the time of adherence) CD4+ T-cell count, and being prescribed concomitant drugs (ie, medications for comorbidities). Of specific drugs investigated, atazanavir, atazanavir/ritonavir, fosamprenavir, indinavir, indinavir/ritonavir, and lopinavir/ritonavir were associated with suboptimal adherence, and tenofovir disoproxil fumarate/emtricitabine was associated with higher adherence.
Conclusions. In this, the largest analysis of ART adherence to date, some protease inhibitor–containing regimens and regimens with >1 dose per day were associated with suboptimal adherence.
PMCID: PMC3666133  PMID: 23204161
antiretroviral drugs; adherence; self-report; HIV infection
2.  Smoking-Related Health Risks Among Persons With HIV in the Strategies for Management of Antiretroviral Therapy Clinical Trial 
American journal of public health  2010;100(10):1896-1903.
We sought to determine smoking-related hazard ratios (HRs) and population-attributable risk percentage (PAR%) for serious clinical events and death among HIV-positive persons, whose smoking prevalence is higher than in the general population.
For 5472 HIV-infected persons enrolled from 33 countries in the Strategies for Management of Antiretroviral Therapy clinical trial, we evaluated the relationship between baseline smoking status and development of AIDS-related or serious non-AIDS events and overall mortality.
Among all participants, 40.5% were current smokers and 24.8% were former smokers. Adjusted HRs were higher for current than for never smokers for overall mortality (2.4; P<.001), major cardiovascular disease (2.0; P=.002), non-AIDS cancer (1.8; P=.008), and bacterial pneumonia (2.3; P<.001). Adjusted HRs also were significantly higher for these outcomes among current than among former smokers. The PAR% for current versus former and never smokers combined was 24.3% for overall mortality, 25.3% for major cardiovascular disease, 30.6% for non-AIDS cancer, and 25.4% for bacterial pneumonia.
Smoking contributes to substantial morbidity and mortality in this HIV-infected population. Providers should routinely integrate smoking cessation programs into HIV health care.
PMCID: PMC2936972  PMID: 20724677
3.  Results of a 25 Year Longitudinal Analysis of the Serologic Incidence of Syphilis in a Cohort of HIV Infected Patients with Unrestricted Access to Care 
Sexually transmitted diseases  2012;39(6):10.1097/OLQ.0b013e318249d90f.
The well described biological and epidemiologic associations of syphilis and HIV are particularly relevant to the military, as service members are young and at risk for sexually transmitted infections. We therefore used the results of serial serologic testing to determine the prevalence, incidence, and risk factors for incident syphilis in a cohort of HIV-infected Department of Defense beneficiaries.
Participants with a positive non-treponemal test at HIV diagnosis that was confirmed on treponemal testing were categorized as prevalent cases, whereas participants with an initial negative non-treponemal test who subsequently developed a confirmed positive non-treponemal test as incident cases.
At HIV diagnosis the prevalence of syphilis was 5.8% (n=202). 4239 participants contributed 27,192 person years (PY) to the incidence analysis and 347 (8%) developed syphilis (rate 1.3/100 PY; [1.1, 1.4]). Syphilis incidence was highest during the calendar years 2006 - 2009 (2.5/100 PY; [2.0, 2.9]). In multivariate analyses, younger age (per 10 year increase HR 0.8;[0.8-0.9]); male gender (HR 5.6; [2.3-13.7]); non European-American ethnicity (African-American (HR 3.2; [2.5-4.2]; Hispanic HR 1.9; [1.2-3.0]); history of hepatitis B (HR 1.5; [1.2-1.9]) or gonorrhea (HR 1.4; [1.1 −1.8]) were associated with syphilis.
The significant burden of disease both at and after HIV diagnosis, observed in this cohort, suggests that the cost-effectiveness of extending syphilis screening to at risk military members should be assessed. In addition, HIV infected persons continue to acquire syphilis, emphasizing the continued importance of prevention for positive programs.
PMCID: PMC3846570  PMID: 22592829
Seroincidence; Seroprevalence; Risk Factors; Syphilis; HIV infected persons
4.  Early Postseroconversion CD4 Cell Counts Independently Predict CD4 Cell Count Recovery in HIV-1–Postive Subjects Receiving Antiretroviral Therapy 
The relationship between CD4+ T-cell counts determined soon after seroconversion with HIV-1 (baseline CD4), nadir CD4, and CD4 levels attained during highly active antiretroviral therapy (HAART) is unknown.
Longitudinal, including baseline (at or soon after HIV diagnosis), intermediate (nadir), and distal (post-HAART) CD4+ T-cell counts were assessed in 1085 seroconverting subjects who achieved viral load suppression from a large well-characterized cohort. The association of baseline with post-HAART CD4+ T-cell count was determined after adjustment for other relevant covariates.
A higher baseline CD4+ T-cell count predicted a greater post- HAART CD4+ T-cell count, independent of the nadir and other explanatory variables. Together, baseline and nadir strongly predicted the post-HAART CD4+ count such that a high baseline and lower nadir were associated with a maximal immune recovery after HAART. Likelihood of recovery of the baseline count after HAART was significantly higher when the nadir/baseline count ratio was consistently ≥0.6.
Among viral load suppressing seroconverters, the absolute CD4+ T-cell count attained post-HAART is highly dependent on both baseline and nadir CD4+ T-cell counts. These associations further support the early diagnosis and initiation of HAART among HIV-infected persons.
PMCID: PMC3786783  PMID: 21546844
CD4 count; highly active antiretroviral therapy; outcomes; predictors; treatment response
5.  HIV/AIDS stigma-associated attitudes in a rural Ethiopian community: characteristics, correlation with HIV knowledge and other factors, and implications for community intervention 
Whether scale-up of HIV prevention and care will reduce negative attitudes and discriminatory practices towards persons living with HIV/AIDS (PLWH) is uncertain. An HIV knowledge and attitude survey was conducted in a rural Ethiopian community where HIV prevention and treatment was being rapidly scaled up. Data were analyzed to identify prevalence of and factors associated with stigma-associated attitudes towards PLWH.
We surveyed 561 adults from 250 randomly selected households in the rural town of Arba Minch and surrounding villages about positive or negative attitudes towards PLWH, as well as demographic characteristics, and knowledge about HIV transmission and treatment.
Eighty percent of respondents agreed with ≥ 1 negative statements indicating blame or shame towards PLWH and 41% agreed with ≥ 1 negative statements associated with distancing themselves from PLWH. However, only 14% expressed negative responses about whether PLWH should receive support from their communities. In multivariate analysis, a greater number of negative attitudes towards PLWH was significantly (p < 0.05) associated with: female gender (Odds Ratio [OR] = 1.51), living in a rural village (vs. town neighborhood) (OR = 3.44), not knowing PLWH can appear healthy (OR = 1.78), lack of knowledge about perinatal transmission (OR = 1.49), lack of knowledge about how HIV is not transmitted (e.g. casual contact) (OR = 2.05), lack of knowledge about HIV treatment (OR = 1.80), and not personally knowing a PLWH (OR = 1.41).
In a rural Ethiopian setting in which rapid scale-up of HIV treatment occurred, many respondents still characterized HIV as associated with shame or blame, or indicated PLWH would be isolated or discriminated against. HIV stigma can hamper both prevention and treatment programs. We identified multiple issues which, if addressed, can help promote a more positive cycle in which PLWH are appreciated as members of one’s own community who are affirmatively interacted with and supported. Stigma reduction programs should address knowledge gaps such as fears of casual contact contagion, and lack of awareness of medical interventions to help prevent HIV disease, as well as building upon community-based attitudes of the importance of supporting and showing compassion for PLWH.
PMCID: PMC3512528  PMID: 22553906
6.  Clinical, demographic and laboratory parameters at HAART initiation associated with decreased post-HAART survival in a U.S. military prospective HIV cohort 
Although highly active antiretroviral therapy (HAART) has improved HIV survival, some patients receiving therapy are still dying. This analysis was conducted to identify factors associated with increased risk of post-HAART mortality.
We evaluated baseline (prior to HAART initiation) clinical, demographic and laboratory factors (including CD4+ count and HIV RNA level) for associations with subsequent mortality in 1,600 patients who began HAART in a prospective observational cohort of HIV-infected U.S. military personnel.
Cumulative mortality was 5%, 10% and 18% at 4, 8 and 12 years post-HAART. Mortality was highest (6.23 deaths/100 person-years [PY]) in those with ≤ 50 CD4+ cells/mm3 before HAART initiation, and became progressively lower as CD4+ counts increased (0.70/100 PY with ≥ 500 CD4+ cells/mm3). In multivariate analysis, factors significantly (p < 0.05) associated with post-HAART mortality included: increasing age among those ≥ 40 years (Hazard ratio [HR] = 1.32 per 5 year increase), clinical AIDS events before HAART (HR = 1.93), ≤ 50 CD4+ cells/mm3 (vs. CD4+ ≥ 500, HR = 2.97), greater HIV RNA level (HR = 1.36 per one log10 increase), hepatitis C antibody or chronic hepatitis B (HR = 1.96), and HIV diagnosis before 1996 (HR = 2.44). Baseline CD4+ = 51-200 cells (HR = 1.74, p = 0.06), and hemoglobin < 12 gm/dL for women or < 13.5 for men (HR = 1.36, p = 0.07) were borderline significant.
Although treatment has improved HIV survival, defining those at greatest risk for death after HAART initiation, including demographic, clinical and laboratory correlates of poorer prognoses, can help identify a subset of patients for whom more intensive monitoring, counseling, and care interventions may improve clinical outcomes and post-HAART survival.
PMCID: PMC3320559  PMID: 22339893
Highly active antiretroviral therapy; mortality; CD4+ lymphocyte count
7.  Development of Diagnostic Criteria for Serious Non-AIDS Events in HIV Clinical Trials 
HIV clinical trials  2010;11(4):205-219.
Serious non-AIDS (SNA) diseases are important causes of morbidity and mortality in the HAART era. We describe development of standard criteria for 12 SNA events for Endpoint Review Committee (ERC) use in START, a multicenter international HIV clinical trial.
SNA definitions were developed based upon the following: (1) criteria from a previous trial (SMART), (2) review of published literature, (3) an iterative consultation and review process with the ERC and other content experts, and (4) evaluation of draft SNA criteria using retrospectively collected reports in another trial (ESPRIT).
Final criteria are presented for acute myocardial infarction, congestive heart failure, coronary artery disease requiring drug treatment, coronary revascularization, decompensated liver disease, deep vein thrombosis, diabetes mellitus, end-stage renal disease, non-AIDS cancer, peripheral arterial disease, pulmonary embolism, and stroke. Of 563 potential SNA events reported in ESPRIT and reviewed by an ERC, 72% met “confirmed” and 13% “probable” criteria. Twenty-eight percent of cases initially reviewed by the ERC required follow-up discussion (adjudication) before a final decision was reached.
HIV clinical trials that include SNA diseases as clinical outcomes should have standardized SNA definitions to optimize event reporting and validation and should have review by an experienced ERC with opportunities for adjudication.
PMCID: PMC3109979  PMID: 20974576
clinical trials; cardiovascular disease; endpoint review committees; HIV; serious non-AIDS events
8.  The Epidemiology of Hepatitis B Virus Infection in a U.S. Cohort of HIV-Infected Individuals During the Last 20 Years 
The epidemiologic trends of hepatitis B virus (HBV) infection in HIV-infected patients over the last twenty years are largely unknown.
Prevalence and risk factors for HBV infection overall, at the time of HIV infection, and following HIV infection were examined in an ongoing observational HIV cohort study. Risk factors for HBV infection at the time of HIV diagnosis were evaluated using logistic regression, and risk for incident HBV infection following HIV diagnosis was evaluated using Cox proportional hazards models.
Of the 2769 evaluable participants, 1078 (39%) had HBV infection, of which 117 (11%) had chronic HBV. The yearly cross-sectional prevalence of HBV infection decreased from a peak of 49% in 1995 to 36% in 2008 (p<0.001). HBV prevalence at the time of HIV diagnosis decreased between 1989 and 2008 from 34% to 9% (p<0.001). The incidence of HBV infection following HIV diagnosis decreased from 4.0/100 person-years in the pre-HAART era to 1.1/100 person-years in the HAART era (p<0.001), but has remained unchanged from 2000 through 2008 (p=0.49), with over 20% of incident HBV infections having chronic HBV. Decreased risk of HBV infection following HIV diagnosis was associated with higher CD4 cell counts and the use of HBV-active HAART. Receipt of ≥1 dose of HBV vaccine was not associated with reduced risk of HBV infection after HIV diagnosis.
While the burden of HBV infection overall is slowly decreasing among HIV-infected individuals, the persistent rate of HBV infection following HIV diagnosis raises concern that more effective prevention strategies may be needed to significantly reduce HBV infections in this patient population.
PMCID: PMC2805765  PMID: 20047484
Hepatitis B Virus; Human Immunodeficiency Virus; Sexually Transmitted Infections; Highly Active Antiretroviral Therapy; Hepatitis B Vaccine
9.  Long-term CD4+ lymphocyte response following HAART initiation in a U.S. Military prospective cohort 
Among HIV-infected persons initiating highly active antiretroviral therapy (HAART), early CD4+ lymphocyte count increases are well described. However, whether CD4+ levels continue to increase or plateau after 4-6 years is controversial.
To address this question and identify other determinants of CD4+ response, we analyzed data for 1,846 persons from a prospective HIV military cohort study who initiated HAART, who had post-HAART CD4+ measurements, and for whom HIV seroconversion (SC) date was estimated.
CD4+ count at HAART initiation was ≤ 200 cells/mm3 for 23%, 201-349 for 31%, 350-499 for 27%, and ≥500 for 19%. The first 6 months post-HAART, the greatest CD4+ increases (93-151 cells) occurred, with lesser increases (22-36 cells/year) through the first four years. Although CD4+ changes for the entire cohort were relatively flat thereafter, HIV viral load (VL) suppressors showed continued increases of 12-16 cells/year. In multivariate analysis adjusting for baseline CD4+ and post-HAART time interval, CD4+ responses were poorer in those with: longer time from HIV SC to HAART start, lower pre-HAART CD4+ nadir, higher pre-HAART VL, and clinical AIDS before HAART (P < 0.05).
Small but positive long-term increases in CD4+ count in virally suppressed patients were observed. CD4+ response to HAART is influenced by multiple factors including duration of preceding HIV infection, and optimized if treatment is started with virally suppressive therapy as early as possible.
PMCID: PMC3037838  PMID: 21244701
10.  Determination of the Underlying Cause of Death in Three Multicenter International HIV Clinical Trials 
HIV clinical trials  2008;9(3):177-185.
Describe processes and challenges for an Endpoint Review Committee (ERC) in determining and adjudicating underlying causes of death in HIV clinical trials.
Three randomized HIV trials (two evaluating interleukin-2 and one treatment interruption) enrolled 11,593 persons from 36 countries during 1999–2008. Three ERC members independently reviewed each death report and supporting source documentation to assign underlying cause of death; differences of opinion were adjudicated.
Of 453 deaths reported through January 14, 2008, underlying causes were as follows: 10% AIDS-defining diseases, 21% non-AIDS malignancies, 9% cardiac diseases, 9% liver disease, 8% non-AIDS-defining infections, 5% suicides, 5% other traumatic events/accidents, 4% drug overdoses/acute intoxications, 11% other causes, and 18% unknown. Major reasons for unknown classification were inadequate clinical information or supporting documentation to determine cause of death. Half (51%) of deaths reviewed by the ERC required follow-up adjudication; consensus was eventually always reached.
ERCs can successfully provide blinded, independent, and systematic determinations of underlying cause of death in HIV clinical trials. Committees should include those familiar with AIDS and non-AIDS-defining diseases and have processes for adjudicating differences of opinion. Training for local investigators and procedure manuals should emphasize obtaining maximum possible documentation and follow-up information on all trial deaths.
PMCID: PMC2441601  PMID: 18547904
cause of death; endpoint review committees; clinical trials; HIV; mortality
11.  Prevalence of tuberculosis, hepatitis B virus, and intestinal parasitic infections among refugees to Minnesota. 
Public Health Reports  2002;117(1):69-77.
OBJECTIVE: The purpose of this study was to define the prevalence of infection with Mycobacterium tuberculosis, hepatitis B virus, and various intestinal parasites among different groups of primary refugees immigrating to Minnesota. METHODS: 2,545 refugees arriving in Minnesota during 1999 received a domestic health examination that included tuberculin skin testing, hepatitis B virus serologic testing, and stool ova and parasite examinations. The Refugee Health Assessment form asked specifically about screening results for amebiasis, ascariasis, clonorchiasis, giardiasis, hookworm, schistosomiasis, strongyloidiasis, and trichuriasis. RESULTS: Forty-nine percent of refugees had a reactive tuberculin test of >or=10 mm induration, with a higher prevalence in males (54%) and refugees >or=18 years of age (63%) (p<0.001). Seven percent had a positive hepatitis B surface antigen, with the highest prevalence in those people from sub-Saharan Africa (8%) (p=0.002) and those refugees >or=18 years of age (9%) (p=0.006). Twenty-two percent had one or more intestinal parasites asked about, including 30% of those refugees <18 years of age (p<0.001). The most commonly reported parasitic infections were trichuriasis (8%) and giardiasis (7%). CONCLUSIONS: Evidence of infection with M. tuberculosis, hepatitis B virus, or one of eight intestinal parasites was present in a substantial proportion of refugees receiving the domestic health assessment. Screening for such infections gives new immigrants the opportunity to receive important medical evaluation and treatment, provides valuable surveillance data, and allows appropriate public health measures to be taken.
PMCID: PMC1497409  PMID: 12297684
12.  Substance abuse and high-risk needle-related behaviors among homeless youth in minneapolis: Implications for prevention 
Homeless and runaway youth face a variety of health, risks, including those related to substance abuse and use of unsterile needles. During 1998–1999, we recruited 201 Minneapolis homeless youths aged 15–22 years; these youths were interviewed by experienced street outreach workers from settings where street youth were known to congregate. Respondents spent a median of 6 months in the previous year living on the streets or “couch hopping.” There were 37% who reported having 15 or more alcoholic drinks per week, 41% smoked 1 pack or more of cigarettes per day, and 37% used marijuana 3 or more times a week; 15% reported lifetime injection drug use, including 6% who used injection drugs within the previous month. Twenty percent had received a tattoo, and 18% body piercing with a needle that had not been sterilized or had been used by someone else. There were 68% who had been tested for human immunodeficiency virus (HIV), 52% for hepatitis B, and 25% for hepatitis C. There were 44% who said they did not have enough information about hepatitis B and C. Less than half (43%) received hepatitis B vaccine; however, 51% of unvaccinated youths indicated that they would receive vaccination if offered. These Midwestern homeless youths face multiple health risks, including those related to substance use and exposure to unsterile needles. Despite unsafe behaviors, many of these youths were interested in methods to protect their health, including education, knowing their HIV or viral hepatitis serostatus, and obtaining hepatitis B immunization.
PMCID: PMC3455879  PMID: 11796815
Adolescence; Hepatitis B virus; Hepatitis C virus; Human immunodeficiency virus; Substance use
13.  Incentives and accessibility: A pilot study to promote adherence to TB prophylaxis in a high-risk community 
A community-based directly observed preventive therapy (DOPT) program for treatment of latent tuberculosis infection among injection drug users (IDUs) in an innercity neighborhood.
To test adherence to a 6-month course of DOPT using cash incentives and an easily accessible neighborhood location.
Street-recruited IDUs (N=205) were screened forMycobacterium tuberculosis (TB) infection using the Mantoux test and two controls. Subjects who had a purified protein derivative (PPD) reaction of ≥5 mm, were anergic, or had a history of a positive PPD received clinical evaluation at a community field site, provided in collaboration with the San Francisco Department of Public Health Tuberculosis Clinic. Twenty-eight subjects were considered appropriate candidates for prophylaxis with isoniazid, and 27 enrolled in the pilot study. Participants received twice-weekly DOPT at a community satellite office, with a $10 cash incentive at each visit.
The 6-month (26-week) regimen was completed by 24/27 (89%) participants. The median time to treatment completion was 27 weeks (range 26 to 34 weeks). The median proportion of dosing days attended in 6 months was 96%.
Community-based DOPT using cash incentives resulted in high levels of adherence and treatment completion among drug users.
PMCID: PMC3456694  PMID: 10609595
Adherence; Incentives; Tuberculosis; Injection Drug Users; Directly Observed Preventive Therapy

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