HIV-infected African Americans are willing to participate in HIV treatment trials.
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ABSTRACT:
SUBMITTER: Garber M
PROVIDER: S-EPMC1824784 | biostudies-other | 2007 Jan
REPOSITORIES: biostudies-other
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Project description:PurposeGeneral notification offers a possible alternative to written informed consent for pragmatic randomized controlled trials (pRCTs). It involves patients being informed through brochures, posters, and letters that research is being conducted simultaneously to providing clinical care and that patients will be enrolled in pRCTs without study-specific consent. A previous survey found that a substantial minority of respondents endorsed general notification. We aimed to know who is willing to enroll in this type of trials using general notification rather than written consent.MethodsThe previous study was a cross-sectional, probability-based survey, with a 2 × 2 factorial design. Two scenarios were assessed: two low-risk pRCTs in hypertension, one comparing two drugs with similar benefit/risk ratio and the other taking the same drug in the morning or at night. Each scenario had two routes: written consent vs verbal consent and written consent vs general notification. In this study, we were interested in the latter route in both scenarios. Respondents' preferences were measured based on their recommendation to the research ethics committee and the respondent's personal preference. We aimed to investigate the characteristics of those supporting general notification in either outcome or the variables explaining consistency and inconsistency between their personal preference and their recommendation. Based on the results of the original survey, we aimed to have at least 200 inconsistent respondents; to this end, the sample size was increased accordingly in a second wave of the survey.ResultsOne thousand six hundre and ten respondents were included; 1003 from the original survey and 607 new ones belonging to the second wave. Thirty-nine percent of respondents chose general notification as personal preference and/or recommendation. Respondents with lower education levels were more prone to accept general notification than those holding a university degree [OR (95% CI)], primary school [2.959 (2.069-4.232)], secondary school [2.899 (2.09-4.021)], or high school [1.620 (1.184-2.217)]. Also unemployed [1.372 (1.064-1.770)] and retired [1.445 (1.049-1.990)], but not students, showed preference for general notification in comparison with those employed. Individuals more than 24 years old and having received high school or university (or postgraduate) education were statistically significantly more consistent in their decisions.ConclusionsThirty-nine percent of respondents is open to not to be asked for their informed consent in low-risk pRCTs; of these, those being less educated and not having current job or being retired are significantly more open to general notification. The use of this alternative method to written consent for simultaneous conduct of pRCTs and care should be considered and educational programs settled up to, in the case of public acceptance, ensure its ethical appropriateness.
| S-EPMC5684310 | biostudies-literature
Project description:BACKGROUND: More and more HIV therapeutic vaccines will enter clinical trials; however, little is known about the willingness to participate (WTP) in HIV therapeutic vaccine trials among HIV-positive individuals. OBJECTIVE: To investigate the WTP in HIV therapeutic vaccine trials among Chinese HIV-infected patients. METHODS: We conducted a cross-sectional survey on HIV-positive inpatients and outpatients at Shanghai Public Health Center. A total of 447 participants were recruited into this study. Following an introduction with general information on HIV therapeutic vaccine and its potential effectiveness and side effects, each participant completed a questionnaire in a self-administered form. The questionnaires covered demographics, high-risk behaviors, clinical characteristics and willingness to participate in HIV therapeutic vaccine trial. RESULTS: The overall willingness to participate in HIV therapeutic vaccine trials was 91.5%. Interestingly, multivariate logistic regression analyses demonstrated that the willingness was higher for those sexually infected by HIV (odds ratio [OR]: 4.36; 95% confidence interval [CI]: 1.53-12.41), diagnosed as HIV-1 infection for greater than 5 years (OR: 7.12, 95% CI: 1.83-27.76), and with the presence of infectious complications (OR: 2.75; 95% CI: 1.02-7.45). The primary reason for participation was to delay or reduce antiretroviral treatment (ART) and to avoid ART side effects (76.6%), and then followed by delaying disease progression (74.9%), increasing immune response to suppress opportunistic infections (57.7%) and preventing the development of drug resistance (37.1%). Reasons for unwillingness to participate mainly included concern for safety (37.0%), lack of knowledge on therapeutic vaccine (33.3%), and satisfaction with ART effectiveness (22.2%). CONCLUSIONS: The WTP in HIV therapeutic vaccine trials was high among HIV-infected Chinese patients. HIV+ subjects who acquired infection through sexual contact and who were diagnosed for more than 5 years may represent a good candidate population for enrollment in therapeutic vaccine trials.
| S-EPMC4221013 | biostudies-other
Project description:BACKGROUND:HIV-positive African Americans have been shown to have lower adherence to antiretroviral therapy (ART) than those of other races/ethnicities, yet adherence interventions have rarely been tailored to the needs of this population. OBJECTIVE:We developed and will evaluate a treatment education adherence intervention (called Rise) that was culturally adapted to address the needs of African Americans living with HIV. METHODS:This randomized controlled trial will examine the effects of the Rise intervention on ART adherence and HIV viral load. African Americans on ART who report adherence problems will be recruited from the community and randomly assigned to receive the intervention or usual care for 6 months. The intervention consists of 6-10 individual counseling sessions, with more sessions provided to those who demonstrate lower adherence. Primary outcomes include adherence as monitored continuously with Medication Event Monitoring Systems (MEMS) caps, and viral load data received from the participant's medical provider. Survey assessments will be administered at baseline and month 6. RESULTS:The trial is ongoing. CONCLUSIONS:If effective, the Rise intervention will provide community-based organizations with an intervention tailored to address the needs of African Americans for promoting optimal ART adherence and HIV clinical outcomes. TRIAL REGISTRATION:Clinicaltrials.gov NCT01350544; https://clinicaltrials.gov/ct2/show/NCT01350544 (Archived by WebCite at http://www.webcitation.org/6fjqqnmn0).
| S-EPMC4829729 | biostudies-literature
Project description:Older African Americans who experience pain are especially at high risk of underassessment and undertreatment. This study examined patterns and correlates of pain medication use: severity of pain, medical conditions, and access to care. African Americans aged 65 and older were recruited from 16 churches located in south Los Angeles (N = 400). Structured face-to-face interviews and visual inspection of each participant's medications were conducted. More than 39% of participants were aged 75 and older, and 65% were female. Forty-seven percent used at least one type of pain medication. The frequency of pain medication use according to pharmaceutical class was nonopioid, 33%; opioid, 12%; adjuvant, 9%; and other drug, 8%. Seventy-seven percent of nonopioids were nonsteroidal anti-inflammatory drugs (NSAIDs), which 25% of participants with hypertension, 28% with stroke, 26% with kidney disease, and 28% with gastrointestinal problems used. Ninety-eight percent of participants who used NSAIDs, 98% experienced potentially inappropriate medication (PIM) use, 69% experienced drug duplication, and 65% experienced drug-drug interactions. This study suggests severe mismanagement of pain in underserved older African Americans, particularly those with comorbidity, multiple providers, and limited access to health care. The use of pain medication was associated with drug-drug interactions, drug duplication, and PIM use. The data show that many participants with severe pain are not taking pain medication or experience PIM use. One in four participants was taking NSAIDs, which can cause serious side effects in older African Americans with multiple chronic conditions.
| S-EPMC5073022 | biostudies-literature
Project description:CONTEXT:African Americans constitute 13% of the US population yet account for nearly 50% of new HIV infections. Implementation of efficacious behavioral interventions can help reduce infections in this vulnerable population. OBJECTIVES:To examine the efficacy of behavioral interventions to reduce HIV for African Americans among 78 randomized controlled trials that sampled at least 50% African Americans (N = 48,585, 81% African American), measured condom use or number of sexual partners, and provided sufficient information to calculate effect sizes. METHODS:Independent raters coded participant characteristics, design and methodological features, and intervention content. Weighted mean effect sizes, using both fixed- and random-effects models, were calculated; positive effect sizes indicated more condom use and fewer sexual partners. RESULTS:Compared with controls, participants who received an HIV risk reduction intervention improved condom use at short-term, intermediate, and long-term assessments; change was better among men who have sex with men and people already infected with HIV, and when interventions provided intensive content across multiple sessions. Intervention participants reduced their number of sexual partners in interventions with intensive interpersonal skills training and in younger samples, especially at delayed intervals. CONCLUSIONS:Sexual risk reduction interventions for African Americans increased condom use without increasing the number of sexual partners. Translating these interventions and further enhancing them continue as a high priority.
| S-EPMC3021417 | biostudies-literature
Project description:BackgroundIt is widely claimed that racial and ethnic minorities, especially in the US, are less willing than non-minority individuals to participate in health research. Yet, there is a paucity of empirical data to substantiate this claim.Methods and findingsWe performed a comprehensive literature search to identify all published health research studies that report consent rates by race or ethnicity. We found 20 health research studies that reported consent rates by race or ethnicity. These 20 studies reported the enrollment decisions of over 70,000 individuals for a broad range of research, from interviews to drug treatment to surgical trials. Eighteen of the twenty studies were single-site studies conducted exclusively in the US or multi-site studies where the majority of sites (i.e., at least 2/3) were in the US. Of the remaining two studies, the Concorde study was conducted at 74 sites in the United Kingdom, Ireland, and France, while the Delta study was conducted at 152 sites in Europe and 23 sites in Australia and New Zealand. For the three interview or non-intervention studies, African-Americans had a nonsignificantly lower overall consent rate than non-Hispanic whites (82.2% versus 83.5%; odds ratio [OR] = 0.92; 95% confidence interval [CI] 0.84-1.02). For these same three studies, Hispanics had a nonsignificantly higher overall consent rate than non-Hispanic whites (86.1% versus 83.5%; OR = 1.37; 95% CI 0.94-1.98). For the ten clinical intervention studies, African-Americans' overall consent rate was nonsignificantly higher than that of non-Hispanic whites (45.3% versus 41.8%; OR = 1.06; 95% CI 0.78-1.45). For these same ten studies, Hispanics had a statistically significant higher overall consent rate than non-Hispanic whites (55.9% versus 41.8%; OR = 1.33; 95% CI 1.08-1.65). For the seven surgery trials, which report all minority groups together, minorities as a group had a nonsignificantly higher overall consent rate than non-Hispanic whites (65.8% versus 47.8%; OR = 1.26; 95% CI 0.89-1.77). Given the preponderance of US sites, the vast majority of these individuals from minority groups were African-Americans or Hispanics from the US.ConclusionsWe found very small differences in the willingness of minorities, most of whom were African-Americans and Hispanics in the US, to participate in health research compared to non-Hispanic whites. These findings, based on the research enrollment decisions of over 70,000 individuals, the vast majority from the US, suggest that racial and ethnic minorities in the US are as willing as non-Hispanic whites to participate in health research. Hence, efforts to increase minority participation in health research should focus on ensuring access to health research for all groups, rather than changing minority attitudes.
| S-EPMC1298944 | biostudies-literature
Project description:We performed a whole-genome association study of human immunodeficiency virus type 1 (HIV-1) set point among a cohort of African Americans (n = 515), and an intronic single-nucleotide polymorphism (SNP) in the HLA-B gene showed one of the strongest associations. We use a subset of patients to demonstrate that this SNP reflects the effect of the HLA-B*5703 allele, which shows a genome-wide statistically significant association with viral load set point (P = 5.6 x 10(-10)). These analyses therefore confirm a member of the HLA-B*57 group of alleles as the most important common variant that influences viral load variation in African Americans, which is consistent with what has been observed for individuals of European ancestry, among whom the most important common variant is HLA-B*5701.
| S-EPMC2838940 | biostudies-literature
Project description:BackgroundIn HIV-infected children, viral diversity tends to increase with age in the absence of antiretroviral treatment (ART). We measured HIV diversity in African children (ages 6-36 months) enrolled in a randomized clinical trial comparing two ART regimens (Cohort I of the P1060 trial). Children in this cohort were exposed to single dose nevirapine (sdNVP) at birth.MethodsHIV diversity was measured retrospectively using a high resolution melting (HRM) diversity assay. Samples were obtained from 139 children at the enrollment visit prior to ART initiation. Six regions of the HIV genome were analyzed: two in gag, one in pol, and three in env. A single numeric HRM score that reflects HIV diversity was generated for each region; composite HRM scores were also calculated (mean and median for all six regions).ResultsIn multivariable median regression models using backwards selection that started with demographic and clinical variables, older age was associated with higher HRM scores (higher HIV diversity) in pol (P = 0.005) and with higher mean (P = 0.014) and median (P<0.001) HRM scores. In multivariable models adjusted for age, pre-treatment HIV viral load, pre-treatment CD4%, and randomized treatment regimen, higher HRM scores in pol were associated with shorter time to virologic suppression (P = 0.016) and longer time to study endpoints (virologic failure [VF], VF/death, and VF/off study treatment; P<0.001 for all measures).ConclusionsIn this cohort of sdNVP-exposed, ART-naïve African children, higher levels of HIV diversity in the HIV pol region prior to ART initiation were associated with better treatment outcomes.
| S-EPMC3842253 | biostudies-literature
Project description:Heme oxygenase-1 (HO-1) is an anti-inflammatory enzyme that maintains homeostasis during cellular stress. Given previous findings that shorter length variants of a HO-1 promoter region GT(n) microsatellite polymorphism are associated with increased HO-1 expression in cell lines, we hypothesized that shorter variants would also be associated with increased levels of HO-1 expression, less inflammation and lower levels of inflammation-associated viral replication in human immunodeficiency virus (HIV)-infected subjects. Healthy donors (n = 20) with shorter GT(n) repeats had higher HO-1 mRNA transcript in peripheral blood mononuclear cells stimulated with lipopolysaccharide (r = -0.38, P = 0.05). The presence of fewer GT(n) repeats in subjects with untreated HIV disease was associated with higher HO-1 mRNA levels in peripheral blood (r = -0.41, P = 0.02); similar observations were made in CD14(+) monocytes from antiretroviral-treated subjects (r = -0.36, P = 0.04). In African-Americans, but not Caucasians, greater GT(n) repeats were correlated with higher soluble CD14 levels during highly active antiretroviral therapy (r = 0.38, P = 0.007) as well as higher mean viral load off-therapy (r = 0.24, P = 0.04). These data demonstrate that the HO-1 GT(n) microsatellite polymorphism is associated with higher levels of HO-1 expression and that this pathway may have important effects on the association between inflammation and HIV replication.
| S-EPMC3330188 | biostudies-literature
Project description:BackgroundHIV-1 natural viral suppressors (NVS) are individuals that control HIV replication without antiretrovirals (also know as HIV elite controllers). We have recently shown that these individuals have an elevated rate of hepatitis C virus (HCV) clearance. Given the association of IL28B genotype, specifically the rs12979860 single nucleotide polymorphism (SNP) based CC genotype, with HCV clearance, we studied its association with HIV control in 172 African American HIV subjects and 173 race-matched controls.FindingsThe frequency of the CC genotype was 12.5% in the NVS, 14.7% in the LVL ("low viral load" cohort with 400-20,000 HIV-1 RNA copies/mL), 17.8% in the MHVL ("medium/high viral load" cohort with >20,000 HIV-1 RNA copies/mL), and 11.6% in an HIV-negative cohort. There was no statistical significance in the CC genotype distribution between these cohorts (p= 0.48 between the NVS and non-NVS HIV positive controls, p= 0.85 between NVS and HIV-negatives). We also did not observe any association between CC genotype distribution and HIV RNA viral load, as a continuous measure.ConclusionsThe IL28B CC genotype does not account for the noted HIV control in our specific NVS cohort. Further studies will be needed to determine if a common genetic factor can primarily account for any joint clearance of HCV and control of HIV.
| S-EPMC3170134 | biostudies-literature