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Allen M, Lau CYHVTNSocial Science & Medicine2/1/2008http://www.ncbi.nlm.nih.gov/pubmed/1816227218162272

​​Preventive HIV vaccine trial participants may experience problems related to trial participation, including difficulties with personal relationships, employment, education, health care, housing, health insurance, disability insurance, life insurance, travel or immigration. During the 19 years that the U.S.-based National Institute of Allergy and Infectious Diseases (NIAID) has conducted preventive HIV vaccine trials, we have developed a model to prevent and resolve social impact related to study participation and assist study participants who report such events. Key elements of the model include: informing potential volunteers of risks prior to enrollment; standardizing data collection methods on social impact events; reviewing and following-up on reported social impact events; assisting participants, including provision of free HIV testing to differentiate HIV infection from vaccine-induced HIV antibody; implementing broad-based and targeted community education programs for achieving community support; communicating with scientific and health care communities; and working with government agencies, non-government agencies and industry on mechanisms to address SI. This approach, established in collaboration with NIAID-funded clinical trial groups, serves as a model for prevention, assessment, monitoring, and intervention for social impact related to preventive HIV vaccine clinical trial participation. Although further research is necessary, this model could be adapted for use in different clinical trials.

 

Risk Assessment, Recruitment & Retention
  
Rerks-Ngarm S, Pitisuttithum P, Nitayaphan SOtherNew England Journal of Medicine12/3/2009http://www.ncbi.nlm.nih.gov/pubmed/19843557http://www.nejm.org/doi/full/10.1056/NEJMoa090849219843557

BACKGROUND: The development of a safe and effective vaccine against the human immunodeficiency virus type 1 (HIV-1) is critical to pandemic control.
METHODS: In a community-based, randomized, multicenter, double-blind, placebo-controlled efficacy trial, we evaluated four priming injections of a recombinant canarypox vector vaccine (ALVAC-HIV [vCP1521]) plus two booster injections of a recombinant glycoprotein 120 subunit vaccine (AIDSVAX B/E). The vaccine and placebo injections were administered to 16,402 healthy men and women between the ages of 18 and 30 years in Rayong and Chon Buri provinces in Thailand. The volunteers, primarily at heterosexual risk for HIV infection, were monitored for the coprimary end points: HIV-1 infection and early HIV-1 viremia, at the end of the 6-month vaccination series and every 6 months thereafter for 3 years.
RESULTS: In the intention-to-treat analysis involving 16,402 subjects, there was a trend toward the prevention of HIV-1 infection among the vaccine recipients, with a vaccine efficacy of 26.4% (95% confidence interval [CI], -4.0 to 47.9; P=0.08). In the per-protocol analysis involving 12,542 subjects, the vaccine efficacy was 26.2% (95% CI, -13.3 to 51.9; P=0.16). In the modified intention-to-treat analysis involving 16,395 subjects (with the exclusion of 7 subjects who were found to have had HIV-1 infection at baseline), the vaccine efficacy was 31.2% (95% CI, 1.1 to 52.1; P=0.04). Vaccination did not affect the degree of viremia or the CD4+ T-cell count in subjects in whom HIV-1 infection was subsequently diagnosed.
CONCLUSIONS: This ALVAC-HIV and AIDSVAX B/E vaccine regimen may reduce the risk of HIV infection in a community-based population with largely heterosexual risk. Vaccination did not affect the viral load or CD4+ count in subjects with HIV infection. Although the results show only a modest benefit, they offer insight for future research. (ClinicalTrials.gov number, NCT00223080.)

Vaccines
  
Amirkhanian YA, Kuznetsova AV, Kelly JAOtherJournal of Immigrant & Minority Health8/6/2010http://www.ncbi.nlm.nih.gov/pubmed/20690041http://www.springerlink.com/content/l49j8r5383h89w3q/fulltext.pdf20690041

​Although the dire life circumstances of labor migrants working in Russia are well-known, their HIV risk vulnerability and prevention needs are understudied. Low socioeconomic status, lack of access to services, separation from family, and limited risk awareness all contribute to migrants' HIV vulnerability. Male labor migrants in St. Petersburg (n = 499) were administered assessments of their sexual behavior practices, substance use, and psychosocial characteristics related to risk and well-being. Thirty percent of migrants reported multiple female partners in the past 3 months. Condom use was low, ranging from 35% with permanent to 52% with casual partners. Central Asian migrants had very low AIDS knowledge, low levels of substance use, moderate sexual risk, high depression, and poor social supports. Eastern European migrants had higher AIDS knowledge, alcohol and drug use, and sexual risk. Improved HIV prevention efforts are needed to reduce the risk vulnerability of migrants who relocate to high disease prevalence areas.

 

Risk Assessment
  
Bärnighausen, TillaAIDS10/13/2010http://www.ncbi.nlm.nih.gov/pubmed/2098087020980870

Antiretroviral treatment (ART) of HIV infection has been considered a potential HIV prevention method since the early 1990s [1,2]. The 2009 modeling study by Granich et al. [3], which predicted that universal HIV testing of sexually active adults and immediate initiation of all HIVinfected individuals on ART could substantially reduce HIV incidence, has put treatment-as-prevention firmly on the HIV prevention agenda [4,5]. Trials of treatmentas-prevention will begin this year in New York and Washington, DC, and several research institutions are currently requesting funding to develop and conduct such trials in hyperendemic communities in sub-Saharan Africa (SSA) [6].​

Risk Assessment
  
Beyrer C, Baral SD, Walker DOtherEpidemiologic Reviews6/23/2010http://www.ncbi.nlm.nih.gov/pubmed/20573756http://epirev.oxfordjournals.org/content/32/1/137.full.pdf+html20573756

Men who have sex with men (MSM) have borne a disproportionate burden of human immunodeficiency virus (HIV) infection and remain a markedly underresourced population globally. To better describe HIV epidemics among MSM in low- and middle-income countries, the authors conducted a systematic review of published and unpublished literature available after January 1, 2000 (2000-2009). A total of 133 HIV prevalence studies from 50 countries met the search criteria. Data were used to develop an algorithmic approach to categorize these epidemics. The authors found that the HIV epidemic in low- and middle-income countries may be described using the following 4 scenarios: 1) settings where MSM are the predominant contributor to HIV cases; 2) settings where HIV transmission among MSM occurs in the context of epidemics driven by injection drug users; 3) settings where HIV transmission among MSM occurs in the context of well-established HIV transmission among heterosexuals; and 4) settings where both sexual and parenteral modes contribute significantly to HIV transmission. The authors focused on Peru, Ukraine, Kenya, and Thailand to describe the diversity across and similarities between proposed epidemic scenarios. This scenario-based categorization of HIV epidemics among MSM may assist public health agencies and civil societies to develop and implement better-targeted HIV prevention programs and interventions.

MSM, Substance Abuse
  
Bissessor M, Fairley CK, Leslie DOtherJAIDS Journal of Acquired Immune Deficiency Syndromes10/1/2010http://www.ncbi.nlm.nih.gov/pubmed/2058526120585261

BACKGROUND: Syphilis continues to be a significant public health problem among HIV-positive men who have sex with men (MSM) internationally. This study aimed to determine whether the routine inclusion of syphilis serology with every blood test performed as part of HIV monitoring increases the detection of early asymptomatic syphilis among HIV-positive MSM.
METHODS: We examined the effect of this intervention, implemented in January 2007, on the detection of early asymptomatic syphilis among HIV-positive MSM attending the Melbourne Sexual Health Centre, Australia, and compared this with the previous clinic policy of annual syphilis screening.
RESULTS: In the 18 months before and after the intervention, the median number of syphilis tests performed per man per year was 1 and 2, respectively. The proportion of MSM diagnosed with early syphilis who were asymptomatic was 21% (3 of 14) and 85% (41 of 48) for the 2 respective periods (P = 0.006). The time between the midpoint since last syphilis serology and diagnosis of syphilis was a median of 107 days (range 9-362) and 45 days (range 23-325) for the 2 periods, respectively (P = 0.018).
CONCLUSIONS: The inclusion of routine syphilis serology with every blood test performed as part of HIV monitoring in HIV-positive MSM resulted in a large increase in the proportion of men diagnosed with early asymptomatic syphilis. This simple intervention probably also decreased the duration of infectiousness, enhancing syphilis control while also reducing morbidity.

MSM, HIV screening, syphilis
  
Brentlinger PE, Torres JV, Martínez PMOtherJAIDS Journal of Acquired Immune Deficiency Syndromes11/1/2010http://www.ncbi.nlm.nih.gov/sites/entrez20562630

INTRODUCTION: In Mozambique, clinical staging may be the primary determinant of HIV/AIDS treatment decisions, and the task of staging commonly falls to nonphysician clinicians (técnicos de medicina). Two years after the first Mozambican técnicos were trained in HIV/AIDS care, the quality of their performance in clinical staging was unknown.
METHODS: Expert clinicians observed 127 clinical encounters conducted by a randomly selected national sample of 44 técnicos and compared observed clinical staging decisions to World Health Organization and Mozambican national norms. They also reviewed relevant Mozambican in-service training curricula in HIV/AIDS care.
RESULTS: Observers agreed with fewer than half (44.1%) of the técnicos' stage-defining diagnoses. Misclassification or misdiagnosis of 3 complaints (weight loss, fever, and diarrhea) accounted for the majority of the observed errors. Review of health worker curricula determined that observed staging errors reflected content errors and omissions in the técnicos' in-service HIV/AIDS training and constraints in local laboratory and imaging capacity.
DISCUSSION: In response to these findings, the Mozambican Ministry of Health has revised the técnicos' scope of work and has developed new guidelines, curriculum materials, and training strategies to improve the quality of clinical staging and opportunistic infection diagnosis in Mozambique.

Mozambique, treatment staging
  
Hook E., Milan J.Other11/1/2009http://www.cdc.gov/hiv/strategic_planning/pdf/exec-summary.pdf
CDCSurveillance
  
CDCOtherMMWR6/25/2010http://www.cdc.gov/mmwr/PDF/wk/mm5924.pdf

CDCScreening and testing
  
CDCOtherMMWR9/24/2010http://www.cdc.gov/mmwr/PDF/wk/mm5937.pdf
CDCMSM
  
Coates TJ, Richter L, Caceres CHPTNLancet8/23/2008http://www.ncbi.nlm.nih.gov/pubmed/1868745918687459

This paper makes five key points. First is that the aggregate effect of radical and sustained behavioural changes in a sufficient number of individuals potentially at risk is needed for successful reductions in HIV transmission. Second, combination prevention is essential since HIV prevention is neither simple nor simplistic. Reductions in HIV transmission need widespread and sustained efforts, and a mix of communication channels to disseminate messages to motivate people to engage in a range of options to reduce risk. Third, prevention programmes can do better. The effect of behavioural strategies could be increased by aiming for many goals (eg, delay in onset of first intercourse, reduction in number of sexual partners, increases in condom use, etc) that are achieved by use of multilevel approaches (eg, couples, families, social and sexual networks, institutions, and entire communities) with populations both uninfected and infected with HIV. Fourth, prevention science can do better. Interventions derived from behavioural science have a role in overall HIV-prevention efforts, but they are insufficient when used by themselves to produce substantial and lasting reductions in HIV transmission between individuals or in entire communities. Fifth, we need to get the simple things right. The fundamentals of HIV prevention need to be agreed upon, funded, implemented, measured, and achieved. That, presently, is not the case.

 

Risk Reduction Counseling
  
Powers KA, Poole C, Pettifor AE, Cohen M.HPTNLancet9/8/2008http://www.ncbi.nlm.nih.gov/pubmed/18684670http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2744983/?tool=pubmed18684670

Studies of cumulative HIV incidence suggest that cofactors such as genital ulcer disease, HIV disease stage, and male circumcision influence HIV transmission; however, the heterosexual infectivity of HIV-1 is commonly cited as a fixed value (approximately 0.001, or one transmission per 1000 contacts). We sought to estimate transmission cofactor effects on the heterosexual infectivity of HIV-1 and to quantify the extent to which study methods have affected infectivity estimates. We undertook a systematic search (up to April 27, 2008) of PubMed, Web of Science, and relevant bibliographies to identify articles estimating the heterosexual infectivity of HIV-1. We used meta-regression and stratified random-effects meta-analysis to assess differences in infectivity associated with cofactors and study methods. Infectivity estimates were very heterogeneous, ranging from zero transmissions after more than 100 penile-vaginal contacts in some serodiscordant couples to one transmission for every 3.1 episodes of heterosexual anal intercourse. Estimates were only weakly associated with study methods. Infectivity differences, expressed as number of transmissions per 1000 contacts, were 8.1 (95 % CI 0.4-15.8) when comparing uncircumcised to circumcised susceptible men, 6.0 (3.3-8.8) comparing susceptible individuals with and without genital ulcer disease, 1.9 (0.9-2.8) comparing late-stage to mid-stage index cases, and 2.5 (0.2-4.9) comparing early-stage to mid-stage index cases. A single value for the heterosexual infectivity of HIV-1 fails to reflect the variation associated with important cofactors. The commonly cited value of 0.001 was estimated among stable couples with low prevalences of high-risk cofactors, and represents a lower bound. Cofactor effects are important to include in epidemic models, policy considerations, and prevention messages.

Adherence
  
Cooper CJ, Metch B, Dragavon JHVTNJAMA7/21/2010http://www.ncbi.nlm.nih.gov/pubmed/2063956120639561

CONTEXT: Induction of protective anti-human immunodeficiency virus (HIV) immune responses is the goal of an HIV vaccine. However, this may cause a reactive result in routine HIV testing in the absence of HIV infection.

OBJECTIVE: To evaluate the frequency of vaccine-induced seropositivity/reactivity (VISP) in HIV vaccine trial participants.
DESIGN, SETTING, AND PARTICIPANTS: Three common US Food and Drug Administration-approved enzyme immunoassay (EIA) HIV antibody kits were used to determine VISP, and a routine diagnostic HIV algorithm was used to evaluate VISP frequency in healthy, HIV-seronegative adults who completed phase 1 (n = 25) and phase 2a (n = 2) vaccine trials conducted from 2000-2010 in the United States, South America, Thailand, and Africa.
MAIN OUTCOME MEASURE: Vaccine-induced seropositivity/reactivity, defined as reactive on 1 or more EIA tests and either Western blot-negative or Western blot-indeterminate/atypical positive (profile consistent with vaccine product) and HIV-1-negative by nucleic acid testing.
RESULTS: Among 2176 participants free of HIV infection who received a vaccine product, 908 (41.7%; 95% confidence interval [CI], 39.6%-43.8%) had VISP, but the occurrence of VISP varied substantially across different HIV vaccine product types: 399 of 460 (86.7%; 95% CI, 83.3%-89.7%) adenovirus 5 product recipients, 295 of 552 (53.4%; 95% CI, 49.2%-57.7%) recipients of poxvirus alone or as a boost, and 35 of 555 (6.3%; 95% CI, 4.4%-8.7%) of DNA-alone product recipients developed VISP. Overall, the highest proportion of VISP (891/2176 tested [40.9%]) occurred with the HIV 1/2 (rDNA) EIA kit compared with the rLAV EIA (150/700 tested [21.4%]), HIV-1 Plus O Microelisa System (193/1309 tested [14.7%]), and HIV 1/2 Peptide and HIV 1/2 Plus O (189/2150 tested [8.8%]) kits. Only 17 of the 908 participants (1.9%) with VISP tested nonreactive using the HIV 1/2 (rDNA) kit. All recipients of a glycoprotein 140 vaccine (n = 70) had VISP, with 94.3% testing reactive with all 3 EIA kits tested. Among 901 participants with VISP and a Western blot result, 92 (10.2%) had a positive Western blot result (displaying an atypical pattern consistent with vaccine product), and 592 (65.7%) had an indeterminate result. Only 8 participants with VISP received a vaccine not containing an envelope insert.
CONCLUSIONS: The induction of VISP in HIV vaccine recipients is common, especially with vaccines containing both the HIV-1 envelope and group-specific core antigen gene proteins. Development and detection of VISP appear to be associated with the immunogenicity of the vaccine and the EIA assay used.

VISP
  
Currier J, Averitt Bridge D, Hagins DACTGAnnals of Internal Medicine9/21/2010http://www.ncbi.nlm.nih.gov/pubmedhttp://www.annals.org/content/153/6/349.long20855799

BACKGROUND: Women account for an increasing proportion of patients with HIV-1 but remain underrepresented in antiretroviral clinical trials.

OBJECTIVE: To evaluate sex-based differences in efficacy and adverse events in treatment-experienced, HIV-positive women and men receiving darunavir-ritonavir therapy over 48 weeks.

DESIGN: Multicenter, open-label, phase 3b study designed to enroll a high proportion of women, with sample size determined on the basis of a noninferiority design with a maximum allowable difference of 15% in virologic response favoring men. (ClinicalTrials.gov registration number: NCT00381303)
SETTING: 65 sites in the United States, Puerto Rico, and Canada.
PATIENTS: 287 women and 142 men.
INTERVENTION: Patients received darunavir-ritonavir, 600/100 mg twice daily, plus an investigator-selected optimized background regimen.
MEASUREMENTS: Virologic response (HIV RNA <50 copies/mL using a time-to-loss of virologic response [TLOVR] algorithm) and adverse events were assessed over 48 weeks.
RESULTS: 67% of patients were women; 84% of patients were black or Hispanic. A higher proportion of women discontinued treatment than men (32.8% vs. 23.2%; P = 0.042); more women than men discontinued treatment for reasons other than virologic failure. Response rates in women and men at week 48 were 50.9% and 58.5%, respectively (intention-to-treat TLOVR), and 73.0% and 73.5%, respectively (TLOVR censored for patients who withdrew for reasons other than virologic failure). The absolute difference in response, based on logistic regression and adjusted for baseline log(10) viral load and CD4(+) cell count, was -9.6 percentage points (95% CI, -19.9 to 0.7 percentage points; P = 0.067) for intention-to-treat TLOVR and -3.9 percentage points (CI, -13.9 to 6.0 percentage points; P = 0.438) for TLOVR population that censored patients who withdrew for reasons other than virologic failure. Adverse events were similar between the sexes. The most common grade 2 to 4 adverse events that were considered at least possibly treatment related in women and men were nausea (5.2% and 2.8%, respectively), diarrhea (4.5% and 4.9%, respectively), and rash (2.1% and 2.8%, respectively).
LIMITATION: Baseline characteristics differed between sexes.
CONCLUSION: Nonsignificant, sex-based differences in response were found during the 48-week study; however, these differences were probably due to higher discontinuation rates in women, suggesting that additional efforts are needed to retain women in clinical trials.

Women
  
DiClemente RJ, Ruiz MS, Sales JMNICHDJAIDS7/1/2010http://www.ncbi.nlm.nih.gov/pubmed/2057141820571418

OBJECTIVES: The inclusion of adolescents in HIV prevention clinical research has the potential to improve the current understanding of the safety and efficacy of biomedical prevention technologies in younger populations that are at increasing risk of HIV infection. However, there are significant individual, operational, and community-level barriers to engaging adolescents in clinical prevention trials.
METHODS: This paper identifies and addresses individual, operational, and community-level barriers to adolescents' participation in HIV biomedical prevention research.
RESULTS: Barriers identified and addressed in this paper include: (1) insufficient understanding of clinic prevention research, (2) self-presentation bias, (3) issues surrounding parental consent, (4) access to clinical trials, (5) mistrust of research, and (6) stigma associated with participation in clinical trials. Examples of programs where adolescents have been successfully engaged in prevention research are highlighted and the lessons learned from these programs indicate that establishing collaborations with key stakeholders in the community are essential for conducting biomedical research with vulnerable populations, including adolescents.
CONCLUSIONS: Given the importance of understanding adolescents' reactions, acceptability, and utilization of new biomedical prevention technologies it is imperative that researchers acknowledge and address these barriers to enhance adolescents' participation and retention in HIV biomedical prevention research.

Recruitment & Retention, Youth
  
Ellen JM, Wallace M, Sawe FKOtherJAIDS7/1/2010http://www.ncbi.nlm.nih.gov/pubmed20571425

There has been a growing awareness of the importance of engaging communities in the development, testing, and eventual dissemination of biomedical strategies. Community engagement offers many benefits but comes with many challenges. This article will discuss these benefits and challenges and describe two examples of community engagement, Connect to Protect in the United States, and the South African Studies on HIV in Adolescents Project in South Africa, that represent investment in community engagement as preparation for biomedical HIV prevention clinical trials for youth.

Recruitment & Retention, Community Engagement; Youth
  
Eyawo O, de Walque D, Ford NOtherLancet11/1/2010http://www.ncbi.nlm.nih.gov/pubmed/2092634720926347

BACKGROUND: Most couples affected by HIV/AIDS in sub-Saharan Africa live in discordant relationships. Men are thought to be the index case in most relationships, and most social marketing and awareness campaigns are focused on men. We investigated serodiscordance in stable relationships to establish the gender balance of index-case infections.

METHODS: We did a systematic review, random-effects meta-analysis, and meta-regression of published and unpublished studies enrolling discordant couples and assessed the proportion of men and women that were index cases. We repeated the analysis with data from demographic and health surveys (DHS) from the 14 countries that have documented the HIV status of couples. Our primary outcome was the total number of HIV discordant couples, including the proportion of HIV-positive women.
FINDINGS: We included data from 27 cohorts of 13,061 couples and DHS data from 14 countries of 1145 couples. The proportion of HIV-positive women in stable heterosexual serodiscordant relationships was 47% (95% CI 43-52), which shows that women are as likely as men to be the index partner in a discordant couple. DHS data (46%, 41-51) and our sensitivity analysis (47%, 43-52) showed similar findings. Meta-regression showed that urban versus rural residence (odds ratio 0.31, 95% CI 0.22-0.39), latitude (β coefficient 0.02, 0.023-0.034), gender equality (β coefficient -0.42, -0.56 to -0.27), HIV prevalence (β coefficient -0.037, -0.04 to -0.030), and older age (β coefficient 0.20, 0.08-0.32) were associated with the proportion of female index cases.
INTERPRETATION: Our study shows the need to focus on both sexes in HIV prevention strategies, such as promotion of condom use and mitigation of risk behaviours.

Serodiscordant Couples
  
Fernandez F., Goforth HOtherFrontiers in HIV and AIDS in Psychiatry5/10/2010http://www.frontiersin.org/hiv_and_aids_in_psychiatry/10.3389/fpsyt.2010.00006/full
Mental Health; Standards of Care and Treatment
  
Frew PM, del Rio C, Clifton SOtherJournal of Community Health8/1/2008http://www.ncbi.nlm.nih.gov/pubmed/18389351http://www.springerlink.com/content/x413781731411813/18389351

The purpose of this exploratory study was to examine personal characteristics, socio-environmental conditions, and motivational factors that potentially influence HIV vaccine research community engagement. Specifically, the study identified predictive aspects that may aid in future community program development on HIV vaccine issues. A cross-sectional survey consisting of evaluative measures, demographics, social interaction, and health information-seeking behaviors was conducted. Participants were a diverse group of 452 adults (≥18 years) at HIV vaccine awareness-building and community education gatherings in Atlanta. The sample included large numbers of women (n = 251) and minorities (n = 224). In multivariate analysis, the overall logistic regression model was significant, with a resulting coefficient of determination (Nagelkerke R 2) of .505. Highly significant factors included an excellent activity/event rating (log odds β = 4.521, P < .001), White race (β = −.835, P = .005), greater educational attainment (β = .725, P = .011), travel distance (β = 1.186, P = .002), and excellent perception of the study site (β = 2.131, P < .001). Subgroup analyses by gender and race revealed similar findings. These data demonstrate the importance of building a favorable study site image and gaining familiarity in the community to aid in the promotion of HIV vaccine research on an ongoing basis.

 

Racial Disparities, Recruitment & Retention
  
Gandhi M, Ameli N, Gange SJOther
  
Schackman B.OtherJAIDS12/1/2010http://www.ncbi.nlm.nih.gov/sites/entrez/2104559621045596

Implementation science is the scientific study of methods to promote the integration of research findings and evidence-based interventions into health care policy and practice and hence to improve the quality and effectiveness of health services and care. Implementation science is distinguished from monitoring and evaluation by its emphasis on the use of the scientific method. The origins of implementation science include operations research, industrial engineering, and management science. Today, implementation science encompasses a broader range of methods and skills including decision science and operations research, health systems research, health outcomes research, health and behavioral economics, epidemiology, statistics, organization and management science, finance, policy analysis, anthropology, sociology, and ethics. Examples of implementation science research are presented for HIV prevention (prevention of mother-to-child transmission of HIV, male circumcision) and HIV and drug use (syringe distribution, treating drug users with antiretroviral therapy and opioid substitution therapy). For implementation science to become an established field in HIV/AIDS research, there needs to be better coordination between funders of research and funders of program delivery and greater consensus on scientific research approaches and standards of evidence.

Adherence, Implementation Sciences
  
Dombrowski JC, Kerani RP, Stekler JDOtherJAIDS12/1/2010http://www.ncbi.nlm.nih.gov/pubmed/2085612920856129

We examined antiretroviral therapy (ART) use among 501 previously diagnosed HIV-infected men who have sex with men who sought care at a sexually transmitted disease clinic in King County, WA, during 2004-2008. Overall, 42% of men were not taking ART, 71% of whom had CD4 counts >350 cells per microliter. Of those who reported unprotected anal intercourse with a partner of nonconcordant HIV status in the prior year, 48% were not taking ART (78% with CD4 counts >350 cells/μL). Sexually transmitted disease clinics may be an important venue in which to identify persons who are not taking ART. Treating these persons could help diminish HIV transmission.

 

Adherence, MSM, Serodiscordant Couples
  
Hansudewechakul R, Sirisanthana V, Kurniati NOtherJAIDS12/1/2010http://www.ncbi.nlm.nih.gov/pubmed/2084204320842043

INTRODUCTION: We report responses to combination antiretroviral therapy (cART) in the Therapeutics Research, Education, and AIDS Training in Asia Pediatric HIV Observational Database.
METHODS: Children included were those who had received cART (ie, ≥3 antiretrovirals) at <18 years. The analysis was intention-to-treat by the first cART regimen. Median values are provided with interquartile ranges; hazard ratios (HRs) with 95% confidence intervals.
RESULTS: Of the 1655 children included, 50.4% were male, with a median age at cART of 7.0 (3.9-9.8) years and CD4 of 8% (2.0%-15%); 92.5% were started on an NNRTI; median duration of follow-up was 2.9 (1.4-4.6) years. Loss-to-follow-up and death rates were 4.2 (3.7-4.8) and 2.1 (1.7-2.5) per 100 person-years, respectively. At 36 months, median CD4 was 26% (21%-31%); 81% of those with viral load (n = 302) were <400 copies per milliliter. Children who reached CD4 ≥25% within 5 years were more likely to be females (HR: 1.4; 1.2-1.7), start before 18 months old (HR: 3.8; 2.4-6.2), lack a history of monotherapy/dual therapy (HR: 1.7; 1.4-2.5), and have a higher baseline CD4 (per 10% increase: HR: 2; 1.9-2.2).
CONCLUSIONS: These data underscore the need for early diagnosis and cART initiation to preserve immune function.

Adherence, Children
  
Glick SN, Golden MROtherJAIDS12/1/2010http://www.ncbi.nlm.nih.gov/pubmed/2083822620838226

BACKGROUND: Stigma may mediate some of the observed disparity in HIV infection rates between black and white men who have sex with men (MSM).
METHODS: We used data from the General Social Survey to describe race-specific trends in the US population's attitude toward homosexuality, reporting of male same-sex sexual behavior, and behaviors that might mediate the relationship between stigma and HIV transmission among MSM.
RESULTS: The proportion of blacks who indicated that homosexuality was "always wrong" was 72.3% in 2008, largely unchanged since the 1970s. In contrast, among white respondents, this figure declined from 70.8% in 1973 to 51.6% in 2008 with most change occurring since the early 1990s. Participants who knew a gay person were less likely to have negative attitudes toward homosexuality (relative risk, 0.60; 95% confidence interval, 0.52 to 0.69). Among MSM, twice as many black MSM reported that homosexuality is "always wrong" compared with white MSM (57.1% versus 26.8%, P = 0.003). MSM with unfavorable attitudes toward homosexuality were less likely to report ever testing for HIV compared with MSM with more favorable attitudes (relative risk, 0.50; 95% confidence interval, 0.31 to 0.78).
CONCLUSIONS: US attitudes toward homosexuality are characterized by persistent racial differences, which may help explain disparities in HIV infection rates between black and white MSM.

Racial Disparities
  
Hong SY, Jonas A, Dumeni EOtherJAIDS12/1/2010http://www.ncbi.nlm.nih.gov/pubmed/2083822420838224

INTRODUCTION: HIV drug resistance (HIVDR) testing is not routinely available in many resource-limited settings, therefore, antiretroviral therapy (ART) program and site factors known to be associated with HIVDR should be monitored to optimize the quality of patient care and minimize the emergence of preventable HIVDR.
METHODS: In 2009, Namibia selected 5 World Health Organization Early Warning Indicators (EWIs) and piloted abstraction at 9 ART sites: "ART prescribing practices, patients lost to follow-up at 12 months, patient retention on first-line ART at 12 months, on-time antiretroviral drug pick-up, and antiretroviral drug-supply continuity".
RESULTS: Records supported monitoring of 3 of 5 selected EWIs. Nine of 9 (100%) sites met the target of 100% initiated on appropriate first-line regimens. Eight of 9 (89%) sites met the target of ≤20% lost to follow-up, although 20.8% of ART starters (range: 4.6%-44.6%) had a period of absence without documented ART coverage of 2.3 months (range: 1.5-3.9 months). Six of 9 (67%) sites met the target of 0% switched to a second-line regimen.
CONCLUSIONS: EWI monitoring directly resulted in public health action which will optimize the quality of care, specifically the strengthening of ART record systems permitting monitoring of 5 EWIs in future years and protocols for improved ART patient defaulter tracing.

HIVDR
  
Fung Chow EP, Wilson DP, Zhang LOtherJAIDS12/1/2010http://www.ncbi.nlm.nih.gov/pubmed/2105199121051991
MSM
  
Lester RT, Ritvo P, Mills EOtherLancet11/10/2010http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)61997-6/fulltext

 

 

Adherence
  
Busch MP, Pilcher CD, Mastro TDOtherAIDS11/27/2010http://www.ncbi.nlm.nih.gov/pubmed/20975514
Adherence
  
Rose CD, Courtenay-Quirk C, Knight KOtherJAIDS9/8/2010http://www.ncbi.nlm.nih.gov/pubmed/2082721820827218

Clinician-delivered prevention interventions offer an opportunity to integrate risk-reduction counseling as a routine part of medical care. The HIV Intervention for Providers study, a randomized controlled trial, developed and tested a medical provider HIV prevention training intervention in 4 northern California HIV care clinics. Providers were assigned to either the intervention or control condition (usual care). The intervention arm received a 4-hour training on assessing sexual risk behavior with HIV-positive patients and delivering risk-reduction-oriented prevention messages to patients who reported risk behaviors with HIV-uninfected or unknown-status partners. To compare the efficacy of the intervention versus control on transmission risk behavior, 386 patients of the randomized providers were enrolled. Over six-months of follow-up, patients whose providers were assigned the intervention reported a relative increase in provider-patient discussions of safer sex (OR = 1.49; 95% CI = 1.06 to 2.09), assessment of sexual activity (OR = 1.60; 95% CI = 1.05 to 2.45), and a significant decrease in the number of sexual partners (OR = 0.49, 95% CI = 0.26 to 0.92). These findings show that a brief intervention to train HIV providers to identify risk and provide a prevention message results in increased prevention conversations and significantly reduced the mean number of sexual partners reported by HIV-positive patients.

Risk Reduction Counseling
  
Young SD, Hlavka Z, Modiba PHPTNJAIDS10/27/2010http://www.ncbi.nlm.nih.gov/pubmed/2098091320980913

OBJECTIVE: HIV testing is necessary to curb the increasing epidemic. However, HIV-related stigma and perceptions of low likelihood of societal HIV testing may reduce testing rates. This study aimed to explore this association in South Africa, where HIV rates are extraordinarily high.
METHODS: Data were taken from the Soweto and Vulindlela, South African sites of Project Accept, a multinational HIV prevention trial. Self-reported HIV testing, stigma, and social norms items were used to study the relationship between HIV testing, stigma, and perceptions about societal testing rates. The stigma items were broken into 3 factors: negative attitudes, negative perceptions about people living with HIV, and perceptions of fair treatment for people living with HIV (equity).
RESULTS: Results from a univariate logistic regression suggest that history of HIV testing was associated with decreased negative attitudes about people living with HIV/AIDS, increased perceptions that people living with HIV/AIDS experience discrimination, and increased perceptions that people with HIV should be treated equitably. Results from a multivariate logistic regression confirm these effects and suggest that these differences vary according to sex and age. Compared with people who had never tested for HIV, those who had previously tested were more likely to believe that the majority of people have tested for HIV.
CONCLUSIONS: Data suggest that interventions designed to increase HIV testing in South Africa should address stigma and perceptions of societal testing.

Stigma