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Background and Objective To evaluate the association between the nature of findings and the switching of registered primary outcomes among randomized controlled trials (RCTs) from mainland China. Methods This is a retrospective cohort study. We retrieved RCTs from trial registries and identified the corresponding journal articles from bibliographic databases until August 2019. Trial registries and journal articles were compared to evaluate whether registered primary outcomes with negative findings were more likely to be switched to secondary outcomes in the subsequent journal articles than those with positive findings. Results Switching of registered primary outcomes occurred in 131 (45%) of 294 RCTs. A total of 450 registered primary outcomes were matched to 522 (37%) primary outcomes and 871 (63%) secondary outcomes in the journal articles. Among RCTs registered before they started, the odds of switching primary outcomes with negative findings were 2.64 (95% CI: 1.16–6.02) times the odds of switching those with positive findings. Among RCTs registered when they were ongoing, the odds of switching primary outcomes with negative findings were 8.84 (95% CI: 3.62–25.93) times the odds of switching those with positive findings. Conclusion The nature of findings may play a role in how likely a prespecified primary outcome is switched subsequently.

Background: Only the independent effect of human immunodeficiency virus (HIV)-infection on coronary artery disease (CAD) has been investigated in cross-section studies, while rather than directly, HIV-infection may accelerate CAD through promoting the effects of risk factors. Furthermore, there is no information on the potential effects of HIV-infection on coronary plaque volumes. Therefore, we investigated whether HIV-infection directly or indirectly promotes clinical and volumetric characteristics of CAD in a observational longitudinal study. Methods: 300 individuals without cardiovascular symptoms (210 male; age: 48·0±7·2 years; 226 HIV-infected) underwent coronary CT angiography at two time points (mean follow-up: 4·0±2·3 years). We quantified Agatston-score, number of coronary plaques, segment stenosis score, and also segmented the coronary plaques to enumerate total, noncalcified (-100–350HU) and calcified (≥351HU) plaque volumes. Linear mixed models were used to assess the effects of HIV-infection, atherosclerotic cardiovascular disease (ASCVD) risk, years of cocaine use and high-sensitivity C-reactive protein on CT markers of CAD. Findings: There was no significant difference in annual progression rates between HIV-infected and -uninfected (p>0·05 for all). Multivariately, HIV-infection was not associated with any CAD parameter (p>0·05 for all). However, among HIV-infected individuals, each year of cocaine use significantly increased all CAD parameters (p

Background Although cocaine use may induce/accelerate HIV-associated comorbidities in HIV-infected individuals on antiretroviral therapy (ART), and that HIV itself may accelerate aging, the issue of whether cocaine use plays a role in HIV-associated aging in HIV-infected cocaine users has not been reported. The goals of this study were (1) to explore factor(s) associated with peripheral blood leukocyte telomere length, a marker of cellular replicative history, and telomere shortening in HIV-infected individuals, and (2) to assess whether cocaine use plays a role in accelerating telomere shortening in cocaine users with HIV infection. Methods Between June 2010 and December 2016, 147 HIV-infected participants in Baltimore, Maryland, were enrolled in a cross-sectional study investigating factor(s) associated with telomere length. Of these 147, 93 participated in a follow-up study to examine factor(s) associated with telomere shortening. Robust regression model was used to analyze cross-sectional data and the generalized estimating equation approach was used to analyze follow-up data. Results Cross-sectional analyses demonstrated that (1) both daily alcohol consumption and use of non-nucleoside reverse transcriptase inhibitors (NNRTIs) were independently associated with telomere length, and cocaine use modified the associations of daily alcohol use and NNRTI use with telomere length. Longitudinal analyses suggested that both daily alcohol consumption and duration of NNRTI use were independently associated with telomere shortening, and (2) cocaine use induced/accelerated telomere shortening in HIV-infected individuals. Conclusions Our findings suggest that cocaine use may promote premature aging in HIV-infected individuals who are on ART. Our results emphasize the importance of cocaine abstinence/reduced use, which may retard HIV-associated premature aging.

This study explores the association between neighborhood social and economic change from 2009 to 2013 and changes in the retail food environment from 2013 to 2017 in Madrid (Spain). We classified neighborhoods into four types: decreasing SES, new housing/gentrifying, increasing SES, and aging (population and housing). Food store data was obtained from a retail spaces census and classified as supermarket, specialized small store, or fruit and vegetable store. Compared to aging areas, new housing/gentrifying and areas with increasing SES had a higher baseline presence and proportion of supermarkets and a lower proportion of specialized stores and fruit and vegetable stores. Areas with decreasing SES had an initially higher presence and proportion of fruit and vegetable stores but showed a declining trend in both presence and proportion of fruit and vegetable stores.

OBJECTIVES: We aim to quantify the longitudinal growth differences during childhood and early adolescence between siblings born at different maternal ages at delivery (adult vs. adolescent/young). METHODS: We analyzed data from siblings of the same biological parents of the young cohort from the Young Lives Study in Peru, over 14 of follow-up. Elder siblings were enrolled at one year of age (2002), while younger siblings were enrolled in the third cohort visit (2009). We include elder siblings who were firstborn only and younger siblings who were second-born children. We performed three-level hierarchical models using Gaussian and Poisson families for height for age Z-score (HAZ) and stunting prevalence, respectively, to estimate predicted values at age 2, 5, 8, and 12. We report absolute marginal average contrasts (Φ) between a younger sibling and elder sibling born to adult (25–34 years) and adolescent/young mothers (15–24 years), respectively. Moreover, we adjust the estimate of interest with expected differences between siblings born to mothers in the same maternal age at delivery group. RESULTS: The total eligible sample included 310 pairs of siblings, where 85% of index children and 65% of younger siblings were born to adolescent/young women. Contrasts between a sibling from an adult mother and a firstborn index were positive up to age 12 for HAZ (Φ: 0.20 95% CI 0.01, 0.39) and negative for stunting (Φ: −5.09% 95% CI −12.28, 2.10). Expected differences between siblings born to adult mothers in the same delivery age group did not substantially change the findings for HAZ (Φ(A): 0.29 95% CI 0.04, 0.53) but increase the magnitude of stunting differences (Φ(A): −9.70% 95% CI −15.40, −4.01). Expected differences between siblings born to adolescent mothers decrease the magnitude of both estimates but remain their direction. CONCLUSIONS: Younger siblings born to adult mothers outperformed older siblings born to adolescent mothers in growth throughout childhood and early adolescence. The long-lasting effects of adolescent pregnancy on their offspring's nutrition ought to be addressed with social policies focused on preventing adolescent pregnancy. FUNDING SOURCES: None.

Background It has been recognized that myocardial and hepatic steatosis may be more prevalent in HIV-infected individuals on antiretroviral therapy (ART); however, factors associated with these conditions have not been thoroughly investigated. The goals of this study were (1) to identify the risk factors for myocardial and hepatic steatosis in HIV-infected African Americans (AAs) and explore whether ART use is independently associated with myocardial and hepatic steatosis, and (2) to examine whether and how cocaine use influences any associations of ART use with myocardial and hepatic steatosis. Methods Between June 2010 and December 2013, 220 HIV-infected AAs in Baltimore, Maryland, were enrolled in a study investigating HIV/ART-associated myocardial and hepatic damage. Proton magnetic resonance spectroscopy was performed to quantify myocardial and hepatic triglyceride contents. Sociodemographic, medical and laboratory data were also obtained. Robust regression model was employed to perform primary statistical analysis. Results Robust regression analyses showed that (1) duration of protease inhibitor (PI) use was independently associated with myocardial and hepatic triglyceride contents, (2) duration of PI use was independently associated with myocardial triglyceride in cocaine users (p = 0.025), but not in cocaine never-users (p = 0.84), and (3) duration of PI use was independently associated with hepatic triglyceride in cocaine users, but not in cocaine never-users (p = 0.52). Conclusions Cocaine use may trigger/exacerbate the toxicity of PI in ART-associated myocardial and hepatic steatosis, suggesting that cocaine abstinence/reduced use may retard these ART-associated comorbidities. Clinical trials should be conducted to examine whether reduced cocaine use improves HIV/AIDS-associated myocardial and hepatic steatosis.

Purpose HIV disproportionately impacts young black men who have sex with men (YBMSM). Preexposure prophylaxis (PrEP) is an effective strategy that can avert new HIV infections in YBMSM. Barriers exist for YBMSM to access PrEP. Methods We sought to determine factors associated with awareness of and willingness to take PrEP in a sample of YBMSM. Results Only 8% were currently on PrEP despite many (66%) reporting condomless anal sex, a recent provider visit (54%), disclosing their sexual orientation to their regular medical provider (62%), or a willingness to take PrEP (62%). In bivariate analysis, increased number of lifetime partners, current PrEP use, and disclosure of sexual orientation to a doctor were associated with awareness of PrEP, while condomless anal sex and higher perceived risk was associated with willingness to take PrEP. Sex with females was associated with lower willingness. Conclusions Providers may be missing key opportunities to educate YBMSM about PrEP and incorporate PrEP into comprehensive sexual health care.

The RV144 Thai vaccine trial has been the only vaccine study to show efficacy in preventing HIV infection. Ongoing molecular surveillance of HIV-1 in Southeast Asia is vital for vaccine development and evaluation. In this study a novel tool, the multi-region subtype specific PCR (MSSP) assay, that was able to identify subtypes B, C, CRF01_AE for Thailand, other Southeast Asian countries, India and China is described. The MSSP assay is based on a nested PCR strategy and amplifies eight short regions distributed along the HIV-1 genome using subtype-specific primers. A panel of 41 clinical DNA samples obtained primarily from opiate users in northern Thailand was used to test the assay performance. The MSSP assay provided 73–100% sensitivity and 100% specificity for the three subtypes in each genome region. The assay was then field-tested on 337 sera from HIV infected northern Thai drug users collected between 1999 and 2002. Subtype distribution was CRF01_AE 77.4% (n = 261), subtype B 3.3% (n = 11), CRF01_AE/B recombinant 12.2% (n = 41), CRF01_AE/C recombinant 0.6% (n = 2), and non-typeable 6.5% (n = 22). The MSSP assay is a simple, cost-effective, and accurate genotyping tool for laboratory settings with limited resources and is sensitive enough to capture the recombinant genomes and dual infections.

Background Buprenorphine/naloxone (BUP/NX), an effective treatment for opioid dependence, has been implicated in hepatic toxicity. However, as persons taking BUP/NX have multiple hepatic risk factors, comparative data are needed to quantify the risk of hepatoxicity with BUP/NX. Methods We compared rates of alanine aminotransferase (ALT) elevation ≥ grade 3 (ALT ≥ 5.1 times the upper limit of normal) and graded bilirubin elevations in HIV-negative opioid injectors randomized to long-term (52 weeks) or short-term (18 days) medication assisted treatment (LT-MAT and ST-MAT, respectively) with BUP/NX in a multisite trial conducted in China and Thailand. ALT and bilirubin were measured at baseline, 12, 26, 40 and 52 weeks, times temporally remote from BUP/NX exposure in the ST-MAT participants. Results Among1036 subjects with at least one laboratory follow-up measurement, 76 (7%) participants experienced ALT elevation ≥ grade 3. In an intent-to-treat analysis, the risk of ALT events was similar in participants randomized to LT-MAT compared with ST-MAT (adjusted hazard ratio 1.25, 95% confidence interval 0.79 to 1.98). This finding was supported by an as-treated analysis, in which actual exposure to BUP/NX was considered. Hepatitis C seroconversion during follow-up was strongly associated with ALT events. Bilirubin elevations ≥ grade 2 occurred in 2% of subjects, with no significant difference between arms. Conclusions Over 52-week follow-up, the risk of hepatotoxicity was similar in opioid injectors receiving brief and prolonged treatment with BUP/NX. These data suggest that most hepatotoxic events observed during treatment with BUP/NX are due to other factors.

Summary Background Use of antiretroviral treatment for HIV-1 infection has decreased AIDS-related morbidity and mortality and prevents sexual transmission of HIV-1. H owever, the best time to initiate antiretroviral treatment to reduce progression of HIV-1 infection or non-AIDS clinical events is unknown. We reported previously that early antiretroviral treatment reduced HIV-1 transmission by 96%. We aimed to compare the eff ects of early and delayed initiation of antiretroviral treatment on clinical outcomes. Methods The HPTN 052 trial is a randomised controlled trial done at 13 sites in nine countries. We enrolled HIV-1-serodiscordant couples to the study and randomly allocated them to either early or delayed antiretroviral treatment by use of permuted block randomisation, stratifi ed by site. Random assignment was unblinded. The HIV-1-infected member of every couple initiated antiretroviral treatment either on entry into the study (early treatment group) or after a decline in CD4 count or with onset of an AIDS-related illness (delayed treatment group). Primary events were AIDS clinical events (WHO stage 4 HIV-1 disease, tuberculosis, and severe bacterial infections) and the following serious medical conditions unrelated to AIDS: serious cardiovascular or vascular disease, serious liver disease, end-stage renal disease, new-onset diabetes mellitus, and non-AIDS malignant disease. Analysis was by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT00074581. Findings 1763 people with HIV-1 infection and a serodiscordant partner were enrolled in the study; 886 were assigned early antiretroviral treatment and 877 to the delayed treatment group (two individuals were excluded from this group af ter randomisation). Median CD4 counts at randomisation were 442 (IQR 373–522) cells per μL in patients assigned to the early treatment group and 428 (357–522) cells per μL in those allocated delayed antiretroviral treatment. In the delayed group, antiretroviral treatment was initiated at a median CD4 count of 230 (IQR 197–249) cells per μL. Primary clinical events were reported in 57 individuals assigned to early treatment initiation versus 77 people allocated to delayed antiretroviral treatment (hazard ratio 0·73, 95% CI 0·52–1·03; p=0·074). New-onset AIDS events were recorded in 40 participants assigned to early antiretroviral treatment versus 61 allocated delayed initiation (0·64, 0·43–0·96; p=0·031), tuberculosis developed in 17 versus 34 patients, respectively (0·49, 0·28–0·89, p=0·018), and primary nonAIDS events were rare (12 in the early group vs nine with delayed treatment). In total, 498 primary and secondary outcomes occurred in the early treatment group (incidence 24·9 per 100 person-years, 95% CI 22·5–27·5) versus 585 in the delayed treatment group (29·2 per 100 person-years, 26·5–32·1; p=0·025). 26 people died, 11 who were allocated to early antiretroviral treatment and 15 who were assigned to the delayed treatment group.

Background Nearly 31% of the world's clinical trials are conducted outside the US and 25% of the new drug applications include data from international sites. The high population growth, demand for medication, increased prevalence of life-style related and rare genetic diseases in the MENA countries should be associated with a consequent scale-up of clinical trials in these countries. However, the region sponsors under 1% of global clinical trials. Methods Determinants including the regulatory environment, patient protection, physician-preparedness, types of diseases, costs of trials and pace of subject recruitment, were analyzed to identify critical factors that influence barriers to the conduct clinical trials in MENA. Results Strategic planning by the CRO can help overcome challenges related to regulatory and oversight requirements. Barriers related to trial quality and subject protection can be mitigated by risk-based monitoring. Growing healthcare infrastructure and communication technologies provide clear advantages for subject recruitment. Low operating costs combined with the increase in pharmaceutical sales provide incentives for the future conduct of clinical trials. Limitations Although the opportunities and challenges cited are common to the MENA region, further studies are needed to assess other potential contributing variables for the conduct of clinical trials specific to each MENA country. Conclusion Challenges in drug importation and site oversight can be overcome with systematic interventions. Social media network and community awareness programs can assist reductions in barriers in obtaining effective informed consents. Increasing pharmaceutical sales, population growth, high prevalence of genetic and life-style related diseases and reduced clinical trial development costs offer expanding opportunities for future clinical trials in MENA.

While urban redevelopment is intended to ameliorate urban decay, some studies demonstrate that it can negatively impact some residents. Few studies have considered its impact on persons with a history of drug use.A convenience sample of 25 current or former injection drug users from Baltimore, Maryland, enrolled in the AIDS Linked to the Intravenous Experience study, and reporting residence in or bordering a redeveloping neighborhood participated in 1-2 semi-structured in-depth interviews from July, 2011 to February, 2012. Interviews explored personal experiences with redevelopment and perceptions of community-wide impact. Data were analyzed using the constant comparison method.Respondents rarely described urban redevelopment as solely negative or positive. Revitalization and increased security in the redeveloping area were reported as positive consequences. Negative consequences included the lack of redevelopment-related employment opportunities, disruption of social ties, and housing instability among relocated residents. Respondents also said that urban redevelopment led to the displacement of drug markets to adjacent neighborhoods and outlying counties. Residential relocation and displacement of drug markets were reported as beneficial for persons in contemplative and later stages of recovery.These findings support a holistic approach to urban redevelopment that increases access to employment opportunities and affordable housing, and ensures equitable coverage of public services such as law enforcement.

Background Buprenorphine/naloxone (BUP/NX) is not licenced for use in China or Thailand and there was little clinical experience with this drug combination in these countries at the inception of HIV Prevention Trial Network (HPTN) 058, a randomized trial comparing risk reduction counselling combined with either short-term or long-term medication assisted treatment with BUP/NX to prevent HIV infection and death amongst opioid-dependent injectors. Methods We conducted a safety phase that included the first 50 subjects enrolled at each of the three initial study sites ( N =150). Clinical and laboratory assessments were conducted at baseline and weekly for the first 4 weeks. Changes in laboratory parameters were estimated with random effects models. Results BUP/NX was well tolerated by study subjects and opioid withdrawal scores decreased substantially during the 3-day induction. Two participants experienced grade 3 clinical adverse events, which were categorized as probably not related to the study drug. Grade 2 or 3 increases in alanine aminotransferase (ALT) occurred in 25 (17%) subjects. The magnitude of ALT increase over 4-week follow-up was strongly associated with baseline ALT elevation. Conclusions In Chinese and Thai opioid-dependent injectors, we found BUP/NX to be effective in reducing opioid withdrawal symptoms and safe during short-term use. ALT increases were observed over 4-week-follow-up, which are consistent with reports from Western populations. Long-term safety and efficacy evaluations are indicated.

The purpose of this study was to examine whether social network factors predict HIV and Hepatitis C (HCV) serostatus after controlling for individual-level factors at baseline among a cohort of male injection drug users in Chennai, India.The sample, which was recruited through street outreach, consists of 1078 males who reported having injected drugs in the last 6 months.The participants reported 3936 social support and risk network members. HIV and HCV positive serostatus were negatively associated with network member providing emotional support, and positively associated with network member providing material support. In addition, HCV positivity was associated with network member being an active drug user known for more than 10 years and network member being male kin networks, even after adjusting for individual demographic factors and risk behaviors.These findings suggest that social network factors are significantly linked to HIV and HCV status among IDUs in Southern India and highlight the mixed effects of social capital on health. Future HIV/HCV prevention efforts should incorporate IDU peers to alter drug network injection risk norms. For drug users who have minimal network support, support groups and other informal and formal support mechanisms may be need to help them with health care and psychological support needs for dealing with HIV/HCV.

With an estimated 2.5 million people living with HIV/AIDS, India has the third highest number of HIV-infected people in the world. Despite reductions in prevalence among the general population, the percentage of all infections occurring among Indian women is continuing to rise. Women's risk of HIV infection from their partner and observed associations between sexual violence and HIV infection in India underscore the importance of understanding determinants of forced sex. A probability survey was conducted from June 2003 to August 2007 in Chennai, India, among alcohol venue ("wine shops") patrons to estimate the prevalence of sexual violence and to identify risk factors associated with perpetrating forced sex. Among 1499 men, 28.5% reported forced sex with at least one partner in the past 3 months. In multivariate analysis, earning income for less than 12 months a year, visiting the wine shop with friends, STD symptoms, perpetration of physical violence, and number of sexual partners were statistically significantly associated with perpetrating forced sex. Men who reported having 3 or more close friends were less likely to perpetrate violence. HIV interventions that facilitate formal groups that foster positive social support and address a range of HIV risk behaviors including sexually and physically abusive behaviors are recommended to reduce sexual violence.

The purpose of this study was to examine the relationship between perceived drug use stigma, acquiescence response bias, and HIV injection risk behaviors among current injection drug users in Chennai, India.The sample consists of 851 males in Chennai, India who reported having injected drugs in the last month and were recruited through street outreach.Results indicate a strong and consistent positive association between drug use stigma and HIV injection drug use risk behaviors. This association held across the injection behaviors of frequency of sharing needles, cookers, cotton filters, rinse water, pre-filled syringes and common drug solutions, even after controlling for acquiescence response bias, frequency of injection, and HIV/HCV serostatus.These findings suggest that future HIV prevention and harm reduction programs for injection drug users and service providers should address drug use stigma.

Sexual risk and STDs are relatively high among injecting drug users (IDUs) in Vietnam. We sought to determine characteristics of sexually active IDUs and correlates of high-risk sexual practices among IDUs in Bac Ninh province in northern Vietnam.We used data collected for a community-based cross-sectional pilot study to identify correlates of recent high-risk sex (1 sex partner and inconsistent/no condom use in the past year). Factors associated with high-risk sex were identified using logistic regression.Among 216 sexually active male IDUs, one third (n=72) had engaged in high-risk sex within the last year. IDUs who reported injecting with others more frequently, having someone else inject their drugs at last injection, sharing needles or sharing any injection equipment were more likely to have reported recent high-risk sex. Factors independently associated with high-risk sexual activity were not injecting oneself [AOR: 2.22; 95% CI (1.09-4.51)], and sharing needles in the past 12 months [AOR: 2.57; 95% CI (1.10-5.99)].IDUs who inject socially and IDUs who share needles are likely to engage in high-risk sexual behaviours and may serve as an important bridge group for epidemic HIV transmission in Vietnam. In addition to messages regarding the dangers of sharing needles and other injection equipment, preventive interventions among newly initiated IDUs should also focus on reducing sexual risk.

HIV/AIDS-related stigma and discrimination have a substantial impact on people living with HIV/AIDS (PLHA). The objectives of this study were: (1) to determine the associations of two constructs of HIV/AIDS-related stigma and discrimination (negative attitudes towards PLHA and perceived acts of discrimination towards PLHA) with previous history of HIV testing, knowledge of antiretroviral therapies (ARVs) and communication regarding HIV/AIDS and (2) to compare these two constructs across the five research sites with respect to differing levels of HIV prevalence and ARV coverage, using data presented from the baseline survey of U.S. National Institute of Mental Health (NIMH) Project Accept, a four-country HIV prevention trial in Sub-Saharan Africa (Tanzania, Zimbabwe and South Africa) and northern Thailand. A household probability sample of 14,203 participants completed a survey including a scale measuring HIV/AIDS-related stigma and discrimination. Logistic regression models determined the associations between negative attitudes and perceived discrimination with individual history of HIV testing, knowledge of ARVs and communication regarding HIV/AIDS. Spearman's correlation coefficients determined the relationships between negative attitudes and perceived discrimination and HIV prevalence and ARV coverage at the site-level. Negative attitudes were related to never having tested for HIV, lacking knowledge of ARVs, and never having discussed HIV/AIDS. More negative attitudes were found in sites with the lowest HIV prevalence (i.e., Tanzania and Thailand) and more perceived discrimination against PLHA was found in sites with the lowest ARV coverage (i.e., Tanzania and Zimbabwe). Programs that promote widespread HIV testing and discussion of HIV/AIDS, as well as education regarding and universal access to ARVs, may reduce HIV/AIDS-related stigma and discrimination.

Depression often co-occurs with amphetamine type stimulant use and can negatively impact drug treatment outcomes. Understanding the temporal relationship between depressive symptoms and methamphetamine use can further inform both treatment and mental health options.Methamphetamine users aged 18-25 years were enrolled in a 12-month randomized behavioral trial in Thailand. Questionnaires were administered every 3 months and included information on substance use and depressive symptoms. Pattern of methamphetamine use during follow-up was characterized into four groups: early cessation, late cessation, relapse and persistent use. Multinomial logistic regression was used to determine the impact of baseline depressive symptoms (CES-D score and %or =22) on patterns of methamphetamine use during follow-up. Linear and logistic regression was used to determine the impact of patterns of methamphetamine use on depressive symptoms at the end of the trial.No association was found between baseline depressive symptoms and subsequent patterns of methamphetamine use. A significant relationship was found between patterns of methamphetamine use and ensuing depressive symptoms, with those achieving cessation experiencing lower levels of depressive symptoms.Many symptoms of depression may resolve with cessation or reduction in methamphetamine use. Clinical and community-based efforts that facilitate drug users' attempts to stop using drugs should be supported as they may contribute to positive cessation outcomes and help to improve overall mental health.

This HIV Prevention Trials Network study assessed the efficacy of a network-oriented peer education intervention promoting HIV risk reduction among injection drug users and their drug and sexual network members in Chiang Mai, Thailand and Philadelphia, USA. The study was designed to test impact on HIV infection, but the infection rate was low and the study was terminated early. This paper reports efficacy on outcomes of self-reported HIV risk behaviors. We enrolled 414 networks with 1123 participants. The experimental intervention consisted of six small group peer educator training sessions and two booster sessions delivered to the network index only. All participants in both arms received individual HIV counseling and testing. Follow-up visits occurred every six months for up to 30 months. There were 10 HIV seroconversions, 5 in each arm. The number of participants reporting injection risk behaviors dropped dramatically between baseline and follow-up in both arms at both sites. Index members in the intervention arm engaged in more conversations about HIV risk following the intervention compared to control indexes. There was no evidence of change in sexual risk as a result of the intervention. Reductions in injection risk behaviors were observed: 37%, 20%, and 26% reduction in odds of sharing cottons, rinse water and cookers, respectively, and 24% reduction in using a syringe after someone else. Analysis of the individual sites suggested a pattern of reductions in injection risk behaviors in the Philadelphia site. In both sites, the intervention resulted in index injection drug users engaging in the community role of discussing reduction in HIV injection risk behaviors. The intervention did not result in overall reductions in self-reported sexual risk behaviors, and although reductions in injection risk behaviors were observed, the overall efficacy in reducing risk was not established.

Purpose Methamphetamine (MA) is the leading illicit drug in Thailand among youth and young adults. Sexual risk behaviors are associated with methamphetamine use, but few data are available on the daily context of methamphetamine use. We developed an inductive behavioral typology that young Thais engage in while using methamphetamine. Methods We conducted a cross-sectional study in Chiang Mai, Thailand, in 2005–2006 among 1,162 street-recruited methamphetamine smokers 18–25 years of age. Data collected included sociodemographic characteristics, sexual behaviors, and drug use patterns. Latent class analysis was used to describe patterns of activities in which participants reported engaging directly after using MA. Logistic regression was used to examine univariate correlates of class membership, separately by gender. Results Participants were 75% male with a median age of 19 years. More than half of participants reported frequent alcohol use (≥4 days/week) and half of the sample reported smoking MA ≥2 days/ week. Three classes of activities emerged for male participants (n = 863): “work” (job related); “high-risk behaviors” (motorcycle riding, fighting, sex); and “combined” (all activities). Two classes emerged for the women (n = 299): “work” (housework) and “high-risk behaviors.” “High-risk behaviors” and “combined” (men only) classes were associated with more frequent alcohol and methamphetamine use compared with the “work” class. Conclusions Our study found a distinct typology of behaviors associated with substance abuse among young adults in Thailand. Behavioral typologies allow a better understanding of the nuances of “risky” behaviors and might prove useful in targeting interventions.

There are no studies that examine street-based female sex workers' vulnerability to HIV from both clients and intimate partners. This study documents street-based female sex workers' experiences of client and intimate partners, examines the intersections of violence, alcohol use in condom use, and highlights survival strategies used to avert harm.Ethnographic data were collected from 49 female sex workers through focus group discussions and in-depth interviews.Female sex workers experienced multifarious forms of severe client and intimate partner violence. Sexual coercion and forced group sex in the context of alcohol use posed formidable barriers for condom use negotiation. Further, traditional gender norms dictated women's inabilities to negotiate condom-use with intimate partners. However, there was evidence of adoption of successful survival strategies in the face of danger and women's positive evaluations of the benefits of sex work and their contributions to family well-being.Harm reduction efforts with female sex workers need to account for their vulnerability to HIV from intimate partners in addition to clients. HIV prevention programmes need to include male clients in order to reduce harm among street-based female sex workers. There is an urgent need to build on sex workers' strengths and involve them in designing individual level, community, and structural interventions that could help in reducing women's vulnerability to intimate partner violence and HIV in India.

Purpose Methamphetamine (MA) has become the leading drug of abuse in northern Thailand over the past several years, particularly among youth. The current qualitative study examines factors associated with initiation of MA use. Methods Between March 2002 and January 2003, 48 in-depth interviews with young MA users were conducted in advance of a randomized, MA harm reduction, peer outreach intervention trial. The interviews were conducted in the city of Chiang Mai and the surrounding district. Data were inductively analyzed using the constant comparative method common to grounded theory methods. Atlas-ti was used for data management. Results Participants were 57% male and had a median age of 20 years (range 15–31 years). A culture of MA ubiquity characterized participants' initiation stories. Drug ubiquity encompassed three elements: the extent of MA use within peer networks; the availability of MA; and exposure to MA before initiation. All participants were introduced to MA by people close to them, most often by their friends. Internal reasons for trying MA were curiosity, a way to lose weight or to enhance hard work, and a way to "forget life's problems." With the prevalence of MA use among participants' peers, initiation seemed inevitable. Conclusions Initiation was characterized as ubiquitous in terms of peer networks' use and availability. Because of the prevalent norm of MA use, these data indicate that interventions targeting social networks and young Thais before MA initiation are needed.

To explore perceptions and attitudes towards needle sharing among clinic-based injecting drug abusers (IDUs) at a drug-treatment clinic in Hat Yai City, Songkla Province, Southern Thailand. Qualitative methods were used to gather data, including: in-depth interviews with 17 active IDUs and with three nurses, participant observation, review of the IDUs' files, and validation after interview completion to ensure data triangulation. A form of comparative content analysis, including thematic analysis, was used for data analysis. After 15 years of the Thai HIV/AIDS epidemic, most southern Thai IDUs still occasionally engaged in needle sharing although they reported reductions in sharing frequency. Withdrawal symptoms and craving were most commonly cited as compelling reasons to share. Misconceptions about how to determine "healthy" from the "sick" was another key factor underlying sharing. Pooling money for drugs (with subsequent cost-savings) was given priority over purchasing new needles/syringes among disadvantaged IDUs. Receiving HIV voluntary counseling and testing (VCT), however, promotes reduced sharing. Our findings suggest that southern Thai IDUs remain at high risk of acquiring HIV infection, primarily through needle sharing. Harm reduction strategies, such as, providing VCT to all IDUs and promoting needle exchange programs might be beneficial approaches to curbing the rapid spread of HIV.

This paper elucidates the social context of HIV risk behavior and intra-couple risk communication among injecting drug users (IDUs) and their main sex partner. Data on shared injection equipment, unprotected sex with multiple partners, unprotected sex with a main partner and couples' dynamics and risk communication were gathered through separate in-depth interviews with 11 active male IDUs and 11 of their primary female sex partners in Northern Vietnam. The majority of IDUs' sex partners does not inject drugs and is monogamous. In contrast, most IDUs reported a wide range of risky practices including needle sharing and unprotected sex with multiple, often concurrent, sex partners. Men rarely used condoms with primary partners. Many IDUs worried about their HIV-status, but none disclosed their injecting or sexual practices to their sex partners, leaving their partners unaware of their HIV risk. Among women who worried about HIV/AIDS, the vast majority was unable to influence their partner's needle sharing or extramarital affairs and most would not initiate condom use because they feared their partner's reaction. Couple-based interventions to facilitate risk communication combined with programs to promote condom use among male IDUs, may help to reduce HIV transmission from IDUs to their primary partners.

To determine predictors of injection drug use cessation and subsequent relapse among a cohort of injection drug users (IDUs).IDUs in Baltimore, MD were recruited through community outreach in 1988-1989. Among IDUs with at least three follow-up visits, parametric survival models for time to injection cessation (or=6 months) and subsequent relapse were constructed.Of 1327 IDUs, 94.8% were African American, 77.2% were male, median age was 34 years, and 37.7% were HIV-infected. Among 936 (70.5%) subjects who ceased injection, median time from baseline to cessation was 4.0 years. Three-quarters subsequently resumed injection drug use, among whom median time to relapse was 1.0 year. Factors independently associated with a shorter time to cessation were: age30 years, stable housing, HIV seropositivity, methadone maintenance treatment, detoxification, abstinence from cigarettes and alcohol, injecting less than daily, not injecting heroin and cocaine together, and not having an IDU sex partner. Factors independently associated with shorter time to injection relapse were male gender, homelessness, HIV seropositivity, use of alcohol, cigarettes, non-injection cocaine, sexual abstinence and having a longer time to the first cessation.This study provides strong support for targeting cessation efforts among young IDUs and severely dependent, unstably housed, and HIV-infected individuals.

In February 2003, the Thai Government enacted a ‘war on drugs' to reduce supply and demand for illicit drugs. This study aimed to examine the impact of this policy on injection drug users (IDUs) drug utilisation patterns and to explore IDU attitudes toward and experiences with the policy in Chiang Mai province. In April 2003, 263 IDU who participated in a study in the preceding year were followed up and 165 IDUs (63%) were available and consented to participate in a cross-sectional survey. Of these 85% had ceased injecting and 70% had done so since the implementation of the policy, with a higher percentage of rural compared to urban IDUs ceasing injection (78% versus 55%, p p

Aims: To investigate the demographic, sexual, and other substance use risk correlates of amphetamine use among men in northern Thailand prior to the current epidemic of amphetamine use in the Kingdom. Design: Cross-sectional quantitative behavioral questionnaires. Setting: Thai Ministry of Health STD and HIV Anonymous Test Sites in the upper northern provinces of Chiang Mai and Lamphun. Participants: Adult Thai men recruited at clinics for enrollment in an HIV seroincidence cohort study (The Thai HIVNET). All men were HIV negative at enrollment, and had at least one self-reported sexual risk for HIV infection (a recent STD, use of sex workers, multiple sexual partners, low or absent condom use, sex with men). Measurements: Participants answered a structured questionnaire. Findings: Lifetime history of amphetamine use was reported by 133/914 men, 14.5%. Older age was protective for use (odds ratio (OR) 0.5) and use was associated with use of other substances; heroin (OR 7.1), thinner (OR 6.2), opium (OR 5.9), and marijuana (OR 5.7). Several STDs were associated with amphetamine use: gonorrhea (OR 2.3) and genital warts (OR 2.4), and any STD (OR 1.9). In multivariate analysis, use of heroin (OR 3.1), soft drugs (OR 4.9), and a history of gonorrhea (OR 2.0) were independently associated with amphetamine use in northern Thai men. Conclusions: Associations between young age, gonorrhea, other substance use and amphetamines indicate that prevention measures could occur at STD clinics and be incorporated into school programs when individuals are entering adolescence.

This prospective study of 2960 injection drug users investigated the dynamic nature of HIV behavioral risk factors between 1988 and 1994. Behavioral risks were assessed semi-annually. Robust regression models of time-dependent covariates were used to identify longitudinal predictors of behavior change. Maintenance of risky behaviors varied over time, with risk reduction seen more among HIV infected participants than among HIV seronegatives. Those at highest risk for HIV transmission were least likely to cease engaging in these behaviors. Interventions staged according to risk behaviors, targeting incremental risk reduction rather than only promoting abstinence, may be more successful in reducing HIV transmission among drug injectors.

Purpose: Most research on preventive health behaviors has focused on individual rather than groups of behaviors. This study examined interrelationships among multiple preventive health behaviors in different age and gender groups. Methods: From 1990 to 1992, Maryland residents were surveyed by telephone through the Behavioral Risk Factor Surveillance System. The study sample of 4455 was divided into 8 groups based on age (18–24, 25–39, 40–54, and 55+) and gender. Correlation and oblique rotated factor analyses were used to examine patterns of 8 to 11 preventive health behaviors in each age-gender group. Results: Medical checkup and cholesterol test formed one behavioral cluster in the four male age groups. Breast and cervical cancer screening (mammogram, clinical breast examination [CBE], and Pap Smear) did not form one cluster until age 55 or older; Pap smear, CBE formed one cluster for women of all ages. Risk-taking behaviors were only prominent in the youngest age group: Seatbelt non-use, smoking, and drinking formed one cluster in younger males, and drinking and driving after drinking clustered in younger females. Conclusion: Screening and risk-taking behaviors form distinct groups, and behavioral patterns differ by age and gender. Public health programs should consider multi-behavioral approaches, and be sensitive to the gender and age of the target population.

Sharing of contaminated needles is one of the primary modes of HIV transmission in the US. This study sought to examine social contextual factors antecedent to needle-sharing in a sample of inner-city drug users in Baltimore, Maryland. Drug users' social context was assessed through an analysis of individual's personal networks. The sample, 330 individuals participating in an HIV-prevention study, were interviewed twice, an average of 5.2 months apart. An examination of the association between personal network characteristics at baseline and needle-sharing at follow-up revealed that higher total personal network density and larger drug network size were positively associated with reports of sharing needles. Attending shooting galleries was positively associated with size of positive feedback network, and negatively associated with size of material aid network. These data suggest that needle-sharing and injecting in shooting galleries is influenced by ecological and resource factors. The findings indicate the potential utility of network-oriented strategies for reducing needle-sharing among injecting drug users.

Few studies have examined the current social relationships of injecting drug users. This paper examines the structural and relationship characteristics of the social networks of injecting drug users, and the relation of social network characteristics to the HIV infection risk behavior of frequency of injecting heroin and cocaine. The study sample was comprised of 293 inner city injecting drug users in Baltimore, Maryland. Most participants (89%) reported at least one family member in their social network, and 44% listed their mother or step-mother in their network. Presence of family members in personal social networks was not related to patterns of drug use examined here; however, those who reported a partner in their personal social network injected significantly less often than those who did not report a partner. Network density and size of drug subnetworks were positively associated with frequency of drug injection. The results of this study suggest that social network analysis may be a useful tool for understanding the social context of HIV/AIDS risk behaviors.

Eighty studies presenting original research are reviewed to explore the correlates of AIDS knowledge in samples of the general population. Results from these studies indicate that being highly educated, young or white increases the chances of being knowledgeable about AIDS and that a relationship exists between strong religious beliefs or conservative political convictions and low AIDS knowledge. Other social or demographic variables appear to have little effect on AIDS knowledge. Evidence from these studies is divided between findings indicating no association and those showing some relationship between low AIDS knowledge and high level of concern. Restrictive attitudes toward persons with AIDS are associated with low level of knowledge. The literature examining the correlates of AIDS knowledge in samples of the general population is characterized by an abundance of studies with small convenience samples of adolescents or students. Larger and more representative samples of the general population tend to confirm the results of the less methodologically sound convenience samples. However, future studies should take into account potential confounders when examining the relation between knowledge and explanatory variables to assess the nature and reliability of purported associations.

In a population-based telephone interview survey of 9,380 Washington County, Maryland, residents 12-29 years of age who reported a headache in the prior year, only 26.7% of women and 13.6% of men had ever sought a physician’s advice for a headache problem. Women (13.9%) were more than twice as likely as men (5.6%) to have consulted a doctor for this condition within the previous 12 months. The likelihood of seeking medical care for headache increased with age among women but not men. Married women were more likely to have consulted with a physician for a headache problem than single or divorced women. Men and women consulting a doctor for this disorder within the previous 12 months described recent headaches (within the prior week) that were more severe, of longer duration (women only), and more likely to have migraine characteristics than recent headaches of persons not seeking medical attention. Compared with persons never consulting a physician for a headache problem, men and women who sought medical care had elevated attack rates of certain, probable, and possible migraine and mixed migraine-tension type headaches within the preceding week. Differences in attack rates for migraine and mixed migraine-tension headaches between those who recently and those who more than 12 months ago sought a physician’s advice were more striking for men than for women.

This study investigated the relationships between health care utilization, knowledge, attitudes, sociodemographic characteristics, and adequacy of cervical cancer screening among a random sample of women from inner-city neighborhoods with high rates of cervical cancer mortality. Of 416 women interviewed, 30.3% reported hysterectomies; women with intact uteri (N = 290) are the subjects of this analysis. Over two-fifths (44.1%) reported not receiving adequate Pap testing during the previous 4 years. Compared with adequately screened women, they were more likely to be 45 years or older, have no medical insurance, report never having been to an obstetrician-gynecologist, recall never having been told by a medical provider how often to get a Pap test, rely on providers for adequate screening, report not seeking care as often as they think they should, have less knowledge of risk factors for cervical cancer, and believe that women should get Pap tests less than yearly. Separate models for younger and older women showed that these factors vary by age, demonstrating the need for interventions to be sensitive to age subgroups. These findings suggest that cancer control activities should place more emphasis on motivating women as well as influencing the health care delivery system to maximize reductions in cervical cancer.

Efforts to develop clinically useful headache classification schemes have generally focused on linking specific symptom groupings with specific headache subtypes. An alternative conceptual approach, the "severity model" of headache, considers a continuum of headache ranging from mild to severe forms with specific headache subtypes distinguished by level of severity rather than unique constellations of symptoms. A population-based telephone interview was carried out among 10,169 subjects aged 12-29 to estimate the prevalence of serious headaches and better characterize symptoms that accompany headache attacks. In an analysis of frequency of occurrence, pain and duration of recent (within 4 weeks prior to interview) headache attacks, the data revealed that common symptoms (such as forehead pain and pain in the back of the head, neck and shoulders) were reported frequently, but headaches with these symptoms were generally characterized by low levels of pain and short duration. Although not an original study objective, the data were analyzed to determine whether distinct symptom constellations could be identified or whether symptoms overlapped between headache types. Symptoms of migraine were frequently experienced concomitant with tension-type symptoms; the resultant headaches were usually characterized as moderate in intensity. In contrast, symptoms usually associated with migraine in the absence of concomitant tension-type symptoms were infrequently experienced, but resulted in headaches causing the greatest disability. The data provide some support for the severity model of headache.

Cancer of the uterine cervix, the sixth most common cancer among women, is still considered a significant health problem, despite declining mortality rates during recent decades. In Baltimore, the age-adjusted mortality rates for cervical cancer are significantly higher than the U.S. average, for both black and white women. Early detection of cervical cancer through screening with the Papanicolaou (Pap) test has been shown to decrease mortality by preventing development of invasive disease, and intervention programs have been developed to increase use of Pap testing. However, the evaluation of those programs is difficult, as self-reports of Pap screening may be inaccurate, and repeated inquiries about Pap tests may influence the behavior being studied. We report in this article a method to use data from cytopathology laboratories to estimate the use of Pap screening by women in a defined population. This approach can be used to evaluate changes in receipt of Pap smears and to provide feedback to intervention programs. [Am J Prev Med 1994;10:235–7]

Unemployment is viewed as one of the more stressful of life events that an adult can experience. Job loss leads to decreased social status, disrupts family and social roles, produces financial strain, and loss of self esteem, all of which have detrimental consequences for mental health. We studied psychiatric symptoms in 269 unemployed adults with dependent children in Baltimore; one-half of the sample had returned to work 1 year following unemployment. A comparison group of 92 community residents who were continuously employed were also interviewed. Using a stressful life events perspective, we examined three models of how life events relate to psychiatric distress suggested by Dohrenwend and Dohrenwend [1. Social Status and Psychological Disorder: A Causal Inquiry. Wiley, New York, 1969. 2. Am. J. commun. Psychol. 9, 128, 1981]. Our results support an 'additive burden' model of the stress process, which also shows recovery in mental health functioning upon subsequent reemployment. We suggest that the models tested did not take into account the meaning of the life event in terms of failure and that this meaning may influence its impact on psychological distress.

Screening procedures and recommendations for early detection of cervical and breast cancer are reviewed with special reference to suggested guidelines for screening among the elderly. Data on preventive practices related to cancer detection were obtained from 675 women in Maryland by telephone interviews. The elderly (65 years of age and older) reported fewer detection tests of any type; specifically, 23% report never having had a Pap test and an additional 28% have not had one within 5 years, compared with women under the age of 65, where 98% report having had a Pap test and 79% have had one within the past two years. Elderly women were also less likely than younger women to report receiving routine breast examinations by their physicians, to perform BSE, or to have been taught BSE by a health professional. Type of provider utilized, having a personal physician, and going to a gynecologist account for a significant proportion of the variance in screening practices.

A review of the literature on the association of alcohol consumption and hypertension shows increasing attention to this topic. The diversity in the nature of the populations studied leads to problems in comparisons across studies, and the differences in the measurement of alcohol consumption and the variety of research designs have led to problems in ascertaining the true relationship between levels of alcohol consumption and blood pressure. An historical review shows an increasing tendency for the assertion of a positive relationship, although the question of threshold effects and the physiological mechanism underlying the association remain unclear. Recent studies have shown the existence of a relationship in well-controlled studies of cohorts of workers, and numerous confounding factors have been adjusted for in the analyses. However, many questions remain in asserting a causal relationship between alcohol consumption and elevated blood pressure in general populations, given the relative dearth of findings for the female population as well as for various other subgroups.