Background The Thai phase III HIV vaccine trial's modest efficacy (VE 31.2% 95% CI 1.1, 51.2) represents the first demonstration that a vaccine can protect against HIV acquisition. Baseline variables of age, gender, marital status, and risk did not modify vaccine efficacy (VE). Here we explore behavioral risk and efficacy at 6 monthly intervals following vaccination. Methods Behavioral risk was assessed with a self-administered questionnaire every 6 months during trial participation. Both the acquisition endpoint and the early viral load endpoint are examined for interactions with risk status over time and temporal effects following vaccination. Finding Risk for HIV acquisition is low in each risk group, but the majority of participants reported higher-risk behavior at least once during the study (N= 9187, 58%). In post-hoc analyses, comparing those participants categorized as high or rising risk at least once during study follow-up versus those who maintained low or medium risk behavior as a time-varying covariate, the interaction of risk status and acquisition efficacy is significant (P = 0.010) with greater benefit in the lower risk individuals. VE appears to peak early with an estimate of cumulative VE = 60% through 12 months after initial vaccination (95% CI 22 –80%), and declines quickly. Vaccination did not appear to affect viral load in either early or late infections. Interpretation Future HIV vaccine trials must recognize potential interactions between challenge intensity and risk heterogeneity in the population and treatment effects. The regimen tested in the Thai phase III trial may benefit from extended immunization schedules.

ALVAC-HIV (vCP1521) and AIDSVAX B/E were evaluated in a phase 1/2 trial of human immunodeficiency virus (HIV)-negative Thai adults. Of 133 volunteers enrolled, 122 completed the trial. There were no serious vaccine-related adverse events, nor were there intercurrent HIV infections. Lymphoproliferative responses to glycoprotein 120 E were induced in 63% of the volunteers, and HIV-specific CD8 cytotoxic T lymphocyte responses were induced in 24%. Antibody responses increased in frequency and magnitude in association with the dose level of AIDSVAX B/E. Binding and neutralizing antibodies to the MN strain were induced in 100% and 98%, respectively, of the volunteers receiving 600 microg of AIDSVAX B/E, and such antibodies to E strains were induced in 96% and 71%, respectively, of these volunteers. This vaccine combination was well tolerated and was immunogenic, meeting milestones for advancement to phase 3 evaluation.

OBJECTIVE To explore and understand key cultural contexts of tobacco use among South Asian communities in the United States. DESIGN Focus groups, with homogenous compositions of gender, generational status, and length of time in the United States, were conducted in two distinct South Asian ethnic enclaves. Focus group findings were triangulated with observational data regarding availability of culturally-specific tobacco from commercial ethnic outlets and cultural events. SUBJECTS Respondents included 88 men and women of South Asian descent, aged 18 to 65 years, immigrant and native born, representing diversity of religion, socioeconomic status, and region of origin, with use of at least one culturally-specific tobacco product in previous 24 months. RESULTS A large number of culturally-specific products are commonly used by community members. Knowledge of product-specific health risks was lacking or inaccurate. Many culturally-specific tobacco products were considered to have beneficial properties. South Asian tobacco items were used to preserve cultural traditions and express ethnic identity in a new dominant culture. The social and cultural value ascribed to use helped distinguish community members from mainstream society and from other minority populations. CONCLUSIONS Many cultural factors govern tobacco use among diverse global populations. Especially for migrants with a common regional origin, the role of ethnic identity may strongly influence culturally-specific tobacco patterns. Qualitative inquiry helps elucidate such culturally-framed behaviors in culturally-diverse populations. These cultural contexts should be integrated into research and practice. Understanding multidimensional factors influencing non-traditional tobacco use is key to ensuring that comprehensive tobacco control strategies address tobacco-related disparities.

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This paper utilizes findings from a qualitative study of methamphetamine among users in three U.S. communities: San Francisco, San Diego, and Honolulu. In-depth interviews were combined with survey questionnaires to explore the patterns, contexts, and consequences among an ethnically and culturally diverse sample of 150 moderate to heavy users in each site. A grounded theory method was used to identify and examine patterns of experiences, beliefs, and environments. One of the most important findings emerging from this study concerns the unexpectedly high proportion of women with substantial experience as methamphetamine dealers and/or distributors. More than two-thirds of the 141 female respondent users were involved in diverse lifestyles and participated in the illicit methamphetamine market on a wide variety of levels. However, the majority considered this activity as a positive experience which provided them with economic independence, self-esteem, increased ability to function, professional pride, and ethics. Dealing was seen as supportive in their important need to maintain control: with social and intimate relationships, with daily living responsibilities, and with their drug use. The major problems reported by women dealers across all sites included: arrests and incarceration; violence; lack of trust in, and betrayal by, customers; and social and emotional dependency on the drug to feel normal and function without fear on a social level.

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Background Perinatal HIV-1 continues to occur due to barriers to effective antiretroviral prevention that might be mitigated by long-acting broadly neutralizing monoclonal antibodies (bNAbs). Methods Extended half-life bNAb, VRC01LS, was administered subcutaneously (SC) at 80 mg/dose after birth to HIV-1-exposed, non-breastfed (Cohort 1, n=10) and breastfed (Cohort 2, n=11) infants. Cohort 2 received a second dose (100mg) at 12 weeks. All received antiretroviral prophylaxis. VRC01LS levels were compared to VRC01 levels determined in a prior cohort. Results Local reactions (all Grade <2) occurred in 67% and 20% after Dose 1 and Dose 2, respectively. The weight-banded dose (mean 28.8 mg/kg) of VRC01LS administrated SC achieved a mean +SD plasma level of 222.3 + 71.6 mcg/mL by 24 hours and 44.0 + 11.6 mcg/mL at week 12, prior to Dose 2. The pre-established target of > 50 mcg/mL was attained in 95% and 32% at week 8 and 12, respectively. The terminal half-life was 37-41 days. VRC01LS level after one dose was significantly greater (p=<0.002) than after a VRC01 dose (20mg/kg). No infants acquired HIV-1. Conclusions VRC01LS was well tolerated with pharmacokinetics that support further studies of more potent long-acting bNAbs as adjunct treatment with ARVs to prevent infant HIV-1 transmission.

A first-trimester transabdominal ultrasound (US) study was performed on twin pregnancies to determine the utility of US in predicting chorionicity and amnionicity. Among 85 dichorionic-diamniotic (DC-DA) twin pairs, a thick membrane was present in 78 (92%). Four of the DC-DA cases without a thick membrane had two distinct placental sites, allowing 82 DC-DA pregnancies (96%) to be predicted. Among 16 monochorionic-diamniotic (MC-DA) twin pairs, a thin membrane was present in 14 (88%). None of the four monochorionic-monoamniotic (MC-MA) cases had an identifiable membrane. The lambda sign had no value in this evaluation and was actually misleading, while a thick membrane or the identification of two separate placentas was always predictive of DC-DA twinning. However, a thin membrane, while usually predictive of an MC-DA pregnancy, did not exclude a DC-DA gestation. When no membrane is present, an MC-MA gestation is probable; however, a diamniotic pregnancy may still be present, and further evaluation is suggested.