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Male circumcision has both health benefits and significance to some cultures. We sought to understand perceptions about male circumcision as part of the HIV prevention toolkit among participants enrolled in a preventive HIV vaccine efficacy trial in South Africa. We conducted a qualitative study with 28 people aged 18-35 years old who self-reported that they were not living with HIV, provided informed consent, and who were participating in the HVTN 702 vaccine efficacy trial in Soweto. Using a semi-structured guide, we facilitated four focus group discussions (FGDs) stratified by age, gender, and sexual orientation. FGDs were audio-recorded, transcribed verbatim, translated into English, and thematically analysed. Four main themes emerged. (1) Everyone had accurate knowledge about what male circumcision is, and some participants stated that it partially reduces acquisition of HIV and sexually transmitted infections. (2) There was an emerging distrust of cultural circumcision because of perceived lack of transparency and adverse events. (3) There was a perception that circumcision boosted masculinity. (4) The choice to circumcise was influenced by parents, family, and female partners. In conclusion, the study found that young South African HIV vaccine trial participants accurately understand the HIV prevention benefits of male circumcision, but uptake decisions are embedded within a context that is informed by culture, sexuality and masculinity norms and values.

HIV pre-exposure prophylaxis (PrEP) uptake among cisgender women in the United States is low. Just4Us, a theory-based counseling and navigation intervention, was evaluated for preliminary efficacy in a pilot randomized controlled trial with PrEP-eligible women (n = 83). The comparison arm was a brief information session. Surveys were completed at baseline, post-intervention and at 3 months. In the study sample, 79% were Black and 26% were Latina. At 3 months follow-up, 45% made an appointment to see a provider about PrEP; only 13% received a PrEP prescription. There were no differences in PrEP initiation by study arm (9% Info vs 11% Just4Us; CI 1.07). Knowledge was significantly higher in the Just4Us group at post-intervention. Analysis revealed high PrEP interest with many personal and structural barriers along the PrEP continuum. Just4Us is a promising PrEP uptake intervention for cisgender women. Further research is needed to tailor intervention strategies on individual circumstances and barriers. Clinicaltrials.gov registration: NCT03699722: A Women-Focused PrEP Intervention (Just4Us)

Background: Intimate partner violence (IPV) and HIV are serious and related public health problems that detrimentally impact women’s health. Because women who experience IPV are more likely to acquire HIV, it is critical to promote HIV prevention strategies, such as HIV pre-exposure prophylaxis (PrEP), that increase autonomy. Setting: This study of cis-gender women eligible for HIV PrEP took place between 2017 and 2019 in Philadelphia and New York City. Methods: This study aimed to examine the relationship between four types of IPV (control, psychological, psychological, physical, sexual) and intention to start PrEP among PrEP-eligible cisgender women; and assess the extent to which HIV relevant factors moderate the association between IPV experience and intention to start PrEP. Results: In this sample (n=214) of PrEP-eligible women, 68.7% indicated intention to start PrEP in the next 3 months. Ethnicity was strongly associated with intention to start PrEP, with Hispanic women having the highest odds of intending to start PrEP in the next 3 months. Having a controlling partner significantly predicted intention to start PrEP. Women with more than one sex partner, any IPV in the past 12 months, past 12-month sexual IPV, or a controlling partner had higher odds of intending to start PrEP as compared with those who had one or no partners and had no IPV. Conclusion: These findings point to a need for patient-centered interventions that address the need for safety and autonomy among cisgender, PrEP-eligible women.

Since the beginning of the HIV epidemic in the USA, effective interventions to reduce HIV risk among cisgender women have been lacking. Although oral HIV pre-exposure prophylaxis (PrEP) is effective in pharmacologically preventing HIV infection, there is a gap between the recommended use of PrEP and PrEP uptake among eligible women. This study aimed to identify the role of patient-provider communication in PrEP decision-making among women considering PrEP. Semi-structured in-depth interviews were conducted with 41 PrEP-eligible women in Philadelphia and New York City. A thematic analysis of the responses was conducted, and a conceptual model developed and confirmed as analysis continued. Of the women interviewed, 53.6% were African American and 29.3% were Latina. Women noted that having a trusting relationship with their health care provider, receiving a tailored recommendation for PrEP based upon their specific needs and using their health care provider as support were crucial facilitators of PrEP decision-making. Lack of provider knowledge about PrEP, perceived health care provider stigma about their drug use and sexual activity, and lack of care continuity were all identified as barriers to effective communication. Study findings can inform future interventions to enhance patient-provider communication about PrEP and increase PrEP uptake among women.

In the United States, pre-exposure prophylaxis (PrEP) uptake among eligible cisgender women has been slow, despite the availability of oral PrEP since 2012. Although women make up nearly 20% of those living with HIV, there are currently few PrEP uptake interventions for cisgender women at elevated risk for acquiring HIV. Here we describe the process used to design and pre-pilot test Just4Us, a theory-based behavioral intervention to promote PrEP initiation and adherence among PrEP-eligible cisgender women. This work was part of a multiphase study conducted in New York City and Philadelphia, two locations with HIV rates higher than the national average. The counselor-navigator component of the intervention was designed to be delivered in a 60- to 90-min in-person session in the community, followed by several phone calls to support linkage to care. An automated text messaging program was also designed for adherence support. Just4Us addressed personal and structural barriers to PrEP uptake using an empowerment framework by building on women's insights and resources to overcome barriers along the PrEP cascade. Usability pre-pilot testing results were favorable and provided valuable feedback used to refine the intervention.

Background Despite multiple available HIV prevention methods, the HIV epidemic continues to affect South Africa the most. We sought to understand willingness to use actual and hypothetical HIV prevention methods among participants enrolled in a preventative HIV vaccine efficacy trial in Soweto, South Africa. Methods We conducted a qualitative study with 38 self-reporting HIV-uninfected and consenting 18–35 year olds participating in the HVTN 702 vaccine efficacy trial in Soweto. Using a semi-structured interview guide, five focus group discussions (FGDs) were held, stratified by age, gender and sexual orientation. The FGDs were composed of: (i) 10 heterosexual women aged 18–24 years; (ii) 9 heterosexual and bisexual women aged 25–35 years; (iii & iv) heterosexual men aged 25–35 years with 7 in both groups; and (v) 5 men aged 18–35 years who have sex with men. FGDs were audio-recorded, transcribed verbatim, translated into English and analysed using thematic analysis. Results We present five main themes: (i) long-lasting methods are preferable; (ii) condoms are well-known but not preferred for use; (iii) administration route of HIV prevention method is a consideration for the user; (iv) ideal HIV prevention methods should blend into the lifestyle of the user; and the perception that (v) visible prevention methods indicate sexual indiscretion. Conclusions The participants’ candour about barriers to condom and daily oral pre-exposure prophylaxis (PrEP) use, and expressed preferences for long-lasting, discreet, lifestyle-friendly methods reveal a gap in the biomedical prevention market aiming to reduce sexually acquired HIV in South Africa. Product developers should consider long-acting injectable formulations, such as vaccines, passive antibodies and chemoprophylaxis, for HIV prevention technologies. Future innovations in HIV prevention products may need to address the desire for the method to blend easily into lifestyles, such as food-medication formulations.

Summary Background Bioinformatically designed mosaic antigens increase the breadth of HIV vaccine-elicited immunity. This study compared the safety, tolerability, and immunogenicity of a newly developed, tetravalent Ad26 vaccine with the previously tested trivalent formulation. Methods This randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study (TRAVERSE) was done at 11 centres in the USA and one centre in Rwanda. Eligible participants were adults aged 18 to 50 years, who were HIV-uninfected, healthy at screening based on their medical history and a physical examination including laboratory assessment and vital sign measurements, and at low risk of HIV infection in the opinion of study staff, who applied a uniform definition of low-risk guidelines that was aligned across sites. Enrolled participants were randomly assigned at a 2:1 ratio to tetravalent and trivalent groups. Participants in tetravalent and trivalent groups were then further randomly assigned at a 5:1 ratio to adenovirus 26 (Ad26)-vectored vaccine and placebo subgroups. Randomisation was stratified by region (USA and Rwanda) and based on a computer-generated schedule using randomly permuted blocks prepared under the sponsor's supervision. We masked participants and investigators to treatment allocation throughout the study. On day 0, participants received a first injection of tetravalent vaccine (Ad26.Mos4.HIV or placebo) or trivalent vaccine (Ad26.Mos.HIV or placebo), and those injections were repeated 12 weeks later. At week 24, vaccine groups received a third dose of tetravalent or trivalent together with clade C gp140, and this was repeated at week 48, with placebos again administered to the placebo group. All study vaccines and placebo were administered by intramuscular injection in the deltoid muscle. We assessed adverse events in all participants who received at least one study injection (full analysis set) and Env-specific binding antibodies in all participants who received at least the first three vaccinations according to the protocol-specified vaccination schedule, had at least one measured post-dose blood sample collected, and were not diagnosed with HIV during the study (per-protocol set). This study is registered with Clinicaltrials.gov , NCT02788045 . Findings Of 201 participants who were enrolled and randomly assigned, 198 received the first vaccination: 110 were in the tetravalent group, 55 in the trivalent group, and 33 in the placebo group. Overall, 185 (93%) completed two scheduled vaccinations per protocol, 180 (91%) completed three, and 164 (83%) completed four. Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events were similar in vaccine groups and higher than in placebo groups. All participants in the per-protocol set developed clade C Env binding antibodies after the second vaccination, with higher total IgG titres after the tetravalent vaccine than after the trivalent vaccine (10 413 EU/mL, 95% CI 7284–14 886 in the tetravalent group compared with 5494 EU/mL, 3759–8029 in the trivalent group). Titres further increased after the third and fourth vaccinations, persisting at least through week 72. Other immune responses were also higher with the tetravalent vaccine, including the magnitude and breadth of binding antibodies against a cross-clade panel of Env antigens, and the magnitude of IFNγ ELISPOT responses (median 521 SFU/106 peripheral blood mononuclear cells [PBMCs] in the tetravalent group and median 282 SFU/106 PBMCs in the trivalent group after the fourth vaccination) and Env-specific CD4+ T-cell response rates after the third and fourth vaccinations. No interference by pre-existing Ad26 immunity was identified. Interpretation The tetravalent vaccine regimen was generally safe, well-tolerated, and found to elicit higher immune responses than the trivalent regimen. Regimens that use this tetravalent vaccine component are being advanced into field trials to assess efficacy against HIV-1 infection. Funding National Institutes of Health, Henry M Jackson Foundation for Advancement of Military Medicine and the US Department of Defense, Ragon Institute of MGH, MIT, & Harvard, Bill & Melinda Gates Foundation, and Janssen Vaccines & Prevention.

BackgroundWe report updated safety, efficacy, and immunogenicity of AZD1222 (ChAdOx1 nCoV-19) from an ongoing phase 3 trial.MethodsAdults at increased risk of SARS-CoV-2 infection were randomized (2:1), stratified by age, to receive 2 doses of AZD1222 or placebo. The primary efficacy end point was confirmed SARS-CoV-2 reverse-transcriptase PCR-positive (RT-PCR-positive) symptomatic COVID-19 at 15 or more days after a second dose in baseline SARS-CoV-2-seronegative participants. The 21,634 and 10,816 participants were randomized to AZD1222 and placebo, respectively.FindingsData cutoff for this analysis was July 30, 2021; median follow-up from second dose was 78 and 71 days for the double-blind period (censoring at unblinding or nonstudy COVID-19 vaccination) and 201 and 82 days for the period to nonstudy COVID-19 vaccination (regardless of unblinding) in the AZD1222 and placebo groups, respectively. For the primary efficacy end point in the double-blind period (141 and 184 events; incidence rates: 39.2 and 118.8 per 1,000 person years), vaccine efficacy was 67.0% (P0.001). In the period to nonstudy COVID-19 vaccination, incidence of events remained consistently low and stable through 6 months in the AZD1222 group; for the primary efficacy end point (328 and 219 events; incidence rates: 36.4, 108.4) and severe/critical disease (5 and 13 events; incidence rates: 0.6, 6.4), respective vaccine efficacy estimates were 65.1% and 92.1%. AZD1222 elicited humoral immune responses over time, with waning at day 180. No emergent safety issues were seen.ConclusionAZD1222 is safe and well tolerated, demonstrating durable protection and immunogenicity with median follow-up (AZD1222 group) of 6 months.Trial registrationClinicalTrials.gov NCT04516746.FundingAstraZeneca; US government.

Purpose: To lower the HIV risk of transgender women, it is imperative to understand their unique HIV prevention needs and design biomedical prevention interventions that are responsive to the psychosocial, behavioral, and clinical needs of these communities. Preventive HIV vaccines are an important modality under investigation in diverse study participants. We sought to assess the knowledge of HIV vaccine research and the most common barriers and facilitators to participation in HIV vaccine studies among HIV-negative transgender women living in New York City. Methods: Six focus groups were conducted among 29 participants recruited in the New York City tri-state area from December 2014 to July 2015. Prefocus group quantitative questionnaire assessed demographic, behavioral information, knowledge of preventive vaccine research, and reasons for potential participation in prevention studies. Results: Median age of participants was 29 years and 41.4% identified as white. Over half of participants have heard of preventive vaccine research and majority indicated that an important factor in participating in HIV prevention research is to help the community collective effort. Key barriers that emerged were fear of side effects, feelings of exclusion from biomedical research. Facilitators to participation in prevention studies included trusting relationships with providers. Conclusions: These barriers and facilitators are important to consider in the design of studies inclusive of trans communities and transgender-specific prevention strategies. Barriers may be overcome by disseminating accurate information via social media or health providers.

Background Stigma is an important contributor to the continued HIV epidemic in the United States (US). In 2016, women made up nearly one in five of all new infections. Pre-exposure HIV Prophylaxis or PrEP is a medication that can be taken to prevent HIV acquisition; however, PrEP is significantly underutilized by women at risk for infection. How PrEP stigma relates to PrEP initiation among women is not well understood. Methods Surveys were completed by 160 PrEP-eligible women aged 18-55 in Philadelphia, PA and New York City, NY. Associations between PrEP stigma, HIV stigma, and PrEP initiation intention were modeled using multinomial logistic regression, controlling for sociodemographic and theoretically-relevant variables. Results Participants ranged in age from 18 to 55 years (M = 40.2; SD = 11.78). Most (79%) identified as Black or African-American and/or Latina and 36% had completed high-school or less. Higher PrEP stigma was significantly associated with lower PrEP initiation intention, while controlling for other theoretically-relevant and sociodemographic variables. HIV stigma was not related to PrEP initiation intention. Conclusions HIV prevention interventions seeking to increase PrEP initiation among PrEP-eligible, urban women need to address the role that PrEP stigma plays in PrEP uptake.

Women comprise 19% of those newly diagnosed with HIV in the United States. There is a wide gap between recommended use of pre-exposure prophylaxis (PrEP) and actual uptake among women who are eligible for PrEP. In order to identify women’s beliefs and intentions about starting PrEP, a survey, informed by the Reasoned Action Approach, was administered to 160 cisgender PrEP-eligible women, ages 18–55, in Philadelphia and New York City. The mean age was 40.2 years (SD = 11.78), 44% had completed high school, 75% were unemployed and 85% experienced financial instability in the past 3 months. Multivariate linear regression analyses identified sets of behavioral and normative beliefs associated with intention to start PrEP in the next 3 months. Behavioral beliefs reflected views about PrEP benefits such as preventing HIV and normative beliefs reflected perceptions of support or lack thereof from others including partners, friends, mother, and children. These findings can be used to inform interventions to foster greater PrEP uptake among women.

The 2021 Conference on Retroviruses and Opportunistic Infections included advances in therapy for HIV as well as for SARS-CoV-2. Data presented on COVID-19 therapies included trials showcasing the use of monoclonal antibodies for prevention and treatment of COVID-19. Promising new data were presented on lenacapavir, an investigational HIV capsid inhibitor given as a subcutaneous injection every 6 months. Although encouraging data from settings across the globe reported achievement of 90-90-90 HIV care cascade targets, disparities exist in care engagement and viral suppression, particularly for people of color and young people with HIV. Several interventions were associated with improved care cascade outcomes. The COVID-19 pandemic has impacted HIV care engagement, but mitigation strategies can allow programs to continue to serve people with HIV during the pandemic. Studies examining the resistance patterns of existing antiretroviral therapy (ART) agents were presented, as were resistance mechanisms of novel agents such as lenacapavir and resistance patterns among individuals who seroconverted while on preexposure prophylaxis. Data from large observational cohorts were presented on patterns of ART uptake and trends in mortality and in virologic failure. Pertinent findings relating to pediatric and maternal health issues included data on dolutegravir-based ART in children and adolescents with HIV; safety and tolerability of dolutegravir-based ART in children and pregnant women; similarly high maternal viral suppression at 50 weeks postpartum in women receiving certain ART regimens; weight gain in pregnant women receiving dolutegravir plus tenofovir alafenamide/emtricitabine; and viral suppression with dolutegravir-based ART when started during the third trimester of pregnancy.

BACKGROUND: Understanding donor perception of the blood donation experience is central to maintaining an adequate blood supply. Studies that use questionnaires to assess barriers/facilitators to donation may be influenced by response bias. To address this, we conducted an innovative study integrating quantitative informatics techniques with qualitative data analysis of YouTube video content to explore donor experiences and barriers and facilitators to whole blood donation. METHODS: Sampling of YouTube videos was conducted using search parameters for identifying relevant videos, based on donors’ language used to describe their whole blood donation experiences (e.g. blood donation, blood donor, donated blood, gave/give blood, etc.). We eliminated duplicate videos; filtered out non-English videos, those made outside the U.S., and those with no transcripts; and restricted the time period during which videos were posted from 2015 to 2019. Search parameters were fed into a Python script, which downloaded video transcripts for all search results. The final sample was 102 non-commercial and 34 commercial transcripts. The subsequent transcriptions were uploaded into qualitative analysis software and coded two coders. A third coder randomly selected transcripts to review to ensure consistency. RESULTS: Barriers to whole blood donation include having prior negative experiences with donation, and donation-related fear. Facilitators included altruism, having a personal connection to donation, donation center incentives, and positive experiences with blood center staff. CONCLUSION: Themes identified in this study were similar to those in the existing literature. This suggests that current questionnaires to address barriers/facilitators to donation are unlikely to be meaningfully impacted by response bias.

The underutilization of pre-exposure prophylaxis (PrEP) among cisgender women in the U.S. limits this population’s ability to reduce their risk for HIV infection, especially within the unique individual, social and structural systems they navigate. There is a need to identify the relevant multi-level barriers and facilitators to PrEP use among cisgender women to inform theory-guided efforts that address HIV disparities by race/ethnicity among cisgender women. Guided by the Integrated Behavioral Model and the Behavioral Model of Vulnerble Populations we conducted 41 interviews with PrEP eligible cisgender women in New York City and Philadelphia. Directed content analysis identified 11 modal behavioral beliefs crucial to PrEP uptake, including anticipated negative social consequences, 5 normative beliefs centered on available social supports, and 9 control beliefs such as anticipated barriers such as cost. Awareness and knowledge of PrEP as a biobehavioral HIV prevention method is limited for this sample. Through conventional content analysis we identified interpersonal and structural barriers to PrEP uptake including lack of partner support, transportation, mental health challenges, and challenges in accessing PrEP care. Potential solutions to structural barriers were enumerated along with implications for future intervention work and public health programming. Theory-based contextually relevant interventions are needed to advance PrEP uptake among women in the U.S. Our findings provide a foundation for building the evidence base needed for advancing intervention development for PrEP-eligible cisgender women in the U.S. that address relevant individual, social and structural factors.

In the United States, pre-exposure prophylaxis (PrEP) uptake among eligible cisgender women has been slow, despite the availability of oral PrEP since 2012. Although women make up nearly 20% of those living with HIV, there are currently few PrEP uptake interventions for cisgender women at elevated risk for acquiring HIV. Here we describe the process used to design and pre-pilot test Just4Us, a theory-based behavioral intervention to promote PrEP initiation and adherence among PrEP-eligible cisgender women. This work was part of a multiphase study conducted in New York City and Philadelphia, two locations with HIV rates higher than the national average. The counselor-navigator component of the intervention was designed to be delivered in a 60- to 90-min in-person session in the community, followed by several phone calls to support linkage to care. An automated text messaging program was also designed for adherence support. Just4Us addressed personal and structural barriers to PrEP uptake using an empowerment framework by building on women's insights and resources to overcome barriers along the PrEP cascade. Usability pre-pilot testing results were favorable and provided valuable feedback used to refine the intervention.

BACKGROUND: VRC01, a potent, broadly neutralizing monoclonal antibody, inhibits simian-HIV infection in animal models. The HVTN 104 study assessed the safety and pharmacokinetics of VRC01 in humans. We extend the clinical evaluation to determine intravenously infused VRC01 distribution and protective function at mucosal sites of HIV-1 entry. METHODS: Healthy, HIV-1–uninfected men (n = 7) and women (n = 5) receiving VRC01 every 2 months provided mucosal and serum samples once, 4–13 days after infusion. Eleven male and 8 female HIV-seronegative volunteers provided untreated control samples. VRC01 levels were measured in serum, secretions, and tissue, and HIV-1 inhibition was determined in tissue explants. RESULTS: Median VRC01 levels were quantifiable in serum (96.2 μg/mL or 1.3 pg/ng protein), rectal tissue (0.11 pg/ng protein), rectal secretions (0.13 pg/ng protein), vaginal tissue (0.1 pg/ng protein), and cervical secretions (0.44 pg/ng protein) from all recipients. VRC01/IgG ratios in male serum correlated with those in paired rectal tissue (r = 0.893, P = 0.012) and rectal secretions (r = 0.9643, P = 0.003). Ex vivo HIV-1(Bal26) challenge infected 4 of 21 rectal explants from VRC01 recipients versus 20 of 22 from controls (P = 0.005); HIV-1(Du422.1) infected 20 of 21 rectal explants from VRC01 recipients and 12 of 12 from controls (P = 0.639). HIV-1(Bal26) infected 0 of 14 vaginal explants of VRC01 recipients compared with 23 of 28 control explants (P = 0.003). CONCLUSION: Intravenous VRC01 distributes into the female genital and male rectal mucosa and retains anti–HIV-1 functionality, inhibiting a highly neutralization-sensitive but not a highly resistant HIV-1 strain in mucosal tissue. These findings lend insight into VRC01 mucosal infiltration and provide perspective on in vivo protective efficacy. FUNDING: National Institute of Allergy and Infectious Diseases and Bill & Melinda Gates Foundation.

BACKGROUND To focus interventions, biomarkers of HIV-1 exposure could help in identifying subpopulations at highest risk of acquisition. We assessed whether Y-chromosome single tandem repeat (YSTR) mixtures obtained from rectal swabs could serve as a biomarker of condomless receptive anal intercourse (CRAI) among men who have sex with men and transgender women and evaluated the feasibility of detecting HIV-1 virions to assess exposures. METHODS Twenty-nine sexually active HIV-seronegative men who have sex with men and one transgender woman from New York City answered on-site and mobile app sexual behavior questionnaires. They were randomized to collecting self-administered rectal swabs every morning or after receptive anal intercourse (RAI). YSTR profiles were assessed from blood sample and swabs; HIV-1 exposure was measured by conducting quantitative polymerase chain reaction in swabs. RESULTS After 2 months, the daily mobile survey had 135%-201% more instances of anal sex acts and 170%-193% more RAI than on-site surveys. Daily mobile reporting had 11%-35% less CRAI events than those reported on-site (Pdaily = 0.001; Pper-sex = 0.047). The daily swabbing arm reported less RAI (P < 0.001) and CRAI (P < 0.038) and had 2.95 lower odds of detecting YSTR mixtures (P = 0.021) than the per-sex-event arm. Surprisingly, YSTR detection was not significantly modified by report of bowel movements and lubricant, enema, or condom use. No participant became HIV-1 infected, yet HIV-1 total nucleic acids were detected in 6 independent episodes of CRAI in 2 participants taking pre-exposure prophylaxis. CONCLUSIONS YSTR mixtures demonstrated 80% specificity but only 30% sensitivity as a biomarker of CRAI in self-collected rectal swabs. However, detection of HIV-1 exposures in self-collected swabs may help in identifying those needing further HIV risk reduction strategies.

Accurate HIV risk assessment among men who have sex with men (MSM) is important to help providers assess risk, and target HIV prevention interventions. We sought to develop an evidence-based HIV risk assessment tool for US MSM that is inclusive of Black MSM. Data from four large longitudinal cohorts of MSM were used to develop (EXPLORE), and validate (VAX004, HPTN061, and HVTN505). These data included visits in which participants self-reported HIV risk behavior and underwent HIV testing. We developed a pooled logistic model for incident HIV infection based on self-reported risk behaviors during the 6months before each study visit. A total of 4069 MSM were used for the development cohort, and 8047 MSM in the three validation cohorts through 2013. The final model includes age (

Summary Background Cabotegravir (GSK1265744) is an HIV-1 integrase strand transfer inhibitor with potent antiviral activity and a long half-life when administered by injection that prevented simian-HIV infection upon repeat intrarectal challenge in male macaques. We aimed to assess the safety, tolerability, and pharmacokinetics of long-acting cabotegravir injections in healthy men not at high risk of HIV-1 infection. Methods We did this multicentre, double-blind, randomised, placebo-controlled, phase 2a trial at ten sites in the USA. Healthy men (aged 18–65 years) deemed not at high risk of acquiring HIV-1 at screening were randomly assigned (5:1), via computer-generated central randomisation schedules, to receive cabotegravir or placebo. Participants received oral cabotegravir 30 mg tablets or matching placebo once daily during a 4 week oral lead-in phase, followed by a 1 week washout period and, after safety assessment, three intramuscular injections of long-acting cabotegravir 800 mg or saline placebo at 12 week intervals. Study site staff and participants were masked to treatment assignment from enrolment through week 41 (time of the last injection). The primary endpoint was safety and tolerability from the first injection (week 5) to 12 weeks after the last injection. We did analysis in the safety population, defined as all individuals enrolled in the study who received at least one dose of the study drug. This study is registered with ClinicalTrials.gov identifier, NCT02076178. Findings Between March 27, 2014, and Feb 23, 2016, we randomly assigned 127 participants to receive cabotegravir (n=106) or placebo (n=21); 126 (99%) participants comprised the safety population. Most participants were men who have sex with men (MSM; n=106 [83%]) and white (n=71 [56%]). 87 (82%) participants in the cabotegravir group and 20 (95%) participants in the placebo group completed the injection phase. Adverse events (n=7 [7%]) and injection intolerability (n=4 [4%]) were the main reasons for withdrawal in the cabotegravir group. The frequency of grade 2 or higher adverse events was higher in participants in the long-acting cabotegravir group (n=75 [80%]) than in those in the placebo group (n=10 [48%]; p=0·0049), mostly due to injection-site pain (n=55 [59%]). No significant differences were noted in concomitant medications, laboratory abnormalities, electrocardiogram, and vital sign assessments. Geometric mean trough plasma concentrations were 0·302 μg/mL (95% CI 0·237–0·385), 0·331 μg/mL (0·253–0·435), and 0·387 μg/mL (0·296–0·505) for injections one, two, and three, respectively, indicating lower than predicted exposure. The geometric mean apparent terminal phase half-life estimated after the third injection was 40 days. Two (2%) MSM acquired HIV-1 infection, one in the placebo group during the injection phase and one in the cabotegravir group 24 weeks after the final injection when cabotegravir exposure was well below the protein-binding-adjusted 90% inhibitory concentration. Interpretation Despite high incidence of transient, mild-to-moderate injection-site reactions, long-acting cabotegravir was well tolerated with an acceptable safety profile. Pharmacokinetic data suggest that 800 mg administered every 12 weeks is a suboptimal regimen; alternative dosing strategies are being investigated. Our findings support further investigation of long-acting injectable cabotegravir as an alternative to orally administered pre-exposure prophylaxis regimens. Funding ViiV Healthcare.

This study aimed to identify patients' physical and psychosocial experiences of an investigational long-acting injectable PrEP product to aid in the development of patient and provider education materials. Twenty-eight participants of a Phase 2 safety, tolerability, and acceptability study of long-acting integrase inhibitor cabotegravir (CAB-LA) were interviewed on their physical and psychosocial experiences of the injections. Five themes emerged through a framework analysis on these interview transcripts: (1) injection-related pain is highly variable across individuals; (2) pain is more impactful after the injections than during; (3) patient anxiety is critical, but does not determine the experience of injections and decreases over time; (4) intimacy and awkwardness of gluteal injections impacts patients' experiences; (5) patient education and care strategies can mitigate the above factors. These findings can inform further sociobehavioral research within Phase 3 efficacy trials of CAB-LA, as well as patient education and provider guidance for future injectable PrEP products.

Resistance to reverse transcriptase and protease inhibitors was frequently detected in HIV from black men who have sex with men (MSM) enrolled in the HIV prevention trials network (HPTN) 061 study. In this study, integrase strand transfer inhibitor (INSTI) resistance was analyzed in black MSM enrolled in HPTN 061 (134 infected at enrollment and 23 seroconverters) and a follow-up study, HPTN 073 (eight seroconverters). The ViroSeq HIV-1 Integrase Genotyping Kit (Abbott Molecular) was used for analysis. Major INSTI resistance mutations were not detected in any of the samples. HIV from 14 (8.4%) of the 165 men, including 4 (12.9%) of 31 seroconverters, had accessory or polymorphic INSTI-associated mutations. The most frequently detected mutation was E157Q. These findings are promising because INSTI-based regimens are now recommended for first-line antiretroviral treatment and because long-acting cabotegravir is being evaluated for pre-exposure prophylaxis.

We examined the relationship between economic, physical, and social characteristics of neighborhoods, where men who have sex with men (MSM) lived and socialized, and symptom scores of depression and generalized anxiety disorder (GAD). Participants came from a cross-sectional study of a population-based sample of New York City MSM recruited in 2010–2012 (n = 1126). Archival and survey-based data were obtained on neighborhoods, where the men lived and where they socialized most often. MSM who socialized in neighborhoods with more economic deprivation and greater general neighborhood attachment experienced higher GAD symptoms. The relationship between general attachment to neighborhoods where MSM socialized and mental health depended on the level of gay community attachment: in neighborhoods characterized by greater gay community attachment, general neighborhood attachment was negatively associated with GAD symptoms, while in low gay community attachment neighborhoods, general neighborhood attachment had a positive association with GAD symptoms. This study illustrates the downsides of having deep ties to social neighborhoods when they occur in the absence of broader access to ties with the community of one’s sexual identity. Interventions that help MSM cross the spatial boundaries of their social neighborhoods and promote integration of MSM into the broader gay community may contribute to the reduction of elevated rates of depression and anxiety in this population.

Identifying neighborhood characteristics associated with sexual HIV risk behavior among gay, bisexual and other men who have sex with men (MSM) living in urban areas may inform the development of policies and programs to reduce risk and subsequently HIV prevalence in urban areas. New York City M2M was a cross-sectional study designed to identify neighborhood-level characteristics associated with sexual risk behaviors among MSM living in New York City. This paper presents results of an analysis of neighborhood-level indicators of three distinct social theories of influence of the neighborhood environment on human behavior: physical disorder, social disorganization and social norms theories. Using multilevel modeling on a sample of 766 MSM stratified by race/ethnicity, we found little support for the role of social disorganization on the sexual risk behavior of MSM, whereas different indicators of physical disorder exerted negative effects across race groups. Our results suggest that the beneficial effects of housing stock maintenance and general neighborhood physical orderliness and cleanliness may have positive effects beyond those traditionally studied for African American MSM and that the field needs novel theorizing regarding whether and how neighborhood or virtual community-level factors relate to sexual behavior among MSM.

We assessed how egocentric (i.e., self-generated descriptions of a person's social contacts) network structure and composition corresponded with reported instances of condomless receptive and insertive anal intercourse with men who were reportedly HIV-infected or of unknown HIV serostatus in a sample of black men who have sex with men (MSM) in six U.S. cities. Ratings showing a higher percentage of network members who provided social participation and medical support were positively associated with reporting condomless sex. There were also significant positive associations between stimulant use and condomless insertive and receptive anal sex. Future research should examine the social processes that underlie these associations and explore ways that social support can affect HIV prevention efforts for black MSM.

BACKGROUNDRV144 is the only preventive HIV vaccine regimen demonstrating efficacy in humans. Attempting to build upon RV144 immune responses, we conducted a phase 1, multicenter, randomized, double-blind trial to assess the safety and immunogenicity of regimens substituting the DNA-HIV-PT123 (DNA) vaccine for ALVAC-HIV in different sequences or combinations with AIDSVAX B/E (protein).METHODSOne hundred and four HIV-uninfected participants were randomized to 4 treatment groups (T1, T2, T3, and T4) and received intramuscular injections at 0, 1, 3, and 6 months (M): T1 received protein at M0 and M1 and DNA at M3 and M6; T2 received DNA at M0 and M1 and protein at M3 and M6; T3 received DNA at M0, M1, M3, and M6 with protein coadministered at M3 and M6; and T4 received protein and DNA coadministered at each vaccination visit.RESULTSAll regimens were well tolerated. Antibodies binding to gp120 and V1V2 scaffold were observed in 95%-100% of participants in T3 and T4, two weeks after final vaccination at high magnitude. While IgG3 responses were highest in T3, a lower IgA/IgG ratio was observed in T4. Binding antibodies persisted at 12 months in 35%-100% of participants. Antibody-dependent cell-mediated cytotoxicity and tier 1 neutralizing-antibody responses had higher response rates for T3 and T4, respectively. CD4+ T cell responses were detectable in all treatment groups (32%-64%) without appreciable CD8+ T cell responses.CONCLUSIONThe DNA/protein combination regimens induced high-magnitude and long-lasting HIV V1V2-binding antibody responses, and early coadministration of the 2 vaccines led to a more rapid induction of these potentially protective responses.TRIAL REGISTRATIONClinicalTrials.gov NCT02207920.FUNDINGNational Institute of Allergy and Infectious Diseases (NIAID) grants UM1 AI068614, UM1 AI068635, UM1 AI068618, UM1 AI069511, UM1 AI069470, UM1 AI069534, P30 AI450008, UM1 AI069439, UM1 AI069481, and UM1 AI069496; the National Center for Advancing Translational Sciences, NIH (grant UL1TR001873); and the Bill & Melinda Gates Foundation (grant OPP52845).

T cell responses have been implicated in reduced risk of HIV acquisition in uninfected persons and control of viral replication in HIV-infected individuals. HIV Gag-specific T cells have been predominantly associated with post-infection control, whereas Env antigens are the target for protective antibodies; therefore inclusion of both antigens is common in HIV vaccine design. Yet, inclusion of multiple antigens may provoke antigenic competition, reducing the potential effectiveness of the vaccine. HVTN084 was a randomized, multicenter, double-blind phase 1 trial to investigate whether adding Env to a Gag/Pol vaccine decreases the magnitude or breadth of Gag/Pol-specific T cell responses. Fifty volunteers each received one intramuscular injection of 1×10(10) particle units (PU) rAd5 Gag-Pol, EnvA/B/C (3:1:1:1 mixture) or 5×10(9) PU rAd5 Gag-Pol. CD4(+) T cell responses to Gag/Pol measured 4 weeks post vaccination by cytokine expression were significantly higher in the group vaccinated without Env, whereas CD8(+) T cell responses did not differ significantly between the two groups. Mapping of individual epitopes revealed greater breadth of the Gag/Pol-specific T cell response in the absence of Env compared to Env co-immunization. Addition of an Env component to a Gag/Pol vaccine led to reduced Gag/Pol CD4(+) T cell response rate and magnitude as well as reduced epitope breadth, confirming the presence of antigenic competition. Therefore, T cell based vaccine strategies should aim at choosing a minimalist set of antigens to reduce interference of individual vaccine components with the induction of the maximally achievable immune response.

Substantial literature demonstrates the influence of the neighborhood environment on health behaviors and outcomes. But limited research examines on how gay and bisexual men experience and exist in various geographic and virtual spaces and how this relates to their sexual behavior. New York City Men 2 Men (NYCM2M) was a cross-sectional study designed to identify neighborhood-level characteristics within the urban environment that influence sexual risk behaviors, substance use, and depression among men who have sex with men (MSM) living in NYC. The sample was recruited using a modified venue-based time-space sampling methodology and through select websites and mobile applications. Whether key neighborhoods of human activity, where a participant resided (termed home), socialized (termed social), or had sex most often (termed sex), were the same or different was evaluated. “Congruence” (or the sameness) of home, social, and most often sex neighborhood was reported by 17 % of men, while 30 % reported that none of their neighborhoods were the same. The largest group of men (39 %) reported that their home and sex neighborhoods were the same but their social neighborhood was different while 10 % reported that their home neighborhood was different than their social and sex neighborhood; 5 % men reported same home and social neighborhoods with a different sex neighborhood. Complete neighborhood incongruence was highest among men who were Black and/or Latino, had lower education and personal income levels, and had greater financial insecurity. In adjusted analysis, serodiscordant condomless anal intercourse and condomless anal intercourse with partners from the Internet or mobile applications were significantly associated with having the same social and sex (but not home) neighborhoods. Understanding the complexity of how different spaces and places relate to the health and sexual behavior of MSM is essential for focusing interventions to best reach various populations of interest.

Depression is linked to a range of poor HIV-related health outcomes. Minorities and men who have sex with men (MSM), suffer from high rates of depression. The current study examined the relationship between depressive symptoms and social network characteristics among community-recruited Black MSM in HPTN 061 from 6 US cities. A social network inventory was administer at baseline and depression was assessed with the CES-D at baseline, 6, and 12-months. At baseline, which included 1167 HIV negative and 348 HIV positive participants, size of emotional, financial, and medical support networks were significantly associated with fewer depressive symptoms. In longitudinal mixed models, size of emotional, financial, and medical support networks were significantly associated with fewer depressive symptoms as was the number of network members seen weekly. In the multivariate analyses, size of medical appointment network remained statistically significant (aOR= 0.89, CI=0.81-0.98). These findings highlight the importance of network support of medical care on depression and suggest the value of support mobilization.

To evaluate factors associated with HIV tropism among Black men who have sex with men (MSM) in the United States enrolled in a clinical study (HIV Prevention Trials Network 061).HIV tropism was analyzed using a phenotypic assay (Trofile assay, Monogram Biosciences). Samples were analyzed from 43 men who were HIV infected at enrollment and reported either exclusive insertive intercourse or exclusive receptive intercourse; samples were also analyzed from 20 men who were HIV uninfected at enrollment and seroconverted during the study. Clonal analysis of individual viral variants was performed for seroconverters who had dual/mixed (DM) viruses.DM viruses were detected in samples from 11 (26%) of the 43 HIV-infected men analyzed at the enrollment visit; HIV tropism did not differ between those reporting exclusive insertive vs receptive intercourse. DM viruses were also detected in five (25%) of the 20 seroconverters. DM viruses were associated with lower CD4 cell counts. Seroconverters with DM viruses had dual-tropic viruses only or mixed populations of CCR5- and dual-tropic viruses.DM viruses were frequently detected among Black MSM in this study, including seroconverters. Further studies are needed to understand factors driving transmission and selection of CXCR4- and dual-tropic viruses among Black MSM.

Acculturation is associated with increased sexual risk behaviors among heterosexual Latinos, but its influence among Latino gay, bisexual, and other men who have sex with men (MSM) remains less clear. Elements of acculturation may create distinct lived experiences among sexual minority Latinos, moderating how beneficial and adverse influences contribute to their sexual risk behaviors. Latino MSM living in New York City (n = 412) were recruited using a modified time-space venue- and web-based sampling method. Negative binomial regression models estimated associations between indicators of acculturation (i.e., language use, nativity status, ethnic identification), sexual minority stressors (i.e., internalized homophobia, sexual orientation-based discrimination), peer condom use norms, and the number of serodiscordant condomless anal intercourse (SDCAI) encounters. Acculturation indicators were then tested as simultaneous moderators of the influence of each predictor variable on the outcome. The association between internalized homophobia and SDCAI was significant only among English language speakers (aIRR = 3.05 [2.13, 4.37]) and those born outside of the U.S. (foreign-born = 0, aIRR = 0.17 [0.08, 0.36]). Sexual orientation-based discrimination and SDCAI were also positively associated among both English-speaking (aIRR = 1.82 [1.22, 2.72]) and foreign-born men (aIRR = 0.34 [0.14, 0.84]). Stronger ethnic identification also moderated the protective effects of peer condom use norms on SDCAI (aIRR = 0.28 [0.15, 0.52]). Results suggest that different dimensions of acculturation help shape how both stressors and protective factors influence HIV risk among Latino MSM. Future research is needed to examine the mechanisms through which these differences in acculturation may act on sexual risk behaviors among Latino MSM.

Post-exposure prophylaxis (PEP) is a cost-effective, but underused HIV prevention strategy. PEP awareness, knowledge, access, and usage was assessed among young men of color who have sex with men (YMSMOC; n = 177), transgender women (TW; n = 182), and cisgender women of color (CWOC; n = 170) in New York City. 59% were aware of PEP: 80% among YMSMOC, 63% among TW and 34% among CWOC (p

In order for treatment as prevention to work as a national strategy to contain the HIV/AIDS epidemic in the United States (US), the HIV care continuum must become more robust, retaining more individuals at each step. The majority of people living with HIV/AIDS (PLWHA) in the US are gay, bisexual, and other men who have sex with men (MSM). Within this population, there are distinct race- and ethnicity-based disparities in rates of HIV infection, engagement, and retention in HIV care, and viral suppression. Compared with White MSM, HIV-infected Black MSM are less likely to be on anti-retroviral therapy (ART), adhere to ART, and achieve viral suppression. Among MSM living in urban areas, falling off the continuum may be influenced by factors beyond the individual level, with new research identifying key roles for network- and neighborhood-level characteristics. To inform multi-level and multi-component interventions, particularly to support Black MSM living in urban areas, a clearer understanding of the pathways of influence among factors at various levels of the social ecology is required. Here, we review and apply the empirical literature and relevant theoretical perspectives to develop a series of potential pathways of influence that may be further evaluated. Results of research based on these pathways may provide insights into the design of interventions, urban planning efforts, and assessments of program implementation, resulting in increased retention in care, ART adherence, and viral suppression among urban-dwelling, HIV-infected MSM.

The 2018 Conference on Retroviruses and Opportunistic Infections (CROI) showcased exciting data on new investigational agents including MK-8591 and tri-specific antibody targeting 3 highly conserved epitopes on HIV-1 in a single antibody. Clinical trials of initial antiretroviral therapy (ART) and switch studies involving bictegravir/emtricitabine/tenofovir alafenamide were presented. Intensification of initial ART with integrase strand transfer inhibitors did not increase the risk of immune reconstitution inflammatory syndrome. Pharmacokinetic issues were discussed, including the substantial drug-drug interactions between efavirenz-based ART and hormonal contraception delivered via a vaginal ring. Studies on pre-ART drug resistance and emergence of drug resistance after initial and second-line ART in different settings and populations were highlighted. Novel technologies to identify drug resistance included a free, cloud-based web service for HIV genotyping analysis and a promising technology for point-of-care drug resistance mutations testing. New strategies to improve the HIV care continuum included home-based testing with initiation of same-day ART and stratified care with specialized clinics to serve those disengaged in care, but the data on financial incentives were not encouraging. Several studies provided insights into the impact of early ART on decreasing the size of the HIV reservoir in HIV-infected infants. Pertinent conference findings relating to women's health issues included similar clinical outcomes between breastfeeding and formula feeding HIV-infected women, the problem of viral rebound and ART nonadherence in pregnancy and postpartum.

Background: Suboptimal antiretroviral therapy (ART) adherence and disengagement in care present significant public health challenges because of the increased probability of HIV transmission. In the United States, men who have sex with men (MSM) continue to be disproportionately affected by HIV, highlighting a critical need to engage high-risk MSM living with HIV who are not engaged or retained in care. Objective: The aim of the study was to assess the feasibility of at-home blood self-collection and laboratory quantification of HIV-1 RNA viral load (VL) to report laboratory-based VL outcomes and compare self-reported and laboratory-reported VL Methods: Between 2016 and 2017, 766 US HIV-positive MSM enrolled in a Web-based behavioral intervention were invited to participate in an at-home dried blood spot (DBS) collection study using HemaSpot-HF kits (Spot On Sciences, Inc, Austin, TX) for laboratory-quantified VL. Results: Of those invited to participate, 72.3% (554/766) enrolled in the DBS study. Most (79.2%, 439/554) men enrolled reported attempting to collect their blood, 75.5% (418/554) of participants mailed a DBS specimen to the research laboratory, and 60.8% (337/554) had an adequate blood sample for VL testing. Of the 337 specimens tested for VL by the laboratory, 52.5% (177/337) had detectable VL (median: 3508 copies/mL; range: 851-1,202,265 copies/mL). Most men (83.9%, 135/161) who returned a DBS specimen with laboratory-quantified detectable VL self-reported an undetectable VL during their last clinical visit. Conclusions: Home collection of DBS samples from HIV-positive MSM is feasible and has the potential to support clinical VL monitoring. Discrepant laboratory HIV-1 RNA values and self-reported VL indicate a need to address perceived VL status, especially in the era of treatment as prevention. Most participants were willing to use an at-home DBS kit in the future, signaling an opportunity to engage high-risk MSM in long-term HIV care activities.

The HIV Vaccine Trials Network (HVTN) 087 vaccine trial assessed the effect of increasing doses of pIL-12 (interleukin-12 delivered as plasmid DNA) adjuvant on the immunogenicity of an HIV-1 multiantigen (MAG) DNA vaccine delivered by electroporation and boosted with a vaccine comprising an attenuated vesicular stomatitis virus expressing HIV-1 Gag (VSV-Gag). We randomized 100 healthy adults to receive placebo or 3 mg HIV-MAG DNA vaccine (ProfectusVax HIV-1 gag / pol or ProfectusVax nef / tat / vif , env ) coadministered with pIL-12 at 0, 250, 1,000, or 1,500 μg intramuscularly by electroporation at 0, 1, and 3 months followed by intramuscular inoculation with 3.4 × 10 7 PFU VSV-Gag vaccine at 6 months. Immune responses were assessed after the prime and boost and 6 months after the last vaccination. High-dose pIL-12 increased the magnitude of CD8 + T-cell responses postboost compared to no pIL-12 ( P = 0.02), while CD4 + T-cell responses after the prime were higher in the absence of pIL-12 than with low- and medium-dose pIL-12 ( P ≤ 0.05). The VSV boost increased Gag-specific CD4 + and CD8 + T-cell responses in all groups ( P < 0.001 for CD4 + T cells), inducing a median of four Gag epitopes in responders. Six to 9 months after the boost, responses decreased in magnitude, but CD8 + T-cell response rates were maintained. The addition of a DNA prime dramatically improved responses to the VSV vaccine tested previously in the HVTN 090 trial, leading to broad epitope targeting and maintained CD8 + T-cell response rates at early memory. The addition of high-dose pIL-12 given with a DNA prime by electroporation and boosted with VSV-Gag increased the CD8 + T-cell responses but decreased the CD4 + responses. This approach may be advantageous in reshaping the T-cell responses to a variety of chronic infections or tumors. (This study has been registered at ClinicalTrials.gov under registration no. NCT01578889.)

Little is known about HIV treatment optimism and risk behaviors among Black men who have sex with men (BMSM). Using longitudinal data from BMSM in the HPTN 061 study, we examined participants’ self-reported comfort with having condomless sex due to optimistic beliefs regarding HIV treatment. We assessed correlates of treatment optimism and its association with subsequent risk behaviors for HIV acquisition or transmission using multivariable logistic regression with generalized estimating equations. Independent correlates of treatment optimism included age ≥35 years, annual household income

The HIV Vaccine Trials Network (HVTN) 087 vaccine trial assessed the effect of increasing doses of pIL-12 (interleukin-12 delivered as plasmid DNA) adjuvant on the immunogenicity of an HIV-1 multiantigen (MAG) DNA vaccine delivered by electroporation and boosted with a vaccine comprising an attenuated vesicular stomatitis virus expressing HIV-1 Gag (VSV-Gag). We randomized 100 healthy adults to receive placebo or 3 mg HIV-MAG DNA vaccine (ProfectusVax HIV-1 gag/pol or ProfectusVax nef/tat/vif, env) coadministered with pIL-12 at 0, 250, 1,000, or 1,500 μg intramuscularly by electroporation at 0, 1, and 3 months followed by intramuscular inoculation with 3.4 × 107 PFU VSV-Gag vaccine at 6 months. Immune responses were assessed after the prime and boost and 6 months after the last vaccination. High-dose pIL-12 increased the magnitude of CD8+ T-cell responses postboost compared to no pIL-12 (P = 0.02), while CD4+ T-cell responses after the prime were higher in the absence of pIL-12 than with low- and medium-dose pIL-12 (P ≤ 0.05). The VSV boost increased Gag-specific CD4+ and CD8+ T-cell responses in all groups (P < 0.001 for CD4+ T cells), inducing a median of four Gag epitopes in responders. Six to 9 months after the boost, responses decreased in magnitude, but CD8+ T-cell response rates were maintained. The addition of a DNA prime dramatically improved responses to the VSV vaccine tested previously in the HVTN 090 trial, leading to broad epitope targeting and maintained CD8+ T-cell response rates at early memory. The addition of high-dose pIL-12 given with a DNA prime by electroporation and boosted with VSV-Gag increased the CD8+ T-cell responses but decreased the CD4+ responses. This approach may be advantageous in reshaping the T-cell responses to a variety of chronic infections or tumors. (This study has been registered at ClinicalTrials.gov under registration no. NCT01578889.)

The role of sexual networks in the epidemiology of human immunodeficiency virus (HIV) among black men who have sex with men (MSM) is poorly understood. Using data from 1,306 black MSM in the BROTHERS Study (2009-2010) in the United States, we examined the relationships between multiple sexual dyadic characteristics and serodiscordant/serostatus-unknown condomless sex (SDCS). HIV-infected participants had higher odds of SDCS when having sex at least weekly (odds ratio (OR) = 2.41, 95% confidence interval (CI): 1.37, 4.23) or monthly (OR = 1.94, 95% CI: 1.17, 3.24) versus once to a few times a year. HIV-uninfected participants had higher odds of SDCS with partners met offline at sex-focused venues (OR = 1.79, 95% CI: 1.15, 2.78) versus partners met online. In addition, having sex upon first meeting was associated with higher odds of SDCS (OR = 1.49, 95% CI: 1.21, 1.83) than was not having sex on first meeting, while living/continued communication with sexual partner(s) was associated with lower odds of SDCS (weekly: OR = 0.64, 95% CI: 0.47, 0.85; monthly: OR = 0.60, 95% CI: 0.44, 0.81; yearly: OR = 0.58, 95% CI: 0.39, 0.85) versus discontinued communication. Persons with primary/steady nonprimary partners versus commercial partners had lower odds of SDCS regardless of HIV serostatus. This suggests the need for culturally relevant HIV prevention efforts for black MSM that facilitate communication with sexual partners especially about risk reduction strategies, including preexposure prophylaxis.