Clinical trials provide the evidence critical for patient empowerment

In this issue of the Journal, Delva et al. discuss in a Viewpoint our Perspective article published in the New England Journal of Medicine in which we argue for the urgent need for a clinical trial on when to initiate antiretroviral therapy (ART) in HIV-infected patients in sub-Saharan Africa. The authors posit that there is currently sufficient evidence to make informed decisions regarding this issue and consequently individual patients’ autonomy should be the key factor in determining the timing for ART initiation

When to Start ART in Africa — An Urgent Research Priority

The history of the HIV–AIDS epidemic was profoundly altered by the introduction of antiretroviral therapy (ART). More than 8 million people in low-income and middle-income countries have received lifesaving ART over the past decade, yet in 2011 an estimated 34 million people were living with HIV infection, 6.8 million were eligible for treatment but lacked access to ART, 2.5 million became newly infected, and 1.7 million died of HIV-related disease

When to Start ART in Africa — An Urgent Research Priority

The history of the HIV–AIDS epidemic was profoundly altered by the introduction of antiretroviral therapy (ART). More than 8 million people in low-income and middle-income countries have received lifesaving ART over the past decade, yet in 2011 an estimated 34 million people were living with HIV infection, 6.8 million were eligible for treatment but lacked access to ART, 2.5 million became newly infected, and 1.7 million died of HIV-related disease

Underreported injection drug use and its potential contribution to reported increase in sexual transmission of HIV in Kazakhstan and Kyrgyzstan

Background We conducted a cross-sectional integrated bio-behavioral survey among sex partners of persons who inject drugs (PWID) to explore reasons for reported increase in reporting of heterosexually transmitted HIV in Kazakhstan and Kyrgyzstan. Methods Sexual partners of PWID were recruited through PWID. Behavioral data were collected through semi-structured interviews. Dried blood spots were obtained and tested for HIV and hepatitis C virus antibodies (HCVAb). Descriptive univariate and bivariate analyses, and multivariate analyses using logistic regression modeling were performed to identify factors associated with HIV and HCV infections. Results Among 1982 sex partners of PWID, overall HIV prevalence was 6.4%; 5.1% and 12.9% among those reported never and ever injecting drugs, respectively (p < 0.001). Overall, HCVAb prevalence was 21.3%; 15.0% and 53.9% among those reported never and ever injecting drugs, respectively (p < 0.001). Of HCV-positive participants, 58% and 34% (p < 0.001) reported prior history of injecting drug use among men and women, respectively. HIV prevalence was lower among HCV-negative (4.2%) compared to HCV-positive participants (14.4%) (p < 0.001). HIV prevalence was 3.5% (95%CI = 2.4–4.6) in a subset of female participants with no reported prior injecting drug use history and who were HCVAb-negative and did not report having an HIV-positive sex partner. Participant sex and number of sex partners as well as use of condoms in the past 12 months were not associated with HIV seropositivity. Conclusions High prevalence of HCV among sex partners of PWID who denied ever injecting drugs suggests underreporting of injecting practices. The increased attribution of HIV infection to sexual transmission based on self-report may be partly explained by underreporting of injection drug use due to stigmatization of this behavior

Letting HIV Transform Academia — Embracing Implementation Science

The human immunodeficiency virus (HIV) epidemic has had an extraordinary global impact. Even as it has devastated societies, it has also inspired community empowerment, motivated impressive scientific discoveries, and provoked an unprecedented mobilization of vast resources for a single health condition. Not yet fully realized, however, is the epidemic's potential for expanding the core mission of academic institutions to include the pursuit of a wider range of research

The HIV care continuum: No partial credit given

Despite significant scale-up of HIV care and treatment across the world, overall effectiveness of HIV programs is severely undermined by attrition of patients across the HIV care continuum, both in resource-rich and resource-limited settings. The care continuum has four essential steps: linkage from testing to enrollment in care, determination of antiretroviral therapy (ART) eligibility, ART initiation, and adherence to medications to achieve viral suppression. In order to substantially improve health outcomes for the individual and potentially for prevention of transmission to others, each of the steps of the entire care continuum must be achieved. This will requirethe adoption of interventions which address the multiplicity of barriers and social contexts faced by individuals and populations across each step, a reconceptualization of services to maximize engagement, and ambitious evaluation of program performance using allor-none measurement

When to start ART in Africa.

To the Editor: In their Perspective article, De Cock and El-Sadr (March 7 issue)1 highlight the need for data on when to start antiretroviral therapy (ART) for HIV-infected people in Africa who have CD4+ counts above 350 cells per cubic millimeter. However, their proposed solution — a new randomized, controlled trial in Africa — is flawed

Transgender People and HIV Prevention: What We Know and What We Need to Know, a Call to Action

Abstract: Transgender people have been disproportionally affected by HIV, particularly transgender women. Their increased vulnerability to HIV is due to multiple issues, including biological (eg, increased efficiency of HIV transmission through receptive anal sex), epidemiological (eg, increased likelihood of having HIV-infected partners), structural (eg, social stigma limiting employment options), and individual factors (eg, internalized stigma leading to depression and substance use and risk-taking behaviors). There have been limited culturally appropriate HIV prevention interventions for transgender people, with many key prevention studies (eg, the iPrEx PrEP study) enrolling transgender women in a study focusing on men who have sex with men. This has resulted in limited understanding of the optimal ways to decrease transgender people's risk for HIV acquisition. The current supplement of JAIDS is designed to review what is known about HIV prevention for transgender people and to highlight new insights and best practices. The study reviews recent epidemiologic data, the pharmacology of HIV prophylactic agents in individuals who may be using exogenous hormones, and several recent multi-component interventions designed to address the lived experience of transgender people. Additionally, the study reviews the work going on at the NIH to address transgender health in general and HIV prevention in specific, as well as two important papers related to clinical trial design issues and the ethical conduct of research in this frequently disenfranchised population. It is the hope of the HIV Prevention Trials Network (HPTN) that this supplement will promote new knowledge around transgender health and the requisite issues that need to be addressed in order to conduct optimal clinical trials. The ultimate hope is that the information distilled in this supplement will inform investigators, clinicians, and public health officials in order to design further research to develop optimal prevention interventions for transgender people and to implement these interventions in ways that are culturally congruent and health promoting

Venue-based recruitment of women at elevated risk for HIV: An HIV prevention trials network study

Background: The challenge of identifying and recruiting U.S. women at elevated risk for HIV acquisition impedes prevention studies and services. HIV Prevention Trials Network (HPTN) 064 was a U.S. multisite, longitudinal cohort study designed to estimate HIV incidence among women living in communities with prevalent HIV and poverty. Venue-based sampling (VBS) methodologies and participant and venue characteristics are described. Methods: Eligible women were recruited from 10 U.S. communities with prevalent HIV and poverty using VBS. Participant eligibility criteria included age 18–44 years, residing in a designated census tract/zip code, and self-report of at least one high-risk personal and/or male sexual partner characteristic associated with HIV acquisition (e.g., incarceration history). Ethnography was conducted to finalize recruitment areas and venues. Results: Eight thousand twenty-nine women were screened and 2,099 women were enrolled (88% black, median age 29 years) over 14 months. The majority of participants were recruited from outdoor venues (58%), retail spaces (18%), and social service organizations (13%). The proportion of women recruited per venue category varied by site. Most participants (73%) had both individual and partner characteristics that qualified them for the study; 14% were eligible based on partner risk only. Conclusion: VBS is a feasible and effective approach to rapidly recruit a population of women at enhanced risk for HIV in the United States. Such a recruitment approach is needed in order to engage women most at risk and requires strong community engagement