Fake drugs, real concerns: Counterfeit HIV medications and community trust.

Counterfeit medications infiltrate drug supply chains at various entry points. While scientific advancements continue to deter counterfeit medications, these imitation therapies still manage to circumvent national and international regulations to reach unsuspecting consumers. Certain manufacturers of human immunodeficiency virus (HIV) prevention and treatment medications within the United States recently encountered counterfeit versions of their therapies that in some instances contained antipsychotic and pain reliever products. People on HIV treatment or those taking HIV prevention therapies who consume counterfeit medications are at risk of having their HIV management strategies compromised or seroconverting from an HIV negative to an HIV positive status, respectively. The implicated manufacturers reportedly took legal actions against the discovered counterfeiters, alerted impacted pharmacies, and assisted them with removal of illegitimate drugs. However, communities' gradual awareness or lack thereof in regards to counterfeit HIV prevention and treatment medications is likely to result in speculation about how many consumers took real versus fake medications, contributing to consumer distrust. This commentary provides details of a stakeholder meeting that took place with one of the leading manufacturers of HIV treatment and prevention medications to query its responses to counterfeit medications identified among its available product supplies in pharmacies. This manuscript also recommends to manufacturers ways to augment their communication strategies to communities if similar medicinal breaches occurred in the future.

Perceptions of Sexual Risk, PrEP Services, and Peer Navigation Support among HIV-Negative Latinx and Black Men who have Sex with Men (MSM) Residing in Western Washington.

Introduction: HIV PrEP (pre-exposure prophylaxis) is underutilized among Latinx and Black men who have sex with men (MSM) in the United States. Although peer navigation approaches may increase PrEP uptake and adherence, it remains unclear what strategies work best for MSM of color. Methods: From July 2017 to August 2018, we conducted semi-structured in-depth interviews with 25 purposively sampled Latinx and Black cisgender MSM to evaluate how the intersectionality of race/ethnicity, sexual orientation, and other identities influenced men's views on PrEP in general and on peer navigation specifically. Thematic analysis was used to identify and analyze emergent themes. Results: Emergent themes included: (1) awareness of vulnerability in intimate relationships; (2) barriers to PrEP initiation including perceived side effects, stigma, and financial concerns; (3) a wish to connect with other Latinx and Black MSM in a health and prevention space; and (4) the desire for peer matching based on identity considerations and lived experience. Younger men and Spanish-speaking Latinx men were most interested in peer navigation to access PrEP, while bisexual men had confidentiality concerns. Conclusions: In our study, Latinx and Black MSM viewed peer navigation services favorably, especially if they addressed men's desire to connect with other MSM of color. Policy Implications: Developing culturally-congruent peer navigation programming could help improve PrEP uptake and care engagement for Latinx and Black MSM. Programs should recruit peers from the racial/ethnic minority communities most impacted by HIV and prioritize matching peers to clients based on identity concerns, needs, and preferences.

Impact of supplemental site grants to increase African American accrual for the Selenium and Vitamin E Cancer Prevention Trial.

BACKGROUND: African American accrual to prevention trials at rates representative of the disease burden experienced by this population requires additional resources and focused efforts. PURPOSE: To describe the rationale, context, and criteria for selection of sites that received Minority Recruitment Enhancement Grants (MREGs) to increase African American recruitment to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). To determine if African American accrual was higher among the 15 MREG sites when compared with similar nonawarded sites. METHODS: Changes in African American accrual at sites that received MREGs are compared with changes in a group of 15, frequency-matched, nonawarded sites using a quasi-experimental, post hoc analysis. Successful and unsuccessful recruitment strategies reported by the MREG sites are described. RESULTS: The increased number of African American participants accrued per month at MREG sites post-funding was higher than the change at comparison sites by a factor of 3.38 (p = 0.004, 95% CI: 1.51-7.57). An estimated 602 additional African American participants were recruited at MREG sites due to MREG funding, contributing to the overall 14.9% African American recruitment. Successful recruitment strategies most reported by MREG sites included increasing staff, transportation resources, recruiting through the media, mailings, and prostate cancer screening clinics during off-hours. LIMITATIONS: Comparison sites were chosen retrospectively, not by randomization. Although comparison sites were selected to be similar to MREG sites with regard to potential confounding factors, it is possible that unknown factors could have biased results. Cost-effective analyses were not conducted. CONCLUSIONS: MREG sites increased African American accrual in the post-funding period more than comparison sites, indicating MREG funding enhanced the sites' abilities to accrue African American participants. Targeted grants early in the accrual period may be a useful multi-site intervention to increase African American accrual for a prevention study where adequate African American representation is essential.

Community-researcher partnerships at NIAID HIV/AIDS clinical trials sites: insights for evaluation and enhancement.

BACKGROUND: Community engagement has been a cornerstone of National Institute of Allergy and Infectious Diseases (NIAID)'s HIV/AIDS clinical trials programs since 1990. Stakeholders now consider this critical to success, hence the impetus to develop evaluation approaches. OBJECTIVES: The purpose was to assess the extent to which community advisory boards (CABs) at HIV/AIDS trials sites are being integrated into research activities. METHODS: CABs and research staff (RS) at NIAID research sites were surveyed for how each viewed (a) the frequency of activities indicative of community involvement, (b) the means for identifying, prioritizing, and supporting CAB needs, and (c) mission and operational challenges. RESULTS: Overall, CABs and RS share similar views about the frequency of community involvement activities. Cluster analysis reveals three groups of sites based on activity frequency ratings, including a group notable for CAB-RS discordance. CONCLUSIONS: Assessing differences between community and researcher perceptions about the frequency of and challenges posed by specific engagement activities may prove useful in developing evaluation tools for assessing community engagement in collaborative research settings.