This review explores the policy implications of findings from the HIV Prevention Trials Network (HPTN 052) treatment as prevention (TasP) study.
To date, the potential of antiretrovirals to prevent sexual transmission of HIV by infected persons has been grounded in observational cohort, ecological, mathematical modeling, and meta-analytic studies. HPTN 052 represents the first randomized controlled trial to test the secondary prevention benefit of HIV transmission using antiretroviral treatment in largely asymptomatic persons with high CD4 cell counts.
The US National HIV/AIDS Strategy has among its key goals the reduction of incident HIV infections, improved access to quality care and associated outcomes, and the reduction in HIV-associated health disparities and inequities. HPTN 052 demonstrates that providing TasP, in combination with other effective prevention strategies offers the promise of achieving these life-saving goals. But HPTN 052 also highlights the need for cautious optimism and underscores the importance of addressing current gaps in the HIV prevention, treatment, and care continuum in order for 'TasP' strategies to achieve their full potential. Among these are necessary improvements in the capacity to expand HIV testing, facilitate effective linkage and retention in care, and improve treatment initiation, maintenance, and virus suppression.
"Issues related to the scarcity of HIV prevention and health promotion resources have also led to a set of arguments around targeting efforts at specific population sub-groups considered most at-risk for transmitting HIV for cost-specific reasons , though many acknowledge the ethical complexities associated with deciding how efforts ought to be prioritized during implementation [37,38]. For example, the literature generally acknowledges that population sub-groups that already face the highest levels of stigmatization (e.g., people who inject drugs) are likely the most at risk for HIV acquisition and transmission . "
[Show abstract][Hide abstract] ABSTRACT: Background
Despite the evidence showing the promise of HIV treatment as prevention (TasP) in reducing HIV incidence, a variety of ethical questions surrounding the implementation and “scaling up” of TasP have been articulated by a variety of stakeholders including scientists, community activists and government officials. Given the high profile and potential promise of TasP in combatting the global HIV epidemic, an explicit and transparent research priority-setting process is critical to inform ongoing ethical discussions pertaining to TasP.
We drew on the Arksey and O’Malley framework for conducting scoping review studies as well as systematic approaches to identifying empirical and theoretical gaps within ethical discussions pertaining to population-level intervention implementation and scale up. We searched the health science database PubMed to identify relevant peer-reviewed articles on ethical and implementation issues pertaining to TasP. We included English language articles that were published after 2009 (i.e., after the emergence of causal evidence within this field) by using search terms related to TasP. Given the tendency for much of the criticism and support of TasP to occur outside the peer-reviewed literature, we also included grey literature in order to provide a more exhaustive representation of how the ethical discussions pertaining to TasP have and are currently taking place. To identify the grey literature, we systematically searched a set of search engines, databases, and related webpages for keywords pertaining to TasP.
Three dominant themes emerged in our analysis with respect to the ethical questions pertaining to TasP implementation and scale-up: (a) balancing individual- and population-level interests; (b) power relations within clinical practice and competing resource demands within health care systems; (c) effectiveness considerations and socio-structural contexts of HIV treatment experiences within broader implementation contexts.
Ongoing research and normative deliberation is required in order to successfully and ethically scale-up TasP within the continuum of HIV care models. Based on the results of this scoping review, we identify several ethical and implementation dimensions that hold promise for informing the process of scaling up TasP and that could benefit from new research.
BMC Medical Ethics 07/2014; 15(1):54. DOI:10.1186/1472-6939-15-54 · 1.50 Impact Factor
"The iPrEx trial demonstrated PrEP efficacy for MSM and TG women, but recent studies have raised questions regarding the population-level effectiveness of PrEP in a world of limited public health resources, multiple biomedical HIV prevention approaches, and concerns surrounding appropriate implementation protocols. The recent release of the HPTN 052 trial results has bolstered policy arguments for investing scarce resources in “treatment as prevention” programs , perhaps to the detriment of investment in PrEP. It is in this environment that we obtained findings that we translate here into seven recommendations for PrEP to be “real-world effective”: "
[Show abstract][Hide abstract] ABSTRACT: A recent clinical trial demonstrated that a daily dose tenofovir disoproxil fumarate and emtricitabrine (TDF-FTC) can reduce HIV acquisition among men who have sex with men (MSM) and transgender (TG) women by 44%, and up to 90% if taken daily. We explored how medical and service providers understand research results and plan to develop clinical protocols to prescribe, support and monitor adherence for patients on PrEP in the United States.
Using referrals from our community collaborators and snowball sampling, we recruited 22 healthcare providers in San Francisco, Oakland, and Los Angeles for in-depth interviews from May-December 2011. The providers included primary care physicians seeing high numbers of MSM and TG women, HIV specialists, community health clinic providers, and public health officials. We analyzed interviews thematically to produce recommendations for setting policy around implementing PrEP. Interview topics included: assessing clinician impressions of PrEP and CDC guidance, considerations of cost, office capacity, dosing schedules, and following patients over time.
Little or no demand for PrEP from patients was reported at the time of the interviews. Providers did not agree on the most appropriate patients for PrEP and believed that current models of care, which do not involve routine frequent office visits, were not well suited for prescribing PrEP. Providers detailed the need to build capacity and were concerned about monitoring side effects and adherence. PrEP was seen as potentially having impact on the epidemic but providers also noted that community education campaigns needed to be tailored to effectively reach specific vulnerable populations.
While PrEP may be a novel and clinically compelling prevention intervention for MSM and TG women, it raises a number of important implementation challenges that would need to be addressed. Nonetheless, most providers expressed optimism that they eventually could prescribe and monitor PrEP in their practice.
PLoS ONE 07/2012; 7(7):e40603. DOI:10.1371/journal.pone.0040603 · 3.23 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The recent NIH HPTN 052 study of using HIV treatment to prevent HIV transmission in serostatus discordant heterosexual partnerships has garnered much attention. In subsequent discussions, however, the topic of HIV-related risk behavior has been nearly absent. Here, we identify the critical roles that HIV-related risk behavior plays in determining the unmet needs, optimal targeting, and ultimate impact of treatment as prevention. We describe the size of the population at risk of HIV and three subgroups of persons living with HIV (PLWH) based on awareness of serostatus and risk behavior, and the corresponding HIV transmission rates to seronegative partners. For each of the subgroups of PLWH, we identify which approach is most relevant ("testing and linkage to care," "treatment as prevention," and/or "treatment as clinical care"). We observe that the impact of "treatment as prevention" on HIV incidence will depend heavily on which subgroup of PLWH is targeted for services.
AIDS and Behavior 04/2012; 16(5):1085-91. DOI:10.1007/s10461-012-0186-1 · 3.49 Impact Factor
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