Developing the evidence base for biomedical prevention strategies


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This Mapping Pathways poster was presented at AIDS 2012 on Monday July 23, 2012.

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Developing the evidence base for biomedical prevention strategies

  1. 1. Developing the evidence base for biomedical prevention strategies BACKGROUND METHODS The world has made great progress in containing HIV since the epidemic peaked in the late 1990s. But there are still more than 2 Mapping Pathways used four multimodal, complementary methodologies to million new infections a year. The current toolkit of prevention options is clearly not sufficient: a broader portfolio of approaches, or develop a comprehensive understanding of the evidence base, focusing on India, pathways, to prevention is needed. Recent trial data shows great promise in four antiretroviral (ARV) prevention strategies: South Africa, and the United States. A (1) structured literature review and (2) § Testing, Linkage to Care Plus Treatment (TLC+): earlier treatment for HIV-positive people Delphi ExpertLens on key faultlines provided a foundation for (3) semi-structured § Pre-exposure prophylaxis (PrEP): providing HIV-negative people with ARVs to prevent HIV interviews with grass tops policy perspectives and (4) grass roots opinions from § Vaginal and rectal microbicides: topical applications for HIV-negative people to prevent HIV an online community survey. § Post-exposure prophylaxis (PEP): providing ARVs to HIV-negative people with a potential recent exposure to HIV. Such an adaptive approach to policy development, where “grasstops” Though ARV-based prevention strategies show promise, they raise complex challenges, including access, cost, behavioral impacts, and stakeholders and experts and ”grassroots” communities are engaged in reflexive drug resistance. The broader empirical evidence base for approval and implementation is still under development. and iterative exchanges of knowledge about the evidence needed for policy development, is a methodological innovation in itself. Mapping Pathways is a unique, community-led, study which is providing a multi-layered (scientific and stakeholder-based) synthesis of the evidence base for ARV-based prevention strategies which tackle the HIV epidemic. RESULTS 3. Forty-three stakeholders (India – 9; South Africa – 13; United States – 19, plus two small focus groups in the US) were interviewed across the three countries in order to understand the decisionmaking 1. The literature review retrieved 5,811 articles: 302 selected abstracts were needs of “grasstops” policy experts. The disciplines represented by the stakeholders varied mapped and 100 articles analysed for efficacy, cost-effectiveness, indirect considerably and were not mutually exclusive, but could generally be distilled into one of five categories: outcomes, and epidemiological impact data. Twenty-one clinical trials were clinical, advocacy, research/academician, political, or administrative. reviewed, 31 modelling and cost studies (of which 9 examined cost-effectiveness and Even when looking at the exact same data, stakeholders in India, South Africa, and the United States often 14 looked at epidemiological modelling) and 30 cross-sectional, longitudinal, or came to very different conclusions about the implications of the findings and their relevance for HIV prevention other intervention studies. We observe gaps in the empirical evidence base and and treatment policies in their countries. argue it is still under development in critical areas (see Poster MOPE 591). Do HPTN 052 trial findings support changing treatment guidelines? 2. Thirty-two HIV/AIDS experts participated in a RAND-developed, online Delphi-based discussion called ExpertLens. Views were solicited on a range of topics, including the comparative strengths United States (N=10) South Africa (N=13) of the strategies. Experts generally thought TLC+ had the strongest evidence, was most ready for implementation, and most deserving of funds. India (N=8) Agreement varied on these comparative strengths, though, and consensus only emerged for the TLC+ Mixed Positive Skeptical strategy in three areas: strength of the science, readiness for implementation, and allocation of funds (see Poster MOPE 591 for more information). When looking across all strategies, stakeholders in each country had very different views about which ExpertLens comparative assessment of would be most appropriate for their country. There is a wide divergence in views about whether scientific data alone is necessary but not sufficient to bring about policy change. This range highlights biomedical prevention strategies the importance of context in decisionmaking. Additional nuances were collected through qualitative analysis of responses. Discussions and decisions are taking place, but expert stakeholders need more 1 information, particularly to Percent of positive/mixed stakeholder review Relative assessment 0.8 help contextualise the scientific data. responses by biomedical prevention 0.6 0.4 strategy and country 0.2 100% 0 n s e of tion ty sc of nd tio India nc as t en ss ili fe os fu gy h ie ib ta em ne ca C te gt lo pl di ra n st Stre Al m ea South Africa riR fo United States TLC+, Test & Treat, etc. Microbicides PrEP PEP 50% “In an Indian culture that still struggles to accept condoms, it would be difficult to get the general population to accept PrEP. While risk categories based on global norms are feasible to define and accept, it will be hard for an individual to accept that he or she is “Well, from a programmatic perspective, theres a problem of “high-risk” and should take this treatment.” (Indian stakeholder demand as we have low resources. We are having problems reaching discussing PrEP) people who dont know they are positive now.. That is one of the main concerns, theres no indication that as good idea as it is; that implementation is feasible due to a lack of resources.” (US“The only way there will be more of a chance of them ever being stakeholder discussing TLC+) 0%taken up by communities is if they are marketed as a sex toy orlubricant. If you call them microbicides, youll sell 3 in 20 years; if you PEP Topical PrEP TLC+ PrEPcall them applicators, youll sell 2 in 20 years… they now need to behanded over to a marketing company to consider how to advertise 4.them as a sex toy” (South African stakeholder discussing Relative importance of biomedical prevention 1069 respondents participatedmicrobicides) strategies from all survey respondents in the survey: 47.7% (USA), 32.3% (South African), and 100% 9.4% (India). A majority of the respondents were male (53%), and 59% identified themselves as work Can ARVs and PEP straight/heterosexual, 29.7% as gay, ly biological event, TLC+, Test & Treat, etc. 50% and 6% as bisexual. Though country- to pr clinically treat? PrEP specific demographics of participants not just Microbicides varied, the majority were activists/advocates, worked for AIDS 0% service organisations/NGOs, were doctors, and/or were people living with e gi t, te en n HIV/AIDS. The majority of participants at giv , n po are te en te n t n n of e g d no be ant im gs t or e n an io io at ve or in bu io io ts b n m d b rta at iv in lo ld nta nt nt rt nt t or m r th nt, op ul po felt that TLC+ was the most important ou rta ou p he ta ho im sh im o RVs ld po ot or N t s all e d all p im er A of strategy, followed by microbicides. im the role sh bu at an at ry eliv is How will fect policy? ot ot Ve It N e d tion? N w af do even ‘publics’ How for pr nge s wed a cial t so novat Wh ect in cha n? io ing ? negotia e be rene Will ther over patents? tion CONCLUSIONS aff ork e needed Findings underscore broad, often divergent views regarding the viability of ARV-based prevention, with TLC+ tw stems ar isn’ What sy delivery? garnering the most optimism. However, Mapping Pathways findings provide empirical support for the argument W hat for that an adaptive approach to policy development is required. This will enable understanding of the scientific data behind the strategies (the physical technologies in red, on the left), but also knowing what social technologies (in grey) are needed to shape their implementation in culturally appropriate ways. An important series of questions are raised about the systems in which these strategies might be introduced (in purple), and the pathways needed to guide them.Mapping Pathways has six partner organisations: AIDS Foundation of Chicago, AIDS United, Bairds CMC, Desmond Tutu HIV Foundation, Naz India and RAND. Mapping Pathways is funded by an initial grant fromMerck & Co., as well as an additional NIH ‘Be the Generation Bridge’ grant for dissemination and community engagement activities.Blog: www.mappingpathways.blogspot.comFacebook: @MappingPathways DESMOND TUTU HIV FOUNDATION BAIRD’S CMC