If you want to curb new HIV infections in a specific group, like young gay men of color, what's the best way to do it? You could fund prevention and treatment groups staffed by people from that community. Or you could expand HIV testing for hospital patients. The CDC is thinking carefully about this question -- and is considering whether the answer runs counter to our first instincts.
"If you do routine screening in hospitals and emergency departments, you diagnose a lot of people -- including black gay men -- and it can be much cheaper per person diagnosed than implementing stand-alone programs for a specific group like black gay men," says Jono Mermin, Director of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. "Programs specifically designed to reach one highly affected group can also be inexpensive and very effective -- but it depends how they are designed and implemented."
The basic principles are clear: Look at the desired outcome (increasing HIV testing, identifying new infections, supporting HIV meds adherence, etc.), look at the cost per intervention, find the most cost-effective bang for your buck, and do it, even if it means departing from conventional wisdom. "The way to get the job done may be to do something different," Mermin says.
How It Works
High-Impact Prevention isn't a single program. It's a set of principles with its fingerprints on a range of programs. One of the core principles is that strategies need to target areas with the greatest numbers of new infections. To do this, the CDC distributed $339 million in 2012 -- almost half of its annual prevention budget -- to state and local health departments based on the number of people with HIV in each area. "HIV prevalence isn't equal," Mermin says. In each state, the counties with the highest HIV burden received the most funding and reported individually.
The CDC will also focus on "cost-effective, evidence-based, scaleable" approaches: in other words, approaches that are affordable based on the cost per infection prevented and the medical costs saved by keeping someone HIV-negative. "Evidence-based" is key -- the impact of the strategy must have been studied and evaluated. "Scaleable" means it can done on a larger scale.
There are many examples of how HIP plays out. For example, in 2012, a $339 million funding stream made grants to state and local health departments in areas with the highest HIV prevalence in the country. 75% of this funding had to be focused on four core strategies: HIV testing, prevention with positives (including linkage to care, retention in care, HIV medications, adherence counseling, and behavior change), policy change that facilitates prevention, and condom distribution to high-risk populations. (The funding wasn't rigid -- additional money was available for other strategies, based on local epidemiology and cost-effectiveness.)
To see what's happening so far, check out the CDC's Enhanced Comprehensive HIV Prevention Planning (ECHPP) Project, an initiative that began in September of 2010 and just finished. These were three-year grants given to help 12 cities scale up prevention strategies that the CDC classifies as effective. The CDC publishes regular reports on these projects at cdc.gov (search for ECHPP Year One). These reports present a picture of how health departments are starting to stretch to meet the ambitious targets laid out in the National HIV/AIDS strategy, which is the overarching plan for the U.S.
The majority of grantees met targets in areas like testing, condom distribution, and keeping people with HIV in care. But they lagged behind in implementing post- exposure prophylaxis (PEP -- see article in this issue), even though this is a required intervention for ECHPP grantees. PEP has been recommended by the CDC for some time now, but its report on ECHPP progress says that slow PEP rollout might be because "PEP is relatively new to most health departments" and they have only recently begun to do planning and implementation. Now that it is required by CDC in at least one of its funding streams, perhaps this will change.
The CDC is also taking another look at the "Diffusion of Effective Behavioral Interventions" (DEBIs) -- programs that have been the basis for U.S. HIV prevention since 2000. For example, Mermin says that the DEBIs that focused on preventing heterosexual transmission often don't make the cut for HIP because of the high price tag per infection prevented. Other DEBIs are cost saving, and are listed at effectiveinterventions.org.
Another piece of HIP is the HIV Care Continuum, which President Obama signed into law last July. It directs federal agencies to accelerate efforts to "increase HIV testing, services, and treatment." DHHS, CDC, and OSHA launched a demonstration project that will put $8-10 million a year into community health centers, health departments, and other grantees to improve the care across the continuum of health services.
Figuring It Out
"'Capacity Building Assistance for High Impact Prevention' is a five-year, $130 million investment to implement HIP 'to high-risk populations in high-impacted geographic areas.'"
Sorting out which parts of HIP are new and which older programs have come along for the ride has advocates' heads spinning. In our conversations with them, there was confusion as to what HIP was all about. "There are a bunch of different messages and strategies that have been labeled as HIP. So oftentimes the broader community is not in tune with the lingo," said Kieta Mutepfa of the UCLA Center for Clinical AIDS Research & Education.
Among those we interviewed, some were familiar with different CDC initiatives, like "HIV Prevention for Young MSM and Transgender Persons of Color", which gave grants to community-based organizations (CBOs) to start testing and linkage to care in 2011. Right away, we see the challenge of putting HIP into practice. In the first year, only seven of the 30 funded CBOs achieved their target of testing at least 600 young gay men of color; only two of six CBOs achieved the target of testing at least 75 young transgender people of color. The CDC notes that this was the first year of the program -- and that start-up delays happen in many new programs. But it does highlight the challenges for organizations that may not have experience in providing testing services in meeting ambitious targets. The HIP model (which stresses linkages between testing and services like HIV treatment) emphasizes medical interventions. CBOs that don't work in that area will need to build their capacity to work within the "medicalized" framework of many HIP targets.
The CDC noted, "These findings indicate that the majority of CBOs had difficulty targeting the highest-risk clients, and that additional capacity-building assistance may be needed in this area." Such support could be coming this year. A new initiative, known as "Capacity Building Assistance for High Impact Prevention", is a five-year, $130 million investment to implement HIP "to high-risk populations in high-impacted geographic areas."
The funding is meant to "strengthen the capacity of the HIV prevention workforce to optimally plan, implement, and sustain high-impact HIV prevention interventions and strategies" across health departments, CBOs, AIDS service organizations, and health care organizations. In simpler terms, the grants are meant to get organizations ready for HIP by providing resources to build programs and create an infrastructure to sustain them. The first awards are scheduled to be made in April 2014.
What Do We Know?
The struggles of the CBOs that engaged in previous CDC programs doesn't mean they will be cut out of future funded prevention initiatives. But prevention efforts are become increasingly medicalized, because it is more cost-effective to test, link to care, and treat in the same facility. Advocates are concerned that cultural competency and skills built up over years of providing nonmedical services may be lost, simply because many of these organizations don't provide medical care.
Kenyon Farrow of Treatment Action Group said, "Most medical providers are ill-prepared to treat people with HIV, or to even offer a set of services for people at risk. It would be a real shame if the expertise and cultural competence of CBOs is lost to health care reform. How many jobs of people who actually come from the groups we're trying to reach will be lost to people with MPHs or MSWs who have no experience in these communities?"
"Advocates and CBOs also have a role to play in asking what gets classified as evidence-based. How can they implement an "evidence-based" intervention when there isn't any evidence?"
Advocates and CBOs also have a role to play in asking what gets classified as evidence-based. How can they implement an "evidence-based" intervention when there isn't any evidence? Right now there are eight interventions that the CDC considers as having "good evidence" for improving adherence to HIV medications (search cdc.gov for "good-evidence MA interventions"). But there are no strategies that meet this criteria for recruitment or retention. In other words, we don't yet know what constitutes "evidence-based" or "high-impact" strategies for getting more people into care and on treatment. The ECHPP demonstration projects described above could shed some light on this, but it's important to recognize that there's plenty we don't know about what HIP really is.
Some of the specific issues that emerged in interviews with advocates revolved around the structural factors that affect HIV risk -- housing, substance abuse, mental health issues, etc. Addressing these can reduce HIV risk and lead to improved adherence to meds for people with HIV, but they may not be highlighted in the biomedically oriented landscape of HIP.
Specifically, advocates note that efforts like ECHPP don't ask grantees to report on provision of mental health services (other than alcohol treatment) or for linkage to housing. More than one advocate we spoke to said that the impact of targeted interventions could be lost if the underlying causes of HIV risk are not addressed through partnerships with local housing departments, and by lobbying for more housing assistance from federal agencies. Ebony Johnson of The Women's Collective in D.C. says, "Health does not become your primary focus when you don't have your basic needs met."
It will also be key to watch emerging strategies such as pre-exposure prophylaxis (PrEP) with Truvada (see article in this issue). PrEP doesn't make the cut as a cost-effective option, since the price tag per infection prevented is too high for people who get the drug through private insurance or Medicaid. But Mermin notes PrEP is available for free (for those who qualify) from the drug's manufacturer, Gilead -- a little-known option that could make it cost-effective in poorer communities where it might be a powerful new tool.
There are also little real-world data on the acceptability of PrEP among high-risk groups. There are PrEP demonstration projects and clinical trials happening in the U.S., including Project PrEPare and HPTN 073, which are studying PrEP in black MSM and young MSM. Recent data from Gilead show that more than half of the PrEP prescriptions in the U.S. were for women in the South. Putting together real-world data like that with data from demonstration projects might point to the niches where PrEP could be high impact, and it will be important to watch whether this translates into action. Given the slow movement on PEP within ECHPP, there is cause for concern that newer, less-familiar options might not be taken up without some pushing from advocates and the CDC.
Doing the most with limited resources is essential in a country where "real" HIV prevention dollars haven't increased since 1991.
According to the Kaiser Family Foundation, the 2014 U.S. HIV budget includes only $98 million for prevention out of a total of $23 billion (see chart). That figure is a little misleading, since 55% of the budget goes to HIV treatment, which is a potent prevention strategy in itself. People with HIV who are taking treatment and have an undetectable viral load have a much lower risk of passing the virus to their sexual partners.
But the prevention benefit of treatment works only if people with HIV know their status, are linked to care, and stay on a treatment that keeps their viral load close to undetectable. Those steps (see the chart below) are known as the "treatment cascade." Currently 1.1 million people are living with HIV in the U.S., but only 25% have undetectable viral loads.
Testing is a large focus of HIP and is one of the first elements that rolled out in the three-year Expanded Testing Initiative. It provided nearly 2.8 million HIV tests from 2007 to 2010, and diagnosed more than 18,000 people with HIV. The CDC estimates that the ETI saved almost $2 in medical costs for every dollar invested.
HIP pays attention to how testing is offered. For example, the HIV testing model named "Counseling, Testing, and Referral" (CTR) is being promoted by the CDC as an example of "high-impact testing" intervention. CTR offers risk reduction counseling, testing, and connection to care. It also refers high-risk HIV-negative individuals to preventive and psychosocial support. "Personalized Cognitive Counseling" (PCC) is another approach CDC is highlighting as a high-impact HIV testing intervention. PCC targets HIV-negative MSM who repeatedly test for HIV and engage in unprotected anal sex. Through PCC, they will receive 30 to 50 minutes of counseling that explores the thoughts, attitudes, and beliefs they use when making decisions about sex.
Since HIP promotes cost-effective strategies, its programs make use of organizations that already have linkages to care, which means a continued trend to what some NGOs and CBOs say is a "medicalization" of the HIV response. That means moving testing from CBOs into medical facilities. There's a fear that the move toward clinical settings -- which do have the strength of connecting individuals to health services -- may strip resources from CBOs with the cultural competency to deal with certain populations.
Prevention for High-Risk Negatives
To get a flavor of what types of behavioral interventions make the cut under HIP, we looked at Many Men, Many Voices (3MV), an intervention that uses small group discussions to give gay men tools for identifying HIV risk factors like racism, homophobia, substance use, high-risk sex, and inadequate health care. Researchers evaluated 3MV in 300 black MSM -- the first behavioral intervention for this group to be tested in a randomized trial. They found that men in 3MV reported significant reductions in their number of partners and in unprotected anal sex with casual partners; a trend for consistent condom use during receptive anal sex; and increased HIV testing. These are self-reported data, so they must be taken with a caveat, but in the realm of behavioral interventions, that's relatively strong evidence.
The use of social media for outreach and education are also being explored through CDC initiatives, such as using phone texting to provide appointment or adherence reminders and to answer sexual health questions in real time. Beyond social media campaigns, the new funding can support sex education in schools. This includes developing curriculum that are tailored to specific communities and age groups, as well as training and development for educators.
Condoms remain a core part of HIV prevention, even as other approaches including PrEP and treatment as prevention garner additional attention. Supply is key. Effective condom programming is guided by the three As: Available, Accessible, and Acceptable. Lube also needs to be freely available.
Going forward, it will be critical for advocates to track the reporting of HIP programs. Are grantees reaching the targeted groups? Are groups like transgender women -- who are highlighted in HIP but are not the focus of any DEBIs -- well served? How will organizations that address structural factors or are trusted allies survive if they do not provide medical services?
"Before HIP, the shrinking funding for CBOs meant that cultural competency has been lost. Competency was lost even before that, when people were trying to fit everything into a DEBI framework," says Julie Davids of the HIV Prevention Justice Alliance at the AIDS Foundation of Chicago. "There has been an undocumented and unassessed loss. There is a need to look carefully at what competencies need to be built up to reach distinct and overlapping groups."
It's key to keep an eye on how your organization or community defines HIP and how this does (or doesn't) align with the HIV prevention approach in your area. According to Julie Davids, "I think HIP should be understood as a political and policy term. I think we all need to keep our sights on effective prevention and realize that the CDC has come up with a brand called HIP. I'd like to see the two things overlap but remain distinct."
These cautions shouldn't overshadow the approach though. It is high time that HIV prevention be held to a high standard of effectiveness. Historically, impact has often been reported in indirect measures, like the number of condoms distributed or people reached with safer sex messages. To turn the tide of the epidemic in the U.S., it is essential to look at more concrete measures -- community viral load, HIV incidence in populations where HIP programs are rolling out, etc. High-impact prevention will need robust community responses, focused on more than just medical services, to make progress. Only time will tell whether it achieves its goals.
The authors are staff members at AVAC (avac.org), a non-profit advocacy group focused on research on and implementation of new HIV prevention tools.