Table of Contents
Despite significant advances in the treatment and prevention of HIV, the number of new HIV infections in the United States holds steady at about 50,000.1 Furthermore, 21% of individuals infected with HIV in the United States are not aware of their status, and an estimated 33% of those who know that they are HIV-positive are not engaged in care and treatment for their disease.2 Another 38% of newly diagnosed individuals test positive for HIV so late that they receive an AIDS diagnosis at the same time as, or within a year of testing positive.3 Clearly, novel prevention strategies, ways to engage individuals in care sooner after infection, and methods to maintain them in care and treatment are needed.
One such strategy is the Test, Link to Care, Plus Treat (TLC-Plus) approach. TLC-Plus addresses several aspects of the healthcare system that can be improved to help those with HIV live longer and healthier lives while also reducing transmission of the virus to others. The National HIV/AIDS Strategy places testing, linkage to care, treatment and support services at the center of efforts to improve the health outcomes of HIV-positive individuals and to prevent new infections.4
Key components of TLC-Plus include:
Additionally, TLC-Plus is based on evidence that people who are aware of their HIV-positive status are more likely to take steps to prevent transmission of infection to HIV-negative partners and to take steps to keep the virus under control.5 TLC-Plus often includes prevention-for-positives counseling to reinforce the importance of safer sex strategies to prevent HIV infection of negative partners and STDs among all partners.
Importantly, there are also strong data to support the hypothesis that reducing an individual's viral load through ART lowers his or her potential to transmit HIV, thus providing protective effect for sexual partners. A study of more than 3,000 serodiscordant heterosexual couples in Africa found a significantly lower transmission rate when the HIV-positive partner was receiving treatment than when the HIV-positive partner was not. For those where the infected partner was receiving treatment, there was only 1 seroconversion (a rate of 0.37 per 100 person years) compared with 102 seroconversions among the couples where the partner was not receiving treatment (a rate of 2.24 per 100 person years).6 This represents a 92% reduction in infections.
Recently, HTPN 052 closed more than 3 years early because interim data analysis showed that ARV treatment reduced the risk of HIV transmission from infected partner to uninfected partner by an astonishing 96%. HPTN 052 is a large, international study which randomized 1,736 heterosexual couples in which one partner is HIV-positive either to begin ART immediately, or to wait until treatment was clinically indicated (at a CD4 count of 250 cells/mm3).
The study began enrolling participants in 2005 in Botswana, Brazil, India, Kenya, Malawi, South Africa, and Zimbabwe, and recruited couples in which the HIV-positive partner had a CD4 cell count between 350 and 550 cells/mm3. The median CD4 count at the time of joining the study was 436 cells/mm3. In the interim analysis, 39 infections occurred, 27 of which were in couples where the infected partner did not begin treatment immediately, translating to a reduction in transmission of 96% among those who began therapy immediately (p = <0.0001).
Several North American cities such as San Francisco, Vancouver, Los Angeles, and Washington, D.C. have achieved desirable health outcomes using elements of TLC-Plus, even though such strategies may not have been part of a comprehensive TLC-Plus program. Outcomes include reductions in annual incidence of HIV infections, reductions in community viral load (CVL, the estimated average viral load among all HIV-positive persons in a community), higher CD4 count at time of HIV diagnosis, and/or reductions in the number of AIDS diagnoses within 1 year of HIV diagnosis.
This paper examines successful components of TLC-Plus programs in four jurisdictions and specific strategies used to achieve desired health outcomes, as described by public health officials in each. It is our hope that these strategies may be used to inform the development of TLC-Plus programs across the country. Consideration is also given to funding and to the role of electronic medical records, in Louisiana, in assisting patients who have fallen out of (or never entered into) care.
As communities begin to implement TLC-Plus strategies, HIV Prevention Trials Network (HPTN) 065 is assessing the feasibility of community-level testing, linkage to care, plus treatment strategies in the United States. The study will evaluate the feasibility of some TLC-Plus components and the effectiveness (particularly of financial incentives) of others. The study is being conducted in two intervention communities: Washington, D.C., and Bronx, N.Y. and will take place over 36 months (expected completion date summer 2013).
Although TLC-Plus programs are being implemented in several jurisdictions across the country, this paper profiles four: San Francisco, Washington, D.C., Los Angeles, and Birmingham. Each illustrates strengths in different components of TLC-Plus and exemplifies the successes and challenges of TLC-Plus implementation in diverse settings -- from smaller geographic areas such as San Francisco to larger, more diverse ones such as Los Angeles County and Alabama. Each of these four locations is described briefly here, and details of their TLC-Plus strategies are discussed in the "Components" section below.
San Francisco experienced a decrease in CVL from 2004-2008 as a result of increased rates of HIV testing, ART coverage, and population-level viral suppression that corresponded with a reduction of new HIV infections.8 Data presented at CROI 2011 demonstrated that this trend continued into 2009, the latest year for which data are available.9
Both mean and total CVL decreased from 2004-2008 and were accompanied by decreases in new HIV diagnoses from 798 (in 2004) to 434 (in 2008). During this period, ART uptake among people living with AIDS went from 74% to 90% and virologic suppression was achieved in 78.1% of those with HIV infection in 2008, compared with 46.8% in 2005. The decrease in CVL was highly correlated with the reduction of annual new infections and can be attributed to expanded testing, greater uptake of more potent second- and third-generation ART that had fewer side effects, initiation of therapy at higher CD4 counts based on the accumulating evidence of the efficacy of earlier therapy to patients, and virologic suppression in greater numbers of HIV-infected individuals. Various elements of TLC-Plus worked in tandem not only to reduce new infections but also to achieve improved health outcomes. (See Components of Successful TLC-Plus Programs below.)
In fact, new modeling from San Francisco points to a further reduction of new HIV infections by 59% at 5 years just with the use of universal treatment to all HIV-infected adults already in care in San Francisco. Adding annual HIV testing for all MSM to universal treatment ("test and treat all") yields a decrease of new infections by 76% in 5 years.10
The D.C. Department of Public Health launched a campaign in 2006 to promote routine HIV testing with improved linkage to care at locations throughout the city. Included in the campaign were opt-out testing at medical facilities, testing and treatment in jails, and a widespread social marketing campaign to promote testing. The number of tests rose dramatically (from 20,000 in 2004 to 93,000 in 2009) and resulted in an increase in newly diagnosed HIV cases (from 1,093 in 2004 to 1,280 in 2007) and a decrease in those diagnosed in the advanced stage of the disease (from 66% in 2004 to 57% in 2008). The percentage of people who developed symptomatic AIDS within 1 year after diagnosis decreased from 47% in 2004 to 28% in 2008. Median CD4 count at the time of diagnosis increased by nearly 60%, from 216 cells/mm3 in 2004 to 343 cells/mm3 in 2008.
While expanded testing and linkage to care in Washington, D.C. has not yet resulted in reduced HIV transmission, public health officials in the city suspect that a decrease will eventually happen if the trend of expanded testing and care is maintained.
Alabama, like other rural Southern states, has a hidden epidemic among Blacks and MSM who do not identify as gay or bisexual. There is still significant stigma associated with HIV and lack of knowledge about HIV being a treatable disease. There is also a fair amount of ignorance about HIV not being a "gay" disease.
For the past couple of decades there have been significant education efforts, mostly through communities of churches. Building upon that foundation, public health and other community leaders are working toward universal testing in these communities, particularly through the use of rapid HIV tests. For those who test positive, speedy linkage to care and retention in care is a paramount objective.
The 1917 Clinic in Birmingham serves more than 2,000 patients with HIV, particularly Ryan White clients, from Alabama and surrounding states. The clinic has focused its TLC-Plus efforts on developing partnerships with local HIV testing, clinical, and supportive service providers to integrate HIV testing and linkage services, as well as to coordinate activities around retention and re-engagement for shared patients. As a result, mean CD4 counts at the time of HIV diagnosis are now 310 cells/mm3 as compared with 180 cells/mm3 about 10 years ago.
Los Angeles County (LAC) is home to approximately 10.4 million people, and includes 88 cites and 4,083 square miles. It is one of the most diverse counties in the country with regard to population and geography. The HIV epidemic in LAC is predominantly among MSM, with a smaller proportion IDU and heterosexuals affected compared with jurisdictions in the South and Northeast of the United States. LAC's TLC-Plus strategy includes a focus on scaling up both targeted and routine HIV testing throughout the county, to identify the estimated 13,500 individuals living with HIV in LAC who are unaware that they are infected. LAC has embarked upon a process to increase both the number of publicly funded tests in LAC and to increase positivity rates at testing sites. This includes streamlining HIV testing procedures by using an HIV rapid testing algorithm (RTA) in order to give a presumptive diagnosis at the testing episode.
Linkage to care for both new diagnoses and those who are out of care is another key priority and component of LAC's TLC-Plus strategy. Currently 67% of individuals newly diagnosed with HIV in LAC are linked to care within 12 months. Through a combination of approaches, LAC's goal is to improve linkage to care rates across the county. Publicly funded HIV testing providers are given the goal of 85% linkage to care within 12 months, and this performance measure is included in the pay for performance structure for HIV testing. In addition, LAC is developing protocols to implement ongoing monitoring at the department of public health to identify those who have not linked to care, and deploy an intervention to link these individuals to care. Such interventions include attention from a public health investigator for those who have missed their first HIV care appointment, a youth-based linkage worker to assist newly diagnosed and out-of-care youth, and a peer navigator program to link individuals released from jail to HIV care in the community.
It is estimated that approximately 85% of HIV-infected individuals who are in care in LAC are retained in care, which is defined as 2 or more visits 3 months apart in the past 12 months. However, there is also a significant number of individuals who are out of care all together. It is estimated that, in 2009, approximately 61% of individuals living with HIV/AIDS had one or more HIV care visits, leaving an estimated 39% of individuals who may have been out of care entirely during that year. For those in care, specifically in Ryan White, 72% of patients had a suppressed viral load, and ART coverage rates ranged from 84-92% in 2009-10. The Ryan White system of care serves approximately 19,000 persons living with HIV/AIDS in LAC.
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