Sorting out CDC data and guidelines on preventing HIV transmission from positives.
|Publication:||Name: Research Initiative/Treatment Action! Publisher: The Center for AIDS: Hope & Remembrance Project Audience: General; Professional Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2011 The Center for AIDS: Hope & Remembrance Project ISSN: 1520-8745|
|Issue:||Date: Winter, 2011 Source Volume: 16 Source Issue: 2|
What's new in updated CDC guidelines for prevention in
Mascolini: Why did the CDC first issue guidelines on incorporating HIV prevention into medical practice and why is an update necessary?
Irwin: The guidelines issued in 2003 (1) were to encourage HIV care providers to incorporate HIV prevention in their medical practices by addressing three issues known to curb HIV transmission: early, continuous care, sexually transmitted infection (STI) screening and treatment, and partner services.
The update we're working on now is more comprehensive and will include new evidence that has accumulated since 2003. Because of that new evidence, the new guidelines broaden the domains of prevention strategies. The most important difference with the upcoming guidelines is that they focus on actions of clinical and non-clinical providers--health departments and community-based organizations.
Mascolini: What new issues will the revised guidelines address?
Irwin: The updated guidelines will present new evidence and/or new recommendations in several domains:
* Special considerations for groups with unique HIV prevention needs
* Linkage to and retention in care
* Risk assessment and risk reduction
* Partner services
* Antiretroviral treatment and its role in prevention
* Medication adherence
* STI services
* Referral to other medical and social services
* Sexual and reproductive health
* Preventing HIV transmission during pregnancy
* Policy, legal, and ethical considerations
* Monitoring and evaluation
I can summarize some of the highlights of these new domains and revisions in domains covered in the 2003 guidelines.
The special considerations section addresses issues that may affect minors, adolescents, men who have sex with men (MSM), migrants, immigrants, pregnant women, illicit drug users, sex workers, the homeless, prisoners, persons with mental illness, and other groups that may have unique HIV prevention needs or are medically marginalized. These issues include stigma and legal, financial, language, cultural, and transportation barriers to accessing services or adopting HIV prevention methods.
The section on risk assessment and risk-reduction interventions includes new evidence on strategies for risk assessment and reduction, in particular, brief assessments and interventions that can be done in community or clinical settings. Some of the interventions that clinicians may find attractive include those that can be done by patients in the waiting room without taking clinician time, such as self-administered risk assessment and computer or print tools that provide risk reduction messages tailored to their risk. [For examples, see the table preceding this interview.]
A chapter on antiretroviral treatment and prevention highlights new evidence from a randomized controlled trial that found that antiretroviral therapy prevented heterosexual transmission in HIV-discordant couples from several countries. (2) This new section also presents information from other, less rigorously designed studies in heterosexual and MSM couples that indicates that antiretroviral treatment prevents sexual HIV transmission by lowering genital viral load. The new section on medication adherence summarizes new information about effective clinic-based and community-based interventions to support long-term antiretroviral adherence.
Another new section describes referral to other medical and social services, including mental health, drug rehabilitation, and syringe exchange services, and housing. This section summarizes new evidence that these services are essential to support the health and antirctroviral adherence of HIV-positive individuals as well as to prevent HIV transmission.
A section on sexual and reproductive health care for women and men addresses strategies to prevent sexual transmission, including conception methods that reduce risk of sexual and perinatal transmission and the latest evidence on interactions between hormonal contraceptives and some antiretroviral medications This part of the new guidelines also describes family planning and emergency contraception to prevent unintended pregnancies. Another section assesses preventing HIV transmission during pregnancy and refers to the latest guidance on antiretrovirals for pre- and postexposure prophylaxis to prevent perinatal transmission A new recommendation will discourage prechewing infant food by HIV-positive persons.
A section on policy, legal, and ethical issues will provide updated information on policy and legal environments that affect HIV prevention with PLWH, HIV disclosure and the negative consequences of criminalization of PLWH, standards for privacy and confidentiality, disparities in access to prevention services for PLWH, and implications of health reform on providing prevention services to PLWH.
A new section on monitoring and evaluation urges both clinical and community organizations to monitor or evaluate their HIV prevention strategies, either through quality-improvement initiatives, which are usually done in clinical settings, or through more classic program evaluation, usually by community-based organizations and health departments.
The revised guidelines update advice on linkage to and retention in HIV care because new evidence confirms the importance of early HIV care and staying in care for support of adherence, risk reduction, and behavioral interventions. In addition, the updated section on partner services refers to the 2008 CDC guidelines on partner services (3) and new CDC guidance on using the Internet to contact partners. The updated partner guidelines stress that clinicians have an important role in helping their index patient--the HIV-infected person who has an HIV or STI diagnosis--think through a plan about how they want to notify their partner, either by themselves, through the health department, or with the clinician's help. The revised section on STIs refers to the 2010 CDC STI treatment guidelines, (4) which lay out recommended STI screening tests and frequency, as well as treatment strategies.
Mascolini: Will the revised guidelines differ from the 2003 guidelines in other important ways?
Dr. Irwin: The 2003 prevention-with-positives guidelines did not emphasize actions that could be taken by organizations such as health departments and community-based organizations, so many of their HIV prevention efforts continued to focus on reducing risk behaviors among HIV-negative persons. Because CDC and HRSA want to drive down HIV transmission rates even further, the updated guidelines will more fully engage all HIV prevention providers by including recommendations for health departments and community-based organizations that provide testing, linkage to care, antiretroviral adherence support, referral for substance abuse, mental health, or housing, and other services that support prevention in people with HIV. The new CDC funding announcements for health departments and community-based organizations also stress more activities with HIV-positive people to prevent transmission.
CDC's Medical Monitoring Project (http://www.cdc.gov/hiv/topics/treatment/MMP) is also tracking delivery of prevention services to people living with HIV in more than 20 areas in the US from 2007 through 2013. It will be able to evaluate implementation of several services that were recommended by the 2003 prevention-with-positives recommendations, the upcoming recommendations, and other CDC and federal agency recommendations that relate to prevention with positives: delays in entry to care, frequency of care visits, factors associated with receipt of treatment, treatment adherence, use of HIV prevention services, and screening tests. Data from the
Medical Monitoring Project are expected to be released periodically over several years, including at least 1 year after the expected 2012 release of the upcoming prevention-with-positives recommendations.
Mascolini: What are the CDC's plans for releasing the updated prevention-with-positives guidelines?
Irwin: We expect to release the revised guidelines sometime in 2012, both online and in the MMWR. The Division of HIV/AIDS Prevention is planning several activities to disseminate the guidelines and train providers in their use. We will also distribute implementation materials and tools to help providers in clinical facilities integrate prevention activities into HIV medical care, such as offering prevention counseling in waiting rooms or in other time-efficient ways. We also plan to spread the word about the new guidelines for clinical and nonclinical providers through continuing education and conference presentations.
Did transmission from positives slow after the 2003 CDC guidelines?
Mascolini: After the original positive-prevention recommendations came out in 2003, (1) the CDC reported little change in US HIV incidence from 2006 through 2009. (5) Given this flat incidence, did the original guidelines do any good?
Irwin: You are correct that HIV incidence has been fairly stable from 2006 to 2009. However, this stable incidence has occurred during a period when the number of people living with HIV in the US has steadily increased. (6) The combination of stable incidence and increasing prevalence indicates a declining rate of transmission from people living with HIV.
The HIV transmission rate in the US though 2006 declined consistently by 3% to 4% each year; this represents a nearly 90% reduction since 1984 (early in the epidemic) and a more than 33% reduction since 1997. (7) The Division of HIV/AIDS has not yet calculated the change in transmission rate from 2003 (when original guidelines were published) to the present, but that can now be done with reasonable precision using recent estimates of new infections through 2010 based on surveillance data published in August 2011.
When interpreting transmission rate changes from 2003 through 2010, it is important to keep in mind that the 2003 guidelines, like all guidelines, take time to be adopted into practice. As an example, a survey of 417 HIV physicians in 4 cities found that they were more likely to counsel patients about prevention if they were familiar with antiretroviral treatment guidelines that encouraged prevention counseling. (8)
Although the Division of HIV/AIDS Prevention did not sponsor a comprehensive evaluation of the uptake of the 2003 guidelines, scientists at CDC and other institutions have evaluated the extent of implementation of several interventions recommended by the 2003 guidelines in focused studies, interventions to increase implementation such as use of STI screening in HIV care clinics, (9) use of risk-reduction interventions, (10-13) and interventions to increase medication adherence. (14,15)
Also, as I mentioned earlier, the combination of stable HIV incidence and increasing HIV prevalence indicates some success in reducing the transmission rate. That may be partially attributed to HIV prevention approaches highlighted in the 2003 guidelines. Discussions are underway to evaluate awareness and uptake of the upcoming guidelines by clinical and nonclinical providers. The updated prevention-for-positives guidelines will continue to stress prevention counseling at both initial and follow-up visits.
Overcoming provider reluctance to address prevention in positives
Mascolini: US physicians I surveyed listed several reasons why they don't council their patients on positive prevention, including lack of time, discomfort in discussing specific sex practices, and the perception that they can't change patient behavior. From your personal point of view as someone who studies these issues, can those obstacles be overcome?
Crepaz: These are all commonly cited barriers to provider-delivered prevention, (8,16-20) and overcoming these obstacles is critical. Some evidence in the literature shows that HIV medical care providers with training can successfully conduct an HIV prevention intervention with their clinic patients. (21) Training increases frequency Of provider-patient discussions of safer sex and assessment of sexual activity. (20-22)
Staff training should focus on understanding and utilizing the provider's personal strengths, enhancing communication skills, practicing brief behavioral counseling, giving prevention messages, and providing booster trainings as needed. Clinics with established procedures for HIV prevention counseling are more likely to deliver such services to HIV-diagnosed patients. (16) Some studies in the pipeline are testing computer-based interventions that can be integrated into clinic flow with minimal disruption and that supplement prevention efforts of providers--for example, the NIMH/CDC DHAP Epidemiology branch comprehensive prevention for people living with HIV (https://www.fbo.gov/index?s=opportunity& mode=form&id=f218809367e97758d060ea3012 cacb26&tab=core&_cview=0).
From my personal point of view, there is no easy fix for these obstacles. However, they can be overcome by offering providers with needed training and prevention tools (such as computer-based interventions), obtaining providers' buy-in, and incorporating their input into the training and improvement plan.
Irwin: Although we recognize that some physicians face the barriers you describe, studies indicate that many physicians routinely provide prevention services to people with HIV. For example, a survey of randomly sampled HIV-positive men and women in six public HIV clinics found that, on average, 71% reported that their provider had talked with them about safer sex at least once, and 50% reported specific discussions about disclosure to partners. (23) A self-administered survey of HIV-infected men in San Francisco and New York City found that about three-quarters had been counseled about safe sex by their provider. (24) And a review of medical records of 1334 HIV-infected MSM from eight HIV clinics during 2004-2006 found that more than two-thirds were annually screened for syphilis, a practice recommended by the 2003 guidelines. (9)
Some studies indicate that physicians with extensive experience in HIV care or a large volume of HIV-infected patients may be more likely to establish systems for routine delivery of preventive services than those who see few HIV-infected patients. For example, in a recent study of 165 experienced HIV physicians in the Bronx and Washington, DC, fewer than 10% said they rarely or never spoke with their HIV-positive patients about important issues such as sexual partners, sexual partners' HIV status, use of condoms, and sexual practices.
The CDC's Medical Monitoring Project (http://www.cdc.gov/hiv/topics/treatment/MMP) is tracking what proportion of HIV-positive persons in care reported receiving prevention counseling from their healthcare provider in the preceding 12 months. The results of this study are promising but are not yet available for release; we will provide them as soon as they are available.
Also, several interventions have been developed and shown to be effective in encouraging HIV clinical sites to provide prevention services, including those that do not require provider time. (10-13,25-28) Examples include the "Safe in the City" waiting room video (11) and Positive Choice, a computer-based prevention intervention designed for use in the waiting room and outpatient clinics and requiring little or no clinician time. (13) The 2012 prevention-with-positives guidelines will highlight these interventions for clinical settings as well as non-clinic-based interventions to increase prevention behaviors. The "Ask, Screen, Intervene" training curriculum is an example of another clinician intervention to support prevention with positives in clinical settings (www.cdc.gov/hiv/topics/treatment/pic/ppt/PIC_Workshop.ppt).
Finally, the recent HPTN 052 study found that antiretroviral therapy that suppresses viral load can reduce heterosexual transmission to uninfected partners by more than 95%. (2) The updated prevention-with-positives guidelines will stress the role of antiretroviral use to prevent heterosexual transmission. With this information in hand, providers can use routine discussions about antiretroviral therapy and adherence as an entree to discussing prevention in a context they are comfortable with.
Meta-analyses back value of behavioral intervention for prevention
Mascolini: Dr. Crepaz, can you give an overview of your meta-analysis involving HIV-positive people (25) and suggest the key take-home messages for HIV providers in the United States?
Crepaz: The 2006 paper presents findings from a meta-analysis of 12 controlled trials conducted in the US and published between 1988 and 2004. (25) We systematically searched the HIV prevention literature to identify interventions that were specifically designed to reduce HIV-related risk behaviors (such as unprotected sex and needle sharing) or biologic outcomes (such as STIs) in HIV-positive people. The meta-analysis technique allows us to quantitatively synthesize the findings across studies, estimate the overall effect size of interventions, and identify factors that are associated with intervention effects. We found interventions significantly reduced unprotected sex and decreased acquisition of STIs. A limited number of studies have evaluated intervention effects on injection drug use behaviors, and the evidence is not conclusive.
Several intervention characteristics were found to be associated with reductions in unprotected sex: interventions guided by behavioral theory; specifically focused on HIV transmission behaviors in more than two thirds of intervention sessions; provided skills building; delivered individually; delivered by healthcare providers or professional counselors; delivered in settings where people living with HIV receive care or services; and addressed a myriad of issues related to coping with one's serostatus, medication adherence, and HIV risk behaviors. This meta-analysis also indicated that more intensive HIV interventions--that is, those with 10 or more intervention sessions and lasting 20 or more hours or more than 3 months--were more efficacious than briefer interventions.
The meta-analysis findings suggest some take-home messages for HIV providers:
1. HIV providers play an important role in changing patients' behavior.
2. Clinic settings are an ideal place for delivering prevention messages and interventions.
3. There is a need to address a whole range of issues faced by HIV-positive patients--for example, coping with one's serostatus, medication adherence, HIV risk behaviors, mental health, and substance abuse. But to see the effect on reduction in HIV risk behaviors, patients need to receive sufficient "doses" of interventions.
One important thing to point out is that the intensive interventions evaluated in my meta-analysis were conducted in places where HIV-diagnosed persons received care or services (such as medical care sites, methadone maintenance centers, and community agencies) as individuals or in groups. Currently, there is insufficient evidence to support the efficacy of multi-session, intensive, group-level HIV interventions in busy healthcare settings. Multidisciplinary teams and co-location of care and service may be needed to make multi-session interventions more feasible in healthcare settings. This issue certainly warrants further examination.
Since publication of the meta-analysis, several risk-reduction interventions for HIV-diagnosed persons that have been published. Recently published studies conducted in clinic settings (13,28,29) have demonstrated the effectiveness of screening HIV-diagnosed patients for HIV/STI risk behaviors during their clinic visits and using results to guide individually tailored brief prevention counseling by care providers. Given that HIV-diagnosed persons differ in their risk and prevention needs at different points in time, risk screening to determine the types of interventions that work best for HIV-diagnosed persons may allow intervention resources to be applied most appropriately. HIV providers may consider incorporating this approach into their clinics.
Mascolini: Did your meta-analyses uncover important differences between risk-reduction interventions that work for HIV-positive people (25) versus people at risk for HIV? (30-32)
Crepaz: There are a few factors that seem to work both for HIV-positive people and for people at risk for HIV when you review all four of these meta-analyses. (25,30-32) All found that interventions that are theory-based (usually addressing personal knowledge, attitude, motivation to change, and readiness to change) and provide skill training are critical for interventions to work. These are the underlying mechanisms of behavioral change that are applicable to HIV-positive people and also people at risk for HIV.
However, there are certainly differences between risk-reduction interventions that work for HIV-positive people and for people at risk for HIV, although these differences are not explicitly pointed out in these meta-analyses. From my point of view, HIV-positive persons face issues different from people at risk for HIV--for example, how to disclose HIV-seropositive status to others without being stigmatized, when to start HIV treatment, how to ensure medication adherence and regular clinic visits, whether the cost of treatment will be covered, how to manage HIV symptoms, and treatment side effects. People at risk for HIV face none of these issues. But for HIV-positive persons, these issues may negatively impact their behaviors and thus they need to be addressed with prevention efforts.
Mascolini: All four of your meta-analyses found that multiple or intensive theory-based interventions are among the most effective. (25,30-32) Does this mean clinicians have to plan multi-session, theory-based, culturally tailored risk-reduction programs and pay someone to conduct them regularly?
Crepaz: All four meta-analysis did point out that interventions based on behavioral change theories work better. The common components of these theories are personal knowledge, attitude, motivation to change, readiness to change, social norms, social support, communication, perceived behavioral control, self-efficacy, and outcome expectations. While all four meta-analyses suggest that more intensive theory-based interventions are efficacious, the feasibility of conducting this type of intervention in busy clinics is still a question.
We also found that conducting formative research to identify the most relevant behavioral determinants that affect participants' behavior is a critical component. This is consistent with the findings from HIV clinic settings where HIV providers first screen HIV-diagnosed patients for HIV/STI risk behaviors and use the information to guide individual prevention counseling based on motivational interviewing and strength-based principles. As I pointed out in my previous answer, there is increasing evidence suggesting that risk screening and brief, tailored prevention counseling reduce HIV risk behavior among HIV-positive clinic patients. This type of intervention is often brief but routinely offered to patients during their clinic visits.
After reviewing and incorporating the recent literature, we recommend the following screening and prevention strategies in the updated prevention-with-positives guidelines:
* Screen HIV-diagnosed persons for sex or drug use behaviors (including alcohol and injection and noninjection drug use) at the initial visit and subsequent routine visits (at least twice yearly) or periodically, as the provider deems necessary.
* Use risk screening information to guide prevention messages individually tailored to the HIV-diagnosed person's needs and circumstances, with the goal of increasing safer behaviors.
* Become familiar with available resources and make referrals to prevention specialists within or outside the clinic who can offer intensive HIV prevention interventions as needed.
Mascolini: Do your meta-analyses (25,30-32) suggest differences in effective behavioral interventions for MSM versus black heterosexuals versus Hispanic heterosexuals versus IDUs?
Crepaz: Our meta-analyses point out more common components than differences in effective behavioral interventions for the groups you list. This is not surprising because, as I pointed out earlier, common components address the underlying mechanisms of behavioral change which, in general, apply to various groups.
I would make the same argument as I did in answering your question about whether there are differences in effective behavioral interventions for HIV-positive persons versus people at risk. From my point of view, the prevention needs may be different for MSM, black heterosexuals, Hispanic heterosexuals, and IDUs as each group (and individual) faces different issues or barriers that prevent them from engaging in safer behavior. For behavioral interventions to work well, it is important to engage the individual and community of interest to identify the issues and barriers to behavioral changes. A participatory approach is likely to yield a better outcome.
Mascolini: Overall, what do your meta-analyses (25,30-32) say about the impact of behavioral interventions delivered by providers versus counselors or peers?
Crepaz: For HIV-positive persons, (25) interventions delivered by providers and counselors seem to work better than interventions delivered by peers. This may be confounded by the finding that interventions delivered in settings where HIV-positive persons receive routine services or medical care are more effective. In other words, selection bias may favor interventions with people in routine care because HIV-positive people who seek and sustain care are probably more motivated than HIV-positive people who do not. The other meta-analyses, in which the majority of study participants are at risk for HIV, (30-32) suggest that providers, counselors, and peers are equally effective in impacting participant's behavior.
Mascolini: Do these studies or other research you know say whether behavioral interventions continue to lower risk behavior after the formal intervention period ends?
Crepaz: Yes, our meta-analyses evaluated the intervention effects after completion of the formal intervention period. (25,30-32) The common follow-up assessment is 3 or 6 months after completion of the entire intervention. Few studies conduct a follow-up assessment after more than 12 months.
There is evidence that behavioral interventions work after the interventions end--mostly after 3 or 6 months and sometimes 12 months after completion of intervention. However, we do not know if the interventions still work further out, after 12 months.
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Kathleen Irwin, MD, MPH, FIDSA (Fellow of the Infectious Diseases Society of America)
Nicole Crepaz, PhD Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention
Dr. Irwin leads the guidelines development team for the Division of HIV/AIDS Prevention. In collaboration with HIV experts at CDC, the Health Resources and Services Administration (HRSA), and several national HIV organizations, including organizations that represent people living with HIV (PLWH), she is updating guidelines for prevention of HIV transmission from PLWH.
Dr. Crepaz is a Project Officer for the HIV/AIDS Research Synthesis Project (PRS), which conducts systematic reviews and meta-analyses to evaluate behavioral interventions for risk reduction and for linkage to care, retention in care, and medication adherence among HIV-positive people. The PRS group produces a compendium of evidence-based behavioral interventions (EBIs) (http://www.cdc.gov/hiv/topics/research/prs/index.htm), which are recommended to the Replicating Effective Programs (REP, http://www.cdc.gov/hiv/topics/prev_prog/rep/index.htm) for developing user-friendly packages of materials. The completed intervention packages are passed on to the DEBI (Diffusion of Effective Behavioral Interventions) project for dissemination to providers (http://www.effectiveinterventions.org/en/home.aspx).
Statements are those of the interviewees and do not necessarily represent the official position of the US Centers for Disease Control and Prevention.
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