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HIV Prevention in Clinical Care Allen McCutchan, MD, MSc Professor of Medicine, UCSD Jose Burgos, MD UCSD, UABC, COLEF, SDSU Overview of Lecture To reduce transmission of HIV by their patients medical care providers can: 1. screen and counsel HIV-infected patients for risk behaviors, by – discussing sexual and drug-use behaviors – communicating prevention messages – reinforcing changes to safer behavior 2. refer patients for services such as, – substance abuse treatment – partner counseling and referral and 3. identify and treat other sexually transmitted infections that increase HIV transmission 4. recommend circumcision to uncircumcised men A clinical study shows the value and effect of these interventions. Different Scenarios • What should the approach be on a patient attending an office visit on different scenarios: – A patient with newly-diagnosed HIV infection comes to a physicians office for initial evaluation. – Patient with stable chronic HIV infection and Sexual transmitted disease (STD)? – chronic, stable HIV and not complaints coming for a routine visit. Principles • HIV-infected patients: – in clinical care are the source of a large number of new cases of HIV infections – who are not treated with HAART and continue unsafe sex are most likely to transmit HIV • HIV expert medical providers: – have strong influence on their patients – see them in clinic regularly – can ask them about their behavior and deliver brief counseling if needed – need training and support to accomplish their role in prevention Recommendations for screening HIV-infected patients for HIV transmission risk. • Sponsors/authors – – – – – Centers for Disease Control and Prevention (CDC), Health Resources Services Administration (HRSA), National Institutes of Health (NIH), HIV Medicine Association (HIVMA) Infectious Diseases Society of America (IDSA) • Publication: CDC’s Morbidty and Mortality Weekly Reports (MMWR) 2003; 52(RR-12):1–24. – Available at http://www.cdc.gov/mmwr/mmwr_rr.html Recommendations for screening HIV-infected patients for HIV transmission risk. • What - behaviors associated with HIV transmission (A-II) • How - nonjudgmental history by clinician or self-report questionnaire • When - initial visit and minimally once a year • Action – any reported risky behavior prompts more thorough assessment and discussion of risk reduction Recommendations for screening HIV-infected patients for HIV transmission risk. Strength of recommendation • A Should always be offered = Both strong evidence of efficacy and substantial benefit. • B Should generally be offered = Moderate evidence for efficacy—or strong evidence for efficacy but only limited • C Optional = Evidence for efficacy is insufficient • D Should generally not be offered = Moderate evidence for lack of efficacy or for adverse outcome • E Should never be offered = Good evidence for lack of efficacy or for adverse outcome Recommendations for screening HIV-infected patients for HIV transmission risk. Quality of supporting evidence • I - Good – at least 1 properly randomized, controlled trial • II - Fair – at least 1 well-designed clinical trial without randomization, – a cohort or case-con-trolled analytic studies (preferably from 11 center), – multiple time-series studies; – dramatic results from uncontrolled experiments. • III - Minimal – opinions of respected authorities based on clinical experience, – descriptive studies, or – reports of expert committees. Questions about Sex-related behaviors • • • • Is patient engaging in sex? Number and sex of partners Partners’HIV status (infected, not infected, or unknown) Types of sexual activity (insertive or receptive; oral, vaginal, or anal) • How often are condoms used • What are the barriers to abstinence or correct condom use (e.g., difficulty talking with partners about or disclosing HIV status, alcohol and other drug use before or during sex) • If potentially childbearing, are you pregnant, interested in becoming pregnant, considering pregnancy or sexually active and not using reliable contraception Questions about injection-drug related behaviors • Has the patient been injecting drugs? • Does the patient share needles and syringes or other injection equipment • With how many persons does patient share needles • HIV serostatus of needle-sharing partners (infected, not infected, or unknown) • Does the patient use new or sterilized needles, syringes, and other injection equipment • What barriers prevent the patient from ceasing illicit drug use or, failing that, to safer injection practices (e.g., lack of access to sterile needles and syringes) Recommendations for screening HIV-infected patients for HIV transmission risk. • What - symptoms of STDs (e.g., urethral or vaginal discharge; dysuria; intermenstrual bleeding; genital or anal lesions; anal pruritis, burning, or discharge; and, for women, lower abdominal pain, with or without fever) (A-I/II) • How - written or nurse administered patient self report review of symptoms • When - Routinely regardless of reported sexual behavior or other epidemiologic risk information, • Action - STI signs or symptoms prompt diagnostic testing with specific lab screening tests and, when appropriate, treatment. Recommendations for screening HIV-infected patients for HIV transmission risk. • What and how– laboratory screening for STIs (B-II/III) – Vaginal exam for women with lab tests for • cervical chlamydial (<25 years old), • vaginal trichomonias – Serology for both men and women • Syphilis (STS), and • type-specific antibody for herpes simplex virus, type 2 (HSV-2) • When – initial visit and annually if sexually active or history of STI • Action – treat appropriately STIs and HIV Acquisition and Transmission • Both ulcerative (HSV and syphilis) and inflammatory (gonorrhea or chlamydia) STIs increase risk of HIV acquisition • However, a randomized clinical trial of syndromic STI treatment failed to reduce rates of new HIV infections in rural Uganda Syndromic management of sexually-transmitted infections and behaviour change interventions on transmission of HIV-1 in rural Uganda: a community randomised trial. Kamali, A , Lancet. 2003 Feb 22;361(9358):645-52. Herpes Simplex Virus – 2 (HSV-2) and risk of HIV transmission • Observational studies suggest that + HSV-2 serology is a risk factor for acquisition of HIV by American MSM (x 2) and for heterosexual African men (x 6) and women (x 1.3) • Acyclovir has been associated with decreased rates of HIV progression in the pre-HAART era • Suppression of HSV with antiviral drugs is an untested, but potentially interesting preventive measure Recommendations for screening HIV-infected patients for HIV transmission risk. • What – pregnancy assessment (possible current pregnancy, interest in future pregnancy, or sexual activity without reliable, contraception) (A-I) • Who - women of childbearing potential • How - history and pregnancy testing • Action - referral for appropriate counseling, reproductive health care, or prenatal care, as indicated. Using clinic environments to support prevention • All patients should receive printed information about – HIV transmission risks and preventing transmission of HIV to others. – Information can be conveyed throughout the clinic; for example, posters and other visual cues containing • Prevention messages can be displayed in examination rooms and waiting rooms. • Materials in Spanish can be obtained through health department HIV/AIDS and STD programs or from the National Prevention Information Network (NPIN) (telephone: 1-800-458-5231; Web site: http://www.cdcnpin.org). Circumcision for HIV Prevention • Observational studies in Africa have shown that risk of HIV and other STIs (syphilis, chancroid, and HSV) is reduced by about half (OR = .52) by circumcision in infancy or adulthood • A randomized clinical trial has confirmed this protection (RR=0.40, CI= 0.24–0.68, p = 0.0006) in 3,274 uncircumcised, HIV-neg, South African men, aged 18–24 years. Randomized, Controlled Intervention Trial of Male Circumcision for Reduction of HIV Infection Risk: The ANRS 1265 Trial; Bertran Auvert et al, PLoS Med. 2005 November; 2(11): e298. Topics that can be successfully addressed by clinicians and clinic support staff • Lack of knowledge about HIV transmission risks • Misconceptions about risk of specific types of sexual and drug-use practices • Misconceptions about viral load and transmission of HIV • How to disclose HIV + status to a sex partner, family member, or friend • Importance of using condoms and not exchanging fluids • Ways to reduce number of sex or drug partners Topics that can be successfully addressed by clinicians and clinic support staff • Ways to obtain support (e.g., emotional, financial) from family, friends, and lovers • Ways to keep condoms accessible • Ways to remember to use condoms • How to persuade a sex partner to use a condom • Ways to clean/disinfect injection equipment • Ways to obtain clean needles • Ways to avoid sharing injection equipment • Ways to deal with mild psychological distress stemming from situational circumstances Issues that might need referral to outside agencies • Need for intensive HIV prevention intervention • Excessive use of alcohol or recreational drug use • Drug addiction, including injection drug use • Depression, anger, guilt, fear, or other mental health needs • Need for social support Issues that might need referral to outside agencies • Desire to have children, contraceptive counseling • Housing or transportation needs • Nutritional needs • Financial emergencies • Child custody, parole, or other legal matters • Insurance Effect of brief safer-sex counseling by medical providers to HIV-1 patients: a multi-clinic assessment Jean L. Richardson, Susan Stoyanoff, Joel Milam, Allen McCutchan, Jony Weiss, et al AIDS 2004, 18:1179–1186 Study Intervention • Clinic environment contains prevention messages • Primary medical provider component reinforced at every visit - Introduce/discuss partnership - Ask about sexual behavior - Verbalize prevention messages to patient - Brief risk-reduction counseling • Provider initiates a 3 - 5 minute interaction focused on: – Patient Self Protection – Partner Protection – Disclosure of status to sex partners • Emphasizes the patient/provider partnership Provider Communication Styles Gain Loss Study Design Baseline _______ 10-month intervention Follow-up _________________ ________ Intervention Assess Assess Gain Frame 01 [……...…X1………..] 02 Loss Frame 01 [……...…X2………..] 02 Control 01 [……...…X3………..] 02 (Adherence) Scope of Study • 6 public HIV Clinics in Southern California • 9,600 HIV patients received at least 1 intervention session • 52,000 patient visits in 10-month intervention period • 75 primary care providers and over 100 support staff trained in prevention Demographic Characteristics of Follow-up Sample (n=585) Gender Male Female 86% 14% Sexual Orientation MSM Heterosexual men Heterosexual women WSW 74% 12% 13% 1% Ethnicity White Hispanic Black Other 41% 37% 16% 6% Results Unprotected Anal or Vaginal (UAV) Intercourse at Follow-Up in Patients With 2+ Partners at Baseline Adjusted OR UAV at Time 2 Adj for Time 1 Controls Gain Loss 95% CI P 1.00 .81 .42 .36 - 1.82 .21 - .83 .61 .01 UAV Adj. for Multiple Covariates* Controls 1.00 Gain 1.38 Loss .42 .51 - 3.75 .20 - .91 .53 .03 *UAV at baseline, age, ethnicity, income, education, viral load, CD4, on ART, time since testing HIV+ Case Scenario 1. A patient with newly-diagnosed HIV infection comes to the clinic for initial evaluation. • Many things must be addressed during this initial visit – medical or psychiatric problems, – education about HIV, – history, physical examination, initial laboratory tests • When and how does one address prevention? • What is the minimum that should be done, and how can it be incorporated into this visit? Conlcusion • If trained and supported, medical providers can deliver prevention messages effectively in the clinic • Emphasizing “loss” or “negative health consequences” of unsafe sex reduced the prevalence of UAV among MSM with initial risky behavioral profiles Case Scenarios • What prevention issues should be addressed at clinic visits for patient with: – newly-diagnosed HIV infection coming for initial evaluation? – chronic, stable HIV and a new sexually transmitted infection (STI)? – chronic, stable HIV and not complaints coming for a routine visit. Case Scenario 1 Assuming no emergent issues are present, the following should be done: • During the history, question patient about – – – – How the patient might have acquired HIV? What are current risk behaviors? Who (generically and specific) are current partners? Have they notified sexual partners and have they been tested for HIV? – What are their current symptoms or history of sexually transmitted infections (STIs)? • During the physical examination, include genital and rectal examinations, evaluation and treatment of any current STI. • If asymptomatic, perform appropriate screening for STIs Case Scenario 1 Preventive Interventions • Discuss – Current risk behavior • Emphasize the importance of using condoms • Address active injection drug use – Disclosure of HIV status to sex and needle-sharing partners , and discuss potential barriers to disclosure. • Note issues that will require follow-up: – risk behaviors that require continuing counseling and – referral and partners who should be notified by either the patient or a health department. Case scenario 2. A patient with chronic, stable HIV comes to you with a new STD. What prevention considerations should be covered in this visit? Discussion • New STIs suggest emerging social, emotional, or substance abuse problems. These potential problems should be addressed in addition to the STD. • Ask about new partners, number of episodes of unsafe sex, and types of unsafe sex. • Address personal or social problems such as substance abuse or relationships that may have resulted in the new STD; refer to social services, if necessary • Review personal risks associated with high-risk behavior such as superinfection with another HIV strain and HIV/STD interactions. Case scenario 2. A patient with chronic, stable HIV comes to you with a new STD. What prevention considerations should be covered in this visit? Discussion • Address other issues (e.g., adherence to HAART) that may be affected by personal or social problems. • Check viral load if nonadherence is evident or is suspected. • Perform genital and rectal examination and screen for additional STDs, such as syphilis, tichomoniasis (women), chlamydial infection (for sexually active women aged 25 years and selected populations of men and women), and gonorrhea (for selected populations of men and women). • Discuss the need for partner notification and referral for counseling and testing. • Note in the medical record that risk behavior should be addressed in future visits and that tailored counseling may be needed for the patient. Case scenario 3. A patient with chronic, stable HIV has been seen regularly in a healthcare setting. What should be included in this patient’s routine clinical care? Discussion • Discussion of sexual and needle-sharing practices should be integrated into a routine part of clinical care. • Periodically (e.g., annually) screen for STDs. STDs to be included in screening should be determined by the patient’s sex, history of • high-risk behavior, and local epidemiology of selected STDs. • Reiterate general prevention messages and patient education regarding partner notification, high-risk behaviors associated • with transmission, prevention of transmission, or condom use, as deemed appropriate by the clinician