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Samples of Consent Forms provided by the Committee of Human Research, UCSF
- Review the Consent Guidelines and Standard Wording before writing your consent form.
- Keep the upper right-hand corner blank and use at least a 1.25" top margin.
- See the NCNN Informed Consent Language Database for lay language terms.
Howdy, Partner! Using the PARTNER Tool to Track and Analyze Community Partnerships
Self-Report Adherence to Medications
This questionnaire was developed by the AIDS Clinical Trials Group (ACTG) Recruitment, Adherence, and Retention Subcommittee, Margaret A. Chesney, PhD, and Jeannette Ickovics, PhD, co-chairs. Please read the two abstracts on adherence in clinical trials and practice. Instruments:
Scoring: N/A Reliability and/or validity: Chesney MA, Ickovics JR, Chambers DB, Gifford AL, Neidig J, Zwickl B, and Wu AW (2000). “Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committee of the Adult AIDS Clinical Trials Group (AACTG).” AIDS Care 12(3): 255–66.
Club drugs
How do club drugs impact HIV prevention?
What are club drugs?
Club drugs are illegal drugs that are often, although not exclusively, used at dance clubs, raves and circuit parties. Drugs often referred to as club drugs include: MDMA (ecstasy), methamphetamine (crystal meth, speed), GHB (liquid X), Ketamine (special K) and less often, Viagra and amyl nitrites (poppers)1. These drugs also are often used outside of clubs and parties. Raves are large parties featuring house or techno music and visual effects. Mostly younger people attend raves. Circuit parties are a series of large, predominantly gay parties lasting several days and nights in a row that are frequented mostly by younger and older middle-class white men. They occur annually in different cities.2 Some of the physical and psychological effects of club drugs include: elevated mood, increased empathy, altered vision, sensations and emotions, increased alertness, decreased appetite, relaxation, increased physical energy and/or self-confidence. Many people use drugs recreationally with few or no immediate repercussions. Misuse of club drugs can lead to problems with toxicity (from the drugs themselves or from interactions with other drugs), with legal issues and sometimes with addiction. Persons using one or more club drugs during sex often report engaging in extremely high HIV risk behaviors.3 Club drugs can cause a variety of non-HIV-related health risks. This fact sheet will focus on sexual and drug-using HIV risk behaviors that can occur with club drug use.
Who uses club drugs?
Most of the research on club drugs has been with gay men, mainly because HIV prevalence and risk of infection are high among gay men. Use of club drugs varies by different populations and by geography.4 A survey of gay male circuit party attenders in San Francisco found that 80% used ecstasy, 66% ketamine, 43% methamphetamines, 29% GHB, 14% Viagra and 12% poppers during their most recent out-of-town weekend party. Half (53%) used four or more drugs.5 A study of rave attenders in Chicago found that 48.9% had used any club drugs, 29.8% used LSD, 27.7% ecstasy and 8.5% methamphetamine. Rave attenders used club drugs with other drugs such as marijuana (87%), alcohol (65.2%) and cocaine/crack (26.1%).6
What is the risk?
There are many negative physical and psychological side effects of club drugs. The reason club drugs present a potential HIV risk is because they can lower inhibitions, impair judgment, increase sexual endurance and encourage sexual risk-taking. With injected drugs, there is also a potential risk from sharing injection equipment. The risk for HIV occurs mainly when drug use occurs during sexual activity. For example, methamphetamine is often used to initiate, enhance and prolong sexual encounters, allowing individuals to have sexual intercourse with numerous partners. Poppers are used for receptive anal sex, to relax the anal sphincter. Speed is also dehydrating, which may make men and women more prone to tears in the anus, vagina or mouth, and therefore more prone to HIV/STD infections.3,7 In one study, HIV- heterosexual methamphetamine users reported an average of 9.4 sex partners over two months. The number of unprotected sexual acts in two months averaged 21.5 for vaginal sex, 6.3 for anal sex and 41.7 for oral sex. Most users (86%) reported engaging in “marathon sex” while high on methamphetamine. Over one-third (37%) of users reported injecting, and of those, almost half had shared and/or borrowed needles.7 Unprotected sex with a partner whose HIV status is unknown is a high-risk activity. A survey of gay men found that 21% of HIV+ and 9% of HIV- men reported unprotected anal sex with a partner of unknown status at their most recent circuit party.5 A study of gay men at raves in New York City found that about one-third (34%) used ecstasy at least once a month. Men who used ecstasy were more likely to report recent unprotected anal intercourse than men who used other drugs, including alcohol.8
Why do people use club drugs?
For many people, straight or gay, drug use and sex are a natural occurrence at raves and circuit parties, and one of the appeals of these parties. These parties are popular social activities for some groups of youth and gay men, and there can be strong peer pressure to use drugs and be sexually active. While circuit parties and raves may not themselves cause drug use, they may attract persons who are more inclined to use drugs.10 People use club drugs for many reasons. Some people use club drugs to have fun, dance and loosen inhibitions. Others use them to escape their problems and to counter feelings of depression or anxiety. Parental drug use, childhood sexual abuse and depression are some of the factors that may lead to drug use.4
What’s being done?
A drug treatment program for gay methamphetamine users in Los Angeles, CA, sought to reduce drug use and HIV-related sexual risk behaviors. Treatment options included: 1) cognitive behavioral therapy, a 90-minute group session delivered three times a week; 2) contingency management, a behavioral intervention that offered increasingly valuable vouchers for abstinence from drug use; and 3) cognitive behavioral therapy culturally tailored to gay issues. All men reduced their drug use, and those using contingency management reduced drug use longer. The highest reduction in sexual risk-taking occurred in men who used the culturally tailored program.11 DanceSafe promotes health and safety within the rave and nightclub community, with local chapters throughout the US and Canada. DanceSafe trains volunteers to be health educators and drug abuse prevention counselors at raves and nightclubs. They use a harm reduction approach and primarily target non-addicted, recreational drug users. DanceSafe offers information on drugs, safer sex and staying healthy, and in some venues offers pill testing to make sure drugs do not contain harmful substitutes.12 Twelve Step programs such as Crystal Meth Anonymous (CMA), Narcotics Anonymous (NA) and Alcoholics Anonymous (AA) are for people for whom drug use has become a problem. Twelve Step advocates abstinence from crystal meth, alcohol and other illicit drugs. Twelve Step meetings occur in many cities across the US.13 The PROTECT project at the South Florida Regional Prevention Center aims to reduce club-drug use among young gay men. PROTECT trains police officers, teachers and other community stakeholders on club drugs, particularly ecstasy. They also developed a web site with a chat room monitored by peer counselors.14 Stepping Stone, in San Diego, CA, is a residential drug treatment facility for gay men and lesbians. Most of their clients are poly drug users and most are dually diagnosed with psychiatric disorders. They address sexual behaviors and mental health issues in the context of drug abuse treatment. Stepping Stone sponsors a harm reduction social marketing campaign to increase awareness of the dangers of club drugs and alcohol.15
What needs to be done?
Several organizations are currently addressing the negative effects of club drugs at raves and parties across the country. More education is needed about the toxicity of club drugs, poly drug use and the connection between drug use and unsafe sex. Referrals for mental health counseling should also be made available at these venues. The gay community needs to address the very real pressures in some sub-communities to party and be highly sexually active, and ask the question “is drug use worth the risks men are taking?”3 It is not enough to attempt to reduce drug use and abuse at circuit parties without also addressing the powerful sexual motivations to using drugs.3,9 When prescribing Viagra, physicians should counsel men on safer sex and the harmful effects of combining Viagra with methamphetamines, poppers and ecstasy. Physicians should inquire about club drug use among their HIV+ patients and counsel them on the danger of combining them with HIV treatment drugs.16 Physicians should be aware that club drug use can affect adherence to HIV drugs.
Says who?
1. Freese TE, Miotto K et al. The effects and consequences of selected club drugs. Journal of Substance Abuse Treatment. 2002;23:151-156. 2. Swanson J, Cooper A. Dangerous liaison: club drug use and HIV/AIDS. IAPAC Monthly. 2002;8:1-15. 3. Halkitis PN, Parsons JT, Stirratt MJ. A double epidemic: crystal methamphetamine drug use in relation to HIV transmission among gay men. Journal of Homosexuality. 2001;41:17-35. 4. Stall R, Paul JP, Greenwood G et al. Alcohol use, drug use and alcohol-related problems among men who have sex with men: the Urban Men’s Health Study. Addiction. 2001;96:1589-1601. 5. Colfax GN, Mansergh G, et al. Drug use and sexual risk behavior among gay and bisexual men who attend circuit parties: a venue-based comparison. Journal of Acquired Immune Deficiency Syndromes. 2001;28:373-379. 6. Fendrich M, Wislar JS, Johnson TP et al. A contextual profile of club drug use among adults in Chicago. Addiction. 2003;98:1693-1703. 7. Semple SJ, Patterson TL, Grant I. The context of sexual risk behavior among heterosexual methamphetamine users. Addictive Behavior. 2004;29:807-810. 8. Klitzman RL, Pope HG, Hudson JI. MDMA (“ecstacy”) abuse and high-risk sexual behaviors among 169 gay and bisexual men. American Journal of Psychiatry. 2000;157:1162-1164.10. Adlaf EM, Smart RG. Party subculture or dens of doom? An epidemiological study of rave attendance and drug use patterns among adolescent students. Journal of Psychoactive Drugs. 1997;29:193-198. 11. Shoptaw S, Reback CJ. Drug and sex risk behavior reductions with behavioral treatments for methamphetamine dependence among gay/bisexual men. Presented at the National HIV Prevention Conference, Atlanta, GA. 2003. Abstract #T3-D1004. 12. www.dancesafe.org 13. www.crystalmeth.org, www.na.org, www.aa.org 14. Rothaus S. Workshop targets young gays with a penchant for club drugs. Miami Herald. July 16, 2003. 15. Johnson SB. Stepping Stone: a catalyst for change. Presented at Methamphetamine Use and Gay Men Meeting. Sacramento, CA. April 24, 2003. 16. Romanelli F, Smith KS, Pomeroy C. Use of club drugs by HIV-seropositive and HIV-seronegative gay and bisexual men. Topics in HIV Medicine. 2003;11:25-32.
Other internet resources:
www.tweaker.org www.crystalrecovery.com www.freevibe.com www.crystalneon.org
Prepared by Mike Pendo*, Pamela DeCarlo** *San Francisco Department of Public health, **CAPSJuly 2004. Fact Sheet #55E Special thanks to the following reviewers of this Fact Sheet: Michael Thomas Angelo, Grant Colfax, Viva Delgado, Paul Galatowitsch, Rob Guzman, Perry Halkitis, Manuel Laureano-Vega, Gary Leigh, Phil Reichert, Frank Romanelli, Mike Siever, Steve Shoptaw, Steven Tierney, Dan Wohlfeiler. Reproduction of this text is encouraged; however, copies may not be sold, and the University of California San Francisco should be cited as the source. Fact Sheets are also available in Spanish. To receive Fact Sheets via e-mail, send an e-mail to [email protected] with the message “subscribe CAPSFS first name last name.” ©July 2004, University of CA.
HIV vaccine
Can an HIV Vaccine make a Difference?
why do we need an HIV vaccine?
Vaccines are among the most powerful and cost-effective disease prevention tools available. A vaccine that could prevent HIV infection or stop progression of the disease would greatly help in the fight against the AIDS pandemic. Vaccines have been pivotal in worldwide smallpox elimination efforts, have nearly eliminated polio and have drastically reduced the incidence of infectious diseases like measles and pertussis in the US. A crucial question is whether a vaccine based on one strain of HIV would be effective for populations in which a different strain is predominant. There are also questions about how an HIV vaccine would protect individuals: the vaccine might not be able to actually prevent infection, but could prevent or delay progression to disease, or simply reduce the infectiousness of people who do become infected with HIV. HIV prevention education and counseling are important components of vaccine programs. Even after the release of a vaccine, there will be an ongoing need for effective behavioral prevention programs. An HIV vaccine will not be a “magic bullet” but it could play an extremely powerful role as part of a package of prevention interventions.
has progress been made?
Twenty-two years into the epidemic, researchers are still struggling with the daunting scientific challenges involved in HIV vaccine research: 1) traditional approaches to vaccine design (i.e. use of inactivated or attenuated viruses) are considered too dangerous with HIV; 2) the virus is highly variable and mutates rapidly; 3) the viral infection is permanent, full recovery from HIV has not been documented, and thus, it is unclear how the body could mount an effective immune response and 4) there is no perfect animal model for use in AIDS vaccine research.1 There is still no HIV vaccine that has been tested and found to be effective. There have been over 70 small-scale human clinical trials of over 35 different candidate HIV vaccines, but only one product, AIDSVAX, produced by VaxGen, has been tested in a large-scale (Phase III) trial. Unfortunately, two separate trials of AIDSVAX conducted in 1) North America, Puerto Rico and the Netherlands2 and 2) Thailand, found that the vaccine did not prevent HIV infection in the overall study populations and did not slow progression of disease among participants who became HIV-infected during the trial.3 A successful HIV vaccine would train the immune system to recognize HIV before it does extensive damage. Vaccine concepts now in development use a variety of methods to train the immune system to recognize parts of HIV without exposing people to HIV itself. Early AIDS vaccine research focused on developing bio-engineered vaccines that represent a portion of HIV’s outer surface (envelope) protein. Different vaccine approaches are currently in development, none of which include the actual virus (HIV) and none of which can cause a recipient to acquire HIV from the vaccine itself.
what is the impact on HIV prevention?
An effective HIV vaccine cannot take the place of HIV prevention efforts, any more than prevention efforts can take the place of a vaccine. The best way to address the HIV pandemic is using multiple interventions at multiple levels, and the protective power of a vaccine could one day be of enormous benefit in HIV prevention. There have been increases in sexual risk behavior in men who have sex with men (MSM) since the advent of ART (antiretroviral treatment).4 There is concern that when a vaccine becomes available there could be similar increases in risk behavior among people who receive the HIV vaccine because they feel they can’t become infected with HIV. In the VaxGen efficacy trial in North America, younger participants and MSM who believed they had received the actual vaccine rather than a placebo were more likely to report unprotected anal intercourse during the trial. Overall, self-reported risk behavior did not increase throughout the trial.5 In the VaxGen efficacy trial in Thailand, injecting drug users reported decreases in injection drug use and needle sharing during the first 12 months of the trial.6 This may have been due to the prevention education and risk-reduction counseling received.
what are the ethical issues?
HIV vaccines can only be tested for safety and effectiveness if thousands of individuals are willing to participate in clinical trials. These trials raise concerns about the potential harm to trial participants. Certain HIV vaccines may cause trial volunteers to test HIV+ on standard HIV antibody tests, even though they are not infected with the virus. A positive HIV test result could expose individuals to discrimination in health insurance, employment and immigration, or lead to social stigma. The simple act of participating in an HIV vaccine trial may result in someone being labeled as a “high risk” individual, a gay person or a drug user, and discrimination against these and other groups is a very real issue in many places. It is the responsibility of researchers to ensure that vaccine trial participants receive assistance to alleviate the risks of discrimination or other harm that may result.7 Communities must be closely involved in clinical trial design and implementation. Researchers also need to ensure that true informed consent is acquired before individuals are enrolled in a vaccine trial. Community members and potential volunteers need to be fully informed about the vaccine trial process and must understand such concepts as “placebo,” “randomization” and “blinding” to be able to truly evaluate whether participation is right for them. Using community educators and peers to help with the community education that accompanies HIV vaccine research will also help increase participants’ understanding and acceptance of vaccine trials.8
what are barriers?
Much of the expertise to develop and manufacture HIV vaccines rests in private-sector pharmaceutical and biotechnology companies. Yet industry commitment to HIV vaccines has not matched the enormity of the public health need.9,10 An HIV vaccine will only bring the pandemic under control if it is widely available in the developing world, where more than 95% of new HIV infections are occurring. People in resource-poor countries have often had to wait a decade or more for vaccines after they have been licensed for use in industrialized nations.11,12 There are numerous challenges to HIV vaccine access in addition to price. Marginal health care infrastructures in some developing countries may make it difficult to distribute a vaccine. Even countries that can afford vaccines may not see them as a high priority and may not allocate adequate resources to fund research or vaccine purchase. Vaccination programs generally focus on children. With HIV, it is sexually active adolescents and adults who will need a vaccine most immediately, necessitating new approaches to immunization. Vaccine acceptance may be problematic in communities where there is a distrust of government or stigma in being associated with HIV/AIDS.
what needs to be done?
Public sector funding for research on HIV vaccines has increased in recent years, and additional resources are needed. The private sector must be encouraged to invest in HIV and other priority vaccines through a range of incentives, including direct funding, public support for clinical research infrastructure and product manufacture, and through public/private partnerships.9 Wealthy governments should commit in advance to purchase AIDS vaccines for people in the developing world. Continued political leadership is needed to prioritize resources for vaccines. Vaccine trials conducted to date have included HIV prevention education and risk reduction counseling. Vaccine trials can further benefit participants by offering drug treatment services and STD screening and treatment. Combining medical, behavioral and psychological efforts as part of a vaccine initiative can be a powerful tool for combatting the HIV pandemic. Vaccines are an integral part of an effective disease prevention strategy, and vaccine development is critical in arresting the spread of HIV. Yet, a vaccine alone will not eliminate the social and structural conditions that created and fuel the epidemic. Even when HIV vaccines are available, communities will continue to need quality behavioral interventions to control the HIV epidemic and policies that ensure access to vaccines. Prepared by Chris Collins, MPP, AIDS Vaccine Advocacy Coalition
Says who?
1. National Institute of Allergy and Infectious Diseases. Challenges in designing AIDS vaccines. May 2003. www.niaid.nih.gov/factsheets/challvacc.htm 2. AIDS Vaccine Advocacy Coalition. Understanding the results of the AIDSVAX trial. May 2003. https://www.avac.org/sites/default/files/resource-files/understanding_a…; 3. VaxGen Announces Results of its Phase III HIV Vaccine Trial in Thailand: Vaccine Fails to Meet Endpoints. Press release from VaxGen. www.vaxgen.com/pressroom/ 4. Valdiserri RO. Preventing new HIV infections in the US: what can we hope to achieve? Presented at the 10th Conference on Retroviruses and Opportunistic Infections, Boston, MA. February 10-14, 2003. 5. Bartholow B. Risk behavior and HIV seroincidence in the US trial of AIDSVAX B/B. Presented at the AIDS Vaccine 2003 Conference, New York, NY. September 2003. 6. Vanichseni S, van Griensven F, Phasithiphol B, et al. Decline in HIV risk behavior among injection drug users in the AIDSVAX B/E vaccine trial in Bangkok, Thailand. Presented at the XIV International AIDS Conference, Barcelona, Spain. July 2002. 7. UNAIDS. Guidance Document on Ethical Considerations in HIV Preventive Vaccine Research. June 2002. 8. van Loon KV, Lindegger GC, Slack CM. Informed consent: A review of the experiences of South African clinical trial researchers. Presented at the XIV International AIDS Conference, Barcelona, Spain. July 2002. Abst #TuOrG1170. 9. AIDS Vaccine Advocacy Coalition. https://www.avac.org/avac-report 10. Klausner RD, Fauci AS, Corey L, et al. The need for a global HIV vaccine enterprise. Science. 2003;300:2036-2039. 11. Public health considerations for the use of a first generation HIV vaccine: Report from a WHO-UNAIDS-CDC Consultation, Geneva, 20-21 November 2002. AIDS. 2003;17:W1-W10. 12. International AIDS Vaccine Initiative. AIDS Vaccines for the New World: Preparing Now to Assure Access. July 2000. www.iavi.org Resources AIDS Vaccine Advocacy Coalition (AVAC) 101 West 23rd St. #2227 New York, NY 10011 212/367-1021 www.avac.org HIV InSite: Vaccine Overview http://hivinsite.ucsf.edu/InSite?page=kb-08-01-11 HIV Vaccine Trials Network http://www.hvtn.org International AIDS Vaccine Initiative (IAVI) 110 William Street New York, NY 10038-3901 212/847-1111 www.iavi.org National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS Vaccines www.niaid.nih.gov/aidsvaccine NIAID Vaccine Research Center https://www.niaid.nih.gov/about/vrc
January 2004. Fact Sheet #38ER Special thanks to the following reviewers of this Fact Sheet: Barbara Adler, Emily Bass, Mark Boaz, Susan Buchbinder, Jose Esparza, Jorge Flores, Paula Frew, Ingelise Gordon, Ashraf Grimwood, Margaret McCluskey, Catherine Slack, Robert Smith, Steven Tierney, Steven Wakefield, Doug Wassenaar, Sandra Wearins, Dan Wohlfeiler.
Reproduction of this text is encouraged; however, copies may not be sold, and the Center for AIDS Prevention Studies at the University of California San Franciso should be cited as the source of this information. For additional copies of this and other HIV Prevention Fact Sheets, please call the National Prevention Information Network at 800/458-5231. Comments and questions about this Fact Sheet may be e-mailed to [email protected]. © January 2004, University of California