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Paving the Road to an HIV Vaccine: Employing Tools of Public Policy to Overcome Scientific, Economic, Social and Ethical Obstacles

In June 1996, the Center for AIDS Prevention Studies published the second occasional paper in this monograph series, entitled Sustaining Support for Domestic HIV Vaccine Research: Social Issues Over the Long Haul of Human Trials. Authored by Chris Collins, the research was supported by grants from the National Institute of Mental Health, National Institutes of Health and the University of California, San Francisco. This new report is intended to function as an update to the 1996 monograph. Most of the social and ethical issues discussed in the original paper have not changed during the past two years. Therefore, you will find many of the previously identified challenges and stages of vaccine research and development, concerns about the design of HIV vaccine efficacy trials, goals of community education, potential benefits and harms for impacted communities, and levels of industry involvement, among others, retained. As a progress report on the state of HIV vaccine research, this paper attempts to highlight, generally, both the progress and lack of progress toward the primary recommendations laid out in the earlier paper. By focusing, up front, on the latest activities of government, affected communities, and industry, a clearer landscape of the state of HIV vaccine efforts comes into view; gaps in certain areas point to the work which remains to be done.

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Motivators and Barriers To Use Of Combination Therapies In Patients With HIV Disease

The successful two-drug combination therapy in 1994 and protease inhibitors in 1995 set the stage for a new era in treatment of HIV disease, creating a burst of optimism over the prospect that HIV might be a controllable disease. Initial studies of protease containing triple-drug regimens suggested that these combinations could, in some cases, slow clinical progression of the disease and prolong the lives of patients. In anecdotal reports, physicians and patients described a kind of "Lazarus" effect in which previously disabled individuals found themselves regaining lost functions, returning to work and planning their futures, instead of preparing for death. There are still many unknowns about these multi-drug regimens, including their durability of effect and how many individuals for whom they will be effective. Nonetheless, the drugs have proven quite effective in clinical trials and are helping many people stay alive longer and experience better quality of life while they are alive. We thought it important to understand better why people do and do not take advantage of these therapeutic advances. Developing the medications may be only half of the battle; the other half involves making sure that HIV infected individuals have access to the drugs and that they make thoughtful decisions about whether or not to take them. If some of the barriers to taking the drugs can be addressed, they should. We conducted in-depth qualitative interviews with 114 individuals in the HIV community--75 HIV infected men and women, 18 hotline operators and supervisors, 11 case managers, and 10 physicians and nurse practitioners.
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Do As I Say…Should We Teach Only Abstinence in Sex Education?

Politics rather than scientific evidence is driving the debate over abstinence-only vs. comprehensive sexuality education programs. It is an approach to making policy that may satisfy the needs of some adults, but does nothing to address the crucial needs of young people. In health promotion, as in medical care, the informed practitioner usually chooses a proven effective strategy over one for which there is no indication of effectiveness. Anything else is malpractice. If policy makers were physicians, they would prescribe what the current sexuality education research indicates actually works: tested comprehensive sexuality education programs. They would not be willing to take a chance on an unproven therapy (i.e., abstinence-only sexuality education), outside of limited studies designed specifically to test the intervention’s effectiveness. The U.S. Congress recently approved one quarter billion dollars in new sexuality education funding. But the money comes with strict restrictions on program content. The mandated “abstinence-only” approach dictated by Congress has not been proven effective in scientific studies, runs counter to the sexuality education approaches of most states, and is based on assumptions inconsistent with the behavior of the majority of the youth in this country. The costs of unprotected adolescent sex are clear. American teens have the highest rates of unplanned pregnancies and sexually transmitted diseases in the industrialized world. One in four sexually active adolescents acquires a sexually transmitted disease (STD) in any given year. This adds up to three million adolescent STD cases annually. Every 30 minutes another person under 20 becomes newly infected with HIV. Nearly one in ten high school seniors reports becoming pregnant or getting someone else pregnant. About 406,000 teens have abortions annually, 134,000 miscarry, and 313,000 unmarried teens give birth to a child. In order to address these problems more effectively, it is not necessary to settle any of the political debates that whirl around the issue of sexuality education. What is needed is a commitment to results. Elected officials, teachers, school boards and parents need to choose: is the function of sexuality education in public schools primarily to prevent disease and unplanned pregnancy or to promote traditional ideology? We need to use the information currently available to set responsible sexuality education policy focused on improved outcomes for youth. Quality research on program effectiveness, along with a close analysis of the needs of young people at especially high risk, provides important guidance. Comprehensive sexuality education programs discourage teens from having sex before they are ready, and encourage condom and contraceptive use for teens who choose to have sex. The substantial body of current behavioral research indicates that some of these programs have been effective at delaying the onset of sexual intercourse, decreasing the number of sexual partners, and increasing condom and contraceptive use among young people. To date, no published, peer reviewed research has been able to demonstrate positive outcomes for abstinence-only sexuality education programs like those recently funded by Congress. It makes scientific sense that the more comprehensive programs would demonstrate promising results. Even the most effective behavioral interventions succeed with only a portion of their intended audience. And given that two thirds of high school seniors report having had intercourse, it is fanciful to expect that abstinence-only programs will be able to bring an absolute end to adolescent sexual activity. Given that a large percentage of young people are destined to be sexually active, it follows that they will need to know how to protect themselves in sexual situations, and have access to condoms and other contraceptives. Abstinence-only programs fail to deliver these protections. They ignore the complexity of risk factors relating to youth STD and pregnancy rates. And abstinence-only programs are typically silent or condemning on subjects that are critical to many of the young people at highest risk, including gay sex, dynamics with older sexual partners, and abortion.
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Dangerous Inhibitions: How America Is Letting AIDS Become an Epidemic of the Young

This monograph was produced as part of the Marketing HIV Prevention project, a collaborative project between the Center for AIDS Prevention Studies at the University of California, San Francisco (Thomas J. Coates, , Director) and the Harvard AIDS Institute (Richard Marlink, MD, Executive Director). We would like to thank SmithKline Beecham Consumer Health Care, makers of OraSure, for its unrestricted grant in support of the Marketing HIV Prevention project. We would also like to acknowledge the support of the Office of AIDS, National Institute of Mental Health, National Institutes of Health, for its ongoing support of the Center for AIDS Prevention Studies under grant number MH42459. The author would like to thank Thomas Coates and Mario Cooper for their significant contributions to this report. I am also indebted to several colleagues who reviewed earlier drafts of the paper, including: Paula Brewer, James Colgrove, Peggy Dolcini, Kevin Filocamo, Katherine Haynes-Sanstad, Lisa Heft, Susan Kegeles, Clark Moore, Ric Marlink, Maureen Michaels, James Riggs, Mark Steitz, Jeff Stryker, and Steve Wakefield. And thanks to Susan Lausten for the design and layout of this piece.
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Sustaining Support for Domestic HIV Vaccine Research

By the time Kevin Shancady walked into the Denver Department of Public Health to enroll in an HIV vaccine trial, he'd managed to put most of his fears behind him: fears of a government hostile to gay men, fears that researchers might inject volunteers with a dangerous vaccine. "So many people have died," he said, "and I feel an obligation to advance prevention research. I'm willing to take some risk. And if the vaccine works, then I'll have protection." It's that mix of optimism, altruism and hope for personal benefit that has made it possible for the National Institute of Allergy and Infectious Diseases (NIAID) to recruit over 4800 Americans into a cohort being readied for HIV vaccine trials. But what Kevin heard when he sat down with a study counselor shows why recruiting volunteers is just the first step on the long and difficult road of HIV vaccine testing. In the best tradition of public health, the study counselor warned him of the possible risks of trial participation. "He told me participants in this trial might not be able to join other vaccine trials," Kevin said, "and if a different vaccine is eventually developed later, it might not work as well in me as in people who had not been in one of these early vaccine studies. I felt blindsided, actually."