The following academic paper is a literature review of a San Fransisco based research article entitled “Risk Behavior for HIV Infection in Participants in Preventive HIV Vaccine Trials: A Cautionary Note.” The authorship consists of Margaret Chesney and Donald Chambers, representing the Center for Aids Prevention Studies at the University of California and James Kahn, representing San Fransisco General Hospital.
This article aims to realize how preventative HIV vaccine trials can affect the sexual risk-behavior of participants, with a focus on unprotected anal sex. Although there was no hypothesis distinctly announced, the researchers maintained a primary predictor that unsafe behavior during the vaccine trials could be attributed to similar behavior before involvement.
This purpose of this study is exploratory and evaluative. The study explores the social side effects of preventative HIV vaccine trials in early phase I and phase II safety and immunogenicity trials. The exploration uncovers that the risk-behavior of participants increases and evaluation made on this basis. The evaluative part of this paper states that in the case where a developed vaccine is available for public use, such behavior could negate the positive aspects of the vaccine, as no vaccine will guarantee 100% immunity from HIV. Considering the trend that shows participants acting more liberally in their sexual activity and engaging in high-risk behavior after participation, it is evident this social trend could undermine the benefits of such a vaccine.
Relevance of Study
The research question is important as it relates to the effects of social work practice may have on individuals who are at high-risk for HIV infection. It provides a cautionary note to social studies researchers as to the need for proper counseling and education of vaccine trial candidates before involving these candidates in experimental research. The issue relates to the perceived perception that HIV vaccine trials prevent infection as a means to the end that is increased risk behavior.
Prior literature relevant to the research problem was reviewed extensively. This documentation includes a previous AIDS vaccine study as well as other vaccine-related research, research on sexual activity and contraception and protection usage, as well as other clinical, epidemiologic, and statistical studies on related behavioral and social sciences. The literature is up to date, with the earliest research dating back to 1984 and a concentration of writing published in the late nineties.
The theoretical framework was not presented individually in this study. However, one can derive the conceptual framework through the ‘Method’ section of the paper. The structure involved two cases of vaccine studies, entitled phase I and phase II. The cases explored how independent variable such as alcohol and drug use, HIV optimism/ pessimism, reasons to volunteer for trials, as well as involvement itself affected the dependent variable of sexual risk behavior. As is stated in the paper, an alternative approach could focus on the perceived protection from HIV by the vaccine as a dependent variable rather than the effects of sexual risk behavior alone. Other than the dependent mentioned above and independent variables, sexual behavior before testing, age, and some sex behavior proved to be important in the determination of the implications of the study.
Concepts and Definitions
The author provided simple definitions to further the major ideas presented in this paper. High-risk behavior is defined by the presence of unprotected vaginal, anal or oral sex in the last six months or being in a serodiscordant (where one partner is infected, and the other is not) or non-monogamous relationship. Participants who reported engaging in sex without using protection even 1% of the time were classified as having unprotected sex. A high-risk primary sexual partner is defined as one whose HIB serostatus was positive or unknown or who were reported to be sexually active outside the relationship, or both. It is interesting that many of the findings treated as unidimensional findings. For instance, classifying a cause of an effect of an increase in an activity as “prior engagement in similar activities” does not provide much insight into the problem. Perhaps, lack of resources or lack of time contributed to this, but it is arguably insufficient to make such a proclamation. From a psychological perspective, it is not fair to rely on extrinsic motivators such as instruction as an answer to a particular problem. As a researcher, it is essential to focus on the multidimensional aspects of high-risk behavior in individuals, and for this, a proper psychological screening is required
The units of analysis in this research were individuals. In the discussion section of the paper, the authors break down the complex psychological system of these sexually active participants and attribute their tendencies to two variables, which are: age, prior experience, and some sex partners. The study was designed using longitudinally, over the span of 24 months. As the investigation used the same sample of participants at different points in time, and determined change in a dependent variable, it can be classified as a panel study. An interval panel was used as the assessment was conducted once every six months.
Reliability and Validity
The authors define each variable in the Measures section of the paper. These measures include the following: socio-demographic characteristics, alcohol and drug use, HIV optimism and pessimism, recall of trial information regarding sexual risk behavior, sexual risk behavior, reasons to volunteer for vaccine trials, and HIV testing and social harms. The measures are reflected upon in a sample consisting mostly of educated and employed bisexual and gay men representing a population of vaccine trial participants. The validity of this study could have been furthered with a more diverse sample size, which included non-gay and bisexual men and women. Nevertheless, after defining these variables operationally, the authors establish reliability and validity of the variables using the comparison between trials and predictors. It was executed through t-tests for normally distributed continuous variables, Mann-Whitney tests for ordered qualitative and non-normal continuous variables, and Fisher’s exact tests for dichotomous variables. Cochran’s Q tests were used to compare the subjects at three separate times for dependence in the correlated proportions.
The sample selection followed specific criteria, including eligibility only where participants were enrolled in one of two vaccine trials conducted at the AIDS program, San Fransisco General Hospital and had no history of substance abuse. The total sample size consisted of 55 individuals, and the sample was relatively homogenous. Selection of the example utilized nonprobability sampling with what seems to be defined either as convenience sampling or snowball sampling method. There was not an adequate representation of women or people of color, which leads one to believe that the sample is not entirely representative of the population from which it was drawn. As with most convenience samples, there is little evidence that this example is representative. Furthermore, the study takes place in San Fransisco, more namely in a health facility, which limits the generalizability of the study to a specific culture of people. For these reasons, it is not likely that this sample can be generalized to other populations.
The response rate for this study was adequate. The authors report that only seven chose not to participate in the research and that just two participants were lost throughout the first 12 months. At the 24-month follow up, another nine were lost. The overall participation rate was 77%. The authors claim that those who chose not to participate and those who were lost shared similar characteristics as those who attended. However, the authors do not give room for the reader to explore this statement with data. The lack of discussion of such data leaves the reader questioning whether or not those individuals who chose not to participate were markedly different and could have added insight to the study.
The research utilized interviewer-administered questionnaires, administered by staff at the Center for Aids Prevention Studies at the University of California. The interviews occurred three times, once at entry, once at six months and once at 12 months, as well as a follow up at 24 months. The study utilized interviewers independent of the staff at the vaccine trial to create a more comfortable atmosphere where the participants would not feel ashamed to report behaviors that they had been counseled to avoid beforehand. The design depends on the truth-telling of the participants. To be specific, the study could have used an alternative approach such as utilizing anonymity and comparing the anonymous submissions of questionnaires to the responses in the administered interviews. Initially, data collection was aimed to identify rates of and predictors of unprotected anal intercourse at different stages, investigating changes over time. However, because there were no significant statistical differences in either prices or predictors for three different time periods, the data were combined.
The causal assertion was made in regards to previous UAI, both insertive or receptive, during the vaccine trials was primarily a result of past engagement in similar activity but also attributed to young age and to have multiple sex partners. Measurement indicated that temporal precedence was indicated by the data gathered at the 6-month assessment (13% increase) and the 12-month assessment (20% increase). Covariation was evident in high-risk behavior when comparing young and non-monogamous participants to older monogamous participants. Nevertheless, not all criteria for establishing causal relationships was apparent, for example, there was not extensive enough research conducted to indicate that no plausible alternative explanations would fit.
The authors concluded that the most important findings of this research are that participants in HIV preventative vaccine trials are subject to perceive that they are protected from HIV infection through the tests, and in turn lead to an increase in the participants’ high-risk sexual behavior. Statistical data indicated a significant increase in insertive UAI and further proof is indicated by the seroconversion of two of the participants. It is substantively crucial for researchers, and therefore for all potential HIV infected individuals, to practice careful selection of participants. It can be done by questioning their motivation for participation, where the desired response should be more intensive risk behavior counseling rather than protection from HIV infection. Furthermore, researches should make an effort to look for evidence of understanding the social risks of disclosing their participation with friends, family members, and work associates (for which informational material should be provided). The authors also state that efficacy testing must be balanced with the potential public health risks and ethical blurring that stems from increased sexual risk behavior encouraged by vaccine trials. The conclusions in the discussion section were well grounded according to the statistical analysis and the methods for analysis.
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