Community perspectives on care options for HIV prevention trial participants.

There is on-going global debate and policy-setting concerning researchers' obligations to meet the health needs of people participating in HIV prevention trials in resource-poor settings. The perspectives of local community stakeholders on this issue are poorly understood as most of what is presented on behalf of communities where research takes place is anecdotal commentary. Using qualitative methods (130 in-depth interviews and 20 focus groups) we assessed perceived fairness of different strategies to meet the health needs of women who become HIV-infected during a hypothetical vaginal microbicide trial. Respondents included HIV prevention research participants, community stakeholders and health-care service providers in ten sites in seven countries (South Africa, Malawi, Tanzania, Zimbabwe, Zambia, India, US). Many respondents perceived referrals to be a potentially fair way to address care and treatment needs but concerns were also voiced about the adequacy of local health-care options and the ability of trial participants to access options. Most respondents viewed the provision of antiretroviral treatment by researchers to HIV-infected trial participants as unfair if treatment was not sustained beyond the end of the trial. The results underscore the importance of effectively linking trial participants to sustainable, community-based treatment and care.

What is community? An evidence-based definition for participatory public health.

Increased emphasis on community collaboration indicates the need for consensus regarding the definition of community within public health. This study examined whether members of diverse US communities described community in similar ways. To identify strategies to support community collaboration in HIV vaccine trials, qualitative interviews were conducted with 25 African Americans in Durham, NC; 26 gay men in San Francisco, Calif; 25 injection drug users in Philadelphia, Pa; and 42 HIV vaccine researchers across the United States. Verbatim responses to the question "What does the word community mean to you?" were analyzed. Cluster analysis was used to identify similarities in the way community was described. A common definition of community emerged as a group of people with diverse characteristics who are linked by social ties, share common perspectives, and engage in joint action in geographical locations or settings. The participants differed in the emphasis they placed on particular elements of the definition. Community was defined similarly but experienced differently by people with diverse backgrounds. These results parallel similar social science findings and confirm the viability of a common definition for participatory public health.

Willingness to volunteer in future preventive HIV vaccine trials: issues and perspectives from three U.S. communities.

UNLABELLED: This study examined perceived risks, benefits, and desired information related to willingness to volunteer in preventive HIV vaccine trials. SAMPLE: Purposive sampling was used to select 90 participants among injecting drug users (Philadelphia, PA, U.S.A.); gay men (San Francisco, CA, U.S.A.); and black Americans (Durham, NC, U.S.A.). METHODS: A qualitative interview guide elicited perceived benefits, risks, and desired information relating to trial participation. Themes were developed from the transcribed texts and from freelists. RESULTS: Stated willingness to volunteer in a preventive HIV vaccine trial was similar across the three communities. Eight perceived benefits were reported, including self-benefits, altruism, and stopping the spread of AIDS. Seven perceived risks were reported, including negative side effects and vaccine safety issues, contracting HIV from the vaccine, and social stigmatization. Participants voiced the desire for eight types of information about issues relating to trust and confidentiality in the research process, health complications and later assistance, and vaccine trial methodology. CONCLUSIONS: In this study, many benefits as well as risks of preventive HIV vaccine trial participation were cited. Scientists conducting preventive HIV vaccine trials need to address community perceptions of risks and provide information about the research if trial enrollment is to be diverse and successful.

Willingness of injection drug users to participate in an HIV vaccine efficacy trial in Bangkok, Thailand.

We assessed willingness to participate in an HIV recombinant gp120 bivalent subtypes B/E candidate vaccine efficacy trial among 193 injection drug users (IDUs) attending drug treatment clinics in Bangkok, Thailand. IDUs previously enrolled in a prospective cohort study were invited to group sessions describing a potential trial, then completed questionnaires assessing comprehension and willingness to participate. A week later, they completed a follow-up questionnaire that again assessed comprehension and willingness to participate, as well as barriers to and positive motives for participation, with whom (if anyone) they talked about the information, and whether others thought participation was a good, bad, or neutral idea. At baseline, 51% were definitely willing to participate, and at follow-up 54%; only 3% were not willing to participate at either time. Comprehension was high at baseline and improved at follow-up. Participants who viewed altruism, regular HIV tests, and family support for participation as important were more willing to volunteer. Frequency of incarceration and concerns about the length of the trial, possible vaccine-induced accelerated disease progression, and lack of family support were negatively associated with willingness. Overall, IDUs comprehended the information needed to make a fully informed decision about participating in an rgp120 vaccine efficacy trial and expressed a high level of willingness to participate in such a trial.

Feasibility and suitability of targeting young gay men for HIV vaccine efficacy trials.

We evaluated factors affecting the feasibility of including young high-risk HIV-negative gay and bisexual men in preventive HIV vaccine trials using data from the U.S. Centers for Disease Control and Prevention Collaborative HIV Seroincidence Study. Of 2189 men enrolled in this study, 17% were <25 years of age. HIV seroincidence was 4.2/100 person-years (95% confidence interval [CI], 2.6-7.0) in young men compared with 2.0/100 person-years (95% CI, 1.4-2.6) for older men. Compared with men 25 and older, young men were more likely to report several high-risk behaviors, to perceive themselves to be at risk for HIV infection, and to report that their risk behavior might be increased by participation in an HIV vaccine trial. The majority of both young men (69%) and older men (74%) expressed willingness in participate in HIV vaccine trials. Young men were less likely to answer questions about vaccine concepts correctly and were more likely to be lost to follow-up. Young gay and bisexual men are important candidates for future HIV vaccine trials, but they may need targeted approaches to recruitment, retention, education about trial concepts prior to enrollment, and behavioral interventions during the trial.

HIV vaccine development and evaluation: realistic expectations.

As of January 1998, more than 85 vaccines for 24 clinical indications are currently licensed in the United States. From the time of discovery of the etiologic agent to the development of a licensed vaccine, many years have usually been required. Although many vaccines have been licensed on the basis of one efficacy trial, multiple vaccine concepts and multiple efficacy trials (both in the United States and internationally) have at times been necessary. Over a relatively short period of time, there has been remarkable progress in human immunodeficiency virus (HIV) vaccine development, with over 34 different HIV candidate vaccines having been tested in phase 1 trials, and three having been tested in phase 2 trials. In spite of our incomplete understanding of HIV pathogenesis and correlates of protection, the first phase 3 efficacy trial has been initiated in the U.S. and tentative plans have been announced for three other phase 3 efficacy trials with the most advanced HIV candidate vaccines to begin in the next 3 years. Like many previous vaccine development efforts, these initial HIV vaccine efficacy trials could be the first of many large-scale efficacy trials in the future, testing various vaccine design concepts among different high-risk populations in both developed and developing countries. The choice of when and how to proceed to phase 3 trials remains a complex decision, but it is likely that only through such trials will further knowledge be gained to advance this important effort and reach our goal of a safe and effective HIV vaccine.

Assessment of the changing willingness to participate in phase III HIV vaccine trials among men who have sex with men.

This paper describes the willingness of 1267 men who have sex with men (MSM) enrolled in a prospective HIV vaccine preparedness study from Chicago, Denver, and San Francisco to enroll in HIV vaccine efficacy trials. Respondents were interviewed at baseline and followed-up at 6, 12, and 18 months. At each visit respondents were tested for HIV antibodies using enzyme-linked immunosorbent assay (ELISA) testing with Western blot confirmation. Over 18 months, the annualized HIV seroincidence of this cohort was 2.4%. At baseline, 37% of the men reported that they would be "definitely" willing to participate in an HIV vaccine efficacy trial; however, this dropped to 21% at 12 months and remained stable at 18 months. Greater willingness to participate (WTP) was related to lower education, engaging in HIV risk behavior, living in Denver, white ethnicity, and older age. Changing WTP suggests that the decision to participate in HIV vaccine efficacy trials may be complex and dynamic and take an extended time. These data underscore the importance of informed consent and raise questions regarding the influence of decision-making processes on HIV vaccine efficacy trial design, compliance, and validity.

Obstacles and progress toward development of a preventive HIV vaccine.

AIDS: Researchers have been seeking an HIV vaccine almost since the disease was first discovered, and while a number of phase I trials have been carried out, few have been extended to phase II trials and none have progressed to phase III trials. AIDS advocates agree that an HIV vaccine is not only necessary, but should also be safe, effective, stable, affordable, orally administered, and able to create long-lasting immunity. However, not everyone can agree on whether it should induce humoral, cell-mediated, or mucosal immune responses, or if it should induce all three of the immune responses. Other questions remain regarding the animals' roles in testing, how to work in the global genetic variability of HIV, and whether the vaccine should prevent infection. Despite the scientific uncertainties and inherent social difficulties, several candidate vaccines have been developed. However, the debate on how to proceed to large-scale phase III trials, designed to evaluate protective efficacy, is still unresolved. Concluding comments offer observations about continuing vaccine development to phase III trials.^ieng

Feasibility of human immunodeficiency virus vaccine trials in homosexual men in the United States: risk behavior, seroincidence, and willingness to participate.

Human immunodeficiency virus (HIV)-seronegative high-risk homosexual men were enrolled in a vaccine feasibility study in three US cities. HIV seroincidence was 2.3/100 person-years (95% confidence interval [CI], 1.7-2.9) over 18 months in 1975 men. After receiving an explanation of HIV vaccine trial design, 37% stated they were "definitely" willing to participate in future trials; seroincidence was 3.7/100 person-years (95% CI, 2.5-4.9) in this subgroup. An additional 57% "might be" or were "probably" willing. Independent predictors of HIV seroconversion in multivariable pooled logistic regression analysis were having a known HIV-seropositive sex partner (odds ratio [OR], 4.5; 95% CI, 2.6-7.8), injection drug use (OR, 3.6; 95% CI, 1.2-10.7), unprotected receptive anal sex (OR, 2.4; 95% CI, 1.4-4.2), condom failure (OR, 2.4; 95% CI, 1.4-4.1), gonococcal/nongonococcal urethritis (OR, 2.3; 95% CI, 1.1-4.7), and age < 25 years (OR, 2.2; 95% CI, 1.2-4.2). Interest in vaccine trials and seroincidence in high-risk homosexual men are sufficiently high to initiate efficacy trials once a suitable candidate vaccine is identified. Risk factors for seroconversion highlight important area for development of ancillary intervention strategies.

Alcohol consumption, brothel attendance, and condom use: normative expectations among Thai military conscripts.

This article investigates the relationship between alcohol consumption and inconsistent condom use with brothel-based commercial sex workers among Thai military conscripts in Northern Thailand. Data from 10 focus groups indicate that alcohol consumption (1) is consciously used by men to reduce inhibitions that constrain their interpersonal interaction with women and with each other; (2) reduces inhibitions of individuals to sexual risk taking; (3) provides a socially acceptable excuse for nonuse of condoms; (4) is associated by conscripts with brothel attendance; and (5) is seen to enhance male sexual pleasure, in contrast to condoms, which are said to reduce pleasure. Understanding the culturally defined expectations that surround alcohol consumption and sexual behavior is critical for developing realistic interventions to reduce HIV transmission.

The epidemiology of HIV transmission: trends, structure and dynamics.

"This review summarizes dynamic processes in human immunodeficiency virus (HIV) transmission. A brief overview of current trends in the HIV epidemic is followed by a discussion of the basic components of HIV transmission. Several epidemiologic models are then described that seek to delineate how HIV transmission is structured by human relationships and the implications of those structural relationships for the evolving epidemic."

Patterns of supplementation, nursing behavior, and lactation: a simulation analysis.

PIP: The use of computer simulation has many advantages for the study of human milk production. The simulation presented here deals with the interactions between infant calorie requirements and mothers' responses to these requirements, measured in terms of milk production. The simulated mother-infant interactions include: 1) the effects of different patterns of the use of breast milk supplements; 2) the effects of varying degrees of responsiveness on the part of the mother to increased infant calorie needs due to growth; 3) the interaction between supplementation patterns and responsiveness, and 4) the effects of varying degrees of reliability in the milk let-down response. In order to assess these interactions 2 hypothetical situations are simulated: a deterministic pattern of supplementation and a stochastic pattern of supplementation. Milk production is also assessed for the effects of stochastic variation in the let-down response, and in the mother's willingness to increase milk production through increased nursing. A major aspect of the model are points where milk production is seen as susceptible to variation in mother-infant interactions; they are noted as stress points. A series of simulation runs were made with formula substitution beginning in the 3rd, 5th, or 7th week. The results indicate a similar pattern of milk production, which increased as supplementation was delayed. The deterministic pattern of supplementation is related only to the 1st stress point in the model, but the stochastic pattern influences all 3. The results of the various simulation runs should be taken as a qualitative indication of the effects on milk production of certain behavioral patterns. The different effects of stochastic and deterministic stress at each of the 3 stress points are discussed and implications derived. The results of the simulation suggest that it is random interference in the breastfeeding relationship, especially radom supplementation at the 1st stress point, that most significantly affects a mother's ability to keep pace with her growing infant. Regular supplementation, i.e., a structured mixed feeding strategy, does not seem detrimental in and of itself, as long as the nonsupplemented feedings are free of interference.^ieng