scholarly journals “Why Don’t You Go Into Suburbs? Why Are You Targeting Us?”: Trust and Mistrust in HIV Vaccine Trials in South Africa

2018 ◽  
Vol 13 (5) ◽  
pp. 525-536 ◽  
Author(s):  
Siyabonga Thabethe ◽  
Catherine Slack ◽  
Graham Lindegger ◽  
Abigail Wilkinson ◽  
Douglas Wassenaar ◽  
...  
Keyword(s):  
Vaccine Trial ◽  
Hiv Vaccine ◽  
Community Advisory Board ◽  
Future Research ◽  
Community Members ◽  
Group Discussions ◽  
Hiv Vaccine Trials ◽  
Vaccine Trials ◽  
Community Stakeholders ◽  
Site Staff

Trust is a key element of high-quality stakeholder relations, which are themselves essential for the success of HIV vaccine trials. Where trust is absent, community stakeholders might not volunteer to become involved in key trial activities, and potential participants might not volunteer for enrollment. We explored site staff and Community Advisory Board (CAB) members’ experiences of trust/mistrust among community members and potential participants. We analyzed 10 focus group discussions with site staff and CAB members at two active South African HIV vaccine trial sites. We report on key characteristics perceived to contribute to the trustworthiness of communicators, as well as factors associated with mistrust. Attributes associated with trustworthy communicators included shared racial identity, competence, and independence (not being “captured”). Key foci for mistrust included explanations about site selection, stored samples, vaccination, and Vaccine Induced Sero-Positivity (VISP). Our findings suggest that community members’ trust is not necessarily global, in which trials are trusted or not; rather, it appears fairly nuanced and is impacted by various perceived attributes of communicators and the information they provide. We make recommendations for clinical trial site stakeholders invested in building trust and for future research into trust at these sites.

Community Members' Perceptions of Enablers and Inhibitors to Participation in HIV Vaccine Trials

2006 ◽  
Vol 36 (4) ◽  
pp. 734-761 ◽  
Author(s):  
Anthea Lesch ◽  
Zuhayr Kafaar ◽  
Ashraf Kagee ◽  
Leslie Swartz
Keyword(s):  
Hiv Vaccine ◽  
Community Members ◽  
Hiv Vaccine Trials ◽  
Vaccine Trials

scholarly journals Evaluating the surrogacy of multiple vaccine-induced immune response biomarkers in HIV vaccine trials

Biostatistics ◽  
2019 ◽  
Author(s):  
Sayan Dasgupta ◽  
Ying Huang
Keyword(s):  
Immune Response ◽  
Vaccine Trial ◽  
Hiv Vaccine ◽  
Clinical Endpoints ◽  
Hiv Vaccine Trials ◽  
Marker Selection ◽  
Vaccine Trials ◽  
Potential Marker ◽  
Potential Biomarker ◽  
Response Biomarkers

Summary Identifying biomarkers as surrogates for clinical endpoints in randomized vaccine trials is useful for reducing study duration and costs, relieving participants of unnecessary discomfort, and understanding vaccine-effect mechanism. In this article, we use risk models with multiple vaccine-induced immune response biomarkers to measure the causal association between a vaccine’s effects on these biomarkers and that on the clinical endpoint. In this setup, our main objective is to combine and select markers with high surrogacy from a list of many candidate markers, allowing us to get a more parsimonious model which can potentially increase the predictive quality of the true markers. To address the missing “potential” biomarker value if a subject receives placebo, we utilize the baseline immunogenicity predictor design augmented with a “closeout placebo vaccination” group. We then impute the missing potential marker values and conduct marker selection through a stepwise resampling and imputation method called stability selection. We test our proposed strategy under relevant simulation settings and on (partially simulated) biomarker data from a HIV vaccine trial (RV144).

BioBoard

2006 ◽  
Vol 10 (18) ◽  
pp. 999-1007
Keyword(s):  
Drug Research ◽  
Vaccine Trial ◽  
Hiv Vaccine ◽  
Chinese Government ◽  
Bird Flu ◽  
Hiv Vaccine Trials ◽  
Vaccine Trials ◽  
Drug Companies ◽  
Flu Vaccine ◽  
European Program

Australia — ASIC Sues Citrofresh. Australia — IDT's Blackman, Mattick Awarded "Science Oscars". Australia — Medical Fellowship in Honor of Zhou. Australia — Stem Cell Sciences Joins European Program. China — Johnson & Johnson Breaks Ground for the Biggest Base in Asia. China — Beijing Sinovac Biotech Seeks Volunteers for 2nd Bird Flu Vaccine Trial. China — CAS Establishes Five More Research Institutes. China — China to Increase Support for Drug Research and Production. China — Chinese Government Reduces Drug Price. Hong Kong — Shaw Prize for Six Scientists. India — India Ayurvedic Medicine Gives Hope to Alzheimer. India — Indian Drug Maker Buys DHA. Japan — Takeda's Actos Reduces Risk of Second Stroke. Malaysia — KL's New Initiatives for its Biotech Industry. Singapore — Professor Philip Ingham to Boost Singapore's Biomedical Drive. Singapore — Health Agreements Between Singapore and Chinese Companies. Singapore — Biosensors Confident of Approval for its Stent. Singapore — More Drug Companies Conducting Trials in Singapore. Singapore — New Breed of Doctors to be Trained at Duke-NUS Medical School. Taiwan — Taiwan Hosts International Biologics and Vaccine Conference. Taiwan — Taiwan and Vietnam Sign Agreement to Fight Disease. Taiwan — Taiwan to Invest NT$300 million for Biofuel Research Efforts. Taiwan — Taiwan's Medical Sensor Breakthrough. Taiwan — HIV Vaccine Trials in Taiwan. Others — Vietnam Prepares for Potential Bird Flu Outbreaks Among Humans. Others — AIDS Meeting Urged to Rethink Prevention Strategy. Others — WHO Warns About Drug-Resistant TB.

scholarly journals Social Impacts Among Participants in HIV Vaccine Trial Network (HVTN) Preventive HIV Vaccine Trials

2020 ◽  
Vol 84 (5) ◽  
pp. 488-496
Author(s):  
Michele P. Andrasik ◽  
Fredericka Albertina Sesay ◽  
Abby Isaacs ◽  
Linda Oseso ◽  
Mary Allen
Keyword(s):  
Vaccine Trial ◽  
Social Impacts ◽  
Hiv Vaccine ◽  
Trial Network ◽  
Hiv Vaccine Trials ◽  
Vaccine Trials

scholarly journals Recruitment using respondent driven sampling, risk behaviors assessment and willingness of young female sex workers (18–25 years) in Dar Es Salaam, Tanzania to participate in HIV vaccine trials

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Theodora Mbunda ◽  
Edith A. M. Tarimo ◽  
Muhammad Bakari ◽  
Eric Sandström ◽  
Asli Kulane
Keyword(s):  
Risk Behaviors ◽  
Sex Workers ◽  
Female Sex Workers ◽  
Vaccine Trial ◽  
Young Female ◽  
Hiv Vaccine ◽  
Willingness To Participate ◽  
Female Sex ◽  
Hiv Vaccine Trials ◽  
Vaccine Trials

Abstract Background Despite the present HIV preventive and treatment programs, the prevalence of HIV is still high in eastern and southern Africa, among young women and populations at high. risk for HIV transmission such as sex workers. There is a need to prepare a suitable population that will participate in efficacy HIV vaccine trials to determine the efficacy of HIV vaccines that had proven to be safe and immune potent. Methods It was a cross-sectional study that recruited 600 female sex workers using respondent-driven sampling in Dar es Salaam. The study examined recruitment approaches, risk behaviors and willingness of young female sex workers to participate in an HIV vaccine trial. Descriptive statistics described risk behaviors and willingness of the participants to participate in efficacy HIV vaccine trials. The logistic regression model computed the likelihood of willingness to participate in the trials with selected variables. Results The study demonstrated 53% were less than 20 years old, 96% were single, and 22% lived in brothels. Eighty percent of the participants started selling sex at the age between 15 and 19 years old, 61% used illicit drugs for the first time when they were less than 20 years old, 24% had anal sex ever. Eighty-nine percent had more than 20-lifetime sexual partners, and 56% had unprotected sexual intercourse with sex clients. Ninety-one percent expressed a willingness to participate in the HIV vaccine trial. Sixty-one percent did not need permission from anyone for participating in a trial. Ninety-one percent expressed willingness to participate in the efficacy of HIV vaccine trial. In the logistic regression model, willingness was significantly associated with the need to ask permission for participation in HIV vaccine trial from sex agent. Conclusion Respondent-driven sampling provided a rapid means of reaching young female sex workers who reported high-risk behaviors. The majority expressed a high level of willingness to participate in the HIV vaccine trial which was marginally correlated to the need to seek consent for participation in the trial from the sex brokers. Future HIV vaccine trials involving this population should consider involving the brokers in the trials because they form an essential part of the community for the participants.

scholarly journals Post-HIV vaccine trials’ misperception and associated factors among participating communities in Dar es Salaam, Tanzania

2020 ◽  
Vol 21 (1) ◽  
pp. 1-10
Author(s):  
Edith Andrew Mroso Tarimo ◽  
Candida Moshiro ◽  
Joel Ambikile ◽  
Patricia Munseri ◽  
Muhammad Bakari ◽  
...  
Keyword(s):  
Phase I ◽  
Associated Factors ◽  
Vaccine Development ◽  
Vaccine Trial ◽  
Dar Es Salaam ◽  
Hiv Vaccine ◽  
Cross Sectional ◽  
Adjusted Risk ◽  
Hiv Vaccine Trials ◽  
Vaccine Trials

 Background: Despite the successful conduct of three Phase I/II HIV vaccine trials in Dar es Salaam, Tanzania, misperception around the trials has been reported. In this study, misperception means incorrect understanding that in Phase I/II HIV vaccine trial, the researchers infected the volunteers with HIV. We describe the magnitude of misperception around HIV vaccine trials and associated factors among participating communities in Dar es Salaam, Tanzania. Methods: We conducted a cross-sectional study that included 605 respondents aged ³18 years from the communities that participated in Phase I/II HIV vaccine trials. These communities comprised of youths, Police and Prison officers. Respondents were interviewed using a pre-tested questionnaire on socio-demographic characteristics, HIV knowledge, and responses to HIV vaccine trial related questions. Results: Of the 605 respondents, 156 (26%) had misperception that the researchers infected the volunteers with HIV during the trials, while 58% weren’t sure whether the researchers infected the volunteers with the HIV or not. Awareness about progress in HIV vaccine development (adjusted risk ratio (RR)=1.50; 95% CI=1.11 – 2.04), participation in an HIV vaccine sensitization meeting (adjusted RR=1.50; 95% CI=1.14-1.97) and advanced secondary education (adjusted RR=1.92; 95% CI=1.19 – 3.09) were associated with an increased likelihood of having the misperception that researchers infected the volunteers. Nevertheless, the majority (94.5%) of respondents showed a willingness to know more about ongoing HIV vaccine studies while about 44.3% had reservations of taking part in HIV vaccine trials due to fear of getting HIV from the vaccine. Conclusions: The misperception that researchers infected volunteers with HIV in Phase I/II trial is significant and was associated with respondents’ awareness about HIV vaccine development, participation in sensitization meetings and advanced education. Partial knowledge about HIV vaccine trials was of note. Future HIV vaccine trials should strive to address the knowledge gap.

Adolescent Participation in HIV Vaccine Trials: Cognitive Developmental Considerations

2007 ◽  
Vol 37 (3) ◽  
pp. 576-594 ◽  
Author(s):  
Zuhayr Kafaar ◽  
Leslie Swartz ◽  
Ashraf Kagee ◽  
Anthea Lesch ◽  
Heather Jaspan
Keyword(s):  
Decision Making ◽  
Sexual Debut ◽  
Vaccine Trial ◽  
Early Adolescents ◽  
Incidence Rates ◽  
Hiv Vaccine ◽  
Cognitive Changes ◽  
Multiple Sexual Partners ◽  
Hiv Vaccine Trials ◽  
Vaccine Trials

Adolescents form an important target group for HIV vaccine trials for a number of reasons. These include the high HIVprevalence and incidence rates amongst adolescents, early sexual debut, multiple sexual partners, and other high-risk sexual behaviours. It has therefore been argued that the focus of HIV vaccination attempts should be on early adolescents younger than 15 years of age. Indeed, vaccination of adolescents prior to their sexual debut has been argued to have the potential to be one of the most effective ways to curb the HIV pandemic. While the biological and epidemiological arguments for vaccination of adolescents have been elucidated, this article offers some insight into the cognitive aspects of decision making in adolescence that may inform strategies vaccine trial sites might employ when dealing with adolescent participants. After a brief overview of the educational, biological, and relationship changes that occur during adolescence, this article explores some of the more pertinent cognitive changes that occur during adolescence. More specifically, this article explores the cognitive changes during adolescence that affect decision making, such as differences between younger and older adolescents in (a) choice, (b) comprehension, (c) creativity, (d) compromise, (e) consequentiality, (f) correctness, (g) credibility, (h) consistency, and (i) commitment. Research findings relating to the above changes are discussed, creating an argument for the exclusion of early adolescents in vaccine trials and the concomitant active engagement with middle adolescents.

scholarly journals What motivates or demotivates intravenous drug users to participate in hypothetical HIV vaccine efficacy trial? A qualitative study from urban Tanzania

2020 ◽  
Vol 4 (2) ◽  
pp. 128-139
Author(s):  
Masunga K Iseselo ◽  
Edith AM Tarimo ◽  
Eric Sandstrom ◽  
Asli Kulane
Keyword(s):  
Low Income ◽  
Vaccine Efficacy ◽  
Drug Users ◽  
Vaccine Trial ◽  
Sampling Technique ◽  
Hiv Vaccine ◽  
Low Income Countries ◽  
Hiv Vaccine Trials ◽  
Efficacy Trials ◽  
Vaccine Trials

Background: HIV vaccine efficacy trials require the active participation of volunteers who are committed and adherent to the study protocol. However, information about the influence of Injecting Drug Users (IDUs) to participate in HIV vaccine efficacy trials in low-income countries is inadequate. The present study explored the factors that motivate or hinder IDUs from participating in HIV vaccine efficacy trials in Dar es Salaam, Tanzania. Methods: A qualitative descriptive study design was employed among IDUs at Muhimbili National Hospital (MNH). A purposeful sampling technique was used to recruit the participants. Three (3) focus group discussions (FGDs) and 10 In-Depth Interviews (IDIs) were used to collect the data. The data from participants were audio-recorded, transcribed, and analysed using the content analysis approach. Findings: The participants reported that altruism and the desire to reduce risks of HIV infection were the motivators to participate in hypothetical HIV vaccine trials. In addition, participants reported to consult close relatives towards motivation to participate in the vaccine trial. In contrast, the perceived fear of vaccine side effects, lack of information about HIV vaccine studies, and HIV-related stigma towards participants were described as barriers to participate in the HIV vaccine trials. Conclusion: Participation in a hypothetical HIV vaccine trial among IDUs is influenced by positive and negative factors. Actual recruitment plans could be made through a better explanation of HIV vaccine trials, the expected individual and collective benefits associated with the trials. Community involvement and sensitisation is likely to enhance participation in future HIV vaccine trials in Tanzania.

scholarly journals Human Immunodeficiency Virus (HIV) Vaccine Trials: a Novel Assay for Differential Diagnosis of HIV Infections in the Face of Vaccine-Generated Antibodies

2006 ◽  
Vol 80 (5) ◽  
pp. 2092-2099 ◽  
Author(s):  
Surender Khurana ◽  
James Needham ◽  
Bonnie Mathieson ◽  
Isaac R. Rodriguez-Chavez ◽  
Andrew T. Catanzaro ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Vaccine Trial ◽  
Hiv Infections ◽  
Hiv Vaccine ◽  
Health Concern ◽  
Hiv Vaccines ◽  
Hiv Vaccine Trials ◽  
Vaccine Trials ◽  
Immunodeficiency Virus ◽  
Trial Participants

ABSTRACT All current human immunodeficiency virus (HIV) vaccine candidates contain multiple viral components and elicit antibodies that react positively in licensed HIV diagnostic tests, which contain similar viral products. Thus, vaccine trial participants could be falsely diagnosed as infected with HIV. Additionally, uninfected, seropositive vaccinees may encounter long-term social and economic harms. Moreover, this also interferes with early detection of true HIV infections during preventive HIV vaccine trials. An HIV-seropositive test result among uninfected vaccine trial participants is a major public health concern for volunteers who want to participate in future HIV vaccine trials. Based on the increased number of HIV vaccines being tested globally, it is essential to differentiate vaccine- from virus-induced antibodies. Using a whole-HIV-genome phage display library, we identified conserved sequences in Env-gp41 and Gag-p6 which are recognized soon after infection, do not contain protective epitopes, and are not part of most current HIV vaccines. We established a new HIV serodetection assay based on these peptides. To date, this assay, termed HIV-SELECTEST, demonstrates >99% specificity and sensitivity. Importantly, in testing of plasma samples from multiple HIV vaccine trials, uninfected trial participants scored negative, while all intercurrent infections were detected within 1 to 3 months of HIV infection. The new HIV-SELECTEST is a simple but robust diagnostic tool for easy implementation in HIV vaccine trials and blood banks worldwide.

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