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

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.

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Factors that influence the willingness of young adults in Dar es Salaam, Tanzania, to participate in phase I/II HIV vaccine trials

Global Health Action ◽

10.3402/gha.v7.22853 ◽

2014 ◽

Vol 7 (1) ◽

pp. 22853 ◽

Cited By ~ 8

Author(s):

Theodora Mbunda ◽

Muhammad Bakari ◽

Edith A. M. Tarimo ◽

Eric Sandstrom ◽

Asli Kulane

Keyword(s):

Young Adults ◽

Phase I ◽

Dar Es Salaam ◽

Hiv Vaccine ◽

Hiv Vaccine Trials ◽

Vaccine Trials

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Willingness to Participate in Hypothetical HIV Vaccine Trial and Associated Factors among People Who Inject Drugs in Dar es Salaam, Tanzania

BioMed Research International ◽

10.1155/2020/8507981 ◽

2020 ◽

Vol 2020 ◽

pp. 1-9

Author(s):

Masunga K. Iseselo ◽

Edith A. M. Tarimo ◽

Eric Sandstrom ◽

Asli Kulane

Keyword(s):

Associated Factors ◽

People Who Inject Drugs ◽

Hiv Transmission ◽

Dar Es Salaam ◽

Education Level ◽

Sexual Partners ◽

Hiv Vaccine ◽

Willingness To Participate ◽

Hiv Vaccine Trials ◽

Vaccine Trials

This study is aimed at assessing the willingness to participate in the HIV vaccine trials and the associated factors among people who inject drugs (PWIDs) in Tanzania. Information about the willingness to participate and the associated factors was collected using interviewer-administered questionnaires at the medication treatment for opioid use disorder (MOUD) clinic in Dar es Salaam. Data analysis was performed using the IBM SPSS Statistic 20. The mean age of respondents was 36.7, and the standard deviation (SD) was ±7.2. The majority of respondents (68%) had primary education, and a high proportion of them were single (61.5%). More than one-third (37.9%) shared needles and syringes. Most (87.3%) had more than three sexual partners, and almost half (51.4%) did not use condoms during sexual intercourse with nonregular partners. About 63% had knowledge of HIV transmission while 27% had heard about HIV vaccine trials. Generally, 76% of the respondents expressed willingness to participate in future HIV vaccine trials regardless of prior knowledge of HIV vaccine trials. Willingness to participate in HIV vaccine trials was not associated with education level, people living with, knowledge about HIV transmission, awareness of HIV vaccine trials, sharing of syringe/needles, and number of sexual partners. Only older age (OR=1.6, 95%CI=1.01, 2.6) and condom use (OR=0.49, 95%CI=0.26, 0.97) showed an association with willingness. However, after performing logistic regression with factors at p value ≤ 0.2 to ascertain the other factors on the effects of age, condom use, education level, and sharing of needles/syringes, the results were not statistically significant. Although participants reported a high willingness to participate in hypothetical HIV vaccine trials, no definitive conclusion can be drawn about the associated factors. Further studies with intensive educational programs are needed to investigate the factors on willingness to participate in actual HIV vaccine trials among PWIDs.

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Contraceptive Use in Women Enrolled into Preventive HIV Vaccine Trials: Experience from a Phase I/II Trial in East Africa

PLoS ONE ◽

10.1371/journal.pone.0005164 ◽

2009 ◽

Vol 4 (4) ◽

pp. e5164 ◽

Cited By ~ 15

Author(s):

Hannah Kibuuka ◽

David Guwatudde ◽

Robert Kimutai ◽

Lucas Maganga ◽

Leonard Maboko ◽

...

Keyword(s):

Phase I ◽

East Africa ◽

Contraceptive Use ◽

Hiv Vaccine ◽

Hiv Vaccine Trials ◽

Vaccine Trials

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

Journal of Empirical Research on Human Research Ethics ◽

10.1177/1556264618804740 ◽

2018 ◽

Vol 13 (5) ◽

pp. 525-536 ◽

Cited By ~ 4

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.

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

Biostatistics ◽

10.1093/biostatistics/kxz039 ◽

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).

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Motivations to participate in a Phase I/II HIV vaccine trial: A descriptive study from Dar es Salaam, Tanzania

BMC Public Health ◽

10.1186/s12889-016-2875-6 ◽

2016 ◽

Vol 16 (1) ◽

Cited By ~ 2

Author(s):

E. A. M. Tarimo ◽

M. Bakari ◽

D. C. V. Kakoko ◽

T. W. Kohi ◽

F. Mhalu ◽

...

Keyword(s):

Phase I ◽

Vaccine Trial ◽

Descriptive Study ◽

Dar Es Salaam ◽

Hiv Vaccine

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BioBoard

Asia-Pacific Biotech News ◽

10.1142/s0219030306001534 ◽

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.

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