Exploring a community's understanding of HIV vaccine-induced seropositivity in a South African research setting

Background. The high HIV prevalence and incidence in South Africa makes it suitable for recruitment of participants for large-scale HIV preventive vaccine trials. However, fear of vaccine-induced seropositivity (VISP) may be a barrier for community acceptability of the trial, for volunteers to participate in HIV preventive vaccine trials and for uptake of an efficacious vaccine. Prior to 2015, when the first phase 1 safety HIV vaccine trial was undertaken at Setshaba Research Centre, Soshanguve, the local community stakeholders and healthcare workers were naive about HIV vaccine research and HIV preventive vaccines. Objective. To explore knowledge and perceptions regarding VISP among community stakeholders and healthcare workers in peri-urban Soshanguve, Tshwane.Methods. Using a quantitative-qualitative mixed-methods study design, surveys (n=50) and in-depth interviews (n=18) were conducted during July - August 2015. Participants included community stakeholders, community advisory board members and healthcare workers, who were >18 years old and had attended community educational workshops during September 2014 - May 2015. Audio recordings of interviews were transcribed verbatim and coded using content thematic analysis. Data were further analysed by sex, age and educational level.Results. Of a maximum score of 2 on knowledge on VISP, the 50 survey participants (mean age 33.78 years; 45 females) obtained an average of 0.88 (44%). Of 17 in-depth interviewees (one interview could not be transcribed; mean age 30.9 years; 12 females), 8 (47%) displayed some knowledge about VISP, of whom only 5 defined VISP correctly. Women were more knowledgeable about VISP than men; 5 of 12 women (42%) came close to defining VISP correctly, while none of the 5 men did so. The main fear of trial participation expressed by most participants (n=6) was testing HIV-positive as a result of the vaccine. While some participants believed that the community's perceptions of VISP would negatively affect HIV vaccine trial support and recruitment efforts, others noted that if trial participants understand the concept of VISP and are part of support groups, then they would have the information to combat negative attitudes within their community. Conclusion. Most participants had an inaccurate and incomplete understanding of VISP. Many feared testing HIV-positive at clinics; therefore, education on improving a basic understanding of how vaccines work and why VISP occurs is essential. In addition, assessing participant understanding of HIV testing, transmission and VISP is critical for recruitment of participants into HIV vaccine trials and may improve acceptability of an HIV preventive vaccine

Developing capacity for implementation and evaluation of vaccine trials in Uganda: Perspective of the Makerere University Walter Reed Project

Introduction: Infectious diseases and neglected tropical diseases continue to be a major challenge in resource limited settings, causing significant morbidity and mortality. Although vaccines are a key biomedical prevention tool, resource limited settings often lack the infrastructure, regulatory frameworks, and skilled human resource to conduct vaccine clinical trials. To address this gap, the Makerere University Walter Reed Project (MUWRP) was established and has contributed to vaccine research in Uganda and globally. Methods: This was achieved through training a strong vaccine clinical trial workforce; development of requisite clinical trial infrastructure for research activities and management of investigational products; conducting phase I-III vaccine trials and contribution to national ethical and regulatory frameworks that protect participants. Results: As of 2022, MUWRP had successfully conducted and completed five phase I/II HIV vaccine clinical trials, five for Ebola and Marburg, while one phase I/II Schistosomiasis and one phase III COVID-19 vaccine clinical trial are ongoing. Discussion: The completed vaccine trials provided critical scientific knowledge on the safety and immunogenicity of investigational products which informed the design of better vaccines for diseases of global health importance. Conclusion: Academia, through establishment of appropriate partnerships can contribute to the identification of solutions to complex public health challenges

Attracting; Equipping and Retaining Young Medical Doctors in HIV Vaccine Science in South Africa

Background: HIV remains a significant health problem in South Africa (SA). The development of a preventive vaccine offers promise as a means of addressing the epidemic; yet development of the human resource capacity to facilitate such research in SA is not being sustained. The HIV Vaccine Trials Network (HVTN) has responded by establishing South African/HVTN AIDS Early Stage Investigator Programme (SHAPe); a programme to identify; train and retain clinician scientists in HIV vaccine research in SA.Objectives: The present study sought to identify factors influencing the attraction and retention of South African medical doctors in HIV vaccine research; to understand the support needed to ensure their success; and to inform further development of clinician research programmes; including SHAPe.Methods: Individual interviews and focus groups were held and audio-recorded with 18 senior and junior research investigators; and medical doctors not involved in research. Recordings were transcribed; and data were coded and analysed.Results: Findings highlighted the need for: (1) medical training programmes to include a greater focus on fostering interest and developing research skills; (2) a more clearly defined career pathway for individuals interested in clinical research; (3) an increase in programmes that coordinate and fund research; training and mentorship opportunities and (4) access to academic resources such as courses and libraries. Unstable funding sources and inadequate local funding support were identified as barriers to promoting HIV research careers.Conclusion: Expanding programmes that provide young investigators with funded research opportunities; mentoring; targeted training and professional development may help to build and sustain SA's next generation of HIV vaccine and prevention scientists

Willingness to participate in future HIV prevention trials in Beira, Mozambique

In preparation for trials of new HIV prevention methods; willingness to participate (WTP) was assessed in Beira; Mozambique. A totla of 1 019 women participating in an HIV incidence study; and 97 men participating in a separate WTP survey; were interviewed. When comparing the answers to questions that were identical in the two studies; WTP was higher among women than men for all prevention methods. Among women; WTP was highest for trials evaluating daily oral pre-exposure prophylaxis (PrEP; 84.4 reporting very likely to participate); followed by vaccination (77.8); daily vaginal gel use (67.7); coital vaginal gel use (67.1) and monthly vaginal ring use (47.7). Among men; WTP was highest for trials evaluating vaccination (57.6); followed by daily vaginal gel use for female sexual partners (52.5); daily oral PrEP (49.5); coital vaginal gel use for female sexual partners (46.4) and monthly vaginal ring use for female sexual partners (39.4). Among men; the most important motivators for trial participation were social benefits; whereas personal risks (most notably receiving injections and/or blood draws) were deterrents; this was not assessed in women. Other important lessons learnt are that male circumcision and antiretroviral drugs were not generally recognised as ways to prevent HIV; that having to use hormonal contraception during trial participation will likely reduce WTP; and that evening clinics are not likely to be popular. The barriers reported in this and other studies may be challenging but are not impossible to overcome

The Role of Community Advisory Boards in Health Research: Divergent Views in the South African Experience

In the light of the growing involvement of community advisory boards (CABs) in health research; this study presents empirical findings of the functions and operations of CABs in HIV/AIDS vaccine trials in South Africa. The individual and focus group interviews with CAB members; principal investigators; research staff; community educators; recruiters; ethics committee members; trial participants and South African AIDS Vaccine Initiative (SAAVI) staff members demonstrated differences in the respondents' perceptions of the roles and responsibilities of CABs. These findings question the roles of the CABs. Are they primarily there to serve and be accountable to the community; or to serve the accomplishment of the research objectives? Four emergent themes are discussed here: purpose; membership and representation; power and authority; sources of support and independence. The CABs' primary purpose carries significant implications for a wide range of issues regarding their functioning. The dual functions of advancing the research and protecting the community appear to be fraught with tension; and require careful reconsideration

HIV vaccine research - South Africa's ethical-legal framework and its ability to promote the welfare of trial participants

An effective ethical-legal framework for the conduct of research is critical. We describe five essential components of such a system; review the extent to which these components have been realised in South Africa; present brief implications for the ethical conduct of clinical trials of HIV vaccines in South Africa and make recommendations. The components of an effective ethical-legal system that we propose are the existence of scientific ethical and policy-making structures that regulate research; research ethics committees (RECs) that ethically review research; national ethical guidelines and standards; laws protecting research participants; and mechanisms to enforce and monitor legal rights and ethical standards. We conclude that the ethical-legal framework has; for the most part; the necessary institutions; and certain necessary guidelines but does not have many of the laws needed to protect and promote the rights of persons participating in research; including HIV vaccine trials. Recommendations made include advocacy measures to finalise and implement legislation; development of regulations; analysis and comparison of ethical guidelines; and the development of measures to monitor ethical-legal rights at trial sites

Chemotherapy of AIDS

The epidemic of AIDS took the world unawares. However; scientists and drug manufacturers have responded promptly to this dreadful challenge. It has now become possible to consider vaccine against AIDS by 2000 ADS