Who to engage in HIV vaccine trial benefit-sharing negotiations? An empirical proposition of a framework.

BACKGROUND: A morally sound framework for benefit-sharing is crucial to minimize research exploitation for research conducted in developing countries. However, in practice, it remains uncertain which stakeholders should be involved in the decision-making process regarding benefit-sharing and what the implications might be. Therefore the study aimed to empirically propose a framework for benefit-sharing negotiations in research by taking HIV vaccine trials as a case. METHODS: The study was conducted in Tanzania using a case study design and qualitative approaches. Data were collected using in-depth interviews (IDI) and focus group discussions (FGD). A total of 37 study participants were selected purposively comprising institutional review board (IRB) members, researchers, community advisory board (CAB) members, a policymaker, and HIV/AIDS advocates. Deductive and inductive thematic analysis approaches were deployed to analyze collected data with the aid of MAXQDA version 20.4.0 software. RESULTS: The findings indicate a triangular relationship between the research community, researched community and intermediaries. However, the relationship ought to take into consideration the timing of negotiations, the level of understanding between parties and the phase of the clinical trial. The proposed framework operationalize partnership interactions in community-based participatory research. CONCLUSION: In the context of this study, the suggested framework incorporates the research community, the community being researched, and intermediary parties. The framework would guarantee well-informed and inclusive decision-making regarding benefit-sharing in HIV vaccine trials and other health-related research conducted in resource-limited settings.

Efficacy of mobile phone intervention to increase male partner antenatal care attendance for HIV testing in Moshi municipal, Tanzania: a randomized controlled trial.

BACKGROUND: HIV partner counselling and testing in antenatal care (ANC) is a crucial strategy to raise the number of males who know their HIV status. However, in many settings like Tanzania, male involvement in antenatal care remains low, and there is a definite need for innovative strategies to increase male partner involvement. This study was designed to evaluate the efficacy of mobile phone intervention increase male partner ANC attendance for HIV testing in Moshi municipal, Tanzania. METHODS: Between April and July 2022, we enrolled pregnant women presenting to a first ANC visit at Majengo and St. Joseph reproductive health facilities without their male partners. Eligible pregnant women were randomly assigned to invitation of their male partners either via phone calls, text messages from clinic staff and verbal invites from pregnant partners (intervention arm) or verbal invites only from the pregnant partners (control arm). Neither healthcare provider nor participant were blinded. The primary outcome was the proportion of male partners who attended ANC with their pregnant partners during a follow-up period of two consecutive visits. The secondary outcome measure was HIV testing among male partners following the invitation. Participants were analyzed as originally assigned (intention to treat). RESULTS: A total of 350 pregnant women presenting to ANC for the first time were enrolled, with 175 women enrolled in each arm. The efficacy of male attendance with their pregnant women following the invitations was 83.4% (147/175) in the intervention arm and 46.3% (81/175) in the control arm. Overall, the results suggest a positive and statistically significant average treatment effect among men who received mobile phone intervention on ANC attendance. For the secondary outcome, the percent of male partners who accepted HIV counselling and testing was 99.3% (146/147) in the intervention arm and 93.8% (76/81) in the control arm. Married men were having higher odds of ANC attendance compared with single men (aOR:6.40(3.26-12.56), Males with multigravida women were having lower odds of ANC attendance compared with primigravida women (aOR:0.17(0.09-0.33). CONCLUSION: The study demonstrates that supplementing verbal invitations with mobile phone calls and text messages from clinic staff can significantly increase male partner ANC attendance and HIV testing. This combined approach is recommended in improving ANC attendance and HIV testing of male partners who do not accompany their pregnant partners to antenatal clinics in the first visits. TRIAL REGISTRATION: PACTR202209769991162.

Should HIV Vaccines Be Made Available at No or Subsidized Cost? A Qualitative Inquiry of HIV Vaccine Trial Stakeholders in Tanzania.

BACKGROUND: The world has come closer than ever to discovering a viable HIV vaccine. However, it remains less certain whether HIV vaccines should be made available to participants and communities in which trials are run no or subsidized cost. Hence the essence of this inquiry. METHODOLOGY: This is a case study design using in-depth interviews (IDI) and focus group discussions (FGD) with researchers of HIV vaccine trials, institutional review board (IRB) members, HIV advocates, a policy maker, and members of community advisory board (CAB) in Tanzania. Participants were purposively selected and data thematically analyzed using MAXQDA software. RESULTS: Hosting a vaccine trial and the financial incapacity of individuals at increased risk of HIV were among the reasons in favor of free access to HIV vaccines. In contrast, the view that vaccines should be provided at a subsidized cost was related to high costs of vaccine development, financial return expectations by investors, and the fear of labeling the free vaccine as less important. Moreover, apart from governments and international organizations, well-off individuals could share the cost burden. CONCLUSION: Stakeholders engaging in active discussion about sharing the viable vaccine ought to take the aforementioned concerns into account and ensure unhindered access to individuals and host communities in Tanzania and beyond.

Mentorship of young researchers in resource-limited settings: experiences of the mentees from selected health sciences Universities in Tanzania.

INTRODUCTION: Mentorship is an essential component of research capacity building for young researchers in the health sciences. The mentorship environment in resource-limited settings is gradually improving. This article describes mentees' experiences in a mentorship program for junior academicians amid the COVID-19 pandemic in Tanzania. METHODS: This is a survey study that examined the experiences of mentees who participated in a mentorship program developed as part of the Transforming Health Education in Tanzania (THET) project. The THET project was funded by the US National Institutes of Health (NIH) under a consortium of three partnering academic institutions in Tanzania and two collaborating US-based institutions. Senior faculty members of respective academic institutions were designated as mentors of junior faculty. Quarterly reports submitted by mentees for the first four years of the mentorship program from 2018 to 2022 were used as data sources. RESULTS: The mentorship program included a total of 12 mentees equally selected from each of the three health training institutions in Tanzania. The majority (7/12) of the mentees in the program were males. All mentees had a master's degree, and the majorities (8/12) were members of Schools/Faculties of Medicine. Most mentors (9/10) were from Tanzania's three partnering health training institutions. All mentors had an academic rank of senior lecturer or professor. Despite the onset of the COVID-19 pandemic, the regular weekly meetings between mentors and mentees were not affected. By the fourth year of the mentorship program, more than three-quarters of mentees had published research related to the mentorship program in a peer-reviewed journal, over half had enrolled in Ph.D. studies, and half had applied for and won competitive grant awards. Almost all mentees reported being satisfied with the mentorship program and their achievements. CONCLUSION: The mentorship program enhanced the skills and experiences of the mentees as evidenced by the quality of their research outputs and their dissemination of research findings. The mentorship program encouraged mentees to further their education and enhanced other skills such as grant writing. These results support the initiation of similar mentorship programs in other institutions to expand their capacity in biomedical, social, and clinical research, especially in resource-limited settings, such as Sub-Saharan Africa.

"By only considering the end product it means that our participation has always been in vain": Defining benefits in HIV vaccine trials in Tanzania.

Debates about what constitutes benefits in human research continue to be less informed due to a lack of empirical evidence from the developing world. This study aimed to explore what constitutes benefits in HIV vaccine trials in Tanzania and examine inherent ethical implications. A qualitative case study design was deployed and a total of 29 purposively selected study participants comprising of experienced researchers, institutional review board members and community advisory board members were included. Collected data were analyzed by thematic analysis aided by computer software: MAXQDA version 20.4.0. The study findings indicate that there is a growing appreciation of benefits beyond actual vaccines to include 1) capacity building at individual, community, institutional and regulatory levels; and 2) non-capacity building related benefits such as strengthened collaborations, ancillary care and employment opportunities. So, as the struggle for viable HIV vaccines continues, other benefits that have accrued from such trials are not to be blindsided especially for developing countries like Tanzania.

Can HIV vaccines be shared fairly? Perspectives from Tanzania.

BACKGROUND: For over 35 years, Africa has continued to host HIV vaccine trials geared towards overturning the HIV/AIDs pandemic in the continent. However, the methods of sharing the vaccines, when available remain less certain. Therefore, the study aims to explore stakeholders' perspectives in the global South, in this case, Tanzania, on how HIV vaccines ought to be fairly shared. METHODS: The study deployed a qualitative case study design. Data were collected through in-depth interviews and focus group discussions with a total of 37 purposively selected participants. This included researchers, institutional review board members, a policymaker, HIV/AIDS advocates, and community advisory board members. The data obtained were inductively and deductively analyzed. RESULTS: Findings indicate that HIV vaccines can be shared fairly under the principles of distributive justice (contribution, need and equality). Thus, contribution-based sharing ought to be utilized upon the necessity to prioritize vaccine access or subsidized trial benefits to host communities. Need-based sharing ought to be considered for non-host communities that are at an increased risk of HIV infection. Lastly, equal-based sharing would be useful at later stages of vaccine distribution or when the aforementioned principles are deemed morally inappropriate. However, none of the benefit-sharing approaches is free of limitations and a counterbalancing sense of unfairness. CONCLUSION: Fair sharing of HIV vaccines, when available, ought to be informed by the contribution, need and equality principles of distributive justice. Countries in the global south including Tanzania are likely to be prioritized during the distribution of the HIV vaccines due to their participation in HIV vaccine trials and due to the disproportionate HIV burden evident in the region.

The role of community advisory boards in community-based HIV clinical trials: a qualitative study from Tanzania.

BACKGROUND: Community Advisory Boards (CAB) have become essential organs of involving communities in HIV clinical trials especially in developing countries. However, limited empirical evidence exists on the role of CABs in low and middle-income countries including Tanzania. This study aims at exploring the role of CABs in community-based HIV clinical trials conducted in Tanzania. METHODOLOGY: We adopted a phenomenological approach to purposefully select HIV clinical trial stakeholders. These included CAB members, researchers and Institutional Review Board (IRB) members in Tanzania. We conducted In-depth Interviews (IDIs) with ten participants and three Focus Group Discussions (FGDs) with eighteen participants. The data were thematically analyzed with the aid of MAXQDA software version 20.2.1. RESULTS: The findings indicate that at every stage of implementation of a community-based HIV clinical trial, a functioning CAB is important for its success. This importance is based on contextualization of the informed consent process and protocol, managing rumours in the community, weighing trial risks and benefits, sensitizing the community, assisting participant recruitment, tracing and retention. However, being perceived as financial beneficiaries than community representatives emerged as a challenge to CAB members. CONCLUSION: The study empirically indicates the need for functioning CABs in every stage of implementation of community-based HIV clinical trials. The roles of which are interwoven in serving research goals and protecting the interests of the community and that of trial participants.

How do community advisory boards fulfil their ethical role in HIV clinical trials? A protocol for a systematic review of qualitative evidence.

INTRODUCTION: Community advisory boards (CABs) continue to gain wide use and acceptance in global health research including in HIV clinical trials. They provide means through which community concerns regarding the trial can be considered by the research team, and provide an important platform of communication between the researchers and the community about study goals. Therefore, this systematic review protocol will guide the review of qualitative evidence on the ethical roles of CABs in HIV clinical trials based on the three fundamental ethical principles: respect for the person, beneficence and justice. METHODS AND ANALYSIS: This systematic review of qualitative evidence will involve searching four medical databases: PubMed, ScienceDirect, CINAHL and Cochrane Library. Additionally, other relevant evidence will be obtained through hand searching and grey literature. Searches will be limited to studies published in the English language from 1989 (the year that CABs were first established in HIV clinical trials) to 2019. Articles searched will be screened by two independent authors based on inclusion and exclusion criteria. Included articles will be appraised for quality using the Critical Appraisal Skills Programme checklist and followed by qualitative data extraction. Findings will be analysed based on the meta-aggregative approach with the aid of EPPI-Reviewer 4 web-based software. ETHICS AND DISSEMINATION: Ethical approval does not apply to this review. Data will be disseminated through scientific conferences and peer-reviewed journals to inform policies and stake-holders about the ethical role of CABs. PROSPERO REGISTRATION NUMBER: CRD42019133787.

Non-medical facilitators and barriers towards accessing haemodialysis services: an exploration of ethical challenges.

BACKGROUND: Like most of the sub-Saharan countries, Tanzania faces significant increase in the number of patients diagnosed with an end-stage renal disease (ESRD) among which only a few manage to receive chronic haemodialysis services (CHD). Yet little is known about the non-medical facilitators and barriers towards accessing these services and the associated ethical challenges. METHODS: A phenomenological study design which employed a qualitative approach was used. The study was conducted at the dialysis unit harboured within Muhimbili National Hospital. Data were collected from purposively sampled health care providers and ESRD patients by using in-depth interviews. Text data obtained were analysed based on inductive and deductive content analysis methods to formulate major themes. RESULTS: Fourteen key informants were interviewed including nephrologists, renal nurses, social workers, nutritionists and ESRD patients. Three major themes were formulated: a) non-medical facilitators towards accessing CHD services which enshrines two sub-themes (membership to health insurance scheme and family support), (b) non-medical barriers towards accessing CHD services which enshrines four sub-themes (affordability of treatment costs, geographical accessibility, availability of CHD resources and acceptability of treatment procedures) and lastly (c) ethical challenges associated with accessing CHD services which also enshrines three sub-themes (dual role of health care providers, patients autonomy in decision making, and treatment disparity). CONCLUSION: Non-medical facilitators to access CHD benefits few patients whereas non-medical barriers leave many ESRD patients untreated or partially treated. On the other hand, ethical challenges like treatment inequality are quickly gaining momentum. There is a need for guideline highlighting importance, position, and limitation of non-medical factors in the delivery of CHD services in Tanzania and other developing countries.