HIV prevention research and COVID-19: putting ethics guidance to the test.

BACKGROUND: Critical public health measures implemented to mitigate the spread of the novel coronavirus disease (COVID-19) pandemic have disrupted health research worldwide, including HIV prevention research. While general guidance has been issued for the responsible conduct of research in these challenging circumstances, the contours of the dueling COVID-19 and HIV/AIDS pandemics raise some critical ethical issues for HIV prevention research. In this paper, we use the recently updated HIV Prevention Trials Network (HPTN) Ethics Guidance Document (EGD) to situate and analyze key ethical challenges related to the conduct of HIV prevention research during the COVID-19 pandemic as well as identify potential areas for refinement of the guidance document based on this unprecedented state of affairs. MAIN BODY: Necessary actions taken for HIV prevention research studies due to the COVID-19 pandemic involve an array of ethical issues including those related to: (1) risk mitigation; (2) behavior change; (3) compounding vulnerability; (4) community engagement; (5) trial reopening; and 6) shifting research priorities. CONCLUSIONS: In the context of the dueling HIV and COVID-19 global pandemics, research teams and sponsors must be nimble in responding to the rapidly changing environment by being sensitive to the associated ethical issues. The HTPN EGD provides a rich set of tools to help identify, analyze and address many of these issues. At the same time, future refinements of the HPTN EGD and other research ethics guidance could be strengthened by providing explicit advice regarding the ethical issues associated with disrupted research and the reopening of studies. In addition, additional consideration should be given to appropriately balancing domains of risk (e.g., physical versus social), addressing the vulnerability of research staff and community partners, and responding to un-anticipatable ancillary care needs of participants and communities. Appropriately addressing these issues will necessitate conceptual work, which would benefit from the careful documentation of the actual ethical issues encountered in research, the strategies implemented to overcome them, and their success in doing so. Throughout all of these efforts, it is critical to remember that the HIV pandemic not be forgotten in the rush to deal with the COVID-19 pandemic.

'I have a lot of faith in her': Value of community health workers in addressing family planning in rural Ghana.

In rural settings with shortages in trained health care workers, community health workers (CHWs) play an important role in the delivery of health care services. The Ghana Health Service initiated a national CHW programme in 2016 to expand health services to rural populations. This study explored the perceived role and value of CHWs in addressing family planning issues in the Amansie West district of Ghana. The study included in-depth interviews (IDIs) with 28 women in the community, ages 18-49, and 30 CHWs. Using inductive thematic analysis, IDIs were coded to explore opinions on the CHWs' role and perceived value in the delivery of family planning. Participants explained that CHWs provided family planning as part of a healthcare package through household visits and referrals to government services. The value of CHWs in delivering family planning was seen in confidentiality, accessibility, and comfort. Participants recommended an enlarged CHW workforce with a range of commodities and programmatic support. The findings suggest CHWs play an important role in promoting family planning, by serving as a bridge between the community and clinics. In rural communities where resources are scarce, CHWs are an invaluable part of the broader healthcare system.

Side effect concerns and their impact on women's uptake of modern family planning methods in rural Ghana: a mixed methods study.

BACKGROUND: Despite availability of modern contraceptive methods and documented unmet need for family planning in Ghana, many women still report forgoing modern contraceptive use due to anticipated side effects. The goal of this study was to examine the use of modern family planning, in particular hormonal methods, in one district in rural Ghana, and to understand the role that side effects play in women's decisions to start or continue use. METHODS: This exploratory mixed-methods study included 281 surveys and 33 in-depth interviews of women 18-49 years old in the Amansie West District of Ghana between May and July 2018. The survey assessed contraceptive use and potential predictors of use. In-depth interviews examined the context around uptake and continuation of contraceptive use, with a particular focus on the role of perceived and experienced side effects. RESULTS: The prevalence of unmet need for modern family planning among sexually active women who wanted to avoid pregnancy (n = 135) was 68.9%. No factors were found to be significantly different in comparing those with a met need and unmet for modern family planning. Qualitative interviews revealed significant concerns about side effects stemming from previous method experiences and/or rumors regarding short-term impacts and perceived long-term consequences of family planning use. Side effects mentioned include menstrual changes (heavier bleeding, amenorrhea or oligomenorrhea), infertility and childbirth complications. CONCLUSION: As programs have improved women's ability to access modern family planning, it is paramount to address patient-level barriers to uptake, in particular information about side effects and misconceptions about long-term use. Unintended pregnancies can be reduced through comprehensive counseling about contraceptive options including accurate information about side effects, and the development of new contraceptive technologies that meet women's needs in low-income countries.

Effect of 3,4-diaminopyridine at the murine neuromuscular junction.

INTRODUCTION: We investigated the effects of 3,4-diaminopyridine (3,4-DAP) and its acetylated metabolite, N-(4-amino-pyridin-3-yl) acetamide (3-Ac), at the mammalian neuromuscular junction. METHODS: Quantal release of acetylcholine was studied in diaphragm muscles of mice, using in vitro intracellular microelectrode recordings. RESULTS: Under conditions of low probability of release, 3,4-DAP produced a 1,000% increase in quantal release, but 3-Ac had no effect. Under conditions of normal probability of release, the effect of 3,4-DAP was modest and limited by concurrent depletion of synaptic vesicles, especially with high concentrations of 3,4-DAP and high frequencies of nerve stimulation. CONCLUSIONS: These findings predict 3,4-DAP is most effective in conditions with low probability of quantal release, such as Lambert-Eaton myasthenic syndrome. A beneficial effect is also expected in disorders of neuromuscular transmission in which the effect of 3,4-DAP on quantal release is not limited by depletion of synaptic vesicles, such as postsynaptic congenital myasthenic syndromes. Muscle Nerve, 2016 Muscle Nerve 55: 223-231, 2017.