Community perspectives on tuberculosis care in rural South Africa

Patient nonadherence to tuberculosis (TB) treatment is an ongoing challenge, particularly since the advent of drug‐resistant TB and complications posed by HIV/AIDS. Some solutions may lie in understanding patient and community perspectives about barriers to TB care and treatment adherence. Using a qualitative framework, we explored community perceptions and beliefs about TB and perceived facilitators and barriers to care in a rural South African community affected by TB. We were particularly interested in capturing cross‐cutting themes and the “merged voices” of participants. Interviews were conducted in 2013 and 2014 with 43 participants, including home‐based care workers, clinic staff, patients living with TB and community members in and around a primary healthcare clinic. The data were analysed using principles of thematic analysis. The study reveals the complex interplay between contextual factors and community understandings of the disease. Cultural beliefs about causality and treatment‐seeking paths were often mentioned in conjunction with biomedical views. There was a strong interface between TB and HIV in this community, and knowledge of TB was often confused with HIV. HIV‐related stigma has been extended to those living with TB. The impact of poverty on treatment adherence was a particularly important theme. Other themes related to the role of the clinic in the community. Our study highlights the socioeconomic vulnerability of this community and the fragility of existing care systems. The findings reinforce the need for a community‐centred approach to TB care that takes cognisance of lifeworld issues. We discuss some implications of this study for practice and policy.     

The ethical involvement of women in HIV vaccine trials in Africa: discussion paper developed for the African AIDS Vaccine Programme

HIV disproportionately affects women in developing countries, especially in Southern Africa. Women thus stand to benefit most from a successful HIV vaccine and must participate in trials to test appropriate, gender-specific products. Several HIV vaccine efforts are currently underway in Africa. Participation in HIV vaccine trials requires that participants not only understand the complex nature of trial procedures, but that they also have autonomous decisional capacity to enroll. Given that the risk factors inherent in women's greater vulnerability constitute an intricate mix of biological, economic and social variables, will women's very vulnerability to HIV be an obstacle to ethical participation in vaccine development? This paper addresses some of the challenges underlying the successful recruitment of women into vaccine research and makes research and policy recommendations for the ethical inclusion of women in HIV vaccine trials in Africa.     

Community preparedness for HIV vaccine trials in the Democratic Republic of Congo

This paper reports on an assessment of community preparedness for HIV vaccine trials in the Democratic Republic of Congo. Formative research was conducted in the capital city of Kinshasa during the period October 2003 to March 2004 to answer questions pertinent to planning trials of a preventive HIV vaccine and to identify related issues. Twenty-seven in-depth interviews and two focus groups were held with potential trial participants and community leaders. Data was collected on the subjects of vaccines, HIV/AIDS and sexual behaviour, and an HIV vaccine. The study also sought to identify factors that motivate a person to volunteer for a vaccine trial or which are disincentives to participation, along with preparedness of the larger community for trials. Personal concerns for health and for the impact of the epidemic on families and country were common motivations for participation. The danger of an experimental vaccine and the stigma of a positive HIV antibody test as the result of vaccination are major concerns and disincentives. The health, educational, and local non-governmental sectors are identified as having important roles to play in assuring preparedness for trials, although significant challenges exist to achieving community preparedness.     

Community preparedness for HIV vaccine trials in the Democratic Republic of Congo

This paper reports on an assessment of community preparedness for HIV vaccine trials in the Democratic Republic of Congo. Formative research was conducted in the capital city of Kinshasa during the period October 2003 to March 2004 to answer questions pertinent to planning trials of a preventive HIV vaccine and to identify related issues. Twenty‐seven in‐depth interviews and two focus groups were held with potential trial participants and community leaders. Data was collected on the subjects of vaccines, HIV/AIDS and sexual behaviour, and an HIV vaccine. The study also sought to identify factors that motivate a person to volunteer for a vaccine trial or which are disincentives to participation, along with preparedness of the larger community for trials. Personal concerns for health and for the impact of the epidemic on families and country were common motivations for participation. The danger of an experimental vaccine and the stigma of a positive HIV antibody test as the result of vaccination are major concerns and disincentives. The health, educational, and local non‐governmental sectors are identified as having important roles to play in assuring preparedness for trials, although significant challenges exist to achieving community preparedness.

Résumé

Cet article est le compte‐rendu d'une évaluation de la disposition communautaire vis‐à‐vis des essais de vaccin anti‐HIV en République Démocratique du Congo. Un programme de recherche et de formation fut entrepris dans la ville de Kinshasa, la capitale, d'octobre 2003 à mars 2004 afin de répondre aux questions concernant un projet d'essais d'un vaccin préventif anti‐HIV et d'identifier d'éventuels problèmes annexes. Vingt‐sept entretiens approfondis et deux groupes de discussion furent mis en place réunissant des participants potentiels à ces essais et des dirigeants communautaires. Des données furent recueillies à propos des vaccins, du HIV/sida et le comportement sexuel, et d'un vaccin anti‐HIV. L'investigation cherchait également à identifier les facteurs qui incitent quelqu'un à se porter volontaire pour un essai de vaccin ou qui ont un effet dissuasif à cet égard, ainsi qu'à préciser la disposition de la communauté au sens large à accueillir de tels essais. Les motifs les plus courants en faveur d'une participation sont le souci de l'individu pour sa propre santé et pour l'impact de l'épidémie sur la vie familiale et le pays. Les inquiétudes avec effet dissuasif portent sur le risque éventuel qu'implique un vaccin encore au stade expérimental et sur la honte engendrée par un résultat séropositif en raison des anticorps suite à la vaccination. L'étude fait ressortir le fait que les services de santé et d'éducation ainsi que les organismes locaux non gouvernementaux ont un rôle majeur à jouer pour promouvoir la disposition à participer dans de tels essais, bien que cet effort rencontre des résistances non négligeables au sein de la communauté.

Resumen

En este ensayo analizamos en qué medida está dispuesta la comunidad de la República Democrática del Congo a participar en ensayos para una vacuna contra el sida. De octubre de 2003 a marzo de 2004 se realizó una investigación formativa en la capital Kinshasa con el objetivo de obtener las respuestas a determinadas preguntas sobre la planificación de ensayos con una vacuna preventiva contra el sida e identificar temas relacionados. Se llevaron a cabo veintisiete entrevistas exhaustivas y dos grupos de discusión con posibles participantes en el ensayo y con líderes de la comunidad. Asimismo se recogieron datos sobre temas relacionados con las vacunas, el VIH y el sida, la conducta sexual y la vacuna contra el sida. La finalidad del estudio también fue identificar qué factores motivan a una persona a presentarse como voluntario para un ensayo de una vacuna o qué factores disuasivos les impiden participar. También se analizó en qué medida está la comunidad más numerosa dispuesta a participar en los ensayos. Algunas de las motivaciones más comunes para participar eran estar preocupados por la salud y el impacto de la epidemia en las familias y el país. Las principales inquietudes e impedimentos eran el peligro de una vacuna experimental y el estigma de dar positivo en la prueba de anticuerpos del VIH como resultado de la vacuna. Identificamos que los sectores sanitarios, educativos y no gubernamentales del municipio desempeñan un importante papel a la hora de asegurar que la población esté preparada para los ensayos, aunque existen aún escollos por superar si queremos conseguir que la comunidad esté preparada.     

Some important issues in the planning of phase III HIV vaccine efficacy trials

Given that interesting HIV vaccine candidates, including live preparations and DNA plasmids, exist and that the first phase III vaccine (AIDSVAX) testing is due to begin this summer, 1998, in the U.S., adequately addressing trial preparedness is a pressing issue. Despite double-blind randomized controlled clinical trial design, there may be difficulties with interpretation and use of the usual measures of vaccinal efficacy and calculation of sample size. Difficulties arise from vaccine characteristics (e.g. mode of action, time-lag, waning) and population heterogeneities (e.g. differences in susceptibility, sexual behaviour, mixing preferences) causing frailty effects that can exacerbate bias and time-dependent effects already known to exist in simple cases. Since vaccine properties, particularly mode of action, are unlikely to be known before the onset of clinical trials, choosing an efficacy measure and the associated analyses and sample size calculations will be problematic. Interim analyses designed to decide whether a study will be prolonged may be tenuous if based on a time-dependent measure and will influence sample size determination. Despite shortcomings, general recommendations can be made to minimise pernicious effects. The objectives of this paper are principally to review the current state of knowledge of the different stages in the preparation of large phase III HIV vaccine efficacy trials, the methodological difficulties related to their design, and the analysis of data collected from them. Mathematical models and trial simulations are used to demonstrate that further research is necessary to study the behaviour of vaccine efficacy measures under heterogeneous conditions of population, vaccine action, and trial design and identify a time-independent efficacy measure. Alternative methods to validate sample size calculations have to be developed in older to reduce the chances of unnecessary economic and human cost in phase III HIV vaccine trials.     

Women's perceptions and experiences of HIV prevention trials in Soweto, South Africa

Persistently high rates of HIV infection in sub-Saharan Africa have driven the exploration for additional methods of prevention, such as microbicides. Multi-site, field-based clinical trials of microbicides are conducted in diverse social and cultural contexts. Local social and cultural perceptions of HIV/AIDS and sexual risk can have profound implications in shaping community responses to the clinical trials, thereby affecting enrollment and retention. Moreover, clinical trials may have a significant impact on trial participants with regard to their views of AIDS, health and relationships. Following these issues, this paper explores the subjective experiences of women enrolled in a microbicide feasibility study. Qualitative data were collected in two phases. The first phase took place prior to the inception of the feasibility study. Men and women from Soweto participated in focus group discussions about their perceptions and experiences of the AIDS epidemic and sexual risk. The second phase started once enrollment into the feasibility study had begun. Twenty-one women who were enrolled in the microbicide feasibility study were interviewed and participated in focus groups, and were asked about their experiences of participating in the microbicide feasibility study. Special attention was placed on how they felt their participation had affected their everyday lives. Interviews and discussions were conducted in local languages, recorded, translated and transcribed. Data were analysed thematically. The central finding of this study is the sense of empowerment that feasibility study participants felt in spite of their being embedded in a culture that has come to fear, deny or ignore AIDS. We discuss the critical role of repeated, voluntary counselling and testing, knowledge of HIV status, and heightened awareness of sexual and reproductive health in reshaping study participants' approaches to sexual relationships and AIDS, as well as the benefits that participation entailed.     

Adolescent and adult participation in an HIV vaccine trial preparedness cohort in South Africa

PURPOSE: The importance of involving adolescents in HIV prevention trials has been recognized, but there have been few experiences reported from sub-Saharan Africa. We analyzed adult and adolescent data from a cohort study conducted to assess the feasibility of involving adolescents and adults in HIV vaccine-related studies. METHODS: Two hundred HIV-negative participants aged 16 to 40 years were enrolled, including 86 (43%) adolescents. At baseline, sexual risk behavior and willingness to participate (WTP) in future HIV vaccine trials questionnaires were administered. Three monthly HIV counseling, pregnancy, HIV and syphilis tests were performed. Risk questionnaires were repeated at 6 months and WTP at 12 months. RESULTS: No significant difference in retention between adults (83%) and adolescents (87%) was noted (p = .58). Initially, more adults (40%) reported WTP compared to adolescents (13%) (p < .001). At the end of the study both groups reported higher levels of WTP; increasing to 40% among adolescents. HIV incidence during the study was 9.2 infections per 100 person-years (95% confidence interval [CI]: 4.4-19.2) among adolescents compared to 5.8 (95% CI 2.6-12.9) in adults (p = .42). CONCLUSIONS: Retention of high-risk HIV-negative adolescents in a cohort study is feasible. Following education, adolescents reported improved WTP. The high HIV incidence rate in adolescents highlights the importance of including this group in prevention trials.     

Insurability and the HIV epidemic: ethical issues in underwriting

The HIV epidemic has focused criticism on standard underwriting practices that exclude people with AIDS or at high risk for it from insurance coverage. Insurers have denied the charge that these practices are unfair, claiming instead that whatever is actuarially fair is fair or just. This defense will not work unless we assume that individuals are entitled to gain advantages and deserve losses merely as a result of their health status. That assumption is highly controversial at the level of theory and is inconsistent with many of our moral beliefs and practices, including our insurance practices. We should reject the insurers' argument. Justice in health care requires that we protect equality of opportunity, and that implies sharing the burden of protecting people against health risks. In a just healthcare system, whether mixed or purely public, the insurance scheme is in systematic terms actuarially unfair, for its overall social function must be to guarantee access to appropriate care. This does not mean that in our system insurers are ignoring their obligation to provide access to coverage. The obligation to assure access is primarily a social one, and the failures of access in our system are the result of public failures to meet those obligations. In a just but mixed system, there would be an explicit division of responsibility among public and private insurance schemes. In our mixed but unjust system, both legislators and insurers cynically pretend that the uninsured are the responsibility of the other. The attempt to treat actuarial fairness as a moral notion thus disguises what is really at issue, namely, the risk to insurers of adverse selection and the economic advantages of standard underwriting practices. Standard underwriting practices will be fair only if they are part of a just system, not if they simply are actuarially fair. The failure of the argument from actuarial fairness means that we must face an issue private insurers had hoped to avoid if we are to defend standard underwriting practices at all. In view of the clear risk that a mixed system will fail to assure access to care, the burden falls on defenders of a mixed system. They must show us that its social benefits outweigh its social costs, and that it is possible to have a mixed system that is not only just, but also is superior to a compulsory, universal insurance scheme.     

Legal and ethical issues in HIV / AIDS care

People in India, including foreigners, can be forced to submit their blood for HIV testing at the discretion of a health officer. Once tested, no statute exists to protect the confidentiality of that medical information. Section 51 of the Goa Public Health Act and local municipal laws provide for the notification of AIDS cases. There are presently 67 AIDS surveillance centers in India. No statute obliges doctors to treat people with HIV. However, once treatment is started, the doctor is obliged to continue treatment to ensure that the patient does not die, with treatment being administered only with the patient's consent. No statute exists which requires the HIV testing of employees in the workplace or prisoners. Only defense personnel are being routinely tested for HIV. Furthermore, there are no specific criminal offenses for transmitting HIV and no policies regarding HIV-infected employees. Preventive measures are contained in local municipal laws, local public health laws, and the Epidemic Diseases Act, and vaccine and drug trials are conducted under the Drugs and Cosmetics Act.     

Randomized controlled trials in environmental health research: ethical issues

Randomized controlled trials (RCTs) are becoming increasingly common in environmental health research. Like all studies involving human subjects, environmental health RCTs raise many ethical challenges, ranging from obtaining informed consent to minimizing risks to protecting privacy and confidentiality. One of the most important issues raised by these studies is whether it is ethical to withhold effective environmental health interventions from research subjects in order to satisfy scientific objectives. Although environmental health investigators usually do not have professional obligations to provide medical care to research subjects, they have ethical obligations to avoid exploiting them. Withholding interventions from research subjects can be ethical, provided that it does not lead to exploitation of individuals or groups. To avoid exploiting individuals or groups, investigators should ensure that research subjects and study populations receive a fair share of the benefits of research.     

Local knowledge and experiences of vaccination: implications for HIV-preventive vaccine trials in South Africa.

This study forms part of the preparation of communities for HIV-preventive vaccine trials in South Africa. On the basis of the assumption that attitudes to any HIV vaccine or vaccine trials will partly be influenced by experiences of vaccination in general, this study aimed to investigate knowledge of, attitudes to, and experiences of vaccination in a small semirural community in KwaZulu-Natal, South Africa. The study also sought to investigate the effect of traditional, cultural, and religious beliefs on attitudes to vaccination, as well as to get some indication of willingness to participate in potential HIV vaccine trials. Overall, the findings reveal a good knowledge of, and positive attitudes to, vaccination, with little negative effect of traditional, cultural, and religious beliefs. The findings also reveal a generally positive attitude to HIV vaccines and vaccine trials. Barriers identified, such as anxiety about safety, were not surprising.     

Eliminating mother-to-child HIV transmission in South Africa

Problem

The World Health Organization has produced clear guidelines for the prevention of mother-to-child transmission (PMTCT) of the human immunodeficiency virus (HIV). However, ensuring that all PMTCT programme components are implemented to a high quality in all facilities presents challenges.

Approach

Although South Africa initiated its PMTCT programme in 2002, later than most other countries, political support has increased since 2008. Operational research has received more attention and objective data have been used more effectively.

Local setting

In 2010, around 30% of all pregnant women in South Africa were HIV-positive and half of all deaths in children younger than 5 years were associated with the virus.

Relevant changes

Between 2008 and 2011, the estimated proportion of HIV-exposed infants younger than 2 months who underwent routine polymerase chain reaction (PCR) tests to detect early HIV transmission increased from 36.6% to 70.4%. The estimated HIV transmission rate decreased from 9.6% to 2.8%. Population-based surveys in 2010 and 2011 reported transmission rates of 3.5% and 2.7%, respectively.

Lessons learnt

Critical actions for improving programme outcomes included: ensuring rapid implementation of changes in PMTCT policy at the field level through training and guideline dissemination; ensuring good coordination with technical partners, such as international health agencies and international and local nongovernmental organizations; and making use of data and indicators on all aspects of the PMTCT programme. Enabling health-care staff at primary care facilities to initiate antiretroviral therapy and expanding laboratory services for measuring CD4+ T-cell counts and for PCR testing were also helpful.     

Barriers of enrolment in HIV vaccine trials: a review of HIV vaccine preparedness studies

Barriers to participation in an HIV vaccine trial have been examined in many HIV vaccine preparedness studies (VPS). These barriers can be understood in terms of the locus of the barrier (personal vs. social) and the nature of the barrier (risk vs. cost). Another type of barrier is perceived misconceptions. In this systematic review, we categorize barriers, and compare these barriers between the Organization for Economic Co-operation and Development (OECD) countries and the non-OECD countries. In the OECD countries, we retrieved 25 studies reporting personal risks (PR), 9 studies reporting social risks (SR), 10 studies reporting personal costs (PC), and 16 studies reporting misconceptions. In the non-OECD countries, we retrieved 27 studies reporting PR, 19 studies reporting SR, 18 studies reporting PC, 1 study reporting social costs (SC), and 13 studies reporting misconceptions. Important PR were “adverse effects” and “vaccine-induced seropositivity”, “distrust of institutions”, and “temptation to have unsafe sex” in men who have sex with men (MSM). “Discrimination” was a common SR. “Time commitment” was an important PC, and “family commitments” were a SC in one non-OECD country. “HIV infection from the vaccine” was a common misconception. Both the OECD and the non-OECD countries have similar barriers, and people's decisions to participate in a clinical trial involve multiple barriers. However, these barriers apply to hypothetical HIV vaccine trials, and barriers for actual vaccine trials need further assessment.     

Critical issues for agrichemical safety in South Africa

A review is made of the potential for environmental and occupational exposure to agrichemicals in South Africa. Data from the farming industry in the Western and Southern Cape regions of South Africa confirm substantial use of a range of insecticides, fungicides, and other agrichemicals. The potential for worker exposure to hazardous agrichemicals is also substantial but, to date, such exposures have been poorly characterized. Further data identify important deficiencies in industrial hygiene measures with regard to safekeeping of chemicals on farms, disposal of empty containers, use of protective equipment, and levels of safety training among farm workers. Evidence is presented for widespread underreporting of agrichemical morbidity and mortality. Surveys investigating acute health effects among farm workers with occupational exposure to agrichemicals in South Africa have produced conflicting results. The possibility of chronic health sequelae from low-dose long-term exposure is an underresearched area that is only now being investigated. A number of important obstacles to agrichemical safety are identified: the multiplicity of laws relating to pesticides administered by different departments resulting in poor coordination; the failure of existing occupational health legislation to address the agricultural workplace adequately; the unavailability and incoordination of safety training; the absence of adequate surveillance data; and inadequacies in statutory requirements with regard to waste disposal on farms. Drawing on experiences of local initiatives, possible solutions are identified that address the public health context of the problem.