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

Exploring a community's understanding of HIV vaccine­induced 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-urbanb 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.

The Effect of Kinesitherapy Exercises on the Level of Irisin among Females with Cardio-vascular diseases depending on the body mass and hormonal status.

The observation was conducted on 41 female subjects age 32 to 69 with compensated cardio-vascular diseases. 23 of the subjects had an increased body mass index (BMI). It was established that the older the females the less of the irisin muscle hormone is found in the blood. In the subjects with a higher BMI the level of irisin in the blood is also higher. Direct correlations were found between the level of irisin and the level of female sex hormones - estrogen and progesterone. Under the effect of kinesitherapy exercises the level of irisin in females with normal BMI increases; whereas in the females with a higher BMI it generally stays the same or is decreased. The characteristics of irisin's response to the kinesitherapy exercises depends on its original level, the intensity of physical exercise and the subject's physique.

The role of partnership dynamics in determining the acceptability of condoms and microbicides.

Microbicides are a class of substances under development that could reduce the sexual transmission of HIV and other sexually transmitted diseases when applied locally to genital mucosal surfaces. Microbicide acceptability research has largely focused on product characteristics, rather than processes of negotiation within relationships about use. Gender relations, decision-making power and communication within sexual relationships are recognised as important determinants of condom and contraceptive use, and are likely to determine microbicide use also. As part of social science research linked to the Microbicides Development Programme (MDP) we combine relationship-based theories with anthropological work conducted with women and men using a placebo gel. We explore communication and decision-making in gel and condom use, including constructions of risk and trust. During the MDP301 Phase III pilot study, in-depth interviews were conducted at sites in South Africa, Tanzania, Uganda and Zambia. Following four weeks of placebo gel use, women and their partners were asked about gel use and acceptability, partner involvement, sexual practices and condom use. Data from 45 couples at five sites were analysed using a grounded theory approach in NVivo. Participation in the study did not require women to inform their partners, yet our data shows women seeking permission from their partners, negotiating disclosure, exchanging information and persuading or motivating for gel use. Although gel was supposedly 'woman-controlled', men exercised considerable influence in determining whether and how it was used. Despite this, negotiations around use were largely successful, since the gel increased sexual pleasure and provided opportunities for intimate communication and the building of trust. Decisions about condom and microbicide use are made in a dyadic context and involve a complex negotiation of risk and trust. Whilst preferences relating to product characteristics are largely individual, use itself is dependent on partnership dynamics and the broader social context in which sexual risk management occurs.

Community perspectives on care options for HIV prevention trial participants.

There is on-going global debate and policy-setting concerning researchers' obligations to meet the health needs of people participating in HIV prevention trials in resource-poor settings. The perspectives of local community stakeholders on this issue are poorly understood as most of what is presented on behalf of communities where research takes place is anecdotal commentary. Using qualitative methods (130 in-depth interviews and 20 focus groups) we assessed perceived fairness of different strategies to meet the health needs of women who become HIV-infected during a hypothetical vaginal microbicide trial. Respondents included HIV prevention research participants, community stakeholders and health-care service providers in ten sites in seven countries (South Africa, Malawi, Tanzania, Zimbabwe, Zambia, India, US). Many respondents perceived referrals to be a potentially fair way to address care and treatment needs but concerns were also voiced about the adequacy of local health-care options and the ability of trial participants to access options. Most respondents viewed the provision of antiretroviral treatment by researchers to HIV-infected trial participants as unfair if treatment was not sustained beyond the end of the trial. The results underscore the importance of effectively linking trial participants to sustainable, community-based treatment and care.

Fatal toxic epidermal necrolysis due to lansoprazole.

Toxic epidermal necrolysis (TEN) is a serious cutaneous reaction and is most commonly drug induced. It is associated with significant morbidity and mortality. We describe a patient who developed fatal TEN after re-exposure to lansoprazole. Three years previously he presented with erythema multiforme due to the same drug. To our knowledge this is the first published report of TEN occurring with lansoprazole.

Recalcitrant cutaneous sarcoidosis: an evidence-based sequential approach.

BACKGROUND: Cutaneous sarcoidosis in black-skinned people is more severe and, in a subset, recalcitrant to therapy. Management of these patients is a challenge. AIM: To document the clinical features of recalcitrant cutaneous sarcoidosis (RCS) and its response to sequential therapy. A treatment algorithm is suggested. METHODS: A cross-sectional retrospective analysis was made of patients with RCS. Demographic data, clinical features, histology, blood parameters, radiology and management and response to therapy were recorded. RESULTS: A total of 30 patients with cutaneous sarcoidosis were seen, of which six had recalcitrant lesions. All had black skin, with a male to female ratio of 1:5. The average age was 48.5 years (41-67) and the average duration of lesions was 11.3 years (2-29). Skin lesions were papules (three), plaques (four), annular (three), nodules (four), ulcers (one), alopecia (one) and lupus pernio (one). Extracutaneous involvement was noted in four of six patients as follows: pulmonary (three of six), dactylitis (two of six) and hepatosplenomegaly (one of six). Histopathology was undertaken in all confirmed non-caseating granulomas. None of the cases responded to systemic prednisone alone. Alternative therapies were: chloroquine (six of six), methotrexate (four of six), doxycycline (two of six), allopurinol (two of six) and isotretinoin (one of six), and azathioprine (one of six). All patients responded well to a stepwise approach to therapy using second-line agents with no relapses during the follow-up period. CONCLUSION: Sequential therapy avoids the side effects of toxic drugs whilst controlling aggressive cutaneous lesions.

Therapeutic options for the treatment of tinea capitis caused by Trichophyton species: griseofulvin versus the new oral antifungal agents, terbinafine, itraconazole, and fluconazole.

Tinea capitis is a relatively common fungal infection of childhood. Griseofulvin has been the mainstay of management. However, newer oral antifungal agents are being used more frequently. A multicenter, prospective, randomized, single-blinded, non-industry-sponsored study was conducted in centers in Canada and South Africa to determine the relative efficacy and safety of griseofulvin, terbinafine, itraconazole, and fluconazole in the treatment of tinea capitis caused by Trichophyton species. The regimens for treating tinea capitis were griseofulvin microsize 20 mg/kg/day x 6 weeks, terbinafine [> 40 kg, one 250 mg tablet; 20-40 kg, 125 mg (half of a 250 mg tablet); < 20 kg, 62.5 mg (one-quarter of a 250 mg tablet)] x 2-3 weeks, itraconazole 5 mg/kg/day x 2-3 weeks, and fluconazole 6 mg/kg/day x 2-3 weeks. Patients were asked to return at weeks 4, 8, and 12 from the start of the study. Griseofulvin was administered for 6 weeks and the final evaluation was at week 12. Terbinafine, itraconazole, and fluconazole were administered for 2 weeks and the patient evaluated 4 weeks from the start of therapy. At this time, if clinically indicated, one extra week of therapy was given. There were 200 patients randomized to four treatment groups (50 in each group). At the final evaluation at week 12, the number of evaluable patients were griseofulvin, 46; terbinafine, 48; itraconazole, 46; and fluconazole, 46. Patients who discontinued therapy or were lost to follow-up were griseofulvin, 1/3; itraconazole, 0/4; terbinafine, 0/4; and fluconazole, 0/4. The causative organisms were Trichophyton tonsurans and T. violaceum species. Patients were regarded as effectively treated at week 12 if there was mycologic cure and either clinical cure or only a few residual symptoms. Effective treatment was recorded in, intention to treat, griseofulvin (46 of 50, 92.0%), terbinafine (47 of 50, 94.0%), itraconazole (43 of 50, 86.0%), and fluconazole (42 of 50, 84.0%) (p=0.33). Adverse effects were reported only in the griseofulvin group (gastrointestinal effects in six patients). Discontinuation from therapy due to adverse effects occurred only in the griseofulvin group (nausea in one patient). For the treatment of tinea capitis caused by the Trichophyton species, in this study, griseofulvin given for 6 weeks is similar in efficacy to terbinafine, itraconazole, and fluconazole given for 2-3 weeks. Each of the agents has a favorable adverse-effects profile.

Pemphigus in South Africa.

BACKGROUND: Pemphigus is an autoimmune disease characterized by intraepidermal blistering. We describe the demography, prevalence, clinical features, response to treatment, and human leukocyte antigen (HLA) characteristics of pemphigus in Kwa-Zulu Natal, South Africa. METHODS: All patients with pemphigus were prospectively recruited over 12 years from January 1987 to December 1999. The demography, clinical features, histology, and immunofluorescence (IF) were recorded. In a subset of patients, HLA tests were performed. RESULTS: One hundred and twelve patients had pemphigus. Pemphigus foliaceus (PF) was the commonest variant seen (62 patients) and 80% of these patients were black. The mean age was 43 years (12-93 years) and the male to female ratio was 1 : 1.4. Fifty patients had pemphigus vulgaris (PV), of whom 82% were Indian. The mean age of presentation of PV was 48 years (21-82 years). The male to female ratio was 1 : 1.7. There was no mucosal involvement in PF. PV patients had painful oral lesions. The mortality rate was 14% in the total sample (six in PV and two in PF). HLA-B8 was positive in 41% of patients with PF (P < 0.001). CONCLUSIONS: PF occurs more commonly in black people, while most cases in Indians present with the PV subtype. Pemphigus patients present with severe and extensive disease, and PV patients share features in common with patients from their land of origin (India), suggesting a genetic link.

Clinico-pathological study of causes of perinatal mortality in a developing country.

Perinatal mortality rates are an important indicator of the overall obstetric and neonatal services available, and the socio-economic status of the community. These rates are also used to identify shortcomings in services provided. The aim of this study was to identify clinical causative factors of perinatal deaths (supported by post mortem evidence where possible). This was a prospective descriptive study. The total number of deliveries and perinatal deaths over a 6-month period were recorded and clinico-demographic data noted. Post mortem examination information, if available, was also recorded. There was a total of 7789 deliveries over the 6-month period and 460 perinatal deaths, giving a perinatal mortality rate of 59/1000 deliveries; 45% (n = 207) of the perinatal deaths had post mortem examinations. The mean age was 26 years; 84.8% were single mothers. One-third of the group were un-booked: the mean gestational age of fetal death was 31 weeks, and the mean birth weight was 1700 g. Two-thirds of the perinatal deaths were stillbirths. The leading obstetric causes of deaths were: abruptio placentae (25.3%), hypertension in pregnancy (24.9%), prematurity (17.4%), unexplained stillbirth (13.4%) and intrapartum asphyxia (9.2%). The perinatal mortality rate of 59/1000 deliveries is high. Although this is comparable with other developing countries, there is a need for improvement in organisation of obstetric and neonatal care, staffing levels and access to and effective utilisation of antenatal services. These will probably lead to a significant reduction of this relatively high perinatal mortality rate.