Dataset Information

Using surrogate vaccines to assess feasibility and acceptability of future HIV vaccine trials in men: a randomised trial in inner-city Johannesburg, South Africa.

ABSTRACT: Developing an effective HIV vaccine is the overriding priority for HIV prevention research. Enrolling and maintaining cohorts of men into HIV vaccine efficacy trials is a necessary prerequisite for the development and licensure of a safe and efficacious vaccine.One hundred-fifty consenting HIV-negative men were enrolled into a pilot 1:1 randomised controlled trial of immediate vaccination with a three-dose hepatitis B vaccine compared to deferred vaccination (at 12 months) to investigate feasibility and acceptability of a future HIV vaccine trial in this population. Adverse events, changes in risk behaviour, acceptability of trial procedures and motivations for participation in future trials were assessed.Men were a median 25 years old (inter-quartile range?=?23-29), 53% were employed, 90% secondary school educated and 67% uncircumcised. Of the 900 scheduled study visits, 90% were completed in the immediate vaccination arm (405/450) and 88% (396/450) in the delayed arm (P?=?0.338). Acceptability of trial procedures and services was very high overall. However, only 65% of the deferred group strongly liked being randomised compared to 90% in the immediate group (P?=?0.001). Informed consent processes were viewed favourably by 92% of the delayed and 82% of the immediate group (P?=?0.080). Good quality health services, especially if provided by a male nurse, were rated highly. Even though almost all participants had some concern about the safety of a future HIV vaccine (98%), the majority were willing to participate in a future trial. Future trial participation would be motivated mainly by the potential for accessing an effective vaccine (81%) and altruism (75%), rather than by reimbursement incentives (2%).Recruitment and retention of men into vaccine trials is feasible and acceptable in our setting. Findings from this surrogate vaccine trial show a high willingness to participate in future HIV vaccine trials. While access to potentially effective vaccines is important, quality health services are an equally compelling incentive for enrolment.

SUBMITTER: Chimoyi L

PROVIDER: S-EPMC5498868 | biostudies-other | 2017 Jul

REPOSITORIES: biostudies-other

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Using surrogate vaccines to assess feasibility and acceptability of future HIV vaccine trials in men: a randomised trial in inner-city Johannesburg, South Africa.

Chimoyi Lucy L Kamndaya Mphatso M Venables Emilie E von Knorring Nina N Stadler Jonathan J MacPhail Catherine C Chersich Matthew F MF Rees Helen H Delany-Moretlwe Sinead S

BMC public health 20170704 Suppl 3

<h4>Background</h4>Developing an effective HIV vaccine is the overriding priority for HIV prevention research. Enrolling and maintaining cohorts of men into HIV vaccine efficacy trials is a necessary prerequisite for the development and licensure of a safe and efficacious vaccine.<h4>Methods</h4>One hundred-fifty consenting HIV-negative men were enrolled into a pilot 1:1 randomised controlled trial of immediate vaccination with a three-dose hepatitis B vaccine compared to deferred vaccination (a ...[more]

PMID: 28832280

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Project description:Alcohol misuse is a key factor underlying the remarkable vulnerability to HIV infection among men and women in sub-Saharan Africa, especially within urban settings. Its effects, however, vary by type of drinking, population group and are modified by socio-cultural co-factors.We interviewed a random sample of 1465 men living in single-sex hostels and 1008 women in adjacent informal settlements in inner-city, Johannesburg, South Africa. Being drunk in the past week was used as an indicator of heavy episodic drinking, and frequency of drinking and number of alcohol units/week used as measures of volume. Associations between dimensions of alcohol use (current drinking, volume of alcohol consumed and heavy episodic drinking patterns) and sexual behaviours were assessed using multivariate logistic regression.Most participants were internal migrants from KwaZulu Natal province. About half of men were current drinkers, as were 13% of women. Of current male drinkers, 18% drank daily and 23% were drunk in the past week (women: 14% and 29% respectively). Among men, associations between heavy episodic drinking and sexual behaviour were especially pronounced. Compared with non-drinkers, episodic ones were 2.6 fold more likely to have transactional sex (95%CI = 1.7-4.1) and 2.2 fold more likely to have a concurrent partner (95%CI = 1.5-3.2). Alcohol use in men, regardless of measure, was strongly associated with having used physical force to have sex. Overall effects of alcohol on sexual behaviour were larger in women than men, and associations were detected between all alcohol measures in women, and concurrency, transactional sex and having been forced to have sex.Alcohol use and sexual behaviours are strongly linked among male and female migrant populations in inner-city Johannesburg. More rigorous interventions at both local and macro level are needed to alleviate alcohol harms and mitigate the alcohol-HIV nexus, especially among already vulnerable groups. These should target the specific dimensions of alcohol use that are harmful, assist women who drink to do so more safely and address the linkages between alcohol and sexual violence.

Project description:For adolescents growing up in poor urban South African settings, violence is often a part of daily life and has lasting effects on physical and mental health outcomes in adulthood. We conducted a qualitative study to document and understand the forms of interpersonal violence experienced by adolescents living in Hillbrow, Johannesburg. In this article, we explore how violence is experienced differently by adolescent boys and girls, how they conceptualise 'dangerous' and 'safe' spaces in their neighbourhood and what gaps exist in available services for youth in Hillbrow.The article draws on data collected in the formative phase of the 'Wellbeing of Adolescents in Vulnerable Environments' (WAVE) Study of challenges faced by adolescents (15-19 years) growing up in impoverished parts of five cities. This article reports on analysis using only data from the Johannesburg site. Using both purposive and snowball sampling to select participants, we conducted in-depth interviews (n = 20) and community mapping exercises with female (n = 19) and male (n = 20) adolescents living in Hillbrow, as well as key informant interviews with representatives of residential shelters, CBOs, and NGOs working with youth (n = 17). Transcripts were coded manually and analysed using an inductive thematic analysis approach.Both girls and boys reported high exposure to witnessing violence and crime. For girls, the threat of sexual harassment and violence was pervasive, while boys feared local gangs, the threat of physical violence, and being drawn into substance-abuse. Home was largely a safe haven for boys, whereas for girls it was often a space of sexual violence, abuse and neglect. Some adolescents developed coping mechanisms, such as actively seeking out community theatres, churches and other places of sanctuary from violence. Community-based services and shelters that support adolescents reported a lack of resources, overall instability and difficulties networking effectively.Adolescents in Hillbrow commonly witnessed and had direct experience of many forms of violence in their environment, and these experiences differed markedly by gender. Interventions that build young peoples' social capital and resilience are essential for reducing violence-related trauma and long-term health and social consequences for adolescents in this community.

Project description:The overall unemployment rate in South Africa was impacted by the coronavirus (COVID-19) pandemic, which led many people to resort to informal work such as street trading opportunities in big cities. However, this work is located in the same cities where air pollution is of concern. Furthermore, literature has indicated the lack of regulation of the informal trading sector as compared to the formal sector. An analytical cross-sectional study is proposed to be conducted amongst all of the informal food street vendors (indoor/inside buildings and outdoor/street pavements stalls) in the inner city of Johannesburg, South Africa. By adopting a total sampling method of 746 vendor stalls, this study's key focus is on inhalation as an occupational exposure. In addition, the study aims to assess the respiratory risk factors amongst informal food street vendors' stalls and their impact on vendors' respiratory health. The risk factors to be assessed include the five common air pollutants: street vendor's infrastructure; socioeconomic factors; personal behavior such as tobacco smoking and handwashing practices; wearing of respiratory protective equipment; and vendors' exposure duration. The data collection will follow three phases using quantitative methods. In the pre-assessment phase, it will include a pilot study to test the walkthrough survey checklist and the respiratory symptoms and diseases questionnaire. The assessment phase includes a total of eight area samples, which will be taken in a 1-day event over four yearly seasons, as well as thirty personal samples taken in winter over an 8-h work shift. The post-assessment phase will be the development of a risk impact assessment and a risk management model. The study is essential for healthy occupational conditions as indicated in the Occupational Health and Safety (OHS) Act (no. 85 of 1993) and the Regulations governing general hygiene requirements for food premises, the transport of food, and related matters (no. R638 of 22 June 2018).

Project description:BackgroundPersistent high-risk human papillomavirus (HR-HPV) infection is associated with the development of anogenital cancers, particularly in men living with HIV (MLWH). We describe the prevalence of anogenital HPV infection, abnormal anal cytology and anogenital warts (AGWs) in MLWH in Johannesburg, and explore whether HPV infection and receipt of antiretroviral treatment is associated with detection of abnormal anal cytology and AGWs.MethodsWe enrolled a cohort of 304 sexually-active MLWH ≥18 years, who completed a questionnaire and physical examination. Genital swabs were collected from all men and intra-anal swabs from 250 (82%). Swabs were tested for HPV DNA and genotypes, and anal smears graded using the Bethesda classification. Factors associated with anogenital disease were assessed by logistic regression models.ResultsTwo thirds were receiving antiretroviral treatment, for a median 33 months (IQR = 15-58) and 54% were HIV-virologically suppressed. Only 5% reported ever having sex with men. Among 283 genital swabs with valid results, 79% had any HPV, 52% had HR-HPV and 27% had >1 HR-HPV infection. By comparison, 39% of the 227 valid intra-anal swabs had detectable HPV, 25% had any HR-HPV and 7% >1 HR infection. While most anal smears were normal (51%), 20% had ASCUS and 29% were LSIL. No cases had HSIL or cancer. Infection with >1 HR type (adjusted OR [aOR] = 2.39; 95%CI = 1.02-5.58) and alpha-9 types (aOR = 3.98; 95%CI = 1.42-11.16) were associated with having abnormal cytology. Prevalence of AGWs was 12%. Infection with any LR type (aOR = 41.28; 95%CI = 13.57-125.62), >1 LR type (aOR = 4.14; 95%CI = 1.60-10.69), being <6 months on antiretroviral treatment (aOR = 6.90; 95%CI = 1.63-29.20) and having a CD4+ count <200 cells/μL (aOR = 5.48; 95%CI: 1.60-18.78) were associated with having AGWs.ConclusionsIn this population, anogenital HR-HPV infection and associated low-grade disease is common, but severe anal dysplasia was not detected. Findings reinforce the need for HPV vaccination in men for preventing both AGWs and HR-HPV infection. Given the absence of anal HSILs, however, the findings do not support the use of anal screening programmes in this population.

Project description:OBJECTIVE:To assess whether decentralising colposcopy services to a primary care facility in inner-city Johannesburg, South Africa raises access to colposcopy. DESIGN:Before-after study comparing 2?years before and 2 years after decentralisation, using clinical records and laboratory data on cervical cytology and histology. PRIMARY OUTCOME:The proportion of all women attending Hillbrow Community Health Centre (HCHC) with an abnormal Papanikolaou (Pap) smear who had a colposcopy post-decentralisation. SETTING:Charlotte Maxeke Johannesburg Academic Hospital (CMJAH) has provided colposcopy services for several decades. HCHC, located about 3?km away, began colposcopy services in 2014. PARTICIPANTS:Women, aged above 18 years, who had a colposcopy for diagnosis and treatment of precancerous cervical lesions following a Pap smear, from 2012 to 2016 at CMJAH or HCHC. RESULTS:Pre-decentralisation at CMJAH, 910 women had colposcopy (2012-2014). Post-decentralisation (2014-2016), 721 had colposcopy at CMJAH and 399 at HCHC, the decentralised facility. The number who had a Pap smear at HCHC and then a colposcopy rose threefold post-decentralisation (114 vs 350). Post-decentralisation, 43 women at HCHC were referred to CMJAH for colposcopy, compared with 114 pre-decentralisation. Post-decentralisation, 47.3% of women at CMJAH waited >6 months for colposcopy, while 35.5% did at HCHC (p<0.001). Across all three groups, 26.9%-30.3% of women had cervical intraepithelial neoplasia III lesions or carcinoma on colposcopy. The proportion of invalid specimens was similar at CMJAH and HCHC (1.8%-2.8%). Of 401 women who had an abnormal Pap smear at HCHC post-decentralisation, 267 had colposcopy (66.6%). CONCLUSION:Decentralisation can decrease the time to colposcopy and reduce the workload of tertiary hospitals. Overall, more women accessed services. Colposcopy coverage at HCHC is higher than other sites, but could be further improved. Decentralisation did not appear to undermine the quality of services and this model could be extended to similar settings in South Africa and elsewhere.

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Project description:BackgroundSouth Africa has the largest HIV treatment program worldwide. Retention in care and medication adherence remain problematic necessitating innovative solutions for improving HIV care. The increasing availability and use of mobile technology can support positive clinical outcomes for persons living with HIV. iThemba Life is a mobile health app designed with input from South African health professionals and patients, promoting engagement with HIV care through access to medical results.ObjectiveThis study aimed to test the feasibility and acceptability of receiving HIV viral load (VL) results through the app and compare the time to HIV VL result return for study participants before and after app use.MethodsUsing convenience sampling, adults having routine VL phlebotomy were recruited from 2 Johannesburg health facilities. After signed consent, the app was downloaded on their Android smartphones, phlebotomy was performed, and the sample barcode was scanned through their phone to link the sample and app. Participants received a notification of the result availability and logged into the app to view results, their explanation and recommended action.ResultsOverall, 750 people were screened to enroll 500 participants. Of 750, 113 (15.1%) failed eligibility screening. 21.5% (137/637) had smartphone technical limitations preventing enrollment. Results were released to 92.2% (461/500) of participants' phones. App technical issues and laboratory operational issues limited the number of released results. Approximately 78.1% (360/461) results were viewed in the app. Median time from notification of availability to result viewed being 15.5 hours (0.6; range 0-150 days). Turnaround time from phlebotomy to the result being received was 6 (range 1-167) days for users versus 56 days (range 10-430 days; P<.001) before app use. Overall, 4% (20/500) of participants received unsuppressed results (VL>1000 copies/mL). Turnaround time for unsuppressed results was 7 days for participants versus 37.5 days before app use (P<.001). The difference before and after app use in the suppressed and unsuppressed users for time from sample collection to result delivery was statistically significant. Of 20 participants, 12 (60%) returned for a confirmatory VL during the study period. The time from an unsuppressed VL to a confirmatory VL was 106 days for app users versus 203 days before app use (P<.001). Overall, 52.4% (262/500) of participants completed an exit survey; 23.2% (58/250) reported challenges in viewing their VL results. Moreover, 58% (35/60) reported that they overcame challenges with technical assistance from others, and 97.3% (255/262) wanted to continue using the app for VL results.ConclusionsUsing iThemba Life for VL results was well-received despite limited smartphone access for some participants. App users received results 10 times sooner than before the app and 5 times sooner if their VL >1000 copies/mL. This increased notification speed led to participants wanting to continue using iThemba Life.

Dataset Information

Using surrogate vaccines to assess feasibility and acceptability of future HIV vaccine trials in men: a randomised trial in inner-city Johannesburg, South Africa.

Publications

Using surrogate vaccines to assess feasibility and acceptability of future HIV vaccine trials in men: a randomised trial in inner-city Johannesburg, South Africa.

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