7,101 research outputs found

    "One teabag is better than four": Participants response to the discontinuation of 2% PRO2000/5 microbicide gel in KwaZulu-Natal, South Africa.

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    INTRODUCTION: The Microbicides Development Programme evaluated the safety and effectiveness of 0.5% and 2% PRO2000/5 microbicide gels in reducing the risk of vaginally acquired HIV. In February 2008 the Independent Data Monitoring Committee recommended that evaluation of 2% PRO2000/5 gel be discontinued due to futility. The Africa Centre site systematically collected participant responses to this discontinuation. METHODS: Clinic and field staff completed field reports using ethnographic participant observation techniques. In-depth-interviews and focus group discussions were conducted with participants discontinued from 2% gel. A total of 72 field reports, 12 in-depth-interviews and 3 focus groups with 250 women were completed for this analysis. Retention of discontinued participants was also analysed. Qualitative data was analysed using NVivo 2 and quantitative data using STATA 10.0. RESULTS: Participants responded initially with fear that discontinuation was due to harm, followed by acceptance after effective messaging, and finally with disappointment. Participants reported that their initial fear was exacerbated by being contacted and advised to visit the clinic for information about the closure. Operational changes were subsequently made to the contact procedures. By incorporating feedback from participants, messages were continuously revised to ensure that information was comprehensible and misconceptions were addressed quickly thereby enabling participants to accept the discontinuation. Participants were disappointed that 2% PRO2000/5 was being excluded as a HIV prevention option, but also that they would no longer have access to gel that improved their sexual relationships with their partners and assisted condom negotiations. In total 238 women were discontinued from gel and 185 (78%) went on to complete their scheduled follow-up period. DISCUSSION: The use of qualitative social science techniques allowed the site team to amend operational procedures and messaging throughout the discontinuation period. This proved instrumental in ensuring that the discontinuation was successfully completed in a manner that was both understandable and acceptable to participants. TRIAL REGISTRATION: Current Controlled Trials. ISRCTN64716212

    Intravaginal and menstrual practices among women working in food and recreational facilities in Mwanza, Tanzania: implications for microbicide trials.

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    Intravaginal and menstrual practices may potentially influence results of trials of microbicides for HIV prevention through effects on the vaginal environment and on adherence to microbicide and placebo products. As part of the feasibility study for the Microbicides Development Programme Phase 3 trial of a vaginal microbicide in Mwanza, a variety of quantitative and qualitative methods were used to describe these practices, associations with behaviour and underlying social norms among women working in food and recreational facilities. Intravaginal cleansing by inserting fingers and either water alone or soap and water was thought necessary to remove "uchafu" (dirt), referring to vaginal secretions, including menstrual blood and post-coital discharge. Vaginal cleansing was carried out within 2 hours after 45% of sex acts. Sexual enhancement practices were less common. Intravaginal and menstrual practices and associated behaviours and demographic factors should be measured and monitored throughout microbicide trials to enable analyses of their impacts on microbicide effectiveness

    The co-production of gender and technology in HIV prevention research

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    Vaginal microbicides are pharmaceutical products in development that are designed to reduce the sexual transmission of HIV in women. They are commonly known as a `woman-controlled technology' and tool for women's empowerment, and form part of a burgeoning field of clinical research into new biotechnologies for HIV prevention. Little work has critically examined how such research and new technologies are produced, and how they in turn contribute to the construction, maintenance or deconstruction of gender relations. Adopting a Foucauldian understanding of power and discourse, and using theoretical insights from science and technology studies (STS), this research explores the coproduction of gender and technology through the case study of vaginal microbicides. 'T'his account of the relations between science, society and technology draws on empirical research conducted in the UK and Zambia with the pharmaceutical industry, trialists, trial participants and trial communities. It interrogates the techniques of power through which transnational scientific networks are mobilised to test new products, such as microbicides, and how these affect scientific practices, knowledges and identities across socio-geographic boundaries. It attends to the potential multiplicity of interventions in diverse contexts, calling into question the presumed stability and singularity of both the randomized controlled trial and vaginal microbicides. This research makes an empirical contribution to knowledge about new biomedical technologies for HIV prevention, detailing the transformation that may occur when technologies travel from their site of development to their site of use. It provides a detailed analysis of the interaction between gender performativity and science in action, challenging the sense of `gendered' technologies for a `feminized' epidemic. Theoretically, it contributes to debates about the role of social theory in public health research and reconstructivist agendas in STS, concluding with a model for greater collaboration between health technology designers, evaluators, critics, and users

    The development of vaginal microbicides for the prevention of HIV transmission.

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    Microbicides are chemical agents used topically by women within the vagina in order to prevent infection by HIV and potentially by other enveloped viruses and sexually transmitted pathogens. Prototype microbicides are designed to be inserted prior to each act of sexual intercourse and could also be contraceptive, although most current potential microbicides are not. Several proof-of-principle phase III trials of candidate microbicides are currently in progress or are shortly to commence, and a definitive answer to their efficacy and safety is anticipated by 2008

    Microbicides Development Programme: design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention

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    With 2.5 million new HIV infections per year, effective preventive methods against HIV are urgently needed, especially in sub-Saharan Africa. MDP301 is an ongoing trial of the vaginal microbicide PRO 2000/5 being conducted by the Microbicides Development Programme. The main objective of the trial is to determine the efficacy and safety of 0.5% and 2% concentrations of PRO 2000/5 gel compared to placebo in preventing vaginally acquired HIV infection

    How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania.

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    BACKGROUND: HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania. METHODS: A total of 1146 women at increased risk of HIV acquisition working as alcohol and food vendors or in bars, restaurants, hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza. During preparations for the trial, participatory community research methods were used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions. A comprehension checklist is administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits during the trial. To investigate women's perceptions and experiences of the trial, including how well participants internalize and retain key messages provided through a continuous informed consent process, a random sub-sample of 102 women were invited to participate in in-depth interviews (IDIs) conducted immediately after their 4, 24 and 52 week follow-up visits. RESULTS: 99 women completed interviews at 4-weeks, 83 at 24-weeks, and 74 at 52 weeks (a total of 256 interviews). In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV; that this is the key reason for conducting the trial; and that women should stop using gel in the event of pregnancy. CONCLUSIONS: Providing information to trial participants in a focussed, locally-appropriate manner, using methods developed in consultation with the community, and within a continuous informed-consent framework resulted in high levels of comprehension and message retention in this setting. This approach may represent a model for researchers conducting HIV prevention trials among other vulnerable populations in resource-poor settings. TRIAL REGISTRATION: Current Controlled Trials ISRCTN64716212

    How much demand for New HIV prevention technologies can we really expect? Results from a discrete choice experiment in South Africa.

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    BACKGROUND: For the first time in the history of HIV, new bio-medical interventions have been shown to be effective in preventing HIV transmission. For these new HIV prevention technologies (NPTs) to have an impact on the epidemic, they must be widely used. This study uses a discrete choice experiment (DCE) to: understand the relative strength of women's preferences for product characteristics, understand the implications for substitution away from male condoms, and inform realistic modelling of their potential impact and cost-effectiveness. METHODS: A DCE was conducted among 1017 women in urban South Africa. Women were presented with choices between potential women's NPTs (microbicides, diaphragm, female condom) and 'what I did last time' (use or not use a condom) with different HIV and pregnancy prevention effectiveness' and prices. Choice probabilities are estimated using the nested logit model and used to predict uptake. RESULTS: In this high HIV prevalence setting, HIV prevention effectiveness is the main driver of uptake followed by pregnancy prevention effectiveness. For example a microbicide with poor effectiveness would have niche appeal at just 11% predicted uptake, while a highly effective microbicide (95% effective against HIV and pregnancy) would have far wider appeal (56% predicted uptake). Though women who reported not using condoms were more likely to choose the NPTs, at current very high rates of male condom use in South Africa (60%), about half of microbicide uptake is projected to be among those currently not using condoms. CONCLUSIONS: Women are very interested in NPTs, especially if highly effective in preventing HIV and pregnancy. Women in greatest need were also most likely to switch to the new products. Where products are not yet available for distribution, proxy data, such as that generated by DCEs, can bring realism to overly optimistic uptake scenarios found in many current impact models

    Exploring experiences in peer mentoring as a strategy for capacity building in sexual reproductive health and HIV service integration in Kenya.

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    BACKGROUND: The Integra Initiative designed, tested, and adapted protocols for peer mentorship in order to improve service providers' skills, knowledge, and capacity to provide quality integrated HIV and sexual and reproductive health (SRH) services. This paper describes providers' experiences in mentoring as a method of capacity building. Service providers who were skilled in the provision of FP or PNC services were selected to undergo a mentorship training program and to subsequently build the capacity of their peers in SRH-HIV integration. METHODS: A qualitative assessment was conducted to assess provider experiences and perceptions about peer mentoring. In-depth interviews were conducted with twelve mentors and twenty-three mentees who were trained in SRH and HIV integration. Interviews were recorded, transcribed, and imported to NVivo 9 for analysis. Thematic analysis methods were used to develop a coding framework from the research questions and other emerging themes. RESULTS: Mentorship was perceived as a feasible and acceptable method of training among mentors and mentees. Both mentors and mentees agreed that the success of peer mentoring largely depended on cordial relationship and consensus to work together to achieve a specific set of skills. Mentees reported improved knowledge, skills, self-confidence, and team work in delivering integrated SRH and HIV services as benefits associated with mentoring. They also associated mentoring with an increase in the range of services available and the number of clients seeking those services. Successful mentorship was conditional upon facility management support, sufficient supplies and commodities, a positive work environment, and mentors selection. CONCLUSION: Mentoring was perceived by both mentors and mentees as a sustainable method for capacity building, which increased providers' ability to offer a wide range of and improved access to integrated SRH and HIV services

    Early Implementation Projects on Flood Control and Irrigation in Bangladesh - Review of the programme of closure of tidal channels

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    A review of the results in the past 5 years regarding the joint-programme of the Bangladesh Water Development Board and the Netherlands Assistance Programme on the Closure of Tidal Channels in Bangladesh. This review is useful after the successful completion of the Amtali Closure. This joint-programme falls within the frame-work of the Early Implementation Projects on. Flood-Control and Irrigation (EIP). A review of the past should enable the determination of the bottle-necks for the success of a possible continuation of the programme. The removal of these bottlenecks could be a pre-requisite for a continuation. The Resident Advisor EIP has thus requested for this review and a glance in the future

    A process evaluation of the City of Cape Town Business Support Voucher Programme

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    Includes bibliographical references (leaves 74-78).This dissertation focuses on a process evaluation of the City of Cape Town (CoCT) Business Support Voucher Programme (BSVP) which assessed whether this programme was implemented as intended. The BSVP aims to provide access to quality business support services and products to entrepreneurs in order to empower them to develop and grow their businesses. The target beneficiaries of the BSVP are the over 35 year old age group (including women, youth and the disabled) who are potential or start-up entrepreneurs or who own/run existing small businesses. A service utilisation flow chart was used to review the services provided by the allocating agents and the business development service providers. Data providers included the project sponsors, the implementation agent, the allocating agents and a convenience sample of beneficiaries and service providers. Additional materials used included check lists during site visits and a review of records. The findings suggested that whilst the programme was largely implemented as planned, there could be improvements to the definition of the programme targets, the consistency of the implementation across the programme and putting monitoring and reporting systems in place. The dissertation includes selected recommendations for implementation improvement, sustainability and future outcomes and impacts
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