59 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.
No full textINTRODUCTION: 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.
No full textIntravaginal 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
No full textVaginal 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.
No full textMicrobicides 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
How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania.
No full textBACKGROUND: 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
Microbicides Development Programme: design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention
No full textWith 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 much demand for New HIV prevention technologies can we really expect? Results from a discrete choice experiment in South Africa.
No full textBACKGROUND: 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.
No full textBACKGROUND: 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
HIV and dyadic intervention: an interdependence and communal coping analysis.
No full textBACKGROUND: The most common form of HIV transmission in sub-Saharan Africa is heterosexual sex between two partners. While most HIV prevention interventions are aimed at the individual, there is mounting evidence of the feasibility, acceptability, and efficacy of dyadic interventions. However, the mechanisms through which dyadic-level interventions achieve success remain little explored. We address this gap by using Lewis et al's interdependence model of couple communal coping and behaviour change to analyse data from partners participating in an HIV prevention trial in Uganda and Zambia. METHODS AND FINDINGS: We conducted a comparative qualitative study using in-depth interviews. Thirty-three interviews were conducted in total; ten with couples and twenty-three with staff members at the two sites. The Ugandan site recruited a sero-discordant couple cohort and the Zambian site recruited women alone. Spouses' transformation of motivation is strong where couples are recruited and both partners stand to gain considerably by participating in the research; it is weaker where this is not the case. As such, coping mechanisms differ in the two sites; among sero-discordant couples in Uganda, communal coping is evidenced through joint consent to participate, regular couple counselling and workshops, sharing of HIV test results, and strong spousal support for adherence and retention. By contrast, coping at the Zambian site is predominantly left to the individual woman and occurs against a backdrop of mutual mistrust and male disenfranchisement. We discuss these findings in light of practical and ethical considerations of recruiting couples to HIV research. CONCLUSIONS: We argue for the need to consider the broader context within which behaviour change occurs and propose that future dyadic research be situated within the framework of the 'risk environment'
Gender relations in the context of HIV/AIDS in rural South Africa.
No full textAs part of the Microbicides Development Programme, we conducted formative research to explore gender relations at a site in rural KwaZulu-Natal. We were interested in gender relations and in assessing their implications for emerging female initiated and controlled HIV prevention methods in the form of microbicides. Eleven focus group discussions were conducted with men and women in the community. Participants were asked about decision making about sex, family planning and the use of condoms in heterosexual relationships. Findings suggest that gender relations in the context of HIV are complex. The findings suggest that both men and women feel that the final decision about child-bearing and the use of contraceptives and rests with women since they are the ones who bear the burden of child care. This implies that it is feasible for couples to use women-initiated and controlled methods of HIV prevention
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