"It Was Not My Aim to Sleep There": The Impact of Timing and Location of Sex on Adherence to Coitally-Dependent HIV Pre-exposure Prophylaxis.

The FACTS 001 trial found that vaginal pre- and post-coital application of 1% tenofovir gel did not prevent HIV-1 infection amongst young South African women. The trial included a multi-faceted approach to adherence support and collected objective and self-reported adherence measures. Using qualitative data collected from a random sub-set of FACTS 001 participants (135 in-depth interviews at product discontinuation and 13 focus group discussions at dissemination of trial results), we explore the importance of 'place' and 'timing' in shaping acts of sexual intimacy and product adherence. Demographically, this qualitative sub-sample is similar to the trial cohort of predominantly young, unemployed women living with parents or other family members. Sexual intimacy was largely unpredictable and happened across multiple locations in which women had limited privacy, autonomy, or control over the timing of sex. This made adherence to the dosing strategy challenging. Findings may inform the development of future event-driven pre-exposure prophylaxis regimens or products.

Cash transfer interventions for sexual health: meanings and experiences of adolescent males and females in inner-city Johannesburg.

BACKGROUND: In sub-Saharan Africa, there is growing interest in the use of cash transfer (CT) programs for HIV treatment and prevention. However, there is limited evidence of the consequences related to CT provision to adolescents in low-resourced urban settings. We explored the experiences of adolescents receiving CTs to assess the acceptability and unintended consequences of CT strategies in urban Johannesburg, South Africa. METHODS: We collected qualitative data during a pilot randomized controlled trial of three CT strategies (monthly payments unconditional vs. conditional on school attendance vs. a once-off payment conditional on a clinic visit) involving 120 adolescents aged 16-18 years old in the inner city of Johannesburg. Interviews were conducted in isiZulu, Sesotho or English with a sub-sample of 49 participants who adhered to study conditions, 6 months after receiving CT (280 ZAR/ 20 USD) and up to 12 months after the program had ended. Interviews were transcribed and translated by three fieldworkers. Codes were generated using an inductive approach; transcripts were initially coded based on emerging issues and subsequently coded deductively using Atlas.ti 7.4. RESULTS: CTs promoted a sense of independence and an adult social identity amongst recipients. CTs were used to purchase personal and household items; however, there were gender differences in spending and saving behaviours. Male participants' spending reflected their preoccupation with maintaining a public social status through which they asserted an image of the responsible adult. In contrast, female participants' expenditure reflected assumption of domestic responsibilities and independence from older men, with the latter highlighting CTs' potential to reduce transactional sexual partnerships. Cash benefits were short-lived, as adolescents reverted to previous behavior after the program's cessation. CONCLUSION: CT programs offer adolescent males and females in low-income urban settings a sense of agency, which is vital for their transition to adulthood. However, gender differences in the expenditure of CTs and the effects of ending CT programs must be noted, as these may present potential unintended risks.

'Hold on' (Bambelela)! Lyrical interpretations of participation in an HIV prevention clinical trial.

During a five-day workshop, former clinical trial participants and local musicians wrote the lyrics and recorded a song about an HIV prevention trial. Born of concerns about misconceptions regarding experimental drug trials, the aim was to engender engagement with medical researchers and open dialogue about the risks and benefits of trial participation. Composing lyrics that highlighted their credibility as communicators of medical scientific knowledge and their selfless sacrifice to stem the transmission of HIV, women performed their social positioning and cultural authority in contrast to men as well as other women not part of the trial. While involvement in HIV prevention initiatives often attracts stigma, scorn and criticism, the song's lyrics highlighted women's new-found identities as heroines searching for a solution to the spread of HIV, challenging these stereotypes. Methodologically, the paper describes a novel approach that uses artistic expression for public engagement with biomedical research.

"Honey, Milk and Bile": a social history of Hillbrow, 1894-2016.

This commentary constructs a social history of Hillbrow, an inner-city suburb in Johannesburg, South Africa, based on a review of relevant published historical, anthropological and sociological texts. We highlight the significant continuities in the social structure of the suburb, despite the radical transformations that have occurred over the last 120 years.Originally envisaged as a healthy residential area, distinct from the industrial activity of early Johannesburg, Hillbrow was a prime location for health infrastructure to serve the city. By the late 1960s, the suburb had been transformed by the rapid construction of high rise office and apartment buildings, providing temporary low cost accommodation for young people, migrants and immigrants. In the 1980s, Hillbrow defied the apartheid state policy of racial separation of residential areas, and earned the reputation of a liberated zone of tolerance and inclusion. By the 1990s, affected by inner-city decay and the collapse of services for many apartment buildings, the suburb became associated with crime, sex work, and ungovernability. More recently, the revitalisation of the Hillbrow Health Precinct has created a more optimistic narrative of the suburb as a site for research and interventions that has the potential to have a positive impact on the health of its residents.The concentration of innovative public health interventions in Hillbrow today, particularly in the high quality health services and multidisciplinary research of the Hillbrow Health Precinct, creates the possibility for renewal of this troubled inner-city suburb.

Motivations and barriers to uptake and use of female-initiated, biomedical HIV prevention products in sub-Saharan Africa: an adapted meta-ethnography.

BACKGROUND: Women bear a disproportionate burden of HIV throughout the world prompting extensive research into HIV prevention products for women which has met with varied success. With an aim of informing future policy and programming, this review examines the barriers and motivations to the uptake and use of female initiated products in sub-Saharan countries. METHODS: We conducted a systematic review as an adapted meta-ethnography of qualitative data focused on actual use of products. After deduplication, 10,581 and 3861 papers in the first and second round respectively were screened. Following the PRISMA guidance, 22 papers were selected and synthesized using Malpass's definitions of first, second, and third order constructs. First order constructs, consisting of participant data published in the selected papers, were extracted and categorised by second and third order constructs for analysis. A weight of evidence review was conducted to compare and assess quality across the papers. RESULTS: The 22 papers selected span 11 studies in 13 countries. We derived 23 s order constructs that were translated into seven overarching third order constructs: Sexual Satisfaction, Trust, Empowerment and Control, Personal Well-being, Product use in the social-cultural environment, Practical Considerations, Risk Reduction, and Perceptions of Efficacy. Relationships and trust were seen to be as or more important for product use as efficacy. These constructs reveal an inherent inter-relationality where decision making around HIV prevention uptake and use cannot be binary or mono-faceted, but rather conducted on multiple levels. We developed a framework illustrating the central and proximal natures of constructs as they relate to the decision-making process surrounding the use of prevention products. CONCLUSIONS: Health systems, structural, and individual level HIV prevention interventions for women should adopt a holistic approach. Interventions should attend to the ways in which HIV prevention products can serve to reduce the likelihood of HIV transmission, as well as help to protect partnerships, enhance sexual pleasure, and take into account woman's roles in the social environment. Stigma, as well as sexuality, is likely to continue to influence product uptake and use and should be prominently taken into account in large-scale interventions. TRIAL REGISTRATION: Not applicable.

From fear to resilience: adolescents' experiences of violence in inner-city Johannesburg, South Africa.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

'Leaving no one behind': reflections on the design of community-based HIV prevention for migrants in Johannesburg's inner-city hostels and informal settlements.

BACKGROUND: Unmanaged urban growth in southern and eastern Africa has led to a growth of informal housing in cities, which are home to poor, marginalised populations, and associated with the highest HIV prevalence in urban areas. This article describes and reflects on the authors' experiences in designing and implementing an HIV intervention originally intended for migrant men living in single-sex hostels of inner-city Johannesburg. It shows how formative research findings were incorporated into project design, substantially shifting the scope of the original project. METHODS: Formative research activities were undertaken to better understand the demand- and supply-side barriers to delivering HIV prevention activities within this community. These included community mapping, a baseline survey (n = 1458) and client-simulation exercise in local public sector clinics. The intervention was designed and implemented in the study setting over a period of 18 months. Implementation was assessed by way of a process evaluation of selected project components. RESULTS: The project scope expanded to include women living in adjacent informal settlements. Concurrent sexual partnerships between these women and male hostel residents were common, and HIV prevalence was higher among women (56%) than men (24%). Overwhelmingly, hostel residents were internal migrants from another province, and most felt 'alienated' from the rest of the city. While men prioritised the need for jobs, women were more concerned about water, sanitation, housing and poverty alleviation. Most women (70%) regarded their community as unsafe (cf. 47% of men). In the final intervention, project objectives were modified and HIV prevention activities were embedded within a broader health and development focus. 'Community health clubs' were established to build residents' capacity to promote health and longer term well-being, and to initiate and sustain change within their communities. CONCLUSIONS: To improve efforts to address HIV in urban informal settings, intervention designers must acknowledge and engage with the priorities set by the marginalised communities that live here, which may well encompass more pressing issues associated with daily survival.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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%). CONCLUSIONS: 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.

Negotiating the use of female-initiated HIV prevention methods in a context of gender-based violence: the narrative of rape.

Female-initiated methods of HIV prevention are needed to address barriers to HIV prevention rooted in gender inequalities. Understanding the sociocultural context of pre-exposure prophylaxis (PrEP) trials, including gender-based violence, is thus critical. MTN-003C (VOICE-C), a qualitative sub-study of the larger MTN-003 (VOICE) trial, examined sociocultural barriers and facilitators to PrEP amongst women in Johannesburg. We conducted focus-group discussions, in-depth interviews and ethnographic interviews with 102 trial participants, 22 male partners, 17 community advisory board members and 23 community stakeholders. We analysed how discussions of rape are emblematic of the gendered context in which HIV risk occurs. Rape emerged spontaneously in half of discussions with community advisory board members, two-thirds with stakeholders and among one-fifth of interviews/discussions with trial participants. Rape was used to reframe HIV risk as external to women's or partner's behaviour and to justify the importance of PrEP. Our research illustrates how women, in contexts of high levels of sexual violence, may use existing gender inequalities to negotiate PrEP use. This suggests that future interventions should simultaneously address harmful gender attitudes, as well as equip women with alternative means to negotiate product use, in order to more effectively empower women to protect themselves from HIV.

Male Partner Influence on Women's HIV Prevention Trial Participation and Use of Pre-exposure Prophylaxis: the Importance of "Understanding".

There is widespread evidence that male partners influence women's ability and willingness to join HIV prevention trials and to use female-controlled prevention strategies such as microbicide gels. VOICE-C was an ancillary study to the Microbicide Trials Network's VOICE trial at the Johannesburg site that explored social and structural factors influencing women's use of study tablets and vaginal gel. Qualitative data were analyzed from 102 randomly-selected VOICE participants interviewed through in-depth interviews (IDI, n = 41); ethnographic interviews (n = 21) or focus group discussions (FGD, n = 40) and 22 male partners interviewed in 14 IDI and 2 FGD. Male partners' "understanding" pervaded as a central explanation for how male partners directly and indirectly influenced their female partners' trial participation and product use, irrespective of assignment to the gel or tablet study groups. The meaning behind "understanding" in this context was described by both men and women in two important and complementary ways: (1) "comprehension" of the study purpose including biological properties or effects of the products, and (2) "support/agreeability" for female partners being study participants or using products. During analysis a third dimension of "understanding" emerged as men's acceptance of larger shifts in gender roles and relationship power, and the potential implications of women's increased access to biomedical knowledge, services and prevention methods. Despite displays of some female agency to negotiate and use HIV prevention methods, male partners still have a critical influence on women's ability and willingness to do so. Efforts to increase their understanding of research goals, study design and products' mechanisms of action could ameliorate distrust, empower men to serve as product advocates, adherence buddies, and foster greater adherence support for women in situations where it is needed. Strategies to address gender norms and the broader implications these have for female-initiated HIV prevention should likewise be integrated into future research and program activities.

Influences on visit retention in clinical trials: insights from qualitative research during the VOICE trial in Johannesburg, South Africa.

BACKGROUND: Although significant progress has been made in clinical trials of women-controlled methods of HIV prevention such as microbicides and Pre-exposure Prophylaxis (PrEP), low adherence to experimental study products remains a major obstacle to being able to establish their efficacy in preventing HIV infection. One factor that influences adherence is the ability of trial participants to attend regular clinic visits at which trial products are dispensed, adherence counseling is administered, and participant safety is monitored. We conducted a qualitative study of the social contextual factors that influenced adherence in the VOICE (MTN-003) trial in Johannesburg, South Africa, focusing on study participation in general, and study visits in particular. METHODS: The research used qualitative methodologies, including in-depth interviews (IDI), serial ethnographic interviews (EI), and focus group discussions (FGD) among a random sub-sample of 102 female trial participants, 18 to 40 years of age. A socio-ecological framework that explored those factors that shaped trial participation and adherence to study products, guided the analysis. Key codes were developed to standardize subsequent coding and a node search was used to identify texts relating to obstacles to visit adherence. Our analysis includes coded transcripts from seven FGD (N = 40), 41 IDI, and 64 serial EI (N = 21 women). RESULTS: Women's kinship, social, and economic roles shaped their ability to participate in the clinical trial. Although participants expressed strong commitments to attend study visits, clinic visit schedules and lengthy waiting times interfered with their multiple obligations as care givers, wage earners, housekeepers, and students. CONCLUSIONS: The research findings highlight the importance of the social context in shaping participation in HIV prevention trials, beyond focusing solely on individual characteristics. This points to the need to focus interventions to improve visit attendance by promoting a culture of active and engaged participation.

'I heard about this study on the radio': using community radio to strengthen Good Participatory Practice in HIV prevention trials.

BACKGROUND: During the Microbicides Development Program (MDP) 301, a clinical trial of a candidate microbicide amongst women in Johannesburg, South Africa, we used community radio to promote awareness of the trial, to inform community members about specific medical research procedures and terminologies, and to stimulate dialogue between researchers and local citizens. METHODS: We used mixed methods to undertake a retrospective analysis of the social responses to the radio shows, focusing specifically on recruitment and participation in the MDP301 trial. We collected quantitative data that describes the themes and listener responses, the costs per broadcast, and the impact of the radio broadcasts on trial recruitment. Qualitative data on local reactions to the shows was gleaned from in-depth interviews with trial participants. RESULTS: Over a seven-year period, 205 individual broadcasts were made on two separate community radio stations. Show themes were either specifically related to medical research issues (36%), or focused on general health issues (46%), and sexual and reproductive health, including HIV prevention (18%). 403 listeners made telephone calls to the radio station, and 12% of women enrolled as participants in MDP301 (n = 9, 385) reported that they had first heard about the trial from the radio. Qualitative interviews (n = 401) with female MDP301 participants highlighted the effects of the radio shows in making women aware of the trial, impressing them with the importance of health screening and knowledge, legitimizing trial participation, and stimulating dialogue between trial participants and their male partners. CONCLUSIONS: Community radio is a potent tool for raising awareness and local knowledge about medical research and, in addition to other methodologies, can be used to promote recruitment into clinical trials. We suggest that future HIV prevention trials consider an investment in community radio beyond recruitment advertisements that incorporates this into the broader community engagement plan as a key element of Good Participatory Practice in clinical trial settings.

Cognitive mapping: using local knowledge for planning health research.

BACKGROUND: Cognitive mapping is a participatory research methodology that documents, in visual form, a construct of the local environment in which people live and work. We adapted this method to provide detailed data about study locales to inform recruitment and retention strategies for HIV prevention community based clinical trials. METHODS: Four cognitive mapping studies were undertaken between 2005 and 2010, in and around Johannesburg in Orange Farm, and Hillbrow. Participants included members of clinical trial Community Advisory Boards (CAB), young people recruited from schools in Hillbrow and an organization for out of school youth, and men recruited from a database of men in the community interested in taking part in research. These groups participated in reconnaissance walks and in depth interviews, and drew detailed sketch maps. RESULTS: The cognitive maps defined the physical boundaries of the research locales, provided insights into their social histories, and identified important characteristics of the population such as movement, social and sexual networks, ethnic and other divisions. Important differences between the official cartographic maps and the cognitive maps were raised. The mapping data was applied by identifying key areas for recruitment that recruitment staff members were less familiar with and that may otherwise have been overlooked. CONCLUSIONS: Cognitive mapping is an effective, rapid and low cost method that can be used to inform recruitment and retention strategies for community-based clinical trial research. The method also provides a means for clinical trial researchers to involve the local community in research and to familiarise them with the social setting.

Malicious whites, greedy women, and virtuous volunteers: negotiating social relations through clinical trial narratives in South Africa.

As clinical trial research increasingly permeates sub-Saharan Africa, tales of purposeful HIV infection, blood theft, and other harmful outcomes are widely reported by participants and community members. Examining responses to the Microbicide Development Programme 301-a randomized, double-blind, placebo-controlled microbicide trial-we investigate the ways in which these accounts embed medical research within postcolonial contexts. We explore three popular narratives circulating around the Johannesburg trial site: malicious whites killing participants and selling their blood, greedy women enrolling in the trial solely for financial gain, and virtuous volunteers attempting to ensure their health and aid others through trial participation. We argue that trial participants and community members transform medical research into a meaningful tool that alternately affirms, debates, and challenges contemporary social relations.

'The study has taught me to be supportive of her': empowering women and involving men in microbicide research.

Recognising that women often have little control over most HIV-prevention methods, including condoms, researchers have made efforts to develop new bio-technological interventions, such as microbicides, that could allow women greater autonomy in HIV-prevention decision making. In many situations, women are unable to negotiate condom use with their partners, meaning that they could be better protected through the use of an effective microbicide. This paper uses qualitative data from the Microbicide Development Programme 301 (MDP301) microbicide trial in Johannesburg, South Africa. Data is taken from in-depth interviews with male partners of female trial participants (n = 28), six focus-group discussions involving male partners of trial participants (n = 4) and female participants (n = 2). Data show that men's involvement in microbicide research ranges from a disinterest in trials to the desire to actively take part in and promote research that affects the health of themselves and their partners. Results showed that some participants were reluctant to disclose trial involvement and product use to their partners, making identifying men as potential research participants problematic. This paper considers how to involve men in microbicide research without undermining women's sense of empowerment and ownership of the trial and the product that is being tested.

Blockage and flow: intimate experiences of condoms and microbicides in a South African clinical trial.

Based on qualitative research undertaken during a phase-three microbicide gel trial, this paper explores female participants' experiences and perceptions of gel and condom use and the opinions of their male partners and community members. Participants were aware that condoms were effective in preventing HIV infection and that the efficacy of the microbicide was unproven. Yet, in narratives about gel and condom use, participants ascribed improvements to their reproductive health and intimate relationships with men to gel use. In contrast, condoms were believed to prevent disease, yet also embodied mistrust, were believed to contain dangerous substances and were felt to block the womb. These apparently contradictory views about condoms and gels are explored in the light of conceptions of flow and blockage. Health is achieved by maintaining a steady balance of substances within the body, while preventing fluid flow results in illness. We argue that women enrolled in the trial broadened the meaning of the gel beyond its primary intended effect of preventing HIV. Through their accounts of gel use, women 'reinvented' the gel as a substance that transformed their bodies and sexual relations. This has implications for understanding how local knowledge of health and illness intersects with biomedical knowledge.

Investing in the future: lessons learnt from communicating the results of HSV/ HIV intervention trials in South Africa.

BACKGROUND: Communicating the results of randomised controlled trials may present challenges for researchers who have to work with communities and policy-makers to anticipate positive outcomes, while being aware that results may show no effect or harm. METHODS: We present a case study from the perspective of researchers in South Africa about the lessons learnt from communicating the results of four trials evaluating treatment for herpes simplex virus type 2 (HSV-2) as a new strategy for HIV prevention. RESULTS: We show that contextual factors such as misunderstandings and mistrust played an important role in defining the communications response. Use of different approaches in combination was found to be most effective in building understanding, credibility and trust in the research process. During the communication process, researchers acted beyond their traditional role of neutral observers and became agents of social change. This change in role is in keeping with a global trend towards increased communication of research results and presents both opportunities and challenges for the conduct of future research. CONCLUSIONS: Despite disappointing trial results which showed no benefit of HSV-2 treatment for HIV prevention, important lessons were learnt about the value of the communication process in building trust between researchers, community members and policy-makers, and creating an enabling environment for future research partnerships.

Re-framing microbicide acceptability: findings from the MDP301 trial.

Microbicides are most usually conceptualised within a disease prevention framework and studies usually define acceptability in terms of product characteristics, willingness to use and risk reduction. This starting point has led to assumptions about microbicides which, rather than being challenged by empirical studies, have tended to foreclose the data and subsequent conceptual models. Few studies take an emic ('insider') perspective or attempt to understand how microbicides fit into the broader context of women's and men's everyday lives. As part of the integrated social science component of the MDP301 Phase III microbicide trial, in-depth interviews were conducted with female trial participants in South Africa, Zambia, Tanzania and Uganda. Women's experiences of the gel challenge several assumptions that have commonly been reiterated about microbicides. Our analysis suggests that current definitions and conceptual frameworks do not adequately account for the range of meanings that women attribute to gel. Even within the context of a clinical trial, it is possible to obtain a richer, ethnographic and cross-cultural concept of acceptability based on women's practice and emic interpretations. We now need to move beyond limited notions of acceptability and consider how microbicides fit into a more holistic picture of women's and men's sexuality and sexual health.

Gelling medical knowledge: innovative pharmaceuticals, experience, and perceptions of efficacy.

As new pharmaceutical products to combat the acquisition of HIV are produced, their clinical efficacy is determined through large-scale clinical trials. Trial participants, however, also independently evaluate the effectiveness of these technologies. During a phase III microbicide clinical trial in Johannesburg, South Africa, female participants acknowledged that although the gel had not yet been clinically proven to be efficacious, they believed that it was capable of healing infections, cleansing the vagina, increasing fertility, and preventing HIV. These responses were informed by experiences of gel use coupled with ideas regarding the flow of bodily fluids and the removal of dirt for bodily cleanliness and the maintenance of health. Examining participant responses to the gel provides insight into the relationship between knowledge and experience when utilizing previously unfamiliar biotechnologies.

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.