Jonathan Stadler

Women's Experiences with Oral and Vaginal Pre-Exposure Prophylaxis: The VOICE-C Qualitative Study in Johannesburg, South Africa

Background In VOICE, a multisite HIV pre-exposure prophylaxis (PrEP) trial, plasma drug levels pointed to widespread product nonuse, despite high adherence estimated by self-reports and clinic product counts. Using a socio-ecological framework (SEF), we explored socio-cultural and contextual factors that influenced participants’ experience of daily vaginal gel and oral tablet regimens in VOICE. Methods In Johannesburg, a qualitative ancillary study was concurrently conducted among randomly selected VOICE participants assigned to in-depth interviews (n = 41), serial ethnographic interviews (n = 21), or focus group discussions (n = 40). Audiotaped interviews were transcribed, translated, and coded thematically for analysis. Results Of the 102 participants, the mean age was 27 years, and 96% had a primary sex partner with whom 43% cohabitated. Few women reported lasting nonuse, which they typically attributed to missed visits, lack of product replenishments, and family-related travel or work. Women acknowledged occasionally skipping or mistiming doses because they forgot, were busy, felt lazy or bored, feared or experienced side effects. However, nearly all knew or heard of other study participants who did not use products daily. Three overarching themes emerged from further analyses: ambivalence toward research, preserving a healthy status, and managing social relationships. These themes highlighted the profound and complex meanings associated with participating in a blinded HIV PrEP trial and taking antiretroviral-based products. The unknown efficacy of products, their connection with HIV infection, challenges with daily regimen given social risks, lack of support–from partners and significant others–and the relationship tradeoffs entailed by using the products appear to discourage adequate product use. Conclusions Personal acknowledgment of product nonuse was challenging. This qualitative inquiry highlighted key influences at all SEF levels that shaped women’s perceptions of trial participation and experiences with investigational products. Whether these impacted women’s behaviors and may have contributed to ineffective trial results warrants further investigation.

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

Abstract 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.

A mixed methods and triangulation model for increasing the accuracy of adherence and sexual behaviour data: the Microbicides Development Programme

Background The collection of accurate data on adherence and sexual behaviour is crucial in microbicide (and other HIV-related) research. In the absence of a “gold standard” the collection of such data relies largely on participant self-reporting. After reviewing available methods, this paper describes a mixed method/triangulation model for generating more accurate data on adherence and sexual behaviour in a multi-centre vaginal microbicide clinical trial. In a companion paper some of the results from this model are presented [1]. Methodology/Principal Findings Data were collected from a random subsample of 725 women (7.7% of the trial population) using structured interviews, coital diaries, in-depth interviews, counting returned gel applicators, focus group discussions, and ethnography. The core of the model was a customised, semi-structured in-depth interview. There were two levels of triangulation: first, discrepancies between data from the questionnaires, diaries, in-depth interviews and applicator returns were identified, discussed with participants and, to a large extent, resolved; second, results from individual participants were related to more general data emerging from the focus group discussions and ethnography. A democratic and equitable collaboration between clinical trialists and qualitative social scientists facilitated the success of the model, as did the preparatory studies preceding the trial. The process revealed some of the underlying assumptions and routinised practices in “clinical trial culture” that are potentially detrimental to the collection of accurate data, as well as some of the shortcomings of large qualitative studies, and pointed to some potential solutions. Conclusions/Significance The integration of qualitative social science and the use of mixed methods and triangulation in clinical trials are feasible, and can reveal (and resolve) inaccuracies in data on adherence and sensitive behaviours, as well as illuminating aspects of “trial culture” that may also affect data accuracy.

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 womens and mens 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. Womens 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 womens 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 womens and mens sexuality and sexual health.

Assessing the Accuracy of Adherence and Sexual Behaviour Data in the MDP301 Vaginal Microbicides Trial Using a Mixed Methods and Triangulation Model

Background Accurate data on adherence and sexual behaviour are crucial in microbicide (and other HIV-related) research. In the absence of a “gold standard” the collection of such data relies largely on participant self-reporting. The Microbicides Development Programme has developed a mixed method/triangulation model for generating more accurate data on adherence and sexual behaviour. Methodology/Principal Findings Data were collected from a random subsample of 725 women using structured case record form (CRF) interviews, coital diaries (CD) and in-depth interviews (IDI). Returned used and unused gel applicators were counted and additional data collected through focus group discussions and ethnography. The model is described in detail in a companion paper [1]. When CRF, CD and IDI are compared there is some inconsistency with regard to reporting of sexual behaviour, gel or condom use in more than half. Inaccuracies are least prevalent in the IDI and most prevalent in the CRF, where participants tend to under-report frequency of sex and gel and condom use. Women reported more sex, gel and condom use than their partners. IDI data on adherence match the applicator-return data more closely than the CRF. The main reasons for inaccuracies are participants forgetting, interviewer error, desirability bias, problems with the definition and delineation of key concepts (e.g. “sex act”). Most inaccuracies were unintentional and could be rectified during data collection. Conclusions/Significance The CRF – the main source of self-report data on behaviour and adherence in many studies – was the least accurate with regard to measuring sexual behaviour, gel and condom use. This has important implications for the use of structured questionnaires for the collection of data on sexual behaviour and adherence. Integrating in-depth interviews and triangulation into clinical trials could increase the richness and accuracy of behavioural and adherence data.

Perspectives on use of oral and vaginal antiretrovirals for HIV prevention: the VOICE-C qualitative study in Johannesburg, South Africa

Antiretroviral (ARV)‐based pre‐exposure prophylaxis (PrEP) is a promising new HIV prevention strategy. However, variable levels of adherence have yielded mixed results across several PrEP trials and populations. It is not clear how taking ARV – traditionally used for HIV treatment – is perceived and how that perception may affect the use of these products as preventives. We explored the views and experiences of VOICE participants, their male partners and community members regarding the use of ARV as PrEP in the VOICE trial and the implications of these shared meanings for adherence.

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.

Secrecy, disclosure and accidental discovery: perspectives of diaphragm users in Mombasa, Kenya

The diaphragm is receiving renewed attention as a promising female‐controlled method of preventing HIV and other sexually‐transmitted infections. It is anticipated that female‐controlled technologies will reduce womens biological susceptibility and assist in counteracting their sociocultural vulnerability to HIV. Understanding the subjective experiences of diaphragm users in different settings has the potential to inform the development and promotion of such methods. This paper explores the perspectives of female sex workers and women attending sexual and reproductive health services in Mombasa, Kenya. Data are reported from focus group discussions and in‐depth interviews with women and men, following a prospective study investigating diaphragm continuation rates over six months. Discussions highlighted covert use of the diaphragm, during sex work or with casual partners, and coital independence as favourable attributes. These features were especially pronounced compared with male condoms. Few difficulties with diaphragm use were reported, although its insertion and removal occasionally presented problems. Many women—especially those in long term partnerships—wished to disclose its use but found the disclosure process highly problematic. Accidental discovery often resulted in partner conflict. Although future uptake of the diaphragm may be high in this setting, its use may be limited to certain types of relationships and relationship context.

Rumours about blood and reimbursements in a microbicide gel trial

A rumour that emerged during a microbicide gel trial tells the tale of clinic staff purchasing trial participants’ blood. This paper documents the rumour and explores its divergent interpretations and meanings in relation to the context of the trial and the social and economic setting at two of the trial sites (Soweto and Orange Farm) in South Africa. The article is based on qualitative research conducted during the Microbicides Development Programme (MDP) 301 trial to evaluate a microbicide vaginal gel for HIV prevention in women. The research incorporated in-depth interviews with female trial participants and their male partners, focus group discussions with male and female community members, and participant observation in the trial clinic and community setting at the two sites. The article analyses the different perspectives among the clinic staff, community and trial participants in terms of which the rumour about the exchange of blood for cash is seen as: 1) the result of ignorance of the clinical trial procedures; 2) the exploitation of poor and vulnerable women; 3) an example of young womens desire for material gain; and 4) a reciprocal exchange of ‘clean blood’ for cash between women trial participants and the health services. We suggest that the rumours about selling blood verbalise notions of gender and morality while also providing an appraisal of the behaviour of young women and a critique of social relationships between foreign researchers and local participants. Through stories about the clinical trial procedures and its potential reimbursements, the participants were creating and reconfiguring social relationships. Ultimately, rumours are one way in which foreign enterprises such as a clinical trial are rendered local.

‘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 mens 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 womens sense of empowerment and ownership of the trial and the product that is being tested.