Shelley Lees

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.

The benefits of participatory methodologies to develop effective community dialogue in the context of a microbicide trial feasibility study in Mwanza, Tanzania.

BackgroundDuring a microbicide trial feasibility study among women at high-risk of HIV and sexually transmitted infections in Mwanza, northern Tanzania we used participatory research tools to facilitate open dialogue and partnership between researchers and study participants.MethodsA community-based sexual and reproductive health service was established in ten city wards. Wards were divided into seventy-eight geographical clusters, representatives at cluster and ward level elected and a city-level Community Advisory Committee (CAC) with representatives from each ward established. Workshops and community meetings at ward and city-level were conducted to explore project-related concerns using tools adapted from participatory learning and action techniques such as listing, scoring, ranking, chapatti diagrams and pair-wise matrices.ResultsKey issues identified included beliefs that blood specimens were being sold for witchcraft purposes; worries about specula not being clean; inadequacy of transport allowances; and delays in reporting laboratory test results to participants. To date, the project has responded by inviting members of the CAC to visit the laboratory to observe how blood and genital specimens are prepared; demonstrated the use of the autoclave to community representatives; raised reimbursement levels; introduced HIV rapid testing in the clinic; and streamlined laboratory reporting procedures.ConclusionParticipatory techniques were instrumental in promoting meaningful dialogue between the research team, study participants and community representatives in Mwanza, allowing researchers and community representatives to gain a shared understanding of project-related priority areas for intervention.

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

BackgroundHIV 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.MethodsA 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 womens 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.Results99 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.ConclusionsProviding 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 registrationCurrent Controlled Trials ISRCTN64716212

A model for community representation and participation in HIV prevention trials among women who engage in transactional sex in Africa

Abstract Actively engaging communities in effective partnerships for the design and implementation of HIV prevention research is vital to the successful conduct of ethically robust, locally-appropriate clinical trials in developing countries. This is especially true in vulnerable at-risk sub-populations, where definitions of “community”, “participation” and “representation” can be difficult to apply. This study was conducted to investigate the feasibility of a participatory model of community liaison among an occupational cohort of women at high-risk of HIV and sexually-transmitted infections in Mwanza City, northwest Tanzania in preparation for a Phase III vaginal microbicide trial. This approach was rooted in participatory action-orientated research and used tools adapted from participatory learning and action techniques. During the feasibility study, a mobile community-based sexual and reproductive health service for women working as informal food vendors or in traditional and modern bars, restaurants, hotels and guesthouses was established in 10 city wards. Participatory mapping was carried out by project fieldworkers and wards divided into 78 geographical clusters of facilities in consultation with community members and study participants. Representatives at cluster and ward level were elected in a process facilitated by the site Community Liaison Officer and a site-level Community Advisory Committee established. A logical framework was used to guide the implementation, monitoring and evaluation of the community liaison system (CLS) within the broader feasibility study. The CLS was essential to the successful conduct of the feasibility study and has now been consolidated and expanded as part of the on-going MDP301 Phase III microbicide trial in Mwanza. The participatory model presented in this paper is likely to be generalisable to other vulnerable, stigmatised, at-risk study populations in resource-limited settings.

Sexual risk behaviour for women working in recreational venues in Mwanza, Tanzania: considerations for the acceptability and use of vaginal microbicide gels.

Qualitative research was conducted to explore the social context of sexual-risk behaviour among women working in recreational occupations, during a feasibility study in preparation for the Phase III clinical trial of vaginal microbicides in Mwanza, Tanzania. Participant observation was conducted in 68 recreational venues. Six focus group discussions were conducted with women working in recreational occupations and two with male customers at these venues. Findings revealed that these women are at risk of HIV due their dependence on sexual transactions to improve their economic circumstances, which take place in environments and relationships where condom use is difficult. However, the findings revealed that, in spite of constraints, women did take actions to prevent HIV by negotiating for condom use or avoiding perceived risky practices or partnerships, in particular moving to more casual partnerships where condom negotiation is more acceptable. This indicates that, given their perception of their own risk, women working in recreational occupations will welcome an effective microbicide. However, sustained use will depend on how formulations overcome the difficulties women currently experience with condom negotiation and the specific environments and relationships in which they engage in sex.

Validity of coital diaries in a feasibility study for the Microbicides Development Programme trial among women at high risk of HIV/AIDS in Mwanza, Tanzania.

Objectives: To compare coital diaries and face-to-face interviews (FFIs) in measuring sexual behaviour among women at high risk of HIV. To assess the effect of differing levels of support from researchers on reporting in coital diaries and FFIs. Methods: Three groups of 50 women were randomly selected from a cohort of food and recreational facility workers participating in a microbicide trial feasibility study and received differing levels of researcher support. Minimum support involved delivering and collecting coital diaries weekly; medium support included a weekly FFI and discussion of concerns; intensive support also included an unscheduled mid-week visit when diaries were checked and concerns addressed. All respondents participated in an exit FFI, including questions on sexual behaviour over the four-week study period and study acceptability. Results: Sexual behaviours were generally reported more frequently in coital diaries than weekly or exit interviews. Vaginal and anal sex, male and female condom use, vaginal cleaning and lubrication, sex during menstruation and sex with irregular and regular partners were reported more frequently in coital diaries than exit interviews. In coital diaries, level of support was associated with reporting of vaginal sex and cleaning. In exit interviews, support level was associated with reporting of vaginal sex, vaginal cleaning and sex with regular, irregular and commercial partners. Women with minimum support reported least satisfaction with the research process. Women with intensive support were most likely to report that they informed someone about their study participation and that they completed diaries daily. Conclusion: Compared with FFIs, coital diaries resulted in higher reporting of socially stigmatised activities, and sexual behaviour reporting varied less by level of support. More researcher support enhanced study acceptability.

Understanding motives for intravaginal practices amongst Tanzanian and Ugandan women at high risk of HIV infection: The embodiment of social and cultural norms and well-being

Some types of intravaginal practices (IVP) may increase the risk for HIV acquisition. This is particularly worrisome for populations with dual high prevalence of HIV and IVP. Women involved in transactional sex are at increased risk for HIV infection in sub-Saharan Africa. Social, cultural and economic influences are strong drivers of IVP in this population. To explore this, we carried out a qualitative research study to investigate the drivers and motivations for using IVP within a large observational study of women at high risk of HIV in Tanzania and Uganda from September 2008 to September 2009. Of the 201 women selected, 176 women took part in a semi-structured in-depth interview. Additionally, in Tanzania, eight focus group discussions among study participants and community members were carried out to obtain information on community norms and expectations. IVP were motivated by overlapping concerns with hygiene, morality, sexual pleasure, fertility, relationship security, and economic security. These motives were driven by the need to meet cultural and social expectations of womanhood, and at the same time attend to personal well-being. Among women involved in transactional sex in East Africa, interventions aimed at modifying or eliminating IVP should attend to local cultural and social norms as well as the individual as an agent of change.