Neetha S. Morar

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.

The acceptability of an investigational vaginal microbicide, PRO 2000 Gel, among women in a phase I clinical trial.

PURPOSE Vaginal microbicides will provide a woman-initiated prevention strategy that could substantially reduce rates of HIV infection. The acceptability of microbicides will greatly influence the use and, hence, effectiveness of such products. In this study, the acceptability of an investigational microbicide, PRO 2000 Gel (Indevus Pharmaceuticals, Inc., Lexington, MA), was assessed, and womens opinions about microbicides and their potential for real world use were gathered. METHODS Quantitative and qualitative data were collected from 30 U.S. and 33 South African women. All sexually active HIV-uninfected women and all sexually abstinent HIV-infected women participating in this phase I clinical trial stated in a survey that they would use PRO 2000 Gel if they had reason to be concerned about HIV and the product were available. Qualitative data, however, provided insight into the nuances of acceptability ratings. Women rated product safety, ease of use, and positive effects on sexual pleasure among the most important characteristics of acceptable microbicides. RESULTS Opinions regarding product leakage, contraceptive capability, and the ability to be used without partners noticing, as well as characteristics of the product itself, varied substantially based on the context of sex and perceptions of risk within each individual womans life. CONCLUSIONS As microbicide development continues and the first investigational products move into efficacy trials, the needs and preferences of those women who constitute the potential users of microbicides become paramount. Providing woman-initiated microbicides that are safe, easy to use, and pleasurable will be key to the impact these products will have on the AIDS epidemic worldwide.

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.

Recording sexual behavior: comparison of recall questionnaires with a coital diary.

OBJECTIVE To compare sexual behavior data obtained using a weekly-recall questionnaire, a daily-recall questionnaire, and a coital diary. DESIGN Cross-sectional survey of female sex workers from KwaZulu-Natal, South Africa between August and October 1998. METHODS In this study, 52 weekly-recall questionnaires, 27 daily-recall questionnaires, and 79 coital diaries for dates corresponding to the questionnaires were obtained from female sex workers. Variables examined included: number of clients, number of condoms used with clients and partners, and number and type of sexual acts with clients and partners. Statistical analyses were conducted to examine the degree of agreement between the data collection methods and to assess differences between the mean values of the variables in the questionnaires versus the diary. RESULTS Comparison of weekly-recall questionnaires with coital diaries indicated a significantly greater mean number of clients (P < 0.001), number of condoms used (P < 0.001), vaginal acts (P < 0.001), and anal acts (P = 0.044) reported in the diary versus the questionnaire. On comparison of daily-recall questionnaire with coital diary, significant differences were revealed between the means detected for the number of clients (P = 0.027), number of days worked (0.009), and anal acts with clients (P = 0.004). CONCLUSIONS The use of coital diaries for the collection of sexual behavior data may be limited to cross-sectional community surveys. A recall questionnaire may provide more reliable and a better quality of data for longitudinal studies and for human immunodeficiency virus/sexually transmitted disease evaluation programs.

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.

South Africa's Experience of the Closure of the Cellulose Sulphate Microbicide Trial

The researchers who conducted the cellulose sulphate microbicide trial share the lessons they learned from the trials early closure.

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.

Challenges in the conduct of vaginal microbicide effectiveness trials in the developing world.

Conducting a phase III trial of a vaginal microbicide in a developing country poses several important and complex ethical challenges. As part of a process to bridge the gap between ethical theory and practice, we share our experiences in performing a phase III trial of Col 1492 (Advantage S) among female sex workers at four sites world-wide; Durban, Abidjan, Cotonou and Hat Yai. The ethical challenges included: (i) difficulties in obtaining informed consent. Participants were unable to grasp the concepts of a clinical trial for several weeks to months. In Cotonou, 30% of the women did not know the gel was tested for HIV prevention. Only 25% understood what a placebo was. In Durban, 70% of the women did not fully understand the study after 3 months; (ii) in sustaining the use of known HIV prevention strategies. Participants at the Durban site had difficulty in sustaining condom use due to financial and client preferences. Sex without condoms was worth more (

Carraguard Vaginal Gel Safety in HIV-Positive Women and Men in South Africa

20) than sex with condoms (

Acceptability of Carraguard, a candidate microbicide and methyl cellulose placebo vaginal gels among HIV-positive women and men in Durban, South Africa

10); (iii) in maintaining the confidentiality of the subjects HIV status. Novel approaches such as role plays and emphasis on other exclusion criteria were needed to maintain the confidentiality of women not included in the trial due to their HIV status; (iv) in providing care and support to the subjects who became infected with HIV during the trial. Women could only be offered routine sexually transmitted disease treatment and counselling. Anti-retrovirals were not offered. The successes and failures of the solutions attempted are described.