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ABSTRACT: Duet(®) is a microbicide-delivery system and cervical barrier for use daily or precoitally. We conducted a crossover study among 80 Zimbabwean women to explore factors associated with use-regimen preference. Women were assigned in random order to 14 days of precoital and 14 days of daily Duet and BufferGel use. About 51 % of women preferred precoital use, 39 % preferred daily use, and 10 % liked both equally. Overall product adherence during sex was similar for both use-regimens. In multivariable analysis, diaphragm experience was associated with preference for precoital use (AOR 2.80, 95 % CI 1.01-7.76). Reasons for preferring precoital use included use only when needed, cleanliness, and discomfort with daily use. Daily use preference included convenience, discreetness, and being prepared for "sex-on-demand." Different personal and life circumstances may result in varying use-regimen preferences. Methods that can accommodate both coitally-related and daily use may be advantageous by providing more choice to users.
AIDS and Behavior 07/2012; 16(7):1799-1807. · 3.49 Impact Factor
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ABSTRACT: This paper presents empirical data on motivation to join an HIV prevention trial of vaginal microbicide gels in Malawi and Zimbabwe, and participant assumption of a preventive misconception. Interviews were conducted with women participating in the trial and their male partners. Most of the female participants were able to adequately describe basic aspects of the trial design. HIV counseling and testing were primary reasons motivating women's participation, and male partners' support of the trial. 29% of women and 20% of men also provided indications of a preventive misconception, attributing gel use and trial participation to avoiding HIV infection.
AIDS and Behavior 08/2011; 16(3):785-90. · 3.49 Impact Factor
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ABSTRACT: Our current understanding of factors associated with microbicide acceptability and consistent use typically has been derived from separate and distinct qualitative or quantitative studies. Specifically, rarely have investigators used mixed methods to both develop and validate behavioral measures. We utilized an integrated mixed methods design, including qualitative metasyntheses, cognitive interviews and expert reviews, psychometric evaluation, and confirmatory qualitative analyses of the correspondence between quantitative items and original qualitative data to develop and validate measures of factors associated with microbicide acceptability and use. We describe this methodology and use the development of the Relationship Context Scale to illustrate it. As a result of independent confirmatory analyses of qualitative passages corresponding to survey items, we demonstrated that items from the same subscales are frequently double coded within a particular textual passage, and thematically related, suggesting associations that resulted in a unique factor structure within the subscale. This integrated mixed method design was critical to the development of this psychometrically validated behavioral measure, and could serve as a model for future measure development.
Qualitative Health Research 03/2011; 21(7):987-99. · 2.19 Impact Factor
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ABSTRACT: Adherence problems with coitally dependent, female-initiated HIV prevention methods have contributed to several trials' failure to establish efficacy. Continuous use of a cervical barrier with once-daily cleaning and immediate reinsertion may simplify use for women and improve adherence. We assessed the acceptability and safety of precoital and continuous use of the Duet, a cervical barrier and gel delivery system, in Zimbabwean women.
Using a two-arm crossover design with a parallel observation group, we randomized 103 women in a 2:2:1 ratio: (1) to use the Duet continuously for 14 days, followed by a minimum of seven days of washout and then 14 days of precoital use; (2) to use the same Duet regimens in reverse order; or (3) for observation only. Women were aged 18 to 40 years; half were recruited from a pool of previous diaphragm study participants and the other half from the general community. Acceptability and adherence were assessed through an interviewer-administered questionnaire at each of two follow-up visits. Safety was monitored through pelvic speculum exams and report of adverse events.
The proportion of women who reported consistent Duet use during sex was virtually identical during continuous and precoital regimens (88.6% vs. 88.9%). Partner refusal was the most common reason cited for non-use during sex in both use regimens. Not having the device handy was the most common reason cited for non-daily use (in the continuous regimen). Most women were "very comfortable" using it continuously (86.3%) and inserting it precoitally (92.8%). The most favoured Duet attribute was that it did not interfere with "natural" sex (55%). The least favoured Duet attribute was the concern that it might come out during sex (71.3%). No serious adverse events were reported during the study; 57 participants reported 90 adverse events classified as mild or moderate. There were no statistically significant differences in: (1) the proportion of women reporting adverse events; (2) the severity of events among those using the Duet and observational controls; or (3) event severity reported during each regimen use period.
In this study, the Duet was found to be acceptable and safe when inserted precoitally or used continuously for 14 days. Assignment to use of the Duet continuously did not increase adherence to the Duet during sex. Future HIV prevention trials should evaluate use of the Duet (precoitally and continuously) with promising microbicide candidates.
Journal of the International AIDS Society 01/2010; 13:30. · 3.26 Impact Factor
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ABSTRACT: Topical vaginal microbicides are being developed to reduce HIV infection in women for whom correct and consistent condom use is impossible or undesirable. Although microbicides have been heralded as a "women-initiated" method that requires no action of the male partner, gender norms for sexual relationships and sexual practices could impede acceptability and use. To facilitate development of microbicides and look ahead to their eventual introduction, it is necessary to understand couples' sexual dynamics, including power and pleasure. This article presents data from a study of microbicide acceptability ancillary to a microbicide clinical trial in Malawi and Zimbabwe. Female trial participants, male partners, health care professionals and community stakeholders were interviewed about norms for sexual decision-making, sexual pleasure, and associated intravaginal practices that ensure this pleasure. Even though acceptability of microbicides was found to be high, sexual intercourse is accompanied by issues of power and gender norms that place women, particularly those in stable union, at a disadvantage for enactment of risk reduction strategies. Although woman-initiated use is an important goal in development of microbicides, the need for men's cooperation or agreement must be addressed in strategies for future product introduction.
AIDS Education and Prevention 05/2008; 20(2):171-87. · 1.59 Impact Factor
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ABSTRACT: Along with efficacy, a microbicide's acceptability will be integral to its impact on the pandemic. Understanding Product Characteristics that users find most acceptable and determining who will use which type of product are key to optimizing use effectiveness.
To evaluate psychometrically the Important Microbicide Characteristics (IMC) instrument and examine its relationship to willingness to use microbicides.
Exploratory and confirmatory factor analyses revealed 2 IMC subscales (Cronbach's coefficient alpha: Product Characteristics subscale (alpha = 0.84) and Protective Properties subscale (alpha = 0.89)). Significant differences on Product Characteristics subscale scores were found for history of douching (P = 0.002) and employment status (P = 0.001). Whether a woman used a method to prevent pregnancy or sexually transmitted disease (STD) in the last 3 months (P < 0.001) and whether she used a condom during the last vaginal sex episode (P < 0.001) were significantly related to her rating of the importance of microbicides being contraceptive. Product Characteristics (r = 0.21) and Protective Properties (r = 0.27) subscale scores and whether a microbicide had contraceptive properties (r = 0.24) were all significantly associated (P < 0.001) with willingness to use microbicides.
Formulation and use characteristics and product function(s) affect willingness to use microbicides and should continue to be addressed in product development. The IMC instrument serves as a template for future studies of candidate microbicides.
JAIDS Journal of Acquired Immune Deficiency Syndromes 05/2007; 45(1):93-101. · 4.43 Impact Factor
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ABSTRACT: ACHIEVING RESPECT FOR PERSONS is problematic in settings with concepts of autonomy that differ from Western values. For international research, women's autonomy to consent to participation is an increasingly contentious issue. We present data from ancillary studies conducted in preparation for a clinical trial testing the safety and efficacy of topical microbicides, used to prevent HIV infection. These ancillary studies were conducted in seven countries, using qualitative research methods to collect data from female and male community members, and their health care professionals and community leaders. Our findings indicate that by working at the level of the community, couple and individual, researchers may be able to take steps to increase women's ability to make their own independent decisions about participating in research. This approach may, in turn, improve both the conduct and outcomes of research.
Journal of Empirical Research on Human Research Ethics 10/2006; 1(3):11-26. · 1.27 Impact Factor
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ABSTRACT: The concept of acceptability involves a complex set of individual, couple and socio-cultural factors. Within a specific focus on microbicides, this article sets forth the relevant behavioral issues demanding attention as scientists and product developers strive to identify microbicides that will be used in a sustained, long-term fashion to prevent HIV/AIDS. The paper re-conceptualizes long-term acceptability within the ARRM framework, reviews the basic issues and research related to microbicide acceptability, discusses couple relationships (especially the nature of intimate relationships), and identifies related gender and power factors. The importance of the cultural context within various international settings pervades all of these issues. Finally, a set of challenges is discussed for those contemplating such research.
AIDS and Behavior 04/2005; 9(1):121-31. · 3.49 Impact Factor
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ABSTRACT: HIV prevention research in developing countries has resulted in increased attention to and discussion of ethical issues, particularly the issue of the quality of informed consent. We present a conceptual framework for an enhanced informed consent process, drawing on experiences garnered from domestic and international studies conducted by the HIV Prevention Trials Network, funded by the National Institutes of Health. This framework guides the development of an informed consent process designed to help ensure initial and continued comprehension of research participation, with an emphasis on HIV prevention research. Attention is focused at the individual and community levels and on 3 study phases: preenrollment, enrollment, and postenrollment.
American Journal of Public Health 04/2005; 95(3):412-9. · 3.93 Impact Factor
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ABSTRACT: Domains central to the effects of sexual relationships on the acceptability of a vaginal protection method were explored in 14 focus groups and 38 in-depth interviews with women and men recruited from a health department's sexually transmitted infections (STI) and family planning clinics. Findings indicate that acceptability depended on a couple's relationship type, classified as serious, casual, or "new." Potential barriers to communication about product use may be overcome through direct or indirect covert use, depending on relationship type. More men than women thought women should always tell their partners if they use microbicides, regardless of relationship type. Results indicate the importance of the relationship context in understanding the likely acceptability of using microbicides, and perhaps any method of STI/HIV protection.
Journal of Social Issues 03/2005; 61(1):67-93. · 1.96 Impact Factor
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ABSTRACT: Advances in new reproductive health technologies have surfaced an array of social and behavioral issues regarding decision-making and use of these technologies, underscoring the need for research on such topics as reproductive health decision-making, sexual practices, and norms and values for childbearing and family formation. Using topical microbicides as an example of a new method to prevent Sexually Transmitted infections (STIs), Human Immunodeficiency Virus (HIV) and/or pregnancy, we focus on gaps in information to inform reproductive health decision-making, noting in particular the discrepancies between data on clinical efficacy and typical use-effectiveness. Constraints on government and private sector support for research, particularly research on aspects of sexual behavior, contribute to problems with the availability of information for decision-making about use of reproductive health technologies.
Journal of Social Issues 02/2005; 61(1):193 - 205. · 1.96 Impact Factor
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Cynthia Woodsong
Perspectives on Sexual and Reproductive Health 36(3):127-31. · 1.41 Impact Factor
