Elizabeth E. Tolley

A Framework for Examining the Sustained Acceptability of Microbicides

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.

Acceptability and adherence of a candidate microbicide gel among high-risk women in Africa and India

Vaginal microbicides currently under development are substances that may prevent the transmission of HIV. Qualitative, in-depth post-trial interview data from a Phase III clinical trial of 6% Cellulose Sulfate microbicide gel in two sites in Africa (Uganda and Benin) and two in India (Chennai and Bagalkot) were examined in order to better understand factors that influence microbicide acceptability and adherence in a clinical trial setting. Women found the gel relatively easy to use with partners with whom there were no expectations of fidelity, in situations where they had access to private space and at times when they were expecting to engage in sexual intercourse. Adherence to gel seemed significantly more difficult with primary partners due to decreased perceptions of risk, inconvenience or fear of partner disapproval. Findings suggest that women in a variety of settings may find a microbicide gel to be highly acceptable for its lubricant qualities and protective benefits but that adherence and consistent use may depend greatly on contextual and partner-related factors. These findings have important implications for future trial designs, predicting determinants of microbicide use and acceptability and marketing and educational efforts should a safe and efficacious microbicide be found.

Adherence and its measurement in phase 2/3 microbicide trials.

Adherence optimization and measurement have emerged as critically challenging issues for clinical trials of topical microbicides. Although microbicide trials have routinely collected adherence data, their utilization in trial design, implementation, and interpretation has been inconsistent. Drawing on data-driven presentations from several focused meetings, this paper synthesizes lessons from past microbicide trials and provides recommendations for future trials of microbicide and other HIV prevention technologies. First, it describes four purposes for adherence data collection, with particular attention to intention-to-treat versus adherence-adjusted analyses for determining effectiveness. Second, the microbicide field’s experiences with adherence measures and data collection modes are discussed, including the strengths and weaknesses of various options and approaches for improving measurement. Then, several approaches to optimizing trial participants’ adherence are presented. The paper concludes with a set of recommendations for immediate use or further research.

Integrating behavioral and social science research into microbicide clinical trials: challenges and opportunities.

It has been argued that rigid thinking about the types and progression of research needed to evaluate health promotion interventions has stymied the process by which research is translated to action. This argument is particularly salient in the field of HIV/AIDS prevention. We examined microbicide research and identified challenges that obstruct the integration of clinical trial and behavioral and social science research, thereby reinforcing linear programs of research. We found that behavioral and social science research can both support microbicide clinical trial performance and anticipate the information most needed for a rapid and successful introduction of future microbicide products.

Theory-based strategies for improving contraceptive use: a systematic review ☆

BACKGROUND Theories and models help explain how behavior change occurs. We systematically reviewed randomized controlled trials that examined theory-based interventions for improving contraceptive use. STUDY DESIGN We searched electronic databases for eligible trials. Primary outcomes included pregnancy and contraceptive use. We calculated the odds ratio for dichotomous outcomes and the mean difference for continuous data. RESULTS Of 14 included trials, 10 showed positive results for a theory-based group: 2 of 10 studies with pregnancy or birth data, 4 of 9 addressing contraceptive use (for contraception) and 5 of 9 with condom use (to prevent HIV/sexually transmitted infections). An experimental group had favorable results for six of seven trials based on Social Cognitive Theory, two based on other social cognition models and two using motivational interviewing. Most interventions focused on adolescents and involved multiple sessions. CONCLUSIONS Effects were not consistent across outcomes and comparisons. The field could benefit from thorough use of single theories and better reporting on intervention implementation.

Pregnancy in effectiveness trials of HIV prevention agents.

Despite remarkable progress over the past several decades in understanding the biology and epidemiology of the HIV pandemic the virus continues to spread relentlessly. Diverse prevention approaches are desperately needed to reverse this trend. For many women products that can be used without the cooperation of male partners are critical. Multiple such products are currently being tested in large-scale effectiveness trials and many more are in earlier stages of development. These products include physical and chemical barriers to viral entry vaginal pH buffers an antiherpes drug antiretroviral drugs and other agents. Some of these products may have contraceptive as well as anti-infective activity. The basic design of HIV prevention trials is standard: HIV-negative women at risk for HIV infection are randomly assigned to use either the study product or a placebo according to a specified schedule (e.g. daily or before each coital act) and then are followed to assess HIV incidence. Most HIV prevention trials are conducted in resource-poor settings in Africa and Asia where HIV incidence is high. (excerpt)

Acceptability of male circumcision for prevention of HIV infection among men and women in Uganda

In the last decade, three randomized controlled trials in Kenya, South Africa, and Uganda have shown that medical male circumcision (MMC) reduces the sexual transmission of HIV from women to men. Objectives of this assessment were to measure acceptability of adult MMC and circumcision of children to inform policies regarding whether and how to promote MMC as an HIV prevention strategy. This mixed-method study, conducted across four Ugandan districts, included a two-stage household survey of 833 adult males and 842 adult females, focus group discussions, and a health provider survey. Respondents’ acceptability of MMC was positive and substantial after being informed about the results of recent randomized trials. In uncircumcised men, between 40% and 62% across the districts would consider getting circumcised. Across the four districts between 60% and 86% of fathers and 49% and 95% of mothers were supportive of MMC for sons. Widespread support exists among men and women in this study for promoting MMC as part of Ugandas current ‘ABC + ’ HIV prevention strategy.

Getting to 70%: Barriers to modern contraceptive use for women in Rwanda

To identify reasons for non‐use of modern family planning in Rwanda, to examine specific barriers to contraception, and to explore psychosocial factors influencing modern contraceptive use.

The importance of choice in the rollout of ARV-based prevention to user groups in Kenya and South Africa: a qualitative study

Stakeholders continue to discuss the appropriateness of antiretroviral‐based pre‐exposure prophylaxis (PrEP) for HIV prevention among sub‐Saharan African and other women. In particular, women need formulations they can adhere to given that effectiveness has been found to correlate with adherence. Evidence from family planning shows that contraceptive use, continuation and adherence may be increased by expanding choices. To explore the potential role of choice in womens use of HIV prevention methods, we conducted a secondary analysis of research with female sex workers (FSWs) and men and women in serodiscordant couples (SDCs) in Kenya, and adolescent and young women in South Africa. Our objective here is to present their interest in and preferences for PrEP formulations – pills, gel and injectable.

Microbicides 2008 conference: from discovery to advocacy.

Recently revised statistics show the number of individuals living with HIV at over 33 million worldwide, with 68% being in sub-Saharan Africa. Current HIV prevention methods, such as condom use, monogamy and abstinence, are not always feasible. The need for improved HIV preventative technologies remains urgent. Of these, microbicides represent a promising female-initiated preventative method. Microbicides are designed to be applied vaginally to prevent HIV and STI acquisition. Research is also being undertaken to assess the safety of the product during rectal application.The biannual Microbicides conference took place in New Delhi, India from 24–27 February 2008. The conference was open to delegates from the scientific and medical fields, as well as communities and advocates. In addition to microbicide research and development, the conference afforded the opportunity for the discussion of key issues such as ethics, acceptability, access, and community involvement.In this conference report we provide brief summaries of recent advancements made and challenges experienced in microbicide research and development, including updates on basic and clinical science, social and behavioural science, and community mobilisation and advocacy activities pertaining to clinical trials.