Christopher Elias

Challenges for the development of female-controlled vaginal microbicides

The development and testing of safe, effective, and affordable microbicidal products for women at risk of human immunodeficiency virus (HIV) raise complex scientific, ethical, and political issues. Ideal would by range of products (gels, foams, suppositories) that protect against HIV and other sexually transmitted diseases without impairing conception. This, in turn, requires the development of vaginal compounds that prevent the attachment of HIV-infected lymphocytes to epithelial surfaces, the secretion of virus from these cells, or the uptake of the virus by the mucosal epithelium with minimal cell membrane disruption. Problematic would be the design of a Phase III effectiveness trail that distributes the burdens and benefits of research equitably and provides controls with an alternate means of protection against HIV while maintaining scientific rigor. Since clinical trials call for a study population with a high seroincidence rate attributable primarily to the sexual transmission of HIV, prostitutes are the logical choice of subjects; sex workers are, however, the women most vulnerable to physical and economic exploitation. Womens input will be essential at each stage of development and testing, and such consultation can provide valuable feedback on method of application and timing of insertion. Finally, public-sector organizations must assume a leadership role in the coordination of the development of HIV prevention technologies.

Acceptability research on female-controlled barrier methods to prevent heterosexual transmission of HIV: Where have we been? Where are we going?

Acceptability research is an important component of any product development process. As researchers move into a new, accelerated phase of vaginal microbicide development, it is important to take stock of the acceptability research conducted to date and determine future research priorities. In this paper, we review findings from acceptability research conducted to date in four categories: hypothetical product acceptability research, existing product research (spermicide acceptability studies), acceptability research within the context of clinical trials, and postmarketing acceptability research conducted around the female condom. Finally, we highlight areas where additional research is needed in light of recent progress in microbicide development and discuss a possible framework for the introduction and acceptability of new sexually transmitted disease (STD) prevention technologies.

The study of client-provider interactions: a review of methodological issues.

In recent years, increased focus on the quality of family planning and other reproductive health services has led to a better understanding of womens reproductive health needs and has drawn attention to program-client interactions as a critical and neglected dimension of program effort. In this article, the relevant methods and experience related to studying client-provider interactions within family planning programs in southern countries are reviewed. The policy relevance of this work is highlighted first by stressing the operational usefulness of examining what happens when people engage with service-delivery systems that offer family planning or reproductive health services. Subsequently, the content areas encompassed by program-client interactions are clarified by identifying manifest and latent dimensions and by distinguishing the variables that define these interactions from variables related to their determinants and consequences. Finally, a critical review of existing methods is presented, with examples of research and a discussion of ethical issues.

Colposcopic evaluation of a vaginal gel formulation of iota-carrageenan

There is an urgent need to develop safe, effective, and acceptable vaginal products for the prevention of sexually transmitted infections. Preliminary in vitro results suggest that vaginal formulations of sulfated polysaccharides, including iota-carrageenan, have the potential to block mucosal transmission of human immunodeficiency virus (HIV). Twenty-five women in five sites participated in Phase I trials to evaluate the safety of a formulation containing iota-carrageenan (PC 213). The results of this study indicate that a 5 mL 2% gel formulation of iota-carrageenan is not associated with significant irritation of the female reproductive tract when administered once daily in the absence of sexual intercourse. Given the small number of participants in this initial study, careful observation for potential irritation must also be included in larger studies of this and other vaginal formulations.

Women's willingness to participate in microbicide trials in Northern Thailand.

Summary: To assess womens interests and concerns regarding participation in trials of microbicides in Chiang Rai, Thailand, we administered structured questionnaires. Before answering the questionnaire, women attended an educational session on microbicides and clinical trials. Of 370 participants, 82% correctly answered 8 or more of the 11 overall comprehension questions, indicating an adequate knowledge base among the women from which to answer questions about attitudes toward microbicide trials. The most common motivations for participating in a trial were “getting tested for HIV” and “doing something good for womens health.” The greatest barrier to participation was womens fear that if they proposed use of a microbicide, their husbands might feel protected and thereby have more sex partners. Overall, 6.2% said they would be “definitely willing to participate,” and 66.8% said they wanted to participate but wanted to think about it. Most women previously unacquainted with the concept of microbicides or clinical trial design displayed adequate knowledge of these subjects after the short educational session. If womens initial reactions are validated by actual willingness, surveys could prove valuable for selecting sites for microbicide trials, estimating enrollment rates, and tailoring trials to make them most acceptable to women.

Special issues of IUD use in resource-poor settings

IUD providers working within a poorly developed health care infrastructure face constraints in the availability of diagnostic technologies equipment and overall accessibility of services. Budgets only allow minimal laboratory and/or pharmacy support. The inability to identify women at risk of exposure to sexually transmitted diseases poses a special concern for IUD providers. Conditions that place women at risk from IUD use are more prevalent in resource-poor countries and areas. Strategies to optimize the safety of IUD use include improving the selection of clients combining IUD provision with other services and therapeutic interventions to minimize risk. A risk-scoring system can be developed to identify appropriate IUD candidates. It can be based on easily measured variables from historical clinical and laboratory inquiries. A risk-scoring system is limited by its sensitivity to local epidemiology behavioral patterns and variables chosen for measurement however. It needs to be validated within the community where it may be used. Another possible strategy to optimize IUD safety is immediate postpartum/ postabortion IUD insertion which provides double protection to many breast feeding women in developing countries. Yet it is susceptible to abuses and violations of womens rights. Possible therapeutic interventions to minimize risk include iron supplementation for IUD acceptors and prophylactic administration of antibiotics during IUD insertion. Nevertheless there are no quick fixes that allow IUDs to be provided more safely without increased concern for the overall quality of care. In the long term improvement of clinic facilities provider training and mechanisms of client follow-up are needed. In conclusion it is not clear whether resource-poor settings can provide safe use of IUDs.