To ensure that women find future microbicide products acceptable and want to use them, IPM conducts product acceptability studies.
It is important to learn about the preferences of women — and those of their male partners — in Africa where the need is greatest and where microbicide trials are being conducted.
IPM assesses the acceptability of various product forms through market research studies and microbicide clinical trials.
Getting Input From Women and Their Partners
These studies involve women in developing countries who use microbicide products or placebo products (without an active drug) and provide feedback on their experiences.
With participants' consent, some studies ask male partners to share their opinions of the products as well.
Assessing a Variety of Product Forms
IPM has assessed a variety of product forms — including vaginal rings, films, gels, tablets and soft gel capsules — with once-monthly vaginal rings currently being tested as part of IPM clinical trials, and other product forms under development at the preclinical stage.
IPM has conducted three acceptability studies, and continues to collect relevant data in other clinical trials.
Vaginal Ring Safety and Acceptability Study (IPM 011): IPM conducted the first vaginal ring acceptability studies in Africa, among women in South Africa and Tanzania. Data from this study have provided important information on the acceptability of a (placebo) vaginal ring as a means for delivering a microbicide.
Vaginal Gel Acceptability Study (PAS I): In the PAS I study, IPM and research partners assessed the most desirable characteristics of different placebo gel formulations among women in Kenya, South Africa and Zambia. Participants were asked to rate the gels on a range of attributes — including personal likes and dislikes, thickness and color, and impact on sexual pleasure. IPM used this information to guide development and advancement of gel formulations into clinical trials.
Vaginal Tablet, Film and Soft Gel Capsule Acceptability Study (PAS II): IPM and partners explored the acceptability of placebo vaginal tablets, films and soft gel capsules as possible future microbicide forms in the PAS II study, which included women and male partners from Burkina Faso, Zambia and Tanzania. The study sheds light on preferences for these products in the different countries.
Using Daily Monitored Adherence
To better understand and encourage the correct and consistent use of microbicide gel products by women participating in the IPM clinical trials, IPM piloted a Daily Monitored Adherence (DMA) strategy in the IPM 014A and IPM 014B gel safety studies in Africa. DMA is a novel process designed to support women in establishing a pattern of routine daily use of microbicide gels.
The DMA strategy includes daily visits to participants at their homes, or visits by participants to a drop-off center, to collect used and unused gel applicators and quickly gather information about the gel use to further support counseling on the use of product. Participants may choose either option.