Protocol No: | ECCT/15/05/02 | Date of Protocol: | 11-02-2015 |
Study Title: | The TRIO Study: Acceptability of Different Multipurpose Prevention Technology (MPT) Delivery Methods (Placebo) |
Study Objectives: | |
Laymans Summary: | |
Abstract of Study: | The goal of this project is to evaluate the acceptability of three multipurpose prevention technology (MPT) delivery forms for prevention of HIV and unintended pregnancy among young women in Kenya and South Africa: a vaginal ring, an injectable, and a co-formulated daily oral tablet (all placebos). This research will integrate data collected through three primary activities: 1) a clinical study in which HIV-negative, non-pregnant young women will all receive condoms as standard of prevention, and be asked to use each of three placebo product for 1 month, in a randomly allocated order, to determine product preference (cross-over period), and then use their favorite product for up to 2 months; 2) qualitative in-depth interviews (IDIs) with women, their male partners, and health providers (HP); and 3) a structured discrete choice survey with the clinical study participants and a community-recruited sample of product-naïve young women. Rankings, product relative preference (including male condoms), and use data for MPT placebo delivery formulations and specific delivery form attributes will be identified, with the overall goal of informing further development of MPT to optimize the likelihood of end-user adoption. In addition, data collection activities will be designed to inform development of culturally appropriate MPT communication strategies and educational messages tailored for young women in these sub-Saharan African settings. This research will help identify how products and their attributes are viewed by young women at dual risk of HIV and unintended pregnancy, and how messaging about the products can be appropriately tailored to increase adoption of novel formulation(s). This will enhance the potential public health impact of MPT to address the two critical women’s health issues. |