Protocol No: | ECCT/17/11/01 | Date of Protocol: | 02-02-2017 |
Study Title: | MTN 034 A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population |
Study Objectives: | |
Laymans Summary: | |
Abstract of Study: | The trial will be a Phase 2a, Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine (DPV) and Oral Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in an Adolescent and Young Adult Female Population.The trial will enrol approximately 300 healthy, HIV-uninfected, sexually active adolescent and young adult females aged 16 - 21 years old (inclusive), who will be followedfor a period of 73 weeks. Participants will be randomized (1:1) to one of two sequences of a vaginal ring (VR) containing 25mg of DPV to be inserted monthly for 24 weeks and 200 mg FTC/300 mg TDF oral tablets taken daily for 24 weeks. After completing the randomized sequence of two study product use periods, participants will then select between the two study products to use in the final 24 weeks of the trial. Participants will be able to choose either or neither study product every 4 weeks during the third product use period. The primary objectives are to evaluate the safety of and adherence to the DPV VR and oral FTC/TDF among adolescent and young women while the secondary objective are to evaluate the acceptability of each product, compare adherance to the product of the participant’s choosing (final phase of the study) and product preference |