Reversing the Epidemic in Africa With Choices in HIV Prevention (REACH)

Study Overview
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Brief Summary
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Participants will be randomized (1:1) to one of two sequences of a vaginal ring (VR) containing 25mg of dapivirine 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.

Detailed Description
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The MTN-034/IPM 045 trial is a multi-site, randomized, two-sequence, three-period, open-label, crossover Phase 2a trial. Young adult (18-21 years old) and adolescent (16-17 years old) female participants will be enrolled in a 2:1 ratio. All the enrolled participants will use both treatment regimens in sequence. All participants will be randomly assigned to one of two treatment regimen sequences to use for the first two study product use periods, and will be able to choose between treatment regimens during the third study product use period. The total length of follow-up is approximately one and a half years which includes up to 72 weeks of product use (two 24-week periods on randomized treatment regimen and one 24-week period on freely chosen treatment regimen) plus an additional week beyond the Period 3 end visit to collect data on any new or worsening AEs.

Official Title
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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

Conditions
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HIV-1-infection

Intervention / Treatment
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* Drug: Dapivirine
* Drug: Truvada


Participation Criteria
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Eligibility Criteria
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Exclusion Criteria: Become Pregnant and/or use oral PrEP outside the context of study. At Screening or Enrollment, has a positive HIV test. Inclusion Criteria: Age 16 through 21 years at Enrollment, verified per site standard operation procedures. Able and willing to provide adequate locator information and comply with all study procedural requirements.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Phase 2a, open-label, multi-site, two-sequence, crossover, randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal Matrix Ring<br>Dapivirine vaginal ring containing 25 mg of dapivirine to be replaced each month. | Drug: Dapivirine<br>* Silicone elastomer vaginal matrix ring<br>* Other names: Vaginal Ring;|
| Experimental: Oral Emtricitanbine/Tenofovir Disoproxil<br>Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets to be taken orally daily | Drug: Truvada<br>* Tablets to be taken orally daily<br>* Other names: Emtricitabine/tenofovir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by grade 2 or higher adverse event. | To compare the safety profiles of FTC/TDF oral tablet administered daily and dapivirine vaginal matrix ring (25 mg) inserted for use of each study product in an adolescent and young adult female population | 12 months |