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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2020-12-30

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.

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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.

Conditions

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HIV-1-infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Phase 2a, open-label, multi-site, two-sequence, crossover, randomized trial

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vaginal Matrix Ring

Dapivirine vaginal ring containing 25 mg of dapivirine to be replaced each month.

Group Type EXPERIMENTAL

Dapivirine

Intervention Type DRUG

Silicone elastomer vaginal matrix ring

Oral Emtricitanbine/Tenofovir Disoproxil

Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets to be taken orally daily

Group Type EXPERIMENTAL

Truvada

Intervention Type DRUG

Tablets to be taken orally daily

Interventions

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Dapivirine

Silicone elastomer vaginal matrix ring

Intervention Type DRUG

Truvada

Tablets to be taken orally daily

Intervention Type DRUG

Other Intervention Names

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Vaginal Ring Emtricitabine/tenofovir

Eligibility Criteria

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Inclusion Criteria

1. Age 16 through 21 years at Enrollment, verified per site standard operation procedures.
2. Able and willing to provide adequate locator information and comply with all study procedural requirements.