CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
Dolutegravir 50 MG +1 moredrug
Likely dose
Dolutegravir 50 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03512964
NCT03512964N/ACompleted

A Pilot Study of Rapid HIV Treatment Initiation, Access and Engagement in Care (RHAE)

Johns Hopkins University·interventional·Posted May 1, 2018·Updated Oct 27, 2022

In Brief

A clinical study evaluating Dolutegravir 50 MG and Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet [DESCOVY] for Human Immunodeficiency Virus. Completed, enrolled 32 participants across 1 site.

Detailed Summary

The investigators propose to evaluate Rapid HIV Treatment Initiation in Baltimore in newly and previously diagnosed HIV-positive patients not in care through identification of barriers, facilitators and acceptability of Rapid HIV Treatment Initiation among newly and previously diagnosed HIV-positive patients not in care identified at the Johns Hopkins East Baltimore campus and at the Baltimore City Health Department sexually transmitted disease clinics. Using this data, a protocol for Rapid HIV Treatment Initiation among newly and previously diagnosed HIV-positive patients not in care identified at the Johns Hopkins East Baltimore campus and the Baltimore City Health Department sexually transmitted disease clinics will be developed and pilot tested. This pilot data will be used to design a multi-site study evaluating the effectiveness of Rapid HIV Treatment Initiation versus facilitated linkage to care. A model for Rapid HIV Treatment Initiation in Baltimore could be generalized to cities where the HIV epidemic has a similar demographic and risk profile such as Washington DC, Atlanta, and New York City.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 1, 2018
Enrollment StartNov 29, 2016
Primary CompletionSep 13, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 8.2 years ago

Interventions

Dolutegravir 50 MGdrug

Patients newly diagnosed with HIV or previously diagnosed with HIV and not on treatment or in care for at least six months will be given antiretroviral therapy starter packs containing dolutegravir (tivicay) 50 mg 1 tablet by mouth daily. Number of doses dispensed will be determined by the prescribing provider. Pill boxes will be given with each starter pack. At each clinic, patients are provided with 24/7 clinic contact information should he/she experience adverse side effects to medication and/or experience a medical emergency.

Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet [DESCOVY]drug

Patients newly diagnosed with HIV or previously diagnosed with HIV and not on treatment or in care for at least six months will be given antiretroviral therapy starter packs containing emtricitabine 200 mg/tenofovir alafenamide 25 mg (descovy) 1 tablet by mouth daily. Number of doses dispensed will be determined by the prescribing provider. Pill boxes will be given with each starter pack. At each clinic, patients are provided with 24/7 clinic contact information should he/she experience adverse side effects to medication and/or experience a medical emergency.