Clinical trial NCT03512964
Conditions: Human Immunodeficiency Virus
Sponsor: Johns Hopkins University
Start date: 2016-11-29; Completion date: 2020-09-13
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Detailed description:
Prompt initiation of antiretroviral therapy to achieve and sustain viral suppression decreases the morbidity and mortality of HIV and greatly reduces the risk of transmission yet gaps in the care cascade persist. At current testing and treatment rates, an estimated 524,000 new infections and 375,000 deaths will occur between 2015 and 2025 in the US. Rates of HIV are unacceptably high among African Americans and men who have sex with men and a majority of new transmissions originate from patients previously diagnosed but not in care. To curb rates of infection and improve HIV-related outcomes, cities such as Baltimore, where the HIV epidemic predominately affects African Americans and men who have sex with men, must implement more effective ways to identify and treat all individuals with HIV. Compressing the treatment timeline by starting antiretroviral therapy at the time of diagnosis is known as rapid HIV treatment initiation. Early studies of Rapid HIV Treatment Initiation in newly diagnosed patients in South Africa and San Francisco showed significant improvement in care linkage, antiretroviral therapy initiation and time to viral suppression. 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 and pilot testing 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 at the Baltimore City Health Department sexually transmitted disease clinics. 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.

Arms: arm 1: Initiation and reinitiation of antiretroviral therapy with dolutegravir 50 mg by mouth once daily and descovy 1 tablet by mouth once daily the same-day as HIV diagnosis and/or first clinic visit for people newly diagnosed with HIV and patients previously diagnosed with HIV but not on medications and not in care for over six months.
Interventions: intervention 1: Dolutegravir 50 MG intervention 2: Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet [DESCOVY]
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol documents:
Prot_000.pdf: 
 
 
 
Document date: 6/10/19 
Study Protocol Project RHAE: a pilot study of Rapid HIV 
treatment initiation, Access and Engagement in care 
 NCT03512964 
 


6/10/19 Protocol 
Project RHAE: a pilot study of Rapid HIV treatment initiation, Access and Engagement in care 
1. Study Procedures 
The study will enroll for a total of 12 months. Projected enrollment is 32 newly 
diagnosed patients and previously diagnosed patients not in care. As of May 8, 2017 the 
Moore clinic HIV practice will incorporated into a new clinic, the John G. Bartlett 
Specialty Practice (JGBSP). Throughout the rest of this protocol, activities related to this 
practice will be referenced as the JGBSP clinic.  
 
Patient recruitment 
 
 
We will utilize existing HIV linkage to care services for newly and previously 
diagnosed patients identified at the Johns Hopkins East Baltimore campus, the JGBSP 
clinic and at the BCHD STD clinics to explore the feasibility and acceptability of RHTI in 
these settings. All patients identified in the Hopkins ED, Johns Hopkins inpatient HIV 
service, the JGBSP clinic and BCHD STD clinics who are newly diagnosed with HIV (test 
positive by 3rd or 4th generation HIV test or detectable HIV viral load with no previously 
documented positive HIV test by medical record and/or self-report) and patients with 
previous HIV diagnosis but by self-report are not in care and not on ART (> six months 
without HIV care and ART) will be referred to the Rapid HIV treatment initiation, Access 
and Engagement in care (RHAE) Research Assistant (RA) by call or text to a dedicated 
smart phone. At the time they are identified as needing a referral for HIV treatment 
services, a brief description of the study will be given to potentially eligible patients and a 
referral to the RHAE RA will be made with patient permission. In the ED, this referral will 
be made by ED HIV testing team members and/or ED clinicians. In the JGBSP clinic, the 
referral will be made by social work staff, nurses and/or medical providers. In the BCHD 
STD clinics, referrals will be made by patient advocates and/or medical providers. The 
linkage team will provide linkage services as per usual. In situations when potentially 
eligible patients present for clinical care when a Project RHAE staff member is not 
available to accept a referral and/or leave the clinical area before learning about the study, 
referring providers and staff who engage with the patient for treatment after the initial 
interaction will present the study and elicit interest and permission for referral at a later 
date in person or by phone. This may include patients who have been hospitalized at Johns 
Hopkins Hospital in which case the study team will discuss potential enrollment with the 
inpatient care team prior to approaching the patient for consent.  
 
Patient consent, survey administration 
 
After referral to the RA, the RA will describe the study to the patient and assess 
patient eligibility. A study clinician will confirm patient eligibility and the RA will consent 
patients who wish to enroll. Once consented, the RA will collect contact information and 
administer a standardized enrollment survey (Table 1). A tablet or computer will be used 
to record survey responses which will be uploaded to a secure REDCap Database. Domains 
assessed include illicit drug and alcohol use, depression and panic symptoms, stigma, 
quality of life, HIV knowledge and social support. The survey will assess anticipated 
barriers and facilitators to HIV care and adherence to medication and acceptability of 
RHTI. Date, time and location of HIV clinic follow up will be noted. To ensure adequate 
ability to obtain follow up information, patients referred to HIV care outside of Johns 
Hopkins and/or BCHD STD clinics will not be eligible for enrollment.  
 
 
If the patient is eligible but declines enrollment, he or she will be offered enrollment 
in the survey-only study of RHTI (IRB00110075). A log of potentially eligible patients 


6/10/19 Protocol 
Project RHAE: a pilot study of Rapid HIV treatment initiation, Access and Engagement in care 
who are not enrolled in the study will be kept by the Project RHAE study staff. This log 
will be kept in a secure Johns Hopkins network data base and will not include protected 
health information. The log will include: age, clinical site, whether the patient was newly 
or previously diagnosed, HIV risk factor, reason patient did not enroll, and if the patient 
enrolled in the survey-only study. Protected Health Information of patients referred by 
clinical staff who are not eligible or choose not to consent to enrollment will be destroyed.    
 
Implementation of RHTI protocol at the Johns Hopkins ED and JGBSP clinic 
 
 
Patients recruited from the Johns Hopkins ED and/or JGBSP clinic social work will 
complete his/her ED/social work visit and will then be seen in the JGBSP clinic by a JGBSP 
clinic clinician for a medical HIV intake visit and prescription with receipt of ART starter 
pack. Patients recruited from the BCHD STD clinics will see be seen in the BCHD STD 
by a clinician for medical intake visit and prescription and receipt of ART starter pack. The 
clinicians who evaluate patients and initiate treatment will be those who provide continuity 
HIV care in the clinics. The date and time of the medical visit to initiate treatment at JGBSP 
clinic and BCHD STD clinic will be as soon as possible and the visit may occur as soon as 
immediately after recruitment (which is preferable) or may occur on a day other than the 
day of recruitment if the initial encounter occurs while the clinic is closed, is too late in the 
day to complete before clinic closes or patient prefers an appointment at a later date. The 
medical intake will take place no more than one week after consent is obtained. The intake 
will be as per usual in the JGBSP and BCHD HIV clinics. The following clinical labs will 
be obtained at the time of enrollment, as part of standard of care: CD4 count, HIV viral 
load, HIV genotype, CBC, comprehensive metabolic panel, urinalysis, viral hepatitis, 
syphilis serologies, GC/CT screening based on risk. As part of standard of care, clinicians 
and/or clinic staff (registered nurse, pharmacist) provide counseling on medication 
education, potential side effects and adherence. ART prescriptions will be written for at 
least 14 days of an antiretroviral medication regimen chosen at the discretion of the 
prescribing provider. Prescriptions for more than 14 days of medication can be prescribed 
at the discretion of the prescribing provider. Providers in the JGBSP and BCHD HIV 
clinics have expertise in prescribing antiretroviral medications and caring for HIV-infected 
patients and they will take into consideration adverse drug-drug interactions with other 
patient medications and patient comorbidities when choosing the starter pack of 
antiretroviral medications as per standard of care. Providers will also educate patients about 
the antiretroviral regimen and dosing recommendations as per standard of care.   Pill boxes 
will be offered 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. Prescribing providers are responsible for reviewing the 
laboratory results and will follow up with the patient on any regarding any abnormalities 
requiring urgent/emergent medical attention including need to discontinue antiretroviral 
medication due to contraindications to a component in the regimen such as estimated 
creatinine clearance <30 mL/min (a contraindication with tenofovir alafenamide) or due to 
HIV resistance to a component of the antiretroviral regimen. Medical follow up will be 
scheduled within two to four weeks.  
 
Medical visits will be documented and billed as part of the patient’s medical care. 
HIV intake, baseline labs and prescription of ART is standard of care for HIV treatment. 
RHTI accelerates the usual time it takes to receive a medical evaluation for HIV and ART 
prescription but does not involve investigational medications or procedures.  Date of 


6/10/19 Protocol 
Project RHAE: a pilot study of Rapid HIV treatment initiation, Access and Engagement in care 
consent and enrollment in the study will be documented in the medical record by a member 
of the research team. 
 
For patients who enroll in the study who are admitted to the hospital from the Johns 
Hopkins ED, research physicians will consult with the inpatient attending to discuss either 
initiating ART while inpatient, with inpatient ID consultation if admitted to a non-ID 
service, and/or discharging the patient with a starter pack of ART and close follow up in 
the JGBSP clinic after hospital discharge (within one week of discharge).      
 
Patients at Johns Hopkins and BCHD will engage in a social work intake as per 
usual. This intake includes a brief psychosocial and insurance assessment and urgent 
referrals for psychosocial services and/or initiation of medication and/or insurance 
coverage as needed. Intake also includes Ryan White eligibility determination. Ryan White 
eligible patients who are uninsured or need copay assistance at the JGBSP clinic and 
BCHD STD clinics will receive a Ryan White voucher to cover the full cost or copay of 
the antiretroviral medication prescription.  
 
 
Study participants will receive $25 cash payment for study enrollment. It is 
estimated the consent process will take about 30 minutes, the survey portion 45 minutes, 
and the medical intake, phlebotomy, social work intake and receipt of medications will 
take two hours.  
 
At week four, all patient study participants will be contacted by the RA to repeat 
questions from the enrollment survey in addition to questions about medication adherence 
and patient satisfaction with the HIV linkage team (Table 1). Study participants will receive 
$50 for completion of the week four survey. HIV linkage and care outcomes data will be 
extracted from the medical record. 
 
Electronic medical record data extraction 
 
 
HIV linkage and care outcomes will be collected for 48 weeks after enrollment and 
conducted through chart review of the electronic medical record at each site (Appendix 2). 
Data will be entered in REDCap Database by RHAE RAs through a tablet.  
 
2. Inclusion/Exclusion Criteria 
Patient Eligibility 
 
Inclusion Criteria: 
• Men and women 18 to 65 years of age 
• English speaking 
• Patients identified in the Hopkins ED, Hopkins JGBSP clinic or BCHD STD 
clinics who are newly diagnosed with HIV (test positive by 3rd or 4th generation 
HIV test or detectable HIV viral load with no previously documented positive 
HIV test by medical record and/or self-report) and patients with previous HIV 
diagnosis but by self-report are not in care and not on ART (> six months without 
HIV care or ART) 
 
Exclusion Criteria: 
• Women who are currently pregnant or planning on becoming pregnant 
• Adults lacking the capacity to consent 
• 
Patients referred to HIV care outside of Johns Hopkins and/or BCHD STD clinics  
• Patients with estimated creatinine clearance <30 mL/min at last documented 
laboratory testing in the available medical record at site of referral, self-report of 


6/10/19 Protocol 
Project RHAE: a pilot study of Rapid HIV treatment initiation, Access and Engagement in care 
chronic kidney disease without documented creatinine within the last three 
months 
• Patients judged by clinic or study staff to be physically or emotionally unable to 
provide consent or participate in all study procedures 
 
3. Drugs/ Substances/ Devices  
 
Prescriptions for at least fourteen days of the antiretroviral medication regimen 
chosen by the prescribing provider will be prescribed and dispensed to participants. 
These FDA-approved drugs will be used according to the FDA-approved indication. 
Providers in the JGBSP and BCHD HIV clinics have expertise in prescribing 
antiretroviral medications and caring for HIV-infected patients and they will take into 
consideration adverse drug-drug interactions with other patient medications and patient 
comorbidities when choosing the starter pack of antiretroviral medications as per 
standard of care.  
 
4. Study Statistics 
Measures and Outcomes 
Demographic and psychosocial information; barriers, facilitators and acceptability of HIV 
treatment and RHTI: 
 
Table 1. Patient survey instruments and time of collection (Appendix 1) 
Domain 
Instrument 
Collection 
Baseline 
Week 4 
Substance use 
Drug use 
NIDA ASSIST 
X 
X 
Alcohol use 
AUDIT-C 
X 
X 
Mental health 
Depression and panic 
PHQ-8 and PHQ-A 
X 
X 
Quality of life 
EuroQOL-5D  
X 
X 
Psychosocial 
Social support 
MOS-4 
X 
X 
HIV stigma 
HIV stigma scale (Earnshaw)11 
X 
X 
Self-efficacy 
HIV-related self-efficacy (Johnson) 12 
X 
X 
HIV knowledge 
HIV knowledge 
ART knowledge questionnaire 
(Balfour, modified)13 
X 
X 
Adherence 
Medication adherence 
ACTG adherence questionnaire: 
AACTG, VAS, SRS 
X 
X 
Barriers to medication and 
appointments 
Barriers and facilitators to adherence 
questionnaire (derived from Yehia, et 
al)14 
X 
X 
Patient satisfaction 
Patient satisfaction with clinic and 
HIV care linkage team 
Patient satisfaction questionnaire 
(modified from Dang, et al)15 
 
X 


6/10/19 Protocol 
Project RHAE: a pilot study of Rapid HIV treatment initiation, Access and Engagement in care 
Demographics 
Demographic survey 
NIDA Seek, Test, Treat and Retain for 
Vulnerable Populations: Data 
Harmonization Measure16 
X 
X 
Prior HIV treatment history* 
History of past HIV treatment 
JGBSP-ED linkage to care intake 
(selected questions) 
X 
 
*For patients previously diagnosed with HIV only 
 
RHTI acceptability 
• number of patients offered RHTI, number of patients who accept RHTI 
• number of patients who receive RHTI. 
 
HIV linkage and care outcomes (Appendix 2): 
• number of referrals to linkage team 
• number of patients who accept linkage services 
• number of patients who complete initial HIV clinic appointment and time to 
appointment completion 
• number of patients started on ART 
• number of patients who achieve an undetectable HIV viral load 
time to ART initiation and time to achieve undetectable HIV viral load (<200 
copies) 
• baseline creatinine 
• baseline genotype 
• number of patients remain on ART through the end of the study 
• number of patients who achieve an undetectable HIV viral load, time to ART 
initiation 
• time to achieve undetectable HIV viral load (<200 copies) 
 
Safety outcomes (Appendix 2):  
• ART toxicity 
• ART simplification (change in ART regimen from initiation to ART regimen with 
fewer pills after initiation) 
• genotype-driven modification (change in ART regimen from initiation due to HIV 
genotype indicating insufficient potency of initial regimen) 
 
 
Sample Size and Analysis  
 
Based on 2015 data, we estimate identification of 32 newly diagnosed and previously diagnosed 
patients not in care during the 4-month study enrollment period. Assuming a participation rate of 
67%, we will be able to enroll newly diagnosed patients and previously diagnosed patients not in 
care.  
 
5. Risks 
Medical risks include side effects and/or toxicity to antiretroviral medication and need to change 
the antiretroviral regimen due to identification of HIV resistance mutations that preclude the use 


6/10/19 Protocol 
Project RHAE: a pilot study of Rapid HIV treatment initiation, Access and Engagement in care 
of the antiretroviral medication regimen chosen by the prescribing provider. These risks, however, 
are not outside of the usual risks that come with initiating antiretroviral therapy. The major risks 
for participants are (a) discomfort in answering survey questions and (b) loss of privacy or 
confidentiality. In order to minimize the risks associated with discomfort in answering survey 
questions, participants will be told that they have the option to pass on any questions. In order to 
minimize the risks associated with loss of confidentiality, all participant data will be kept 
confidential and secure.  All computers with participant data will be password protected with 
access restricted to certain study team members. No information will be kept on mobile devices, 
such as laptop computers or cell phones, unless such devices are encrypted and password-
protected. 
The Principal Investigator will assume responsibility for reporting any unanticipated problems or 
study deviations to the IRB.  
 
6. Benefits 
There are no individual benefits for any study participants. However, participation in the study 
could show that initiation of ART in HIV positive patients at the time of diagnosis or when 
identified as previously diagnosed with HIV but not in care and antiretroviral naïve or off of ART 
for more than six months can improve clinical outcomes and decrease the risk of transmission of 
HIV. 
 
7. Payment and Remuneration 
Study participants will receive $25 for enrollment and completion of the baseline visit and $50 at 
week 4 for completion of the standardized survey 
 
8. Costs 
Study participants and/or their health insurer will be responsible for paying for the following 
services and/or items that are standard of care, and would be performed regardless of patient 
entering onto the study (outside of the clinical trial): CD4 count, HIV viral load, HIV genotype, 
CBC, comprehensive metabolic panel, urinalysis, viral hepatitis, syphilis serologies, GC/CT 
screening based on risk, and prescriptions for the antiretroviral medication regimen chosen by the 
prescribing provider.  Participants who have health insurance will be responsible for any co-pays 
or deductibles not covered by the insurance. Financial assistance to cover healthcare costs such as 
co-pays and/or medications for patients living with HIV will be used for eligible patients with 
social work assistance as per usual.