Trial Outcomes & Findings for Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC) (NCT NCT04427202)

Results Overview

Number of participants who accept referral to the intervention (divided by the total enrolled who did not have previous engagement prior to the study with the harm reduction services organization).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

306 participants

Primary outcome timeframe

2 years

Results posted on

2024-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort Participants will be taken through the study survey and interview, blood and urine toxicology testing and given a referral to a harm reduction organization.
Baseline STARTED	306
Baseline COMPLETED	306
Baseline NOT COMPLETED	0
6 Months STARTED	306
6 Months COMPLETED	74
6 Months NOT COMPLETED	232
12 Months STARTED	74
12 Months COMPLETED	44
12 Months NOT COMPLETED	30
18 Months STARTED	44
18 Months COMPLETED	17
18 Months NOT COMPLETED	27
24 Months STARTED	17
24 Months COMPLETED	4
24 Months NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ending Transmission of HIV, HCV, and STDs and Overdose in Rural Communities of People Who Inject Drugs (ETHIC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort n=306 Participants Participants will be taken through the study survey and interview, blood and urine toxicology testing and given a referral to a harm reduction organization
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	297 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	42.0 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex/Gender, Customized Sex · Male	199 Participants n=5 Participants
Sex/Gender, Customized Sex · Female	106 Participants n=5 Participants
Sex/Gender, Customized Sex · Intersex	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	296 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	63 Participants n=5 Participants
Race (NIH/OMB) White	230 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: These participants who did not have previous engagement prior to the study with the harm reduction services organization.

Number of participants who accept referral to the intervention (divided by the total enrolled who did not have previous engagement prior to the study with the harm reduction services organization).

Outcome measures

Outcome measures
Measure	Cohort n=207 Participants Participants who have not previous engaged at the HRSO
Total Participants Who Received Referrals to the Harm Reduction Services Organization	121 Participants

SECONDARY outcome

Timeframe: 2 years

Number of unique zip codes that participants received most of their syringes or needles based on mobile unit delivery.

Outcome measures

Outcome measures
Measure	Cohort n=306 Participants Participants who have not previous engaged at the HRSO
Number of Locations Where Participants Received Most of Syringes or Needles	92 Unique zip codes

SECONDARY outcome

Timeframe: 2 years

This was counted as the number of visits made by the hard reduction service organization to distribute sterile syringes and/or equipment.

Outcome measures

Outcome measures
Measure	Cohort n=306 Participants Participants who have not previous engaged at the HRSO
Number of Times Sterile Syringes and/or Equipment Obtained From an Intervention	2.5 Visits Interval 0.0 to 30.0

SECONDARY outcome

Timeframe: 2 years

"How many times (encounters) in the past 30 days did you inject using a syringe or needle that you know had been used by somebody else?"

Outcome measures

Outcome measures
Measure	Cohort n=306 Participants Participants who have not previous engaged at the HRSO
Number of Times Participants Used a Syringe or Needle That They Knew Was Used by Somebody Else	0.9 Encounters Standard Deviation 3.0

SECONDARY outcome

Timeframe: 2 years

"How many times (encounters) in the past 30 days did you use a cotton, cooker, spoon or water for rinsing or mixing that you know had been used by somebody else?"

Outcome measures

Outcome measures
Measure	Cohort n=306 Participants Participants who have not previous engaged at the HRSO
Number of Times Participants Used a Cotton, Cooker, Spoon, or Water for Rinsing or Mixing That They Knew Was Used by Somebody Else	2.5 Encounters Standard Deviation 9.5

SECONDARY outcome

Timeframe: 2 years

"How many times (encounters) in the past 30 days did you let someone else use a cotton, cooker, spoon, or water for rinsing or mixing after you used it?"

Outcome measures

Outcome measures
Measure	Cohort n=306 Participants Participants who have not previous engaged at the HRSO
Number of Times Participants Let Someone Else Use a Cotton, Cooker, Spoon, or Water for Rinsing or Mixing After They Used it	2.3 Encounters Standard Deviation 8.4

SECONDARY outcome

Timeframe: 2 years

Number of participants with drive time less than 30 minutes to nearest syringe or needle exchange.

Outcome measures

Outcome measures
Measure	Cohort n=306 Participants Participants who have not previous engaged at the HRSO
Number of Participants With Drive Time Less Than 30 Minutes to Nearest Syringe or Needle Exchange	148 Participants

SECONDARY outcome

Timeframe: 2 years

"Do you currently have naloxone or Narcan with you or at home?"

Outcome measures

Outcome measures
Measure	Cohort n=306 Participants Participants who have not previous engaged at the HRSO
Number of Participants That Currently Have Naloxone	93 Participants

SECONDARY outcome

Timeframe: 2 years

Total number of participants who received a substance use disorder referrals made by the hard reduction services organization.

Outcome measures

Outcome measures
Measure	Cohort n=306 Participants Participants who have not previous engaged at the HRSO
Number of Participants Who Received Substance Use Disorders (SUD) Treatment Referrals	102 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Participants who already knew their HIV+ diagnoses prior to this study (n=4) and thus, removed from the denominator.

Total number of tests that participants screened for HIV, from baseline to follow-up.

Outcome measures

Outcome measures
Measure	Cohort n=302 Participants Participants who have not previous engaged at the HRSO
Total Number of Participants Who Received an HIV Screening	288 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Participants who already were told they had HCV prior to this study (n=76) were removed from the denominator.

Total participants screened for HCV at least once during baseline and follow-up. For those who had a HCV reactive test were then later referred to further services.

Outcome measures

Outcome measures
Measure	Cohort n=230 Participants Participants who have not previous engaged at the HRSO
Total Number of Participants Who Received an HCV Screening	213 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants did not respond to question (n=5)

"Have you ever heard of medicine people can take to prevent HIV?"

Outcome measures

Outcome measures
Measure	Cohort n=301 Participants Participants who have not previous engaged at the HRSO
Number of Participants With Knowledge of PrEP	155 Participants

SECONDARY outcome

Timeframe: 2 years

Total number of participants who were newly diagnosed with HIV during the study period.

Outcome measures

Outcome measures
Measure	Cohort n=306 Participants Participants who have not previous engaged at the HRSO
Number of Participants Diagnosed With HIV Who Have Access to HIV Care	0 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Total number of participants who had a positive confirmatory HCV test (e.g. positive viral load).

Total number of participants who were newly diagnosed with chronic Hep C who were referred to Hep C care.

Outcome measures

Outcome measures
Measure	Cohort n=11 Participants Participants who have not previous engaged at the HRSO
Number of Participants Diagnosed With HCV Who Have Access to HCV Care	11 Participants

SECONDARY outcome

Timeframe: 6 months

Population: A number of participants did not respond to this question (n=10).

"In the last 30 days, how many times did you have vaginal or anal sex without a condom?"

Outcome measures

Outcome measures
Measure	Cohort n=296 Participants Participants who have not previous engaged at the HRSO
Number of Times a Participant Engaged in Condomless Sex (Vaginal or Anal)	9.9 Encounters Standard Deviation 16.2

Adverse Events

Cohort

Serious events: 5 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Cohort n=306 participants at risk Total participants who responded at baseline up to 24 months.
General disorders Deaths	1.3% 4/306 • Number of events 4 • Study period from baseline to 24-month follow-up.
Psychiatric disorders Suicidial Ideation	0.33% 1/306 • Number of events 1 • Study period from baseline to 24-month follow-up.

Other adverse events

Adverse event data not reported

Additional Information

Mai T. Pho, MD MPH

University of Chicago Medicine

Phone: 773-834-3689

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place