Trial Outcomes & Findings for HIV+ Substance Users Released From Jail (NCT NCT03834779)

NCT ID: NCT03834779

Last Updated: 2023-02-13

Results Overview

Number of participants with an undetectable HIV viral load (\<200 copies/mL) is assessed via blood work.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: At 6 months after enrollment
• Results posted on: 2023-02-13

Participant Flow

31 individuals enrolled and assigned to study arms, all 31 who were enrolled were deemed eligible

Participant milestones

Measure	DOORS-CHW Intervention The type of intervention is behavioral. Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare. DOORS-CHW Intervention: The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees. Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months.	Treatment As Usual TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.
Overall Study STARTED	17	14
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Measure	DOORS-CHW Intervention The type of intervention is behavioral. Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare. DOORS-CHW Intervention: The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees. Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months.	Treatment As Usual TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.
Overall Study Death	1	2
Overall Study Lost to Follow-up	6	4

Baseline Characteristics

HIV+ Substance Users Released From Jail

Baseline characteristics by cohort

Measure	DOORS-CHW Intervention n=17 Participants The type of intervention is behavioral. Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare. DOORS-CHW Intervention: The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees. Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months.	Treatment As Usual n=14 Participants TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.	Total n=31 Participants Total of all reporting groups
Age, Continuous	36.9 years STANDARD_DEVIATION 9.7 • n=5 Participants	34.7 years STANDARD_DEVIATION 9.3 • n=7 Participants	35.9 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex/Gender, Customized Gender · Male	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex/Gender, Customized Gender · Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex/Gender, Customized Gender · Transgender female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Non-Hispanic White	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Non-Hispanic Black	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Hispanic	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
CD count	412 cells per cubic millimeter of blood STANDARD_DEVIATION 359 • n=5 Participants	371 cells per cubic millimeter of blood STANDARD_DEVIATION 275 • n=7 Participants	388 cells per cubic millimeter of blood STANDARD_DEVIATION 306 • n=5 Participants

PRIMARY outcome

Timeframe: At 6 months after enrollment

Population: All participants who had viral load completed at 6 months

Number of participants with an undetectable HIV viral load (<200 copies/mL) is assessed via blood work.

Outcome measures

Measure	DOORS-CHW Intervention n=10 Participants The type of intervention is behavioral. Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare. DOORS-CHW Intervention: The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees. Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months. In other words, participants randomized to the intervention arm will meet with the CHW and a staff member from DOORS. One of the primary study aims is a randomized controlled trial of an intervention which has a reasonable probability of improving the health and well-being of the subject by improving linkage to social services and the HIV clinic. The control arm will receive standard of care (referrals to case management).	Treatment As Usual n=8 Participants TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.
Number of Participants With Undetectable HIV Viral Load	2 Participants	3 Participants

SECONDARY outcome

Timeframe: At 6 months after enrollment

Population: All participants who had urine toxicology screen at 6 months were assessed

Number of participants who are positive/negative for Substance use are assessed via urine drug screen

Outcome measures

Measure	DOORS-CHW Intervention n=9 Participants The type of intervention is behavioral. Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare. DOORS-CHW Intervention: The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees. Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months. In other words, participants randomized to the intervention arm will meet with the CHW and a staff member from DOORS. One of the primary study aims is a randomized controlled trial of an intervention which has a reasonable probability of improving the health and well-being of the subject by improving linkage to social services and the HIV clinic. The control arm will receive standard of care (referrals to case management).	Treatment As Usual n=9 Participants TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.
Number of Participants Who Are Positive/Negative for Substance Use as Assessed Via Urine Drug Screen positive for stimulants	4 Participants	8 Participants
Number of Participants Who Are Positive/Negative for Substance Use as Assessed Via Urine Drug Screen not positive for stimulants	5 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months after enrollment

Population: participants completing ASSIST score at baseline and 6 months

Change in substance use from baseline at 6 months after enrollment (result reported is the baseline minus the 6 month value) is assessed via ASSIST(Alcohol, Smoking, and Substance Involvement Screening Test) v3.1 questionnaire. For the participant's reported DRUG OF CHOICE, the score on the relevant subscale will be used: (A) ASSIST risk score for tobacco (range 0-31); (B) alcohol (range 0-39); (C) cannabis (range 0-39); (D) cocaine (range 0-39); (E) amphetamine-type stimulants (range 0-39); (F) inhalants (range 0-39); (G) for sedatives or sleeping pills (range 0-39); (H) hallucinogens (range 0-39); (I) opioids (range 0-39); (J) 'other' drugs (range 0-39); High values indicate a worse outcome. Subscales are not combined;

Score interpretation:

Lower Risk: Alcohol (0-10), All other substances (0-3); Moderate Risk: Alcohol (11-26), All other substances (4-26); High risk: Alcohol (26+), All other substances (27+);

Outcome measures

Measure	DOORS-CHW Intervention n=13 Participants The type of intervention is behavioral. Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare. DOORS-CHW Intervention: The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees. Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months. In other words, participants randomized to the intervention arm will meet with the CHW and a staff member from DOORS. One of the primary study aims is a randomized controlled trial of an intervention which has a reasonable probability of improving the health and well-being of the subject by improving linkage to social services and the HIV clinic. The control arm will receive standard of care (referrals to case management).	Treatment As Usual n=11 Participants TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.
Change in Substance Use for Reported Drug of Choice From Baseline at 6 Months After Enrollment as Assessed Via ASSIST Questionnaire All	5.7 score on a scale Standard Deviation 14.9	12 score on a scale Standard Deviation 12.8
Change in Substance Use for Reported Drug of Choice From Baseline at 6 Months After Enrollment as Assessed Via ASSIST Questionnaire Participants with alcohol as their drug of choice	10 score on a scale Standard Deviation 0	-3 score on a scale Standard Deviation 0
Change in Substance Use for Reported Drug of Choice From Baseline at 6 Months After Enrollment as Assessed Via ASSIST Questionnaire Participants with cocaine as their drug of choice	-16.2 score on a scale Standard Deviation 16.7	-4.8 score on a scale Standard Deviation 8.7
Change in Substance Use for Reported Drug of Choice From Baseline at 6 Months After Enrollment as Assessed Via ASSIST Questionnaire Participants with amphetamine-type stimulants as their drug of choice	-14.3 score on a scale Standard Deviation 11.8	-1.6 score on a scale Standard Deviation 7.9
Change in Substance Use for Reported Drug of Choice From Baseline at 6 Months After Enrollment as Assessed Via ASSIST Questionnaire Participants with hallucinogens as their drug of choice	-24 score on a scale Standard Deviation 0	—
Change in Substance Use for Reported Drug of Choice From Baseline at 6 Months After Enrollment as Assessed Via ASSIST Questionnaire Participants with opioids as their drug of choice	-3 score on a scale Standard Deviation 0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: at 12 months after enrollment

Population: participants who were alive at the end of the study and were reincarcerated

Number of participants who experienced recidivism is measured by the count of participants who had a re-incarceration in jail or prison at 12 months

Outcome measures

Measure	DOORS-CHW Intervention n=16 Participants The type of intervention is behavioral. Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare. DOORS-CHW Intervention: The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees. Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months. In other words, participants randomized to the intervention arm will meet with the CHW and a staff member from DOORS. One of the primary study aims is a randomized controlled trial of an intervention which has a reasonable probability of improving the health and well-being of the subject by improving linkage to social services and the HIV clinic. The control arm will receive standard of care (referrals to case management).	Treatment As Usual n=12 Participants TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.
Number of Participants Who Experienced Recidivism	6 participants	6 participants

Adverse Events

DOORS-CHW Intervention

Serious events: 12 serious events

Other events: 0 other events

Deaths: 1 deaths

Treatment As Usual

Serious events: 6 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Measure	DOORS-CHW Intervention n=17 participants at risk The type of intervention is behavioral. Participants randomized to the intervention arm will meet with the Community Health Worker (CHW) and a staff member from Unlocking DOORS. The Unlocking DOORS broker will complete a needs assessment, generate an individualized re-entry plan and make referrals to providers in the extensive Unlocking DOORS network. The CHW will assist the participant in navigating these referrals, specifically with regards to HIV care, substance use treatment and mental healthcare. DOORS-CHW Intervention: The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees. Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months.	Treatment As Usual n=14 participants at risk TAU participants will receive standard of care, which involves passive referral by jail medical staff to the outpatient HIV clinic.
General disorders Hospitalization	70.6% 12/17 • Number of events 12 • 12 months	42.9% 6/14 • Number of events 6 • 12 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ank Nijhawan

UT Southwestern Medical Center

Phone: 214-648-2777

Email: ank.nijhawan@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place