Addressing Overdose Risk Among Recently Incarcerated People Living With HIV/AIDS

August 4, 2020 updated by: Drexel University

The overall objective of this study is to evaluate an educational overdose prevention intervention's effectiveness among incarcerated people living with HIV/AIDS, specifically within the context of other outcomes related to health and experiences after incarceration. Results will be used to develop tailored interventions to reduce overdose deaths among high-risk correctional populations.

The research has the following aims:

  • Aim 1: Evaluate a pilot program to provide HIV+ inmates with 1:1 overdose prevention training while incarcerated;
  • Aim 2: Identify the criminal justice, health, and HIV-related factors associated with overdose risk; and
  • Aim 3: Describe the overdose risk experiences of HIV+ former inmates who use opioids after release.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of this research is to establish best practices to address overdose risk in people exiting incarceration, people living with HIV/AIDS (PLWHA), and both populations simultaneously. This contribution is important because this evidence has applications for correctional facilities and HIV clinical practice throughout the United States. The contributions of the proposed pilot study are: to provide evidence on the effectiveness of a targeted intervention on these two high-risk groups, generate exploratory data on predictors of overdose risk specific to HIV status and recent incarceration, and provide context about overdose risk and responses to witnessed overdoses in the first month after release.

In this study, incarcerated PLWHA in the Philadelphia Department of Prisons will be offered overdose training while incarcerated and naloxone (Narcan) at release. Study participants will be given a pre-test on overdose knowledge and attitudes and receive the overdose prevention intervention. Those who are still incarcerated one month later will receive a post-test on overdose knowledge and attitudes. Approximately one month after study participants are released from jail, they will be given a one-month follow-up survey that assesses: overdose knowledge and attitudes (post-test 2), information on personal or witnessed overdoses since release, health and post-incarceration related information, and characteristics of drug use since release. Approximately 20 study participants will participate in a semi-structured interview 4-6 weeks after their release on their experiences with the overdose prevention intervention.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19143
        • Drexel University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV-positive
  • Age 18 and over
  • Speaks English
  • plans to live in Philadelphia area after release

Exclusion Criteria:

  • More than 10 months remaining on a sentence or release date unknown

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Overdose Prevention Intervention
The experimental group will receive a brief overdose prevention education intervention and be issues naloxone upon discharge from jail.
Behavioral: Overdose Prevention Intervention
Evaluate an overdose prevention education with incarcerated people living with HIV/AIDS.
Other Names:
  • Addressing Overdose Risk among Recently Incarcerated People Living with HIV/AIDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overdose knowledge
Time Frame: time of training until one month after release from jail
The scale is adapted from the Opioid Overdose Knowledge Scale (OOKS). OOKS subscales measure overdose risks, signs, actions to take in a witnessed overdose, & naloxone use. It has 4 multiple choice questions, 4 forced-choice questions, and 6 true/false statements. Each correct answer is 1 point and incorrect answers are 0. Subscale ranges are 0-9 for overdose risks, 0-10 for signs, 0-11 for actions to take in a witnessed overdose, and 0-15 for naloxone use. The total score range is summed from subscale scores from 0 to 45, with higher scores indicating greater knowledge. The adapted scale assesses the same domains and consists of 4 multiple choice questions, 1 forced-choice question, and 6 true/false statements. Each correct answer is 1 point and incorrect answers are 0. Subscale ranges are 0-5 for overdose risks, 0-4 for overdose signs, 0-5 for overdose actions, and 0-6 for naloxone use. Scores are summed for a total number of 20 points, with higher scores indicating greater knowled
time of training until one month after release from jail
Overdose attitudes
Time Frame: time of training until one month after release from jail
The scale is adapted from the Opioid Overdose Attitudes Scale (OOAS). OOAS subscales measure overdose response competence (10 items), concerns (8 items), & readiness (10 items). Likert scale options include "Completely Agree", "Agree", "Unsure", "Disagree", and "Completely Disagree" with a score of 1 to 5 assigned to each item. The total score range on the initial measure is summed from the subscales from 28-140 points (1-50 points on subscale competence, 1-40 points on subscale concerns, and 1-50 points on subscale readiness), with higher scores indicating favorable attitudes. The adapted scale also assesses: overdose response competence (4 questions), concerns (3 questions), and readiness (4 questions). Scoring is identical to the full scale, with possible subscales scores ranging from 1-20 for overdose competence, 1-15 for concerns about responding to an overdose, and 1-20 for readiness to respond to an overdose. Scores are summed for a total score range of 11-55. Higher scores in
time of training until one month after release from jail

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Witnessed overdoses
Time Frame: 1 month (release from jail until one month after release)
Information on any witnessed overdoses since release from jail. The domain of witnessed overdoses is not from an existing scale. It is assessed by asking the following: "Have you seen anyone overdose since you left jail? (To be clear, an overdose means someone is unresponsive or cannot be woken up, collapses, has blue skin color, convulsions, difficulty breathing, loses consciousness, or has a heart attack or dies while using drugs.). Answer options are "yes", "no", and "not sure". Those reporting "yes" are directed to a follow-up question: "How many overdoses have you seen since you left jail?" Answer options range include "1", "2", "3", "4", "5 or more". Additional follow-up questions assess the location, response actions of respondent, response actions of others at the scene, and outcome of the overdose for the victim for the most recently witnessed overdose.
1 month (release from jail until one month after release)
Status of naloxone kit
Time Frame: one month after release from jail
Whether participant was given naloxone at release from jail and where the naloxone kit is at time of follow-up. The domain of "status of naloxone kit" is not from an existing scale. It is assessed by asking: "When you were released from jail, the pharmacy should have given you naloxone. Were you given naloxone?". Answer options include "Yes, I was given a kit when I was released", "I was not given a kit at release but I got one after I was released", "I did not get a kit when I was released and I've never had one", and "Don't know/not sure". Follow-up questions assess where participants received naloxone from if they received a kit after release and the current location of the kit for any respondents reporting having received a naloxone kit at any point and what happened to kits that are no longer in possession of respondents.
one month after release from jail

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Drexel University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2018

Primary Completion (Actual)

May 30, 2019

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

June 15, 2018

First Submitted That Met QC Criteria

June 15, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 4, 2020

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1704005362

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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