NCT03569592

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

August 5, 2020

Status Verified

June 1, 2018

Enrollment Period

1.4 years

First QC Date

June 15, 2018

Last Update Submit

August 4, 2020

Conditions

Keywords

HIV/AIDSnaloxoneincarceration

Outcome Measures

Primary Outcomes (2)

  • Overdose knowledge

    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

    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 Outcomes (2)

  • Witnessed overdoses

    1 month (release from jail until one month after release)

  • Status of naloxone kit

    one month after release from jail

Study Arms (1)

Overdose Prevention Intervention

EXPERIMENTAL

The experimental group will receive a brief overdose prevention education intervention and be issues naloxone upon discharge from jail.

Behavioral: Overdose Prevention Intervention

Interventions

Evaluate an overdose prevention education with incarcerated people living with HIV/AIDS.

Also known as: Addressing Overdose Risk among Recently Incarcerated People Living with HIV/AIDS
Overdose Prevention Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19143, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Incarcerated people living with HIV/AIDS will be given a brief training on overdose prevention and be given naloxone at discharge from jail.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2018

First Posted

June 26, 2018

Study Start

January 22, 2018

Primary Completion

May 30, 2019

Study Completion

January 31, 2020

Last Updated

August 5, 2020

Record last verified: 2018-06

Locations