Drug Overdose Accidental Clinical Trial
Official title:
Addressing Overdose Risk Among Recently Incarcerated People Living With HIV/AIDS
| Verified date | June 2018 |
| Source | Drexel University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | January 31, 2020 |
| Est. primary completion date | May 30, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Drexel University | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Drexel University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | Witnessed overdoses | 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) | |
| Secondary | Status of naloxone kit | 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 |