Clinical trial NCT03569592: Addressing Overdose Risk Among Recently Incarcerated People Living With HIV/AIDS
Official title: Addressing Overdose Risk Among Recently Incarcerated People Living With HIV/AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Overdose Accidental
Keywords: HIV/AIDS
naloxone
incarceration
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Incarcerated people living with HIV/AIDS will be given a brief training on overdose prevention and be given naloxone at discharge from jail.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overdose knowledge
timeFrame: time of training until one month after release from jail
measure: Overdose attitudes
timeFrame: time of training until one month after release from jail
Secondary outcomes:
measure: Witnessed overdoses
timeFrame: 1 month (release from jail until one month after release)
measure: Status of naloxone kit
timeFrame: one month after release from jail
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
References: