HIV Prevention, Opioid-Related Disorders
Conditions
Keywords
HIV Prevention, Opioid-Related Disorders, Medication Assisted Treatment, Methadone
Brief summary
Much of the HIV/AIDS epidemic is driven by transmission from or to persons addicted to opiates. Many of these individuals pass through a correctional setting each year, creating an opportunity for linkage to substance abuse treatment. The purpose of this study was to evaluate the effectiveness of initiating opiate replacement therapy prior to release from incarceration on reducing HIV risk behaviors and drug relapse. In addition, this study evaluated the effectiveness of short-term payment versus non-payment of community opiate replacement therapy immediately following release from incarceration.
Detailed description
A substantial proportion of individuals addicted to heroin are incarcerated while addicted and a majority of individuals released from a correctional setting have a history of heroin addiction. The period immediately after release from incarceration is a particularly high-risk time for HIV transmission and other problems, including drug relapse and overdose. Methadone treatment is the most widely used opiate replacement therapy in the United States and has been shown to decrease HIV risk, as well as drug use, addiction relapse, and criminal activity. The purpose of this study was to evaluate the effectiveness of initiating opiate replacement therapy prior to release from incarceration on reducing HIV risk behaviors and drug relapse. In addition, this study evaluated the effectiveness of short-term payment versus non-payment of community opiate replacement therapy immediately following release from incarceration. Participants in this were randomly assigned to 1 of 3 treatment groups. Participants enrolled in Group 1 initiated methadone opiate replacement therapy about 1 month prior to release from incarceration. They proceeded with a methadone program of their choice upon release and received short-term payment to cover treatment costs. Participants enrolled in Group 2 were referred to a methadone program of their choice and received short-term payment to cover treatment costs. Participants enrolled in Group 3 were referred to a program of choice upon release from incarceration without receiving financial assistance. All participants had the opportunity to partake in existing support programs available at the Rhode Island Department of Corrections while incarcerated and in the community upon release. Follow-up assessments occurred at Months 1.5, 6, and 12. These included interviews and urine specimens for toxicology analysis to verify self-reports.
Interventions
BEHAVIORALPost Release Initiation of MMT.
Participants assigned to Arm 2 will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
BEHAVIORALPre-release Initiation of MMT
Participants assigned to arm 1 will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
BEHAVIORALStandard of Care Plus
Participants assigned to Arm 3 will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT.
Sponsors
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Currently incarcerated at the Rhode Island Department of Corrections with a scheduled release date at least 28 days after enrollment * Incarceration length not to have exceeded two years at the time of enrollment * Heroin dependent with self-reported heroin injection in the month prior to incarceration OR enrollment in a methadone treatment program prior to incarceration for heroin addiction with a history of injection drug use * Desire to enter methadone treatment upon release and plans to secure funding for methadone treatment after study completion * History of prior tolerance to methadone * History of at least one drug-related incarceration * Speaks English or Spanish * Plans to remain in Rhode Island for the duration of the study (24 months) * Ability to provide at least two names of individuals who can verify participant information
Exclusion criteria
* Currently receiving methadone at the Rhode Island Department of Corrections * Currently undergoing a non-narcotic detoxification from illicit opiates at the Rhode Island Department of Corrections * Plans to leave Rhode Island within the two years following enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Engagement | within 30 days post release of incarceration | Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome is measured by frequency - yes, participant attended initial clinic appointment within 30 days post release or no, participant did not attend clinic appointment within 30 days post release. Data source was methadone clinic chart review. |
| Time to MMT Initiation Post Release Based on Clinic Chart Review | within 30 days post release from incarceration | Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome measures number of days from release to the first day of clinic attendance, only for those participants who successfully entered methadone treatment post release. Data source was methadone clinic chart review. |
| HIV Risk Behaviors - Self Report | 6 month follow-up interviews | Participants who self-reported injecting illicit drugs in the past 30 days, based on responses to face-to-face administration of the 6 month interview. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug Use | 6 month follow-up interviews | Participants who self-reported heroin use in the past 30 days, based on responses to face-to-face administration of the 6 month interview. |
| Fatal Overdose | Within six months from release of incarceration | Number of participants who died as the result of drug poisoning within six months of release of incarceration. This outcome was based on review of death records. |
| Non-fatal Overdose | 6 month follow-up interviews | Participants who self-reported experiencing an overdose within the past six months, based on responses to face-to-face administration of the 6 month interview. |
Countries
United States
Participant flow
Recruitment details
All recruitment occurred at the Rhode Island Department of Corrections. Screening began on 9/15/2006 and the first participant was enrolled on 9/29/2006. The last participant was enrolled on 2/20/2009.
Pre-assignment details
There were no significant events following participant enrollment and prior to group assignment.
Participants by arm
| Arm | Count |
|---|---|
| Pre-release MMT Initiation + Referral Post Release + Payment Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs. | 29 |
| MMT Referral Post Release + Payment Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs. | 28 |
| MMT Referral Post Release Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance. | 30 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 2 | 1 |
| Overall Study | Lost to Follow-up | 2 | 5 | 5 |
| Overall Study | Other reason | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | MMT Referral Post Release + Payment | MMT Referral Post Release | Pre-release MMT Initiation + Referral Post Release + Payment | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 30 Participants | 29 Participants | 87 Participants |
| Age, Continuous | 37 years STANDARD_DEVIATION 6.69 | 38.4 years STANDARD_DEVIATION 9.25 | 37.3 years STANDARD_DEVIATION 8.79 | 37.6 years STANDARD_DEVIATION 8.27 |
| Region of Enrollment United States | 28 participants | 30 participants | 29 participants | 87 participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 10 Participants | 27 Participants |
| Sex: Female, Male Male | 20 Participants | 21 Participants | 19 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 26 | 8 / 20 | 8 / 23 |
| serious Total, serious adverse events | 0 / 29 | 2 / 28 | 1 / 30 |
Outcome results
Primary
HIV Risk Behaviors - Self Report
Participants who self-reported injecting illicit drugs in the past 30 days, based on responses to face-to-face administration of the 6 month interview.
Time frame: 6 month follow-up interviews
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| As Assigned: Pre-release MMT + Referral Post Release + Payment | HIV Risk Behaviors - Self Report | 3 participants |
| As Assigned: MMT Referral Post Release + Payment | HIV Risk Behaviors - Self Report | 6 participants |
| As Assigned: MMT Referral Post Release | HIV Risk Behaviors - Self Report | 8 participants |
p-value: 0.09Chi-squared, Corrected
Primary
Time to MMT Initiation Post Release Based on Clinic Chart Review
Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome measures number of days from release to the first day of clinic attendance, only for those participants who successfully entered methadone treatment post release. Data source was methadone clinic chart review.
Time frame: within 30 days post release from incarceration
Population: Participants were analyzed as randomized (intent to treat). We calculated the mean number of days (and SD) between release from incarceration and first MMT clinic visit post release. Not all participants attended clinic within 30 days post release - those participants are not included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| As Assigned: Pre-release MMT + Referral Post Release + Payment | Time to MMT Initiation Post Release Based on Clinic Chart Review | 2 days | Standard Deviation 4.37 |
| As Assigned: MMT Referral Post Release + Payment | Time to MMT Initiation Post Release Based on Clinic Chart Review | 9 days | Standard Deviation 9.74 |
| As Assigned: MMT Referral Post Release | Time to MMT Initiation Post Release Based on Clinic Chart Review | 5 days | Standard Deviation 5.16 |
p-value: 0.02Chi-squared, Corrected
Primary
Treatment Engagement
Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome is measured by frequency - yes, participant attended initial clinic appointment within 30 days post release or no, participant did not attend clinic appointment within 30 days post release. Data source was methadone clinic chart review.
Time frame: within 30 days post release of incarceration
Population: We assessed community methadone treatment clinic attendance of all enrolled participants based on clinic chart review.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| As Assigned: Pre-release MMT + Referral Post Release + Payment | Treatment Engagement | 23 participants |
| As Assigned: MMT Referral Post Release + Payment | Treatment Engagement | 11 participants |
| As Assigned: MMT Referral Post Release | Treatment Engagement | 6 participants |
Comparison: Outcome: engage in treatment post release, yes or nop-value: <0.001Chi-squared, Corrected
Secondary
Drug Use
Participants who self-reported heroin use in the past 30 days, based on responses to face-to-face administration of the 6 month interview.
Time frame: 6 month follow-up interviews
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| As Assigned: Pre-release MMT + Referral Post Release + Payment | Drug Use | 6 participants |
| As Assigned: MMT Referral Post Release + Payment | Drug Use | 8 participants |
| As Assigned: MMT Referral Post Release | Drug Use | 11 participants |
p-value: 0.09Chi-squared, Corrected
Secondary
Fatal Overdose
Number of participants who died as the result of drug poisoning within six months of release of incarceration. This outcome was based on review of death records.
Time frame: Within six months from release of incarceration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| As Assigned: Pre-release MMT + Referral Post Release + Payment | Fatal Overdose | 0 participants |
| As Assigned: MMT Referral Post Release + Payment | Fatal Overdose | 1 participants |
| As Assigned: MMT Referral Post Release | Fatal Overdose | 1 participants |
Secondary
Non-fatal Overdose
Participants who self-reported experiencing an overdose within the past six months, based on responses to face-to-face administration of the 6 month interview.
Time frame: 6 month follow-up interviews
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| As Assigned: Pre-release MMT + Referral Post Release + Payment | Non-fatal Overdose | 3 participants |
| As Assigned: MMT Referral Post Release + Payment | Non-fatal Overdose | 3 participants |
| As Assigned: MMT Referral Post Release | Non-fatal Overdose | 2 participants |
p-value: 0.8Chi-squared, Corrected