Hepatitis, HIV
Conditions
Keywords
HIV prevention Intervention, injection drug user,peer-oriented, randomized controlled trial, social network
Brief summary
The purpose of this study is to evaluate a peer-based HIV prevention intervention that targets active injection drug users and their drug and sex partners.
Detailed description
HIV seroincidence among injection drug users remains high, with unprotected sexual contact substantially contributing to new HIV infections among injection drug users (IDUs). Interventions that are culturally competent and target drug users' main sex and drug partners may be especially effective for HIV/STI and HCV control and prevention. The intervention to be tested in this study draws upon theoretical and empirical evidence suggesting that peer educator programs can have significant effects on the risk-related behaviors of both the educators and the peers whom they educate. Specifically, through group and individual focused sessions, participants learn and practice skills designed to reduce drug and sex related risk behaviors. Furthermore, individuals and their main risk partners attend a training session that focuses on risk reduction within their relationship.
Interventions
BEHAVIORALIntervention Condition
In the intervention Condition participants were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
BEHAVIORALControl Condition
The control condition focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
Sponsors
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
(i)Self reported injection drug use within the prior 6 months; (ii)Willingness to invite a risk network member into the study and to talk about HIV prevention; (iii)Age 18 or older
Exclusion criteria
* Not concurrently enrolled in another HIV prevention intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any Sex Risk | 6 months |
| Talked About HIV-related Topics With Drug Buddies (in the Past Month) | 6 months |
| Showed a Needleless Syringe to Drug Buddies | 6 months |
| Talked About Responding to Overdose to Drug Buddies | 6 months |
| Any Injection Risk (Monthly Versus Never) | 12 months |
| Number of Needle or Cooker Sharers (2 or More Versus None) | 12 months |
| Shared Cooker When Preparing Drugs | 18 months |
| Injecting Drugs | 18 months |
| Talked About HIV-related Topics With Drug Buddies (in Past Month) | 18 months |
| Talked About Hepatitis to Drug Buddies | 18 months |
Countries
United States
Participant flow
Recruitment details
Recruitment was conducted from March 2004 to March 2006. Two types of participants were recruited: Index and Risk Network Members. Recruitment methods for Index included: street-based outreach, word of mouth, ads and referrals from community agencies. During the Index's baseline interview, a list of Risk Network Members was generated.
Pre-assignment details
Two types of participants were enrolled in the study- index and networks. Networks did not go through the intervention or control condition. Index participants had to refer a network member AND show up for randomization in order to be enrolled in the intervention or control condition.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Condition Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member. | 114 |
| Control Condition Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions. | 113 |
| Non-Randomized Baseline Index Participants Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition. | 373 |
| Risk Network Members Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant | 424 |
| Total | 1,024 |
Baseline characteristics
| Characteristic | Control Condition | Non-Randomized Baseline Index Participants | Intervention Condition | Risk Network Members | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 113 Participants | 372 Participants | 114 Participants | 422 Participants | 1021 Participants |
| Age Continuous | 43.0 years STANDARD_DEVIATION 7 | 42.4 years STANDARD_DEVIATION 9 | 43.9 years STANDARD_DEVIATION 8 | 43.7 years STANDARD_DEVIATION 8 | 43.2 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 113 participants | 373 participants | 114 participants | 424 participants | 1024 participants |
| Sex: Female, Male Female | 52 Participants | 130 Participants | 51 Participants | 170 Participants | 403 Participants |
| Sex: Female, Male Male | 61 Participants | 243 Participants | 63 Participants | 254 Participants | 621 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 114 | 0 / 113 | 0 / 373 | 0 / 424 |
| serious Total, serious adverse events | 0 / 114 | 0 / 113 | 0 / 373 | 0 / 424 |
Outcome results
Primary
Any Injection Risk (Monthly Versus Never)
Time frame: 12 months
Population: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition | Any Injection Risk (Monthly Versus Never) | 15 participants |
| Control Condition | Any Injection Risk (Monthly Versus Never) | 27 participants |
| Non-Randomized Baseline Index Participants | Any Injection Risk (Monthly Versus Never) | 79 participants |
| Risk Network Members | Any Injection Risk (Monthly Versus Never) | 53 participants |
Primary
Any Injection Risk (Monthly Versus Never)
Time frame: 18 months
Population: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition | Any Injection Risk (Monthly Versus Never) | 12 participants |
| Control Condition | Any Injection Risk (Monthly Versus Never) | 25 participants |
| Non-Randomized Baseline Index Participants | Any Injection Risk (Monthly Versus Never) | 63 participants |
| Risk Network Members | Any Injection Risk (Monthly Versus Never) | 46 participants |
Primary
Any Sex Risk
Time frame: 6 months
Population: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition | Any Sex Risk | 48 participants |
| Control Condition | Any Sex Risk | 62 participants |
| Non-Randomized Baseline Index Participants | Any Sex Risk | 119 participants |
| Risk Network Members | Any Sex Risk | 179 participants |
Primary
Injecting Drugs
Time frame: 18 months
Population: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition | Injecting Drugs | 35 participants |
| Control Condition | Injecting Drugs | 58 participants |
| Non-Randomized Baseline Index Participants | Injecting Drugs | 143 participants |
| Risk Network Members | Injecting Drugs | 108 participants |
Primary
Number of Needle or Cooker Sharers (2 or More Versus None)
Time frame: 18 months
Population: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition | Number of Needle or Cooker Sharers (2 or More Versus None) | 5 participants |
| Control Condition | Number of Needle or Cooker Sharers (2 or More Versus None) | 17 participants |
| Non-Randomized Baseline Index Participants | Number of Needle or Cooker Sharers (2 or More Versus None) | 45 participants |
| Risk Network Members | Number of Needle or Cooker Sharers (2 or More Versus None) | 23 participants |
Primary
Number of Needle or Cooker Sharers (2 or More Versus None)
Time frame: 12 months
Population: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition | Number of Needle or Cooker Sharers (2 or More Versus None) | 5 participants |
| Control Condition | Number of Needle or Cooker Sharers (2 or More Versus None) | 17 participants |
| Non-Randomized Baseline Index Participants | Number of Needle or Cooker Sharers (2 or More Versus None) | 37 participants |
| Risk Network Members | Number of Needle or Cooker Sharers (2 or More Versus None) | 31 participants |
Primary
Shared Cooker When Preparing Drugs
Time frame: 18 months
Population: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition | Shared Cooker When Preparing Drugs | 18 participants |
| Control Condition | Shared Cooker When Preparing Drugs | 36 participants |
| Non-Randomized Baseline Index Participants | Shared Cooker When Preparing Drugs | 84 participants |
| Risk Network Members | Shared Cooker When Preparing Drugs | 66 participants |
Primary
Showed a Needleless Syringe to Drug Buddies
Time frame: 12 months
Population: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition | Showed a Needleless Syringe to Drug Buddies | 78 participants |
| Control Condition | Showed a Needleless Syringe to Drug Buddies | 16 participants |
| Non-Randomized Baseline Index Participants | Showed a Needleless Syringe to Drug Buddies | 35 participants |
| Risk Network Members | Showed a Needleless Syringe to Drug Buddies | 55 participants |
Primary
Showed a Needleless Syringe to Drug Buddies
Time frame: 6 months
Population: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition | Showed a Needleless Syringe to Drug Buddies | 85 participants |
| Control Condition | Showed a Needleless Syringe to Drug Buddies | 18 participants |
| Non-Randomized Baseline Index Participants | Showed a Needleless Syringe to Drug Buddies | 32 participants |
| Risk Network Members | Showed a Needleless Syringe to Drug Buddies | 49 participants |
Primary
Showed a Needleless Syringe to Drug Buddies
Time frame: 18 months
Population: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition | Showed a Needleless Syringe to Drug Buddies | 84 participants |
| Control Condition | Showed a Needleless Syringe to Drug Buddies | 22 participants |
| Non-Randomized Baseline Index Participants | Showed a Needleless Syringe to Drug Buddies | 37 participants |
| Risk Network Members | Showed a Needleless Syringe to Drug Buddies | 67 participants |
Primary
Talked About Hepatitis to Drug Buddies
Time frame: 18 months
Population: Data for this outcome was only measured among randomized participants (intervention and control participants), not among non-randomized and network participants. The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition | Talked About Hepatitis to Drug Buddies | 51 participants |
| Control Condition | Talked About Hepatitis to Drug Buddies | 29 participants |
Primary
Talked About HIV-related Topics With Drug Buddies (in Past Month)
Time frame: 18 months
Population: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition | Talked About HIV-related Topics With Drug Buddies (in Past Month) | 44 participants |
| Control Condition | Talked About HIV-related Topics With Drug Buddies (in Past Month) | 35 participants |
| Non-Randomized Baseline Index Participants | Talked About HIV-related Topics With Drug Buddies (in Past Month) | 96 participants |
| Risk Network Members | Talked About HIV-related Topics With Drug Buddies (in Past Month) | 106 participants |
Primary
Talked About HIV-related Topics With Drug Buddies (in the Past Month)
Time frame: 6 months
Population: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition | Talked About HIV-related Topics With Drug Buddies (in the Past Month) | 80 participants |
| Control Condition | Talked About HIV-related Topics With Drug Buddies (in the Past Month) | 54 participants |
| Non-Randomized Baseline Index Participants | Talked About HIV-related Topics With Drug Buddies (in the Past Month) | 108 participants |
| Risk Network Members | Talked About HIV-related Topics With Drug Buddies (in the Past Month) | 104 participants |
Primary
Talked About HIV-related Topics With Drug Buddies (in the Past Month)
Time frame: 12 months
Population: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition | Talked About HIV-related Topics With Drug Buddies (in the Past Month) | 60 participants |
| Control Condition | Talked About HIV-related Topics With Drug Buddies (in the Past Month) | 46 participants |
| Non-Randomized Baseline Index Participants | Talked About HIV-related Topics With Drug Buddies (in the Past Month) | 98 participants |
| Risk Network Members | Talked About HIV-related Topics With Drug Buddies (in the Past Month) | 105 participants |
Primary
Talked About Responding to Overdose to Drug Buddies
Time frame: 6 months
Population: Data for this outcome was only measured among randomized participants (intervention and control participants), not among non-randomized and network participants. The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition | Talked About Responding to Overdose to Drug Buddies | 2 participants |
| Control Condition | Talked About Responding to Overdose to Drug Buddies | 21 participants |