| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DA016555-05 | U.S. NIH Grant/Contract | View source | |
| 5R01DA016555-04 | U.S. NIH Grant/Contract | View source | |
| 5R01DA016555-03 | U.S. NIH Grant/Contract | View source | |
| 3R01DA016555-03S1 | U.S. NIH Grant/Contract | View source | |
| 3R01DA016555-02S1 | U.S. NIH Grant/Contract | View source | |
| 5R01DA016555-02 | U.S. NIH Grant/Contract | View source | |
| 3R01DA016555-01S1 | U.S. NIH Grant/Contract | View source | |
| 1R01DA016555-01 | U.S. NIH Grant/Contract | View source | |
| R01-16555-1 | |||
| NIDA-16555-1 |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Johns Hopkins University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Condition | Experimental | 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. |
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| Control Condition | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Condition | Behavioral | 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. |
| Measure | Description | 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 | |
| Talked About HIV-related Topics With Drug Buddies (in the Past Month) | 12 months | |
| Showed a Needleless Syringe to Drug Buddies | 12 months | |
| Any Injection Risk (Monthly Versus Never) | 18 months | |
| Shared Cooker When Preparing Drugs | 18 months | |
| Number of Needle or Cooker Sharers (2 or More Versus None) | 18 months | |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Carl Latkin, Ph.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Lighthouse | Baltimore | Maryland | 21231 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Non-Randomized Baseline Index Participants | Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition. |
| FG003 | Risk Network Members | Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Any Sex Risk | The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection. | Posted | Number | participants | 6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carl Latkin, PhD | Johns Hopkins Bloomberg School of Public Health | clatkin@jhsph.edu |
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| ID | Term |
|---|---|
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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|
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| Control Condition | Behavioral | 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. |
|
| Injecting Drugs |
| 18 months |
| Talked About HIV-related Topics With Drug Buddies (in Past Month) | 18 months |
| Showed a Needleless Syringe to Drug Buddies | 18 months |
| Talked About Hepatitis to Drug Buddies | 18 months |
| BG001 | 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. |
| BG002 | Non-Randomized Baseline Index Participants | Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition. |
| BG003 | Risk Network Members | Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
| OG002 | Non-Randomized Baseline Index Participants | Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition. |
| OG003 | Risk Network Members | Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant |
|
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| Primary | Talked About HIV-related Topics With Drug Buddies (in the Past Month) | The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection. | Posted | Number | participants | 6 months |
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| Primary | Showed a Needleless Syringe to Drug Buddies | The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection. | Posted | Number | participants | 6 months |
|
|
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| Primary | Talked About Responding to Overdose to Drug Buddies | 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. | Posted | Number | participants | 6 months |
|
|
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| Primary | Any Injection Risk (Monthly Versus Never) | The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection. | Posted | Number | participants | 12 months |
|
|
|
| Primary | Number of Needle or Cooker Sharers (2 or More Versus None) | The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection. | Posted | Number | participants | 12 months |
|
|
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| Primary | Talked About HIV-related Topics With Drug Buddies (in the Past Month) | The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection. | Posted | Number | participants | 12 months |
|
|
|
| Primary | Showed a Needleless Syringe to Drug Buddies | The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection. | Posted | Number | participants | 12 months |
|
|
|
| Primary | Any Injection Risk (Monthly Versus Never) | The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection. | Posted | Number | participants | 18 months |
|
|
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| Primary | Shared Cooker When Preparing Drugs | The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection. | Posted | Number | participants | 18 months |
|
|
|
| Primary | Number of Needle or Cooker Sharers (2 or More Versus None) | The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection. | Posted | Number | participants | 18 months |
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|
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| Primary | Injecting Drugs | The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection. | Posted | Number | participants | 18 months |
|
|
|
| Primary | Talked About HIV-related Topics With Drug Buddies (in Past Month) | The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection. | Posted | Number | participants | 18 months |
|
|
|
| Primary | Showed a Needleless Syringe to Drug Buddies | The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection. | Posted | Number | participants | 18 months |
|
|
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| Primary | Talked About Hepatitis to Drug Buddies | 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. | Posted | Number | participants | 18 months |
|
|
|
| 0 |
| 114 |
| 0 |
| 114 |
| EG001 | 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. | 0 | 113 | 0 | 113 |
| EG002 | Non-Randomized Baseline Index Participants | Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition. | 0 | 373 | 0 | 373 |
| EG003 | Risk Network Members | Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant | 0 | 424 | 0 | 424 |
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