Trial Outcomes & Findings for A Network & Dyad HIV Prevention Intervention for IDU's - 1 (NCT NCT00218335)
NCT ID: NCT00218335
Last Updated: 2013-04-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1024 participants
Primary outcome timeframe
6 months
Results posted on
2013-04-18
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
Non-Randomized Baseline Index Participants
Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
|
Risk Network Members
Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
114
|
113
|
373
|
424
|
|
Overall Study
6 Month Follow-up
|
103
|
99
|
219
|
301
|
|
Overall Study
12 Month Follow-up
|
95
|
102
|
244
|
303
|
|
Overall Study
18 Month Follow-up
|
101
|
108
|
296
|
368
|
|
Overall Study
COMPLETED
|
108
|
110
|
319
|
388
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
54
|
36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Network & Dyad HIV Prevention Intervention for IDU's - 1
Baseline characteristics by cohort
| Measure |
Intervention Condition
n=114 Participants
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.
|
Control Condition
n=113 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.
|
Non-Randomized Baseline Index Participants
n=373 Participants
Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
|
Risk Network Members
n=424 Participants
Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
|
Total
n=1024 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
114 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
372 Participants
n=206 Participants
|
422 Participants
n=157 Participants
|
1021 Participants
n=390 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
|
Age Continuous
|
43.9 years
STANDARD_DEVIATION 8 • n=99 Participants
|
43.0 years
STANDARD_DEVIATION 7 • n=107 Participants
|
42.4 years
STANDARD_DEVIATION 9 • n=206 Participants
|
43.7 years
STANDARD_DEVIATION 8 • n=157 Participants
|
43.2 years
STANDARD_DEVIATION 8 • n=390 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
170 Participants
n=157 Participants
|
403 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
243 Participants
n=206 Participants
|
254 Participants
n=157 Participants
|
621 Participants
n=390 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=99 Participants
|
113 participants
n=107 Participants
|
373 participants
n=206 Participants
|
424 participants
n=157 Participants
|
1024 participants
n=390 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
Outcome measures
| Measure |
Intervention Condition
n=101 Participants
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.
|
Control Condition
n=98 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.
|
Non-Randomized Baseline Index Participants
n=217 Participants
Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
|
Risk Network Members
n=298 Participants
Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
|
|---|---|---|---|---|
|
Any Sex Risk
|
48 participants
|
62 participants
|
119 participants
|
179 participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
Outcome measures
| Measure |
Intervention Condition
n=95 Participants
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.
|
Control Condition
n=87 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.
|
Non-Randomized Baseline Index Participants
n=206 Participants
Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
|
Risk Network Members
n=252 Participants
Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
|
|---|---|---|---|---|
|
Talked About HIV-related Topics With Drug Buddies (in the Past Month)
|
80 participants
|
54 participants
|
108 participants
|
104 participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
Outcome measures
| Measure |
Intervention Condition
n=103 Participants
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.
|
Control Condition
n=99 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.
|
Non-Randomized Baseline Index Participants
n=219 Participants
Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
|
Risk Network Members
n=300 Participants
Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
|
|---|---|---|---|---|
|
Showed a Needleless Syringe to Drug Buddies
|
85 participants
|
18 participants
|
32 participants
|
49 participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
Outcome measures
| Measure |
Intervention Condition
n=101 Participants
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.
|
Control Condition
n=95 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.
|
Non-Randomized Baseline Index Participants
Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
|
Risk Network Members
Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
|
|---|---|---|---|---|
|
Talked About Responding to Overdose to Drug Buddies
|
2 participants
|
21 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
Outcome measures
| Measure |
Intervention Condition
n=70 Participants
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.
|
Control Condition
n=76 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.
|
Non-Randomized Baseline Index Participants
n=191 Participants
Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
|
Risk Network Members
n=138 Participants
Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
|
|---|---|---|---|---|
|
Any Injection Risk (Monthly Versus Never)
|
15 participants
|
27 participants
|
79 participants
|
53 participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
Outcome measures
| Measure |
Intervention Condition
n=82 Participants
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.
|
Control Condition
n=82 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.
|
Non-Randomized Baseline Index Participants
n=212 Participants
Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
|
Risk Network Members
n=280 Participants
Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
|
|---|---|---|---|---|
|
Number of Needle or Cooker Sharers (2 or More Versus None)
|
5 participants
|
17 participants
|
37 participants
|
31 participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
Outcome measures
| Measure |
Intervention Condition
n=83 Participants
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.
|
Control Condition
n=90 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.
|
Non-Randomized Baseline Index Participants
n=215 Participants
Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
|
Risk Network Members
n=231 Participants
Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
|
|---|---|---|---|---|
|
Talked About HIV-related Topics With Drug Buddies (in the Past Month)
|
60 participants
|
46 participants
|
98 participants
|
105 participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
Outcome measures
| Measure |
Intervention Condition
n=94 Participants
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.
|
Control Condition
n=100 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.
|
Non-Randomized Baseline Index Participants
n=244 Participants
Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
|
Risk Network Members
n=302 Participants
Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
|
|---|---|---|---|---|
|
Showed a Needleless Syringe to Drug Buddies
|
78 participants
|
16 participants
|
35 participants
|
55 participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
Outcome measures
| Measure |
Intervention Condition
n=81 Participants
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.
|
Control Condition
n=83 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.
|
Non-Randomized Baseline Index Participants
n=227 Participants
Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
|
Risk Network Members
n=166 Participants
Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
|
|---|---|---|---|---|
|
Any Injection Risk (Monthly Versus Never)
|
12 participants
|
25 participants
|
63 participants
|
46 participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
Outcome measures
| Measure |
Intervention Condition
n=35 Participants
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.
|
Control Condition
n=58 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.
|
Non-Randomized Baseline Index Participants
n=145 Participants
Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
|
Risk Network Members
n=111 Participants
Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
|
|---|---|---|---|---|
|
Shared Cooker When Preparing Drugs
|
18 participants
|
36 participants
|
84 participants
|
66 participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
Outcome measures
| Measure |
Intervention Condition
n=93 Participants
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.
|
Control Condition
n=93 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.
|
Non-Randomized Baseline Index Participants
n=251 Participants
Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
|
Risk Network Members
n=328 Participants
Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
|
|---|---|---|---|---|
|
Number of Needle or Cooker Sharers (2 or More Versus None)
|
5 participants
|
17 participants
|
45 participants
|
23 participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
Outcome measures
| Measure |
Intervention Condition
n=99 Participants
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.
|
Control Condition
n=107 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.
|
Non-Randomized Baseline Index Participants
n=281 Participants
Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
|
Risk Network Members
n=354 Participants
Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
|
|---|---|---|---|---|
|
Injecting Drugs
|
35 participants
|
58 participants
|
143 participants
|
108 participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
Outcome measures
| Measure |
Intervention Condition
n=68 Participants
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.
|
Control Condition
n=84 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.
|
Non-Randomized Baseline Index Participants
n=219 Participants
Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
|
Risk Network Members
n=265 Participants
Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
|
|---|---|---|---|---|
|
Talked About HIV-related Topics With Drug Buddies (in Past Month)
|
44 participants
|
35 participants
|
96 participants
|
106 participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.
Outcome measures
| Measure |
Intervention Condition
n=100 Participants
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.
|
Control Condition
n=107 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.
|
Non-Randomized Baseline Index Participants
n=286 Participants
Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
|
Risk Network Members
n=360 Participants
Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
|
|---|---|---|---|---|
|
Showed a Needleless Syringe to Drug Buddies
|
84 participants
|
22 participants
|
37 participants
|
67 participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: 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.
Outcome measures
| Measure |
Intervention Condition
n=95 Participants
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.
|
Control Condition
n=100 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.
|
Non-Randomized Baseline Index Participants
Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
|
Risk Network Members
Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
|
|---|---|---|---|---|
|
Talked About Hepatitis to Drug Buddies
|
51 participants
|
29 participants
|
—
|
—
|
Adverse Events
Intervention Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Randomized Baseline Index Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Risk Network Members
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place