A Network & Dyad HIV Prevention Intervention for IDU's - 1

This study has been completed.

Sponsor:

Collaborators:

National Institute on Drug Abuse (NIDA)

Johns Hopkins University

Information provided by (Responsible Party):

Carl Latkin, Johns Hopkins Bloomberg School of Public Health

ClinicalTrials.gov Identifier:

NCT00218335

First received: September 16, 2005

Last updated: March 7, 2013

Last verified: March 2013

History of Changes

Results First Received: January 25, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Prevention
Conditions:	HIV Hepatitis
Interventions:	Behavioral: Intervention Condition Behavioral: Control Condition

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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

Participant Flow: Overall Study

	Intervention Condition	Control Condition	Non-Randomized Baseline Index Participants	Risk Network Members
STARTED	114	113	373	424
6 Month Follow-up	103	99	219	301
12 Month Follow-up	95	102	244	303
18 Month Follow-up	101	108	296	368
COMPLETED	108	110	319	388
NOT COMPLETED	6	3	54	36

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
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
Total	Total of all reporting groups

Baseline Measures

	Intervention Condition	Control Condition	Non-Randomized Baseline Index Participants	Risk Network Members	Total
Number of Participants [units: participants]	114	113	373	424	1024
Age [units: participants]
<=18 years	0	0	1	0	1
Between 18 and 65 years	114	113	372	422	1021
>=65 years	0	0	0	2	2
Age [units: years] Mean (Standard Deviation)	43.9 (8)	43.0 (7)	42.4 (9)	43.7 (8)	43.2 (8)
Gender [units: participants]
Female	51	52	130	170	403
Male	63	61	243	254	621
Region of Enrollment [units: participants]
United States	114	113	373	424	1024

Outcome Measures

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1. Primary:

Any Sex Risk [ Time Frame: 6 months ]

Show Outcome Measure 1

2. Primary:

Talked About HIV-related Topics With Drug Buddies (in the Past Month) [ Time Frame: 6 months ]

Show Outcome Measure 2

3. Primary:

Showed a Needleless Syringe to Drug Buddies [ Time Frame: 6 months ]

Hide Outcome Measure 3

Measure Type	Primary
Measure Title	Showed a Needleless Syringe to Drug Buddies
Measure Description	No text entered.
Time Frame	6 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Reporting Groups

	Description
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