Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT00218335
Status:
COMPLETED
Last Update Posted:
2013-04-18
First Post:
2005-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Network & Dyad HIV Prevention Intervention for IDU's - 1
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006505', 'term': 'Hepatitis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clatkin@jhsph.edu', 'title': 'Carl Latkin, PhD', 'organization': 'Johns Hopkins Bloomberg School of Public Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intervention Condition', 'description': '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.', 'otherNumAtRisk': 114, 'otherNumAffected': 0, 'seriousNumAtRisk': 114, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Condition', 'description': '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.', 'otherNumAtRisk': 113, 'otherNumAffected': 0, 'seriousNumAtRisk': 113, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Non-Randomized Baseline Index Participants', 'description': 'Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.', 'otherNumAtRisk': 373, 'otherNumAffected': 0, 'seriousNumAtRisk': 373, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Risk Network Members', 'description': 'Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant', 'otherNumAtRisk': 424, 'otherNumAffected': 0, 'seriousNumAtRisk': 424, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Any Sex Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}, {'value': '298', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': '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.'}, {'id': 'OG002', 'title': 'Non-Randomized Baseline Index Participants', 'description': 'Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.'}, {'id': 'OG003', 'title': 'Risk Network Members', 'description': 'Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.'}, {'type': 'PRIMARY', 'title': 'Talked About HIV-related Topics With Drug Buddies (in the Past Month)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '252', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': '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.'}, {'id': 'OG002', 'title': 'Non-Randomized Baseline Index Participants', 'description': 'Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.'}, {'id': 'OG003', 'title': 'Risk Network Members', 'description': 'Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.'}, {'type': 'PRIMARY', 'title': 'Showed a Needleless Syringe to Drug Buddies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '300', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': '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.'}, {'id': 'OG002', 'title': 'Non-Randomized Baseline Index Participants', 'description': 'Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.'}, {'id': 'OG003', 'title': 'Risk Network Members', 'description': 'Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.'}, {'type': 'PRIMARY', 'title': 'Talked About Responding to Overdose to Drug Buddies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Participants', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Participants', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Any Injection Risk (Monthly Versus Never)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': '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.'}, {'id': 'OG002', 'title': 'Non-Randomized Baseline Index Participants', 'description': 'Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.'}, {'id': 'OG003', 'title': 'Risk Network Members', 'description': 'Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.'}, {'type': 'PRIMARY', 'title': 'Number of Needle or Cooker Sharers (2 or More Versus None)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}, {'value': '280', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': '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.'}, {'id': 'OG002', 'title': 'Non-Randomized Baseline Index Participants', 'description': 'Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.'}, {'id': 'OG003', 'title': 'Risk Network Members', 'description': 'Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.'}, {'type': 'PRIMARY', 'title': 'Talked About HIV-related Topics With Drug Buddies (in the Past Month)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}, {'value': '231', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': '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.'}, {'id': 'OG002', 'title': 'Non-Randomized Baseline Index Participants', 'description': 'Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.'}, {'id': 'OG003', 'title': 'Risk Network Members', 'description': 'Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.'}, {'type': 'PRIMARY', 'title': 'Showed a Needleless Syringe to Drug Buddies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}, {'value': '302', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': '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.'}, {'id': 'OG002', 'title': 'Non-Randomized Baseline Index Participants', 'description': 'Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.'}, {'id': 'OG003', 'title': 'Risk Network Members', 'description': 'Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.'}, {'type': 'PRIMARY', 'title': 'Any Injection Risk (Monthly Versus Never)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '166', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': '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.'}, {'id': 'OG002', 'title': 'Non-Randomized Baseline Index Participants', 'description': 'Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.'}, {'id': 'OG003', 'title': 'Risk Network Members', 'description': 'Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.'}, {'type': 'PRIMARY', 'title': 'Shared Cooker When Preparing Drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': '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.'}, {'id': 'OG002', 'title': 'Non-Randomized Baseline Index Participants', 'description': 'Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.'}, {'id': 'OG003', 'title': 'Risk Network Members', 'description': 'Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.'}, {'type': 'PRIMARY', 'title': 'Number of Needle or Cooker Sharers (2 or More Versus None)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '251', 'groupId': 'OG002'}, {'value': '328', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': '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.'}, {'id': 'OG002', 'title': 'Non-Randomized Baseline Index Participants', 'description': 'Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.'}, {'id': 'OG003', 'title': 'Risk Network Members', 'description': 'Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.'}, {'type': 'PRIMARY', 'title': 'Injecting Drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '281', 'groupId': 'OG002'}, {'value': '354', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': '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.'}, {'id': 'OG002', 'title': 'Non-Randomized Baseline Index Participants', 'description': 'Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.'}, {'id': 'OG003', 'title': 'Risk Network Members', 'description': 'Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.'}, {'type': 'PRIMARY', 'title': 'Talked About HIV-related Topics With Drug Buddies (in Past Month)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '265', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': '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.'}, {'id': 'OG002', 'title': 'Non-Randomized Baseline Index Participants', 'description': 'Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.'}, {'id': 'OG003', 'title': 'Risk Network Members', 'description': 'Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.'}, {'type': 'PRIMARY', 'title': 'Showed a Needleless Syringe to Drug Buddies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}, {'value': '360', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Condition', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': '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.'}, {'id': 'OG002', 'title': 'Non-Randomized Baseline Index Participants', 'description': 'Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.'}, {'id': 'OG003', 'title': 'Risk Network Members', 'description': 'Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.'}, {'type': 'PRIMARY', 'title': 'Talked About Hepatitis to Drug Buddies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Participants', 'description': '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.'}, {'id': 'OG001', 'title': 'Control Participants', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Condition', 'description': '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.'}, {'id': 'FG001', 'title': 'Control Condition', 'description': '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.'}, {'id': 'FG002', 'title': 'Non-Randomized Baseline Index Participants', 'description': 'Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.'}, {'id': 'FG003', 'title': 'Risk Network Members', 'description': 'Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '113'}, {'groupId': 'FG002', 'numSubjects': '373'}, {'groupId': 'FG003', 'numSubjects': '424'}]}, {'type': '6 Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '219'}, {'groupId': 'FG003', 'numSubjects': '301'}]}, {'type': '12 Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '102'}, {'groupId': 'FG002', 'numSubjects': '244'}, {'groupId': 'FG003', 'numSubjects': '303'}]}, {'type': '18 Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '108'}, {'groupId': 'FG002', 'numSubjects': '296'}, {'groupId': 'FG003', 'numSubjects': '368'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '110'}, {'groupId': 'FG002', 'numSubjects': '319'}, {'groupId': 'FG003', 'numSubjects': '388'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '36'}]}]}], 'recruitmentDetails': "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.", 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '373', 'groupId': 'BG002'}, {'value': '424', 'groupId': 'BG003'}, {'value': '1024', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Condition', 'description': '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.'}, {'id': 'BG001', 'title': 'Control Condition', 'description': '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.'}, {'id': 'BG002', 'title': 'Non-Randomized Baseline Index Participants', 'description': 'Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.'}, {'id': 'BG003', 'title': 'Risk Network Members', 'description': 'Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}, {'value': '422', 'groupId': 'BG003'}, {'value': '1021', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'spread': '8', 'groupId': 'BG000'}, {'value': '43.0', 'spread': '7', 'groupId': 'BG001'}, {'value': '42.4', 'spread': '9', 'groupId': 'BG002'}, {'value': '43.7', 'spread': '8', 'groupId': 'BG003'}, {'value': '43.2', 'spread': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '170', 'groupId': 'BG003'}, {'value': '403', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}, {'value': '621', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '373', 'groupId': 'BG002'}, {'value': '424', 'groupId': 'BG003'}, {'value': '1024', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1024}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-07', 'studyFirstSubmitDate': '2005-09-16', 'resultsFirstSubmitDate': '2013-01-25', 'studyFirstSubmitQcDate': '2005-09-16', 'lastUpdatePostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-07', 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Any Sex Risk', 'timeFrame': '6 months'}, {'measure': 'Talked About HIV-related Topics With Drug Buddies (in the Past Month)', 'timeFrame': '6 months'}, {'measure': 'Showed a Needleless Syringe to Drug Buddies', 'timeFrame': '6 months'}, {'measure': 'Talked About Responding to Overdose to Drug Buddies', 'timeFrame': '6 months'}, {'measure': 'Any Injection Risk (Monthly Versus Never)', 'timeFrame': '12 months'}, {'measure': 'Number of Needle or Cooker Sharers (2 or More Versus None)', 'timeFrame': '12 months'}, {'measure': 'Talked About HIV-related Topics With Drug Buddies (in the Past Month)', 'timeFrame': '12 months'}, {'measure': 'Showed a Needleless Syringe to Drug Buddies', 'timeFrame': '12 months'}, {'measure': 'Any Injection Risk (Monthly Versus Never)', 'timeFrame': '18 months'}, {'measure': 'Shared Cooker When Preparing Drugs', 'timeFrame': '18 months'}, {'measure': 'Number of Needle or Cooker Sharers (2 or More Versus None)', 'timeFrame': '18 months'}, {'measure': 'Injecting Drugs', 'timeFrame': '18 months'}, {'measure': 'Talked About HIV-related Topics With Drug Buddies (in Past Month)', 'timeFrame': '18 months'}, {'measure': 'Showed a Needleless Syringe to Drug Buddies', 'timeFrame': '18 months'}, {'measure': 'Talked About Hepatitis to Drug Buddies', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV prevention Intervention, injection drug user,peer-oriented, randomized controlled trial, social network'], 'conditions': ['HIV', 'Hepatitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(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\n\nExclusion Criteria:\n\n* Not concurrently enrolled in another HIV prevention intervention'}, 'identificationModule': {'nctId': 'NCT00218335', 'briefTitle': "A Network & Dyad HIV Prevention Intervention for IDU's - 1", 'nctIdAliases': ['NCT00597155'], 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': "A Network & Dyad HIV Prevention Intervention for IDU's", 'orgStudyIdInfo': {'id': 'DESPR DA016555-1'}, 'secondaryIdInfos': [{'id': '5R01DA016555-05', 'link': 'https://reporter.nih.gov/quickSearch/5R01DA016555-05', 'type': 'NIH'}, {'id': '5R01DA016555-04', 'link': 'https://reporter.nih.gov/quickSearch/5R01DA016555-04', 'type': 'NIH'}, {'id': '5R01DA016555-03', 'link': 'https://reporter.nih.gov/quickSearch/5R01DA016555-03', 'type': 'NIH'}, {'id': '3R01DA016555-03S1', 'link': 'https://reporter.nih.gov/quickSearch/3R01DA016555-03S1', 'type': 'NIH'}, {'id': '3R01DA016555-02S1', 'link': 'https://reporter.nih.gov/quickSearch/3R01DA016555-02S1', 'type': 'NIH'}, {'id': '5R01DA016555-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01DA016555-02', 'type': 'NIH'}, {'id': '3R01DA016555-01S1', 'link': 'https://reporter.nih.gov/quickSearch/3R01DA016555-01S1', 'type': 'NIH'}, {'id': '1R01DA016555-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA016555-01', 'type': 'NIH'}, {'id': 'R01-16555-1'}, {'id': 'NIDA-16555-1'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Condition', 'description': '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.', 'interventionNames': ['Behavioral: Intervention Condition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Condition', 'description': '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.', 'interventionNames': ['Behavioral: Control Condition']}], 'interventions': [{'name': 'Intervention Condition', 'type': 'BEHAVIORAL', 'otherNames': ['STEP into action'], 'description': '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.', 'armGroupLabels': ['Intervention Condition']}, {'name': 'Control Condition', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Control Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Lighthouse', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Carl Latkin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Carl Latkin', 'investigatorAffiliation': 'Johns Hopkins Bloomberg School of Public Health'}}}}