A Comprehensive Approach to Secondary HIV Prevention and... | NCT01935440

Studies
A Comprehensive Approach to Secondary HIV Prevention and Care Among Positives

NCT01935440

Sponsor

Johns Hopkins Bloomberg School of Public Health

Status

Completed

Last Update Posted

Jul 9, 2018Actual

Enrollment

632Actual

Phase

Not Applicable

Conditions

Interventions

Prevention & Testing
Prevention & Testing Control

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DA032217	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2012Actual

Primary Completion Date

Jan 31, 2017Actual

Completion Date

Jan 31, 2017Actual

First Submitted Date

Aug 20, 2013

First Submission Date that Met QC Criteria

Aug 30, 2013

First Posted Date

Sep 5, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2018

Last Update Posted Date

Jul 9, 2018Actual

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this study is to conduct an HIV prevention intervention to train HIV seropositive drug users to be peer health educators.

Detailed Description

The primary objective of this funded research is to conduct an HIV prevention intervention to train HIV seropositive drug users to be peer health educators to: (1) recruit their high risk social network members for voluntary HIV counseling and testing (VCT) at the research clinic, (2) promote risk reduction among social network members, and (3) promote engagement in HIV care by encouraging HIV seropositive network members to schedule and keep HIV primary care appointments. There will be four types of participants in the Full Trial: 1) Index, 2) Testing Network 3) Longitudinal Network and 4) HIV positive network participants. This longitudinal study includes baseline, 6-months, and 12-month assessments

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

632Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prevention & Testing Control	Active Comparator	The comparison condition is focused on basic HIV risk reduction , safety and preventing drug overdose.	Behavioral: Prevention & Testing Control
Prevention & Testing Intervention	Experimental	The intervention condition is training on peer outreach skills which includes talking to HIV positive social network members about HIV care, medication adherence and HIV risk reduction.	Behavioral: Prevention & Testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prevention & Testing	Behavioral	6 group sessions, 1 individual session, and 1 dyad session	Prevention & Testing Intervention

Measure	Description	Time Frame
change in HIV medication adherence		6 month
change in frequency in attending HIV medical appointments		6 month

Measure	Description	Time Frame
change in sharing injection equipment		6 month
change in condom use		6 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Index

18 years old or older
documentation of HIV positive status
report one of following risk behaviors in past 90 days: sharing injection equipment, use of crack cocaine, or unprotected vaginal or anal sex

Testing network

18 or older
provided testing coupon provided by an index participant

Longitudinal network participant-

tested HIV negative at the Lighthouse via redeeming a testing coupon
reported interacting with index who gave the coupon at least weekly
report one of following risk behaviors in the prior 90 days: sharing injection equipment, use of crack cocaine, or unprotected vaginal or anal sex

Positive Networks

HIV positive
report one of following risk behaviors in the prior 90 days: sharing injection equipment, use of crack cocaine, or unprotected vaginal or anal sex

Exclusion Criteria:

Index- already enrolled in the study as a Network participant

Testing network- already enrolled in the study as a Network participant

Longitudinal network- a) already enrolled in the study as a Network participant b) already enrolled in the study as a Index participant

Positive network- a) already enrolled in the study as a Network participant b) already enrolled in the study as a Index participant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided