NCT01935440

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
632

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
Last Updated

July 9, 2018

Status Verified

July 1, 2018

Enrollment Period

4.3 years

First QC Date

August 20, 2013

Last Update Submit

July 6, 2018

Conditions

Keywords

HIV, drug use

Outcome Measures

Primary Outcomes (2)

  • change in HIV medication adherence

    6 month

  • change in frequency in attending HIV medical appointments

    6 month

Secondary Outcomes (2)

  • change in sharing injection equipment

    6 month

  • change in condom use

    6 month

Study Arms (2)

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

6 group sessions, 1 individual session, and 1 dyad session

Prevention & Testing Intervention

7 group sessions

Prevention & Testing Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Index
  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lighhouse Studies @ Peer Point

Baltimore, Maryland, 21205, United States

Location

Study Officials

  • Carl A Latkin, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 20, 2013

First Posted

September 5, 2013

Study Start

November 1, 2012

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

July 9, 2018

Record last verified: 2018-07

Locations