A Comprehensive Approach to Secondary HIV Prevention and Care Among Positives (P&T)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Carl Latkin, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01935440
First received: August 20, 2013
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
HIV
Behavioral: Prevention & Testing
Behavioral: Prevention & Testing Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • change in HIV medication adherence [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • change in frequency in attending HIV medical appointments [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in sharing injection equipment [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • change in condom use [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: February 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prevention & Testing Control
The comparison condition is focused on basic HIV risk reduction , safety and preventing drug overdose.
Behavioral: Prevention & Testing Control
7 group sessions
Experimental: Prevention & Testing Intervention
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
6 group sessions, 1 individual session, and 1 dyad session

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Index

  1. 18 years old or older
  2. documentation of HIV positive status
  3. 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

  1. 18 or older
  2. provided testing coupon provided by an index participant

Longitudinal network participant-

  1. tested HIV negative at the Lighthouse via redeeming a testing coupon
  2. reported interacting with index who gave the coupon at least weekly
  3. 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

  1. HIV positive
  2. 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01935440

Contacts
Contact: Carl Latkin, PhD 410-502-5368 clatkin@jhsph.edu

Locations
United States, Maryland
Lighhouse Studies @ Peer Point Recruiting
Baltimore, Maryland, United States, 21205
Principal Investigator: Carl Latkin, PhD         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: Carl A Latkin, PhD Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided

Responsible Party: Carl Latkin, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01935440     History of Changes
Other Study ID Numbers: R01DA032217, R01DA032217
Study First Received: August 20, 2013
Last Updated: August 30, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
HIV, drug use

ClinicalTrials.gov processed this record on September 22, 2014