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

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ClinicalTrials.gov Identifier: NCT01935440
Recruitment Status : Completed
First Posted : September 5, 2013
Last Update Posted : July 9, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Carl Latkin, Johns Hopkins Bloomberg School of Public Health

August 20, 2013
September 5, 2013
July 9, 2018
November 1, 2012
January 31, 2017   (Final data collection date for primary outcome measure)
  • change in HIV medication adherence [ Time Frame: 6 month ]
  • change in frequency in attending HIV medical appointments [ Time Frame: 6 month ]
Same as current
Complete list of historical versions of study NCT01935440 on ClinicalTrials.gov Archive Site
  • change in sharing injection equipment [ Time Frame: 6 month ]
  • change in condom use [ Time Frame: 6 month ]
Same as current
Not Provided
Not Provided
 
A Comprehensive Approach to Secondary HIV Prevention and Care Among Positives
A Comprehensive Approach to Secondary HIV Prevention and Care Among Positives
The goal of this study is to conduct an HIV prevention intervention to train HIV seropositive drug users to be peer health educators.
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
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
HIV
  • Behavioral: Prevention & Testing
    6 group sessions, 1 individual session, and 1 dyad session
  • Behavioral: Prevention & Testing Control
    7 group sessions
  • Active Comparator: Prevention & Testing Control
    The comparison condition is focused on basic HIV risk reduction , safety and preventing drug overdose.
    Intervention: Behavioral: Prevention & Testing Control
  • 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.
    Intervention: Behavioral: Prevention & Testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
632
1500
January 31, 2017
January 31, 2017   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01935440
R01DA032217( U.S. NIH Grant/Contract )
R01DA032217 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Undecided
Carl Latkin, Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
National Institute on Drug Abuse (NIDA)
Principal Investigator: Carl A Latkin, PhD Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP