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Trial record 1 of 1 for:    HPTN078
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Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected MSM in the United States

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by HIV Prevention Trials Network
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
HIV Prevention Trials Network
ClinicalTrials.gov Identifier:
NCT02663219
First received: January 13, 2016
Last updated: April 24, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to develop and assess the efficacy of an integrated strategy that includes feasible and scalable interventions to identify, recruit, link to care, retain in care, attain, and maintain viral suppression among HIV-infected men who have sex with men (MSM) in the United States (US).

Condition Intervention
HIV Behavioral: Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected Men Who Have Sex With Men (MSM) in the United States

Resource links provided by NLM:


Further study details as provided by HIV Prevention Trials Network:

Primary Outcome Measures:
  • HIV status at screening for each MSM recruited [ Time Frame: UP to 24 months ]
  • HIV viral load at screening for each MSM recruited [ Time Frame: Up to 24 months ]

Secondary Outcome Measures:
  • HIV prevalence [ Time Frame: Up to 24 months ]
    comparison between those who enrolled

  • HIV viral load after enrollment [ Time Frame: Up to 24 months measured at months 3, 6, 9, 12, 18 and 24 ]
  • Number of times participants are linked to care [ Time Frame: Up to 24 months ]
  • HCV status at baseline [ Time Frame: Up to 24 months ]
  • HIV viral load at end of study [ Time Frame: Up to 24 months ]
  • Baseline Demographics [ Time Frame: Up to 24 months ]
    participant-administered questionnaire

  • CD4 status at baseline [ Time Frame: Up to 24 months ]
  • Self-reported sexual risk behavior of unprotected anal intercourse, characteristics of 3 most recent partners) at baseline and 24 months [ Time Frame: Up to 24 months ]
    participant-administered questionnaire

  • Antiretroviral adherence at 24 months [ Time Frame: Up to 24 months ]
    viral load and cd4 are the biomarkers for adherence


Other Outcome Measures:
  • Health care utilization at baseline and 24 months [ Time Frame: Up to 24 months ]
    computer assisted self interview

  • Stigma at baseline and 24 months [ Time Frame: Up to 24 months ]
    computer assisted self interview

  • Number of contacts (text message, email, phone, in person) for each participant randomized to the CM intervention arm over follow-up [ Time Frame: Up to 24 months ]
  • Satisfaction with the CM intervention components, as measured on a Likert scale during a standardized exit interview [ Time Frame: Up to 24 months ]
  • Usefulness of the CM intervention components, as measured on a Likert scale during a standardized exit interview [ Time Frame: Up to 24 months ]
  • Open-ended questions regarding linkage to HIV care [ Time Frame: Up to 24 months ]
    open ended qualitative data compiled and coded

  • The phylogenetic relationship between HIV sequences [ Time Frame: Up to 24 months ]
    relationship between HIV strains in different men

  • HIV viral load at baseline [ Time Frame: Up to 24 months ]
  • Syphilis positive or negative at baseline [ Time Frame: Up to 24 months ]
  • HIV viral suppression [ Time Frame: Up to 24 months ]

Estimated Enrollment: 356
Study Start Date: March 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
The intervention arm will provide a Case Manager (CM) intervention package designed to enhance linkage to care, antiretroviral treatment (ART) initiation, treatment adherence and retention in care.
Behavioral: Intervention
The intervention arm will provide a Case Manager (CM) intervention package designed to enhance linkage to care, antiretroviral treatment (ART) initiation, treatment adherence and retention in care.
Other Name: Case Management
No Intervention: Control
Standard of care

Detailed Description:
This study will use deep-chain respondent driven sampling (DC-RDS) to the extent possible to identify and recruit HIV-infected MSM who are not virally suppressed. A subset of these men will be enrolled into one of two study arms. The intervention arm will provide a Case Manager (CM) intervention package designed to enhance linkage to care, antiretroviral treatment (ART) initiation, treatment adherence and retention in care. The control arm will provide the standard of care (SOC) for linkage to care, initiation of ART, treatment adherence and retention in care. The primary outcome of the study is viral suppression 24 months after enrollment. Phylogenetic methods will be used to evaluate the relationship between social and sexual networks identified through DC-RDS and viral networks. Mathematical modeling will be performed using demographic, behavioral, and clinical data generated from this study and other sources to estimate the population-level impact of the CM intervention on HIV incidence and to estimate the level of identification, linkage, ART coverage and viral suppression that would be required to achieve a substantial reduction in HIV incidence among MSM in the US settings where the study is conducted.
  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Individuals who meet all of the following criteria are eligible for study screening:

  • Biological male (currently and at birth)
  • Self-report of history of anal intercourse with another man within the last 12 months
  • 16 years or older

Individuals who are eligible for screening and who meet all of the following criteria are eligible for enrollment into the CM intervention and SOC control arms:

  • HIV-infected, as defined in the HPTN 078 Study-Specific Procedures (SSP) Manual
  • Not virally suppressed (defined as HIV VL > 1000 copies/ml, note that this VL cut-off is being used as an indicator of adherence or resistance issues for study inclusion only)
  • Can receive HIV care at one of the pre-determined clinics (as chosen by each site)
  • No current plan to relocate in the 24 months following enrollment

Exclusion Criteria:

Individuals who meet any of the following criteria will be excluded from study screening:

  • Unable or unwilling to provide consent/assent
  • Active or previous participation in an HIV vaccine trial, unless evidence can be provided documenting randomization to the placebo arm.
  • Any condition that, in the opinion of the Investigator of Record (IoR), would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Individuals who are eligible for screening, but who meet the following criteria are excluded from enrollment into the CM intervention and SOC control arms:

• Current participation in a linkage or ART adherence study

  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: NCT02663219

Contacts
Contact: Theresa R Gamble, PhD 919 544 7040 ext 11350 tgamble@fhi360.org
Contact: Anna LeViere, MPH 919 544 7040 ext 11585 aleviere@fhi360.org

Locations
United States, Alabama
Alabama CRS Recruiting
Birmingham, Alabama, United States, 35294
Contact: Edgar T Overton, MD    205-996-2373    toverton@uab.edu   
United States, Georgia
Ponce de Leon CRS Recruiting
Atlanta, Georgia, United States, 30308-2012
Contact: Christin Root    404-251-8893    cmroot@emory.edu   
United States, Maryland
Johns Hopkins Baltimore CRS Recruiting
Baltimore, Maryland, United States, 21287
Contact: Ilene Wiggins, RN    410-614-2766    iwiggin1@jhmi.edu   
United States, Massachusetts
Fenway Health CRS Recruiting
Boston, Massachusetts, United States, 02215-4302
Contact: Julian Dormitzer, RN, BSN    617-927-6309    jdormitzer@fenwayhealth.org   
Sponsors and Collaborators
HIV Prevention Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Chris Beyrer, MD/MPH Johns Hopkins University
Study Chair: Robert H Remien, PhD Columbia University
  More Information

Additional Information:
Publications:
KM Mitchell, B Hoots, D Dimitrov, et al. Potential Impact on HIV Incidence of Increasing Viral Suppression among HIV- positive MSM in Baltimore: Mathematical Modelling for HPTN 078. HIV Research for Prevention (HIVR4P 2016). Chicago, October 17-21, 2016. Abstract OA10.04

Responsible Party: HIV Prevention Trials Network
ClinicalTrials.gov Identifier: NCT02663219     History of Changes
Other Study ID Numbers: HPTN 078
UM1AI068619 ( U.S. NIH Grant/Contract )
11995 ( Other Identifier: DAIDS )
Study First Received: January 13, 2016
Last Updated: April 24, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by HIV Prevention Trials Network:
MSM
ART
CCM
DAIDS
HPTN
ACA
PAF
PEP
RDS

ClinicalTrials.gov processed this record on September 19, 2017