Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected MSM in the United States

• ClinicalTrials.gov Identifier: NCT02663219
• Recruitment Status: Completed
• First Posted: January 26, 2016
• Last Update Posted: August 26, 2022
• Sponsor: HIV Prevention Trials Network
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): HIV Prevention Trials Network

Tracking Information

• First Submitted Date: January 13, 2016
• First Posted Date: January 26, 2016
• Last Update Posted Date: August 26, 2022
• Actual Study Start Date: June 6, 2016
• Actual Primary Completion Date: February 8, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 29, 2021)

• HIV status at screening for each MSM recruited [ Time Frame: At Baseline ]
  HIV status
• HIV viral load at screening for each MSM recruited [ Time Frame: 12 months ]
  HIV viral load
• HIV viral load at month 24 of participants randomized [ Time Frame: 24 months ]
  time driven HIV viral load

Original Primary Outcome Measures (submitted: January 21, 2016)

• 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 ]

Current Secondary Outcome Measures (submitted: October 29, 2021)

• Date of recruitment for each man recruited by DC-RDS [ Time Frame: During recruitment period ]
  recruitment timeline
• Wave of recruitment for each man recruited by DC-RDS [ Time Frame: During recruitment period ]
  recruitment timeline
• HIV viral load of those randomized [ Time Frame: HIV viral load at Months 3, 6, 9, 12 ]
  HIV viral load
• Number of all care visits from randomization through the end of 12 months follow up [ Time Frame: Over 12 months ]
  clinical care uptake
• Time of all care visits from randomization through the end of 12 months follow up [ Time Frame: Over 12 months ]
  clinical care uptake
• HCV status at baseline [ Time Frame: At Baseline ]
  HCV status
• Baseline Demographics [ Time Frame: At Baseline ]
  Participant-administered questionnaire
• CD4 status at baseline [ Time Frame: At Baseline ]
  CD4 cell count
• HIV viral load status at baseline [ Time Frame: At Baseline ]
  HIV viral load
• Syphilis status at baseline [ Time Frame: At Baseline ]
  Syphilis status
• Self-reported sexual risk behavior of unprotected anal intercourse, characteristics of 3 most recent partners) at baseline and 24 months [ Time Frame: 12 months ]
  participant-administered questionnaire

Original Secondary Outcome Measures (submitted: January 21, 2016)

• 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

Current Other Pre-specified Outcome Measures (submitted: October 29, 2021)

• 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 ]
  clinical contact
• Open-ended questions for process evaluation [ Time Frame: Up to 12 months ]
  Open ended qualitative data compiled and coded
• The phylogenetic relationship between HIV sequences [ Time Frame: Up to 24 months ]
  HIV genetic sequencing
• Syphilis positive or negative at baseline [ Time Frame: Up to 24 months ]
  STI description at baseline

Original Other Pre-specified Outcome Measures (submitted: January 21, 2016)

• 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 ]

Descriptive Information

• Brief Title: Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected MSM in the United States
• Official Title: Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected Men Who Have Sex With Men (MSM) in the United States
• Brief Summary: 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).
• Detailed Description: This study will use deep-chain respondent driven sampling (DC-RDS) and direct recruitment (DR) 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 12 months after enrollment. Phylogenetic methods will be used to evaluate the relationship between viruses in study participants. 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: HIV

Intervention

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

Study Arms

• 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.
  Intervention: Behavioral: Intervention
• No Intervention: Control
  Standard of care

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 29, 2021): 144
• Original Estimated Enrollment (submitted: January 21, 2016): 356
• Actual Study Completion Date: February 8, 2019
• Actual Primary Completion Date: February 8, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

• Biological male (at birth)
• Self-report of history of anal intercourse with another man
• 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)
• Can receive HIV care at one of the participating 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 for study participation.
• Active or previous participation in an HIV vaccine trial.
• 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

Sex/Gender

• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: biologically male

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02663219
• Other Study ID Numbers: HPTN 078; UM1AI068619 ( U.S. NIH Grant/Contract ); 11995 ( Other Identifier: DAIDS )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: HIV Prevention Trials Network
• Original Responsible Party: Same as current
• Current Study Sponsor: HIV Prevention Trials Network
• Original Study Sponsor: Same as current
• Collaborators: 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

• PRS Account: HIV Prevention Trials Network
• Verification Date: August 2022