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| ID | Type | Description | Link |
|---|---|---|---|
| UM1AI068619 | U.S. NIH Grant/Contract | View source | |
| 11995 | Other Identifier | DAIDS |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Control | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HIV status at screening for each MSM recruited | HIV status | At Baseline |
| HIV viral load at screening for each MSM recruited | HIV viral load | 12 months |
| HIV viral load at month 24 of participants randomized | time driven HIV viral load | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Date of recruitment for each man recruited by DC-RDS | recruitment timeline | During recruitment period |
| Wave of recruitment for each man recruited by DC-RDS | recruitment timeline |
| Measure | Description | Time Frame |
|---|---|---|
| Health care utilization at baseline and 24 months | computer assisted self interview | Up to 24 months |
| Stigma at baseline and 24 months | computer assisted self interview |
Inclusion Criteria:
Individuals who meet all of the following criteria are eligible for study screening:
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:
Exclusion Criteria:
Individuals who meet any of the following criteria will be excluded from study screening:
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
biologically male
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| Name | Affiliation | Role |
|---|---|---|
| Chris Beyrer, MD/MPH | Johns Hopkins University | Study Chair |
| Robert H Remien, PhD | Columbia University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama CRS | Birmingham | Alabama | 35294 | United States | ||
| Ponce de Leon CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 37243342 | Derived | Maragh-Bass AC, Hucks-Ortiz C, Beyrer C, Remien RH, Mayer K, Del Rio C, Batey DS, Farley JE, Gamble T, Tolley EE. Multilevel Stigma and Its Associations with Medical Care Ratings Among Men Who Have Sex With Men in HPTN 078. J Prim Care Community Health. 2023 Jan-Dec;14:21501319231175362. doi: 10.1177/21501319231175362. |
| Label | URL |
|---|---|
| Potential Impact on HIV Incidence of Increasing Viral Suppression among HIV- positive MSM in Baltimore: Mathematical Modelling for HPTN 078 | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jul 3, 2017 | Mar 20, 2025 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D019090 | Case Management |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D010347 | Patient Care Planning |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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| During recruitment period |
| HIV viral load of those randomized | HIV viral load | HIV viral load at Months 3, 6, 9, 12 |
| Number of all care visits from randomization through the end of 12 months follow up | clinical care uptake | Over 12 months |
| Time of all care visits from randomization through the end of 12 months follow up | clinical care uptake | Over 12 months |
| HCV status at baseline | HCV status | At Baseline |
| Baseline Demographics | Participant-administered questionnaire | At Baseline |
| CD4 status at baseline | CD4 cell count | At Baseline |
| HIV viral load status at baseline | HIV viral load | At Baseline |
| Syphilis status at baseline | Syphilis status | At Baseline |
| Self-reported sexual risk behavior of unprotected anal intercourse, characteristics of 3 most recent partners) at baseline and 24 months | participant-administered questionnaire | 12 months |
| Up to 24 months |
| Number of contacts (text message, email, phone, in person) for each participant randomized to the CM intervention arm over follow-up | clinical contact | Up to 24 months |
| Open-ended questions for process evaluation | Open ended qualitative data compiled and coded | Up to 12 months |
| The phylogenetic relationship between HIV sequences | HIV genetic sequencing | Up to 24 months |
| Syphilis positive or negative at baseline | STI description at baseline | Up to 24 months |
| Atlanta |
| Georgia |
| 30308-2012 |
| United States |
| Johns Hopkins Baltimore CRS | Baltimore | Maryland | 21287 | United States |
| Fenway Health CRS | Boston | Massachusetts | 02215-4302 | United States |
| D006298 | Health Services Administration |