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HIVNCT02663219

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

A study testing Intervention in people with HIV, run by HIV Prevention Trials Network at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 16 years and older, men only
Conditions the study is for
HIV
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
4 sitesUnited States
Study dates
6 Jun 2016to 8 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Ponce de Leon CRS

    Atlanta, Georgia, 30308-2012

  • Johns Hopkins Baltimore CRS

    Baltimore, Maryland, 21287

  • Alabama CRS

    Birmingham, Alabama, 35294

  • Fenway Health CRS

    Boston, Massachusetts, 02215-4302

Other trials in United States

About this study

Official title: Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected Men Who Have Sex With Men (MSM) in the United States

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).

Read the 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.

Conditions
HIV
Being tested
Intervention
Keywords
MSM, ART, CCM, DAIDS, HPTN, ACA, PAF, PEP, RDS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionBehavioural

    Also called Case Management

    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.

Study groups in NCT02663219
Study groupRoleWhat they receive
InterventionExperimentalThe 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.
Receives: Behavioral: Intervention
ControlNo interventionStandard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV status at screening for each MSM recruited

    HIV status

    Measured: At Baseline

  2. HIV viral load at screening for each MSM recruited

    HIV viral load

    Measured: 12 months

  3. HIV viral load at month 24 of participants randomized

    time driven HIV viral load

    Measured: 24 months

Secondary outcomes (11)

  1. Date of recruitment for each man recruited by DC-RDS

    recruitment timeline

    Measured: During recruitment period

  2. Wave of recruitment for each man recruited by DC-RDS

    recruitment timeline

    Measured: During recruitment period

  3. HIV viral load of those randomized

    HIV viral load

    Measured: HIV viral load at Months 3, 6, 9, 12

  4. Number of all care visits from randomization through the end of 12 months follow up

    clinical care uptake

    Measured: Over 12 months

  5. Time of all care visits from randomization through the end of 12 months follow up

    clinical care uptake

    Measured: Over 12 months

  6. HCV status at baseline

    HCV status

    Measured: At Baseline

  7. Baseline Demographics

    Participant-administered questionnaire

    Measured: At Baseline

  8. CD4 status at baseline

    CD4 cell count

    Measured: At Baseline

  9. HIV viral load status at baseline

    HIV viral load

    Measured: At Baseline

  10. Syphilis status at baseline

    Syphilis status

    Measured: At Baseline

  11. Self-reported sexual risk behavior of unprotected anal intercourse, characteristics of 3 most recent partners) at baseline and 24 months

    participant-administered questionnaire

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2016 (estimated)
  2. Study start6 Jun 2016
  3. Primary completion8 Feb 2019
  4. Study completion8 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02663219
Sponsor's protocol ID
HPTN 078
Other IDs
UM1AI068619, 11995
Status last verified
Mar 2025
First submitted
13 Jan 2016
Last updated
25 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • 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.

    PubMed 37243342

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with HIV, run by HIV Prevention Trials Network at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV status at screening for each MSM recruited (time frame: At Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02663219, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.

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