CVCTPlus: A Couples-Based Approach to Linkage to Care and ARV Adherence (CVCTPLUS)

This study is not yet open for participant recruitment.
Verified November 2013 by Emory University
Sponsor:
Collaborators:
Harvard School of Public Health
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Robert Stephenson, Emory University
ClinicalTrials.gov Identifier:
NCT01772992
First received: January 16, 2013
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

Men who have sex with men (MSM) continue to be the most heavily-impacted risk group in the US HIV epidemic. Studies suggest that the majority of incident HIV infections among MSM are attributable to sex with a main male sex partner; however, HIV prevention interventions that target male-male couples are lacking. Because of this, Couples HIV Voluntary Counseling and Testing (CVCT), an intervention that has been repeatedly shown to reduce HIV transmission within heterosexual couples, has been adapted to US MSM couples. Additionally, novel evidence demonstrates that antiretroviral therapy (ART) not only reduces morbidity and mortality among HIV-positive persons, but also serves to reduce the risk of HIV transmission to a negative partner by 96%. As adherence to ART is modifiable, and levels of peer support have been shown to increase ART adherence, this current study proposes to use CVCT combined with dyadic adherence counseling ("CVTCPlus") to improve linkage to care, retention in care, ART adherence and viral suppression among HIV-sero-discordant male-male couples using a cohort of 250 serodiscordant couples in Atlanta, Boston, and Chicago. Sero-discordant couples (125 in each arm) will be followed for two years, with study visits every six months. At each visit, the HIV-negative partner will be tested for HIV and both partners will complete a study survey measuring social and behavioral factors that may influence adherence, such as a couple's coping ability and their concordance of agreements regarding outside sex partners, and EMR extraction will be used to identify linkage and retention in care and viral suppression. Additionally, couples in the intervention arm will receive adherence counseling specific to data provided by real-time monitoring of ART adherence (via Wise pill). The researchers hypothesize such a couples-based, dyadic adherence intervention will serve to increase ART adherence, linkage and retention in care, and achievement of viral suppression. Understanding of the factors associated with progression towards viral suppression among sero-discordant male couples, and the effectiveness of an intervention aimed at increasing linkage, retention and ARV adherence is vital to inform the development and roll-out of couples'-focused HIV prevention efforts.


Condition Intervention
HIV
Behavioral: CVCTPLUS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: CVCTPlus: A Couples-Based Approach to Linkage to Care and ARV Adherence

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Engagement in care [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Within 3 months of HIV diagnosis, (1) attending at least one clinical care appointment, (2) having at least one CD4 test performed, (3) having at least one viral load test performed, (4) participation in continuous care, that is, at least two or more routine HIV visits at least three months apart, (5) receiving two or more CD4 tests, and (6) receiving two or more viral load tests


Secondary Outcome Measures:
  • Adherence to ARV [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Adherence to ARV medication among HIV positive participants, measured through WisePill technology


Other Outcome Measures:
  • Viral suppression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    For each study visit we will extract viral load and CD4 counts from the positive participant's medical record. If there are multiple reports within 30 days of the study visit, we will use the count nearest in date to the study visit. If there is no report within 30 days of the study visit, this will be treated as missing data. In the case of the sero-conversion of the negative partner, we will also collect viral load and CD4 counts from the newly positive partner at each study visit. Viral suppression will be considered achieved if the medical records report a viral load below the level of detection for the site specific assay


Estimated Enrollment: 3360
Study Start Date: April 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group (iVCT)
Male couples randomzed to the control group (iVCT) will each recieve individual HIV counseling and testing, separately. From this group, couples who are sero-discordant (one HIV positive, one HIV negative) will be invited to enroll in the prospective RCT. Sero-discordant couples in the control group (iVCT)will return every 6 months, up to 24 months, for individual visits, in which they will have STI testing, repeat HIV testing for the negative partner, and adherence counseling for the positive partner. All follow-up visits will be conducted separately.
Experimental: Experimental group (CVCTPLUS)
Male couples randomzed to the experimental group (CVCTPLUS) will each recieve HIV counseling and testing as a couple. From this group, couples who are sero-discordant (one HIV positive, one HIV negative) will be invited to enroll in the prospective RCT. Sero-discordant couples in the experimental group (CVCTPLUS)will return every 6 months, up to 24 months, for visits in which they will be seen as a couple, in which they will have STI testing, repeat HIV testing for the negative partner, and adherence counseling delivered to both members of the couples. All follow-up visits will be conducted for the couples together.
Behavioral: CVCTPLUS
For the intervention, couples will receive HIV testing and counseling together as a dyad, and sero-discordant couples will recieve ARV adherence counseling (DYADIC STEPS) together as a dyad.
Other Name: DYADIC STEPS

  Hide Detailed Description

Detailed Description:

Since the earliest reports of AIDS in the United States, men who have sex with men (MSM) have been, and continue to be, the most heavily impacted risk group in the US HIV epidemic [1]. In 2009, MSM accounted for 61% of new HIV diagnoses, an increase from 53% of HIV incidence in 2006 [2,3]. The "test and treat" strategy for HIV infection entails universal testing with immediate treatment for those who test seropositive, with the aim of achieving viral suppression among positives. The efficacy of treatment as prevention demonstrated in HPTN 052 has reinvigorated the discussion over using a "test and treat" strategy to reduce the incidence of HIV infection in the US. However, engagement-in-care research raises a note of caution regarding potential pitfalls in the effectiveness of this strategy. The recently published MMWR "Vital Signs" Report, showed only 28% of all HIV-infected persons in the US has a suppressed viral load [4]. The estimates published by Gardner show that of the estimated 1.1 million persons infected with HIV in the United States, 21% of HIV-infected persons are currently undiagnosed [5]. Of those who are diagnosed, losses occur at initial linkage to care and later in care such that only 50% remain in care, such that only 19% of HIV-infected persons in the US currently having viral load below the limits of assay detection. There is now substantial evidence of the role of couples - or main partnerships - in fueling the HIV epidemic among MSM in the US. A recent CDC analysis found that 68% of new infections among MSM in the US were ascribed to main sex partners, and the proportion of new infections from main sex partners was even higher among younger MSM [6]. Led by Sullivan and Stephenson, recent work has illustrated the feasibility of enrolling couples into HIV prevention efforts, demand for couples-focused services among MSM, and most importantly, that there exist high levels of sero-discordance among MSM couples. A response to the growing demand for couples-focused services has been the adaptation of Couples Voluntary Counseling and Testing (CVCT) for MSM in the US. A recent NIMH-funded RCT of CVCT versus traditional VCT among MSM (Sullivan PI) showed 22% of MSM couples to be sero-discordant. This collective evidence provides the foundation for the proposed activities; we know that a significant proportion of new HIV infections occur within couples, and we know that current levels of linkage to care, retention in care and adherence to ARVs are below par among US MSM. In April 2012, WHO released new guidelines for Couples HIV testing and counseling, including ARV for treatment and prevention among sero-discordant couples [7]. The guidelines report a significant gap in evidence around the uptake and adherence to ARV among sero-discordant couples, and the role of CVCT in shaping uptake and adherence to ARVs: the proposed research has the potential to add significantly to our understanding of these issues. The proposed activities investigate the utility of CVCT combined with dyadic adherence counseling for improving linkage to care, retention in care and adherence to ARVs. Through the screening of 1250 MSM couples and the enrollment of 200 sero-discordant couples in a RCT across 3 cities (Atlanta, Boston and Chicago) the study aims to examine the impact of CVCTPlus (CVCT plus dyadic adherence counseling) versus VCT on linkage to HIV care, retention in HIV care, adherence to ARV and achievement of viral suppression among sero-discordant MSM couples. The specific aims are:

Primary Aims:

  1. Enroll and screen 1680 MSM couples across 3 cities (Atlanta, Boston and Chicago) for HIV, randomizing 739 couples to receive CVCT and 739 couples to receive VCT.
  2. From the initial screening, identify and enroll a cohort of 250 sero-discordant couples to be followed-up for a period of 2 years: couples in the intervention arm will receive CVCTPlus (couples testing plus a couples-focused adherence intervention).
  3. Compare linkage to HIV care, retention in care, adherence to ARVs and achievement of viral suppression between couples originally diagnosed in the intervention (CVCTPlus) and the control (VCT) arms.

Hypothesis: Sero-discordant couples who receive a package of CVCT and a dyadic-focused adherence intervention will achieve greater linkage to care, retention in care, adherence to ARVs and viral suppression than couples who receive the standard of care (individualized VCT and adherence counseling).

With increasing evidence of the role of ARVs in reducing HIV transmission, sero-discordant MSM couples represent a significant target group for new interventions. The proposed activities will provide new information demonstrating the efficacy of using a couples-based approach for increasing ARV adherence and care seeking among sero-discordant couples.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • two men who have been in a relationship with each other for at least 6 months
  • aged over 18 years
  • current residents of metro Atlanta, Boston, or Chicago
  • both not having been tested for HIV in the last 6 months
  • reporting no history of IPV or coercion.

Exclusion Criteria:

  • men who are not currently in a relationship with another man
  • men in relationships with another man less than 6 months duration
  • aged under 18 years
  • not current residents of metro Atlanta, Boston, or Chicago
  • both having been tested for HIV in the last 6 months
  • reporting history of IPV or coercion.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772992

Contacts
Contact: Rob Stephenson, PhD 404 727 9976 rbsteph@sph.emory.edu
Contact: Matthew Mimiaga, PhD mmimiaga@hsph.harvard.edu

Locations
United States, Georgia
Rollins School of Public Health, Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Rob Stephenson, PhD    404-727-9976    rbsteph@sph.emory.edu   
Principal Investigator: Rob Stephenson, PhD         
United States, Illinois
Children's Memorial Hospital Not yet recruiting
Chicago, Illinois, United States
Contact: Robert Garofalo, MD       Rgarofalo@childrensmemorial.org   
Principal Investigator: Robert Garofalo, MD         
United States, Massachusetts
Harvard School of Public Health Not yet recruiting
Boston, Massachusetts, United States
Contact: Matthew Mimiaga, PhD       mmimiaga@hsph.harvard.edu   
Principal Investigator: Matthew Mimiaga, PhD         
Fenway Health Institute Not yet recruiting
Boston, Massachusetts, United States
Contact: Matthew Mimiaga, SCD       mmimiaga@hsph.harvard.edu   
Principal Investigator: Matthew Mimiaga, SCD         
Sponsors and Collaborators
Emory University
Harvard School of Public Health
Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

Responsible Party: Robert Stephenson, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT01772992     History of Changes
Other Study ID Numbers: IRB00065111, 1R01HD075655-01A1
Study First Received: January 16, 2013
Last Updated: November 22, 2013
Health Authority: United States: Institutional Review Board
United States: National Institutes of Health

Keywords provided by Emory University:
HIV couples adherence linkage to care viral suppression

ClinicalTrials.gov processed this record on April 17, 2014