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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by University of Michigan
Harvard School of Public Health
Ann & Robert H Lurie Children's Hospital of Chicago
Emory University
Information provided by (Responsible Party):
Robert Stephenson, University of Michigan Identifier:
First received: January 16, 2013
Last updated: September 23, 2015
Last verified: September 2015

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 ("CVCTPlus") to improve linkage to care, retention in care, ART adherence, and viral suppression among male-male couples using a cohort of 350 serodiscordant (one HIV(+) partner, one HIV(-) partner) couples in the greater Atlanta, Chicago, and Boston areas. Prospective couples (175 in each arm) will be followed for two years. At each visit, they will receive HIV testing, 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. Additionally, couples in the intervention arm will receive two additional sessions of Partner-STEPS.

Condition Intervention
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 University of Michigan:

Primary Outcome Measures:
  • Linkage to Care [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    within three months after HIV diagnosis, having (1) at least one clinical care appointment, (2) at least one CD4 count test performed, and (3) at least one viral load test performed

Secondary Outcome Measures:
  • Retention in care [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    within the past 12 months, having (1) at least two routine HIV care visits at least three months apart, (2) two or more CD4 tests, and (3) two or more viral load tests

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 a 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

  • Decrease sexual risk-taking [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    At each follow-up visit, each partner will be asked about unprotected anal intercourse that occurs within the partnership during the previous follow-up period.

Estimated Enrollment: 3360
Study Start Date: June 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 randomized to the control group (iVCT) will each receive individual HIV counseling and testing, separately.These 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 and repeat HIV testing. All follow-up visits will be conducted separately.
Experimental: Experimental group (CVCTPLUS)
Male couples randomized to the experimental group (CVCTPLUS) will each receive HIV counseling and testing as a couple. These couple will return for two additional visits that members of the control arm do not get, for two one-hour sessions of the Partner-STEPS. Couples in the experimental group (CVCTPLUS) at 8 and 10 weeks after the initial enrollment. They will also 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 and repeat HIV testing. 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 some couples will receive ARV adherence counseling (Partner-STEPS) together as a dyad.
Other Names:
  • Dyadic STEPS
  • Partner STEPS

  Show Detailed Description


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

b. Inclusion Criteria i. Male sex at birth ii. Male gender iii. 18 or older iv. Living in Atlanta, Chicago, or Boston for at least three months v. Has a main Male Sexual Partner of relationship duration one month or longer vi. In a known or assumed serodiscordant relationship, that is, where one member of the couple is HIV-positive and one is either known to be or believed to be HIV-negative or of unknown HIV status vii. If HIV-positive, reporting of one or more of the following forms of suboptimal HIV medication adherence:

  1. Never having seen a prescribing provider for HIV care
  2. Not having a viral load test performed in the past six months, or not knowing if a viral load test has been performed in the past six months
  3. Never having been prescribed anti-HIV medications
  4. Never having begun taking anti-HIV medications
  5. Adherence to 90% or less of anti-HIV medications in the past week viii. No recent (one-year) severe intimate partner violence reported within the couple (note: mutually agreed-upon BDSM practices are excluded and not analogous with experiences of IPV)

(1) In the past six months, has he: i. Punched, hit or slapped you? ii. Kicked you? iii. Pushed or shoved you? iv. Used force or threats of force to make you do something sexual that you didn't want to do? v. Raped you? ix. No coercion to test for HIV reported within the couple x. Willingness to be tested for HIV with one's male sexual partner xi. Willingness to be randomized to either study arm xii. Participant reports feeling safe in his relationship

c. Exclusion Criteria i. Sex at birth other than male ii. Gender other than male iii. Either partner aged 17 or younger iv. Either partner living outside the Atlanta, Chicago, or Boston areas, or having moved to these areas within the past three months v. Does not have a main male sex partner or has a main male sex partner of relationship duration less than one month vi. Both partners have known or assumed negative HIV status vii. Both partners have known or assumed positive HIV status viii. Either partner reports experiencing or perpetrating severe physical or sexual intimate partner violence within the couple within the past year (see above, note that consensual BDSM practices are not classified as IPV) ix. Either partner reports feeling unsafe in his relationship x. Either partner reports feeling coerced or pressured into testing for HIV xi. Either partner reports feeling coerced or pressured into joining the research study xii. Unwillingness to test for HIV together with one's sexual partner xiii. Unwillingness to be randomized

  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 identifier: NCT01772992

Contact: Rob Stephenson, PhD 404 727 9976
Contact: Matthew Mimiaga, PhD

United States, Georgia
Rollins School of Public Health, Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Patrick Sullivan, PhD    404-727-9976   
Principal Investigator: Patrick Sullivan, PhD, DVM         
United States, Illinois
Children's Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Robert Garofalo, MD   
Principal Investigator: Robert Garofalo, MD         
United States, Massachusetts
Fenway Health Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Matthew Mimiaga, SCD   
Principal Investigator: Matthew Mimiaga, SCD         
Harvard School of Public Health Recruiting
Boston, Massachusetts, United States, 02115
Contact: Matthew Mimiaga, PhD   
Principal Investigator: Matthew Mimiaga, PhD         
Sponsors and Collaborators
University of Michigan
Harvard School of Public Health
Ann & Robert H Lurie Children's Hospital of Chicago
Emory University
  More Information

No publications provided

Responsible Party: Robert Stephenson, Professor, University of Michigan Identifier: NCT01772992     History of Changes
Other Study ID Numbers: IRB00065111, 1R01HD075655-01A1
Study First Received: January 16, 2013
Last Updated: September 23, 2015
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by University of Michigan:
HIV couples adherence linkage to care viral suppression processed this record on October 02, 2015