CVCTPlus: A Couples-Based Approach to Linkage to Care and ARV Adherence (CVCTPLUS)
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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 |
- 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
- Adherence to ARV [ Time Frame: 24 months ] [ Designated as safety issue: No ]Adherence to ARV medication among HIV positive participants, measured through WisePill technology
- 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: | July 2013 |
| 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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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| Contact: Rob Stephenson, PhD | 404 727 9976 | rbsteph@sph.emory.edu |
| Contact: Matthew Mimiaga, PhD | mmimiaga@hsph.harvard.edu |
| 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 | |
More Information
No publications provided
| Responsible Party: | Robert Stephenson, Associate Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT01772992 History of Changes |
| Other Study ID Numbers: | 1R01HD075655-01A1 |
| Study First Received: | January 16, 2013 |
| Last Updated: | January 17, 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 May 16, 2013