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

NCT01772992 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 586

Last updated 2020-01-28

No results posted yet for this study

Summary

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 18 months. 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • Ann & Robert H Lurie Children's Hospital of Chicago

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • University of Michigan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01772992 on ClinicalTrials.gov