NCT01772992

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
586

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

5.5 years

First QC Date

January 16, 2013

Last Update Submit

January 24, 2020

Conditions

HIV

Keywords

HIV couples adherence linkage to care viral suppression

Outcome Measures

Primary Outcomes (1)

  • Linkage to Care

    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

    18 months

Secondary Outcomes (1)

  • Retention in care

    18 months

Other Outcomes (2)

  • Viral suppression

    18 months

  • Decrease sexual risk-taking

    18 months

Study Arms (2)

Control group (iVCT)

NO INTERVENTION

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 18 months, for individual visits, in which they will have STI testing and repeat HIV testing. All follow-up visits will be conducted separately.

Experimental group (CVCTPLUS)

EXPERIMENTAL

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 18 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

Interventions

CVCTPLUSBEHAVIORAL

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.

Also known as: Dyadic STEPS, Partner STEPS
Experimental group (CVCTPLUS)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Never having seen a prescribing provider for HIV care
  • 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
  • Never having been prescribed anti-HIV medications
  • Never having begun taking anti-HIV medications
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rollins School of Public Health, Emory University

Atlanta, Georgia, 30322, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Harvard School of Public Health

Boston, Massachusetts, 02115, United States

Location

Fenway Health Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Stephenson R, Suarez NA, Garofalo R, Hidalgo MA, Hoehnle S, Thai J, Mimiaga MJ, Brown E, Bratcher A, Wimbly T, Sullivan P. Project Stronger Together: Protocol to Test a Dyadic Intervention to Improve Engagement in HIV Care Among Sero-Discordant Male Couples in Three US Cities. JMIR Res Protoc. 2017 Aug 31;6(8):e170. doi: 10.2196/resprot.7884.

    PMID: 28860107DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 21, 2013

Study Start

June 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations

US(4)