Ignite Creation Date:
2024-05-06 @ 1:17 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01772992
Status:
COMPLETED
Last Update Posted:
2020-01-28
First Post:
2013-01-16
Brief Title:
CVCTPlus A Couples-Based Approach to Linkage to Care and ARV Adherence
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
CVCTPlus A Couples-Based Approach to Linkage to Care and ARV Adherence
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CVCTPLUS
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 couples 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
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 In 2009 MSM accounted for 61 of new HIV diagnoses an increase from 53 of HIV incidence in 2006 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 The estimates published by Gardner show that of the estimated 11 million persons infected with HIV in the United States 21 of HIV-infected persons are currently undiagnosed 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 Led by Sullivan and Stephenson recent work has illustrated the feasibility of enrolling couples into HIV prevention efforts and demand for couples-focused services among MSM 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 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 350 MSM couples and the enrollment of couples in a RCT the study aims to examine the impact of CVCTPlus CVCT plus dyadic adherence counseling versus the current standard of care individual testing only 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 i Aim 1 Examine if testing together for HIV and receiving dyadic adherence counseling Partner-STEPS increases linkage to care as defined as 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
ii Aim 2 Examine if testing together for HIV and receiving dyadic adherence counseling Partner-STEPS increases retention in care as defined as 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
iii Aim 3 Examine if testing together for HIV and receiving dyadic adherence counseling Partner-STEPS increases adherence to anti-retroviral therapy and reductions in viral loads achievement of viral suppression
iv Aim 4 Examine if testing together for HIV decreases sexual risk-taking both within dyads and with outside sexual partners
v Aim 5 Examine if testing together increases couples coping and communication abilities
Hypothesis 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 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 couples
Primary Aims
1 i Aim 1 Examine if testing together for HIV and receiving dyadic adherence counseling Partner-STEPS increases linkage to care as defined as 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
ii Aim 2 Examine if testing together for HIV and receiving dyadic adherence counseling Partner-STEPS increases retention in care as defined as 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
iii Aim 3 Examine if testing together for HIV and receiving dyadic adherence counseling Partner-STEPS increases adherence to anti-retroviral therapy and reductions in viral loads achievement of viral suppression
iv Aim 4 Examine if testing together for HIV decreases sexual risk-taking both within dyads and with outside sexual partners
v Aim 5 Examine if testing together increases couples coping and communication abilities
Hypothesis 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 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 couples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HD075655-01A1 | NIH | None | httpsreporternihgovquickSearch1R01HD075655-01A1 |