CVCTPlus: A Couples-Based Approach to Linkage to Care and ARV Adherence (CVCTPLUS)
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|ClinicalTrials.gov Identifier: NCT01772992|
Recruitment Status : Active, not recruiting
First Posted : January 21, 2013
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: CVCTPLUS||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||CVCTPlus: A Couples-Based Approach to Linkage to Care and ARV Adherence|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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 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: 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 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.
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.
- Linkage to Care [ Time Frame: 18 months ]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
- Retention in care [ Time Frame: 18 months ]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
- Viral suppression [ Time Frame: 18 months ]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: 18 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772992
|United States, Georgia|
|Rollins School of Public Health, Emory University|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Children's Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|United States, Massachusetts|
|Harvard School of Public Health|
|Boston, Massachusetts, United States, 02115|
|Fenway Health Institute|
|Boston, Massachusetts, United States, 02215|