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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01NR010187-10A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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This is a randomized controlled trial of a new behavioral intervention designed to improve engagement in HIV care for couples. Investigators will compare the HIV viral load outcomes of couples randomized to a couples-based adherence intervention (DuoPACT) or to an individual adherence intervention (LifeSteps).
The investigators will test the intervention to improve HIV care engagement by enrolling 150 sexual or gender minority couples and randomizing 75 couples each to one of two conditions: 1) DuoPACT, a newly-developed couples intervention; or 2) LifeSteps, a standardized antiretroviral adherence intervention for HIV+ individuals. After randomization, intervention sessions will be delivered weekly (6 DuoPACT sessions, or 3 Life Steps sessions). All couples will be assessed pre/post intervention to evaluate intervention effects via behavioral indicators of engagement in HIV care, the couple's relationship dynamics, and the primary outcome of HIV viral load.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DuoPACT | Active Comparator | A 6-session HIV medication adherence support program for couples. |
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| LifeSteps | Active Comparator | A 3-session HIV medication adherence support program for individuals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DuoPACT | Behavioral | 6 couple-based intervention sessions are administered weekly by a counselor. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline HIV viral load at 3, 6 and 9 months | Follow-up blood draws will be performed on all HIV+ partners at 3, 6, and 9 months post randomization. HIV-1 viral load levels will be measured by the COBAS® AmpliPrep/COBAS® TaqMan® HIV test kit (Roche Molecular Systems, Inc.), which has a threshold for undetectability = < 20 copies/mL. | 3, 6 and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline behavioral indicators of engagement in HIV care at 3, 6 and 9 months | The investigators will use a newly developed 8-point scale called the Behavioral Composite of Engagement in HIV Care, which integrates:
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Inclusion Criteria:
Exclusion Criteria:
Sexual and Gender Minorities
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| Name | Affiliation | Role |
|---|---|---|
| Mallory O. Johnson, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for AIDS Prevention Studies | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33753428 | Background | Tabrisky AP, Coffin LS, Olem DP, Neilands TB, Johnson MO. Couples-focused intervention to improve engagement in HIV care: protocol for a randomised controlled trial. BMJ Open. 2021 Mar 22;11(3):e037468. doi: 10.1136/bmjopen-2020-037468. |
| Label | URL |
|---|---|
| Couples-focused intervention to improve engagement in HIV care: protocol for a randomised controlled trial | View source |
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A de-identified dataset will be made available to investigators upon reasonable request and following completion of primary study analyses.
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| LifeSteps | Behavioral | 3 individual-based intervention sessions are administered weekly by a counselor. |
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| 3, 6 and 9 months |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012725 | Sexual Behavior |
| D001519 | Behavior |