HIV/AIDSDuoPACTNCT02925949
Duo Partnership Adherence Commitment Therapy
A study testing DuoPACT and LifeSteps in people with HIV/AIDS, run by University of California, San Francisco at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- DuoPACT and LifeSteps
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2017to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ years old;
- Identifies as a sexual or gender minority;
- In a primary romantic relationship for at least 3 months;
- At least one partner is HIV+;
- English-speaking;
- Able to provide informed consent; and
- For HIV+ participants: Evidence of suboptimal engagement in HIV care.
Who cannot join
- Must be able to consent to and follow study protocol;
- Evidence of severe cognitive impairment or active psychosis;
- Lives outside California or plans to relocate from the state of California in the next 6 months; or
- Participation in the DuoPACT pilot.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for AIDS Prevention Studies
San Francisco, California, 94158
About this study
Official title: A Couples-based Approach to Improving Engagement in HIV Care
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).
Read the detailed description
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.
- Conditions
- HIV/AIDS
- Being tested
- DuoPACT, LifeSteps
- Keywords
- Treatment, Adherence, Intervention, Sexual and Gender Minority Couples
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuoPACTBehavioural
6 couple-based intervention sessions are administered weekly by a counselor.
LifeStepsBehavioural
3 individual-based intervention sessions are administered weekly by a counselor.
| Study group | Role | What they receive |
|---|---|---|
| DuoPACT | Active comparator | A 6-session HIV medication adherence support program for couples. Receives: Behavioral: DuoPACT |
| LifeSteps | Active comparator | A 3-session HIV medication adherence support program for individuals. Receives: Behavioral: LifeSteps |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3, 6 and 9 months
Secondary outcomes (1)
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:
- Current/past ART use (participant self-report and verification by HIV medication pill bottles or current pharmacy prescription).
- HIV appointment attendance (participant self-report categorized according to current HRSA standards of the minimum annual number and spacing of HIV primary care appointments).
- ART adherence (participant self-report and Walsh visual analog scale),
- Knowledge of current CD4 cell count (participant self-report).
Measured: 3, 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start14 Aug 2017
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Mallory O. Johnson, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925949
- Sponsor's protocol ID
- 2R01NR010187-10A1
- Other IDs
- 2R01NR010187-10A1
- Acronym
- DuoPACT
- Status last verified
- Feb 2024
- First submitted
- 28 Sep 2016
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A de-identified dataset will be made available to investigators upon reasonable request and following completion of primary study analyses.
Publications
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.
PubMed 33753428
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Couples-based Approach to Improving Engagement in HIV Care
- ClinicalTrials.gov ID
- NCT02925949
- Acronym / sponsor ID
- DuoPACT / 2R01NR010187-10A1
- Conditions
- HIV/AIDS
- Keywords
- Treatment, Adherence, Intervention, Sexual and Gender Minority Couples
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DuoPACT | Active comparator | Behavioral: DuoPACTA 6-session HIV medication adherence support program for couples. |
| LifeSteps | Active comparator | Behavioral: LifeStepsA 3-session HIV medication adherence support program for individuals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18+ years old;
- Identifies as a sexual or gender minority;
- In a primary romantic relationship for at least 3 months;
- At least one partner is HIV+;
- English-speaking;
Key exclusion criteria (4 listed)
- Must be able to consent to and follow study protocol;
- Evidence of severe cognitive impairment or active psychosis;
- Lives outside California or plans to relocate from the state of California in the next 6 months; or
- Participation in the DuoPACT pilot.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuoPACT6 couple-based intervention sessions are administered weekly by a counselor. | Behavioural | DuoPACT |
| LifeSteps3 individual-based intervention sessions are administered weekly by a counselor. | Behavioural | LifeSteps |
Primary outcome
Change from Baseline HIV viral load at 3, 6 and 9 months
Time frame: 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.
1 secondary outcome
Change from Baseline behavioral indicators of engagement in HIV care at 3, 6 and 9 months
Time frame: 3, 6 and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Background: PubMed 33753428Tabrisky 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.
- Couples-focused intervention to improve engagement in HIV care: protocol for a randomised controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: No. A de-identified dataset will be made available to investigators upon reasonable request and following completion of primary study analyses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mallory O. Johnson, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DuoPACT and LifeSteps in people with HIV/AIDS, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline HIV viral load at 3, 6 and 9 months (time frame: 3, 6 and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02925949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.