HIV/AIDSNCT02181881
DuoPACT Pilot Intervention
A study testing DuoPACT and Life Steps in people with HIV/AIDS, run by University of California, San Francisco at 1 site in United States.
Trial summary
The investigators will pilot test the intervention by randomizing 30 couples to one of three conditions: 1) DuoPACT, the newly-developed couples intervention; 2) Life Steps, a standardized antiretroviral adherence intervention for HIV+ individuals; and 3) a treatment as usual (TAU) assessment-only control condition. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- DuoPACT and Life Steps
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Sep 2014
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gay male couple.
- One or both partners must be HIV positive and on antiretroviral medications.
Who cannot join
- Must be able to consent to and follow study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for AIDS Prevention Studies
San Francisco, California, 94105
About this study
Official title: Relationship Factors and HIV Treatment Adherence
The investigators will pilot test the intervention by randomizing 30 couples to one of three conditions: 1) DuoPACT, the newly-developed couples intervention; 2) Life Steps, a standardized antiretroviral adherence intervention for HIV+ individuals; and 3) a treatment as usual (TAU) assessment-only control condition. 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 acceptability and feasibility.
- Conditions
- HIV/AIDS
- Being tested
- DuoPACT, Life Steps
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuoPACTBehavioural
Intervention sessions are administered weekly by a counselor.
Life StepsBehavioural
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 |
| Life Steps | Active comparator | A 3-session HIV medication adherence support program for individuals. Receives: Behavioral: Life Steps |
| Treatment as usual (TAU) | No intervention | HIV positive individuals will continue to follow their current HIV treatment plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with the intervention
All participants are assessed post intervention to evaluate intervention satisfaction and acceptability.
Measured: 3 months
Secondary outcomes (1)
Feasibility
All participants are assessed post intervention to evaluate the study's feasibility.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT02181881
- Sponsor's protocol ID
- R01NR010187
- Other IDs
- R01NR010187
- Status last verified
- Feb 2024
- First submitted
- 2 Jul 2014
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Factors and HIV Treatment Adherence
- ClinicalTrials.gov ID
- NCT02181881
- Acronym / sponsor ID
- R01NR010187
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- May 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Jul 2014 (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.
The investigators will pilot test the intervention by randomizing 30 couples to one of three conditions: 1) DuoPACT, the newly-developed couples intervention; 2) Life Steps, a standardized antiretroviral adherence intervention for HIV+ individuals; and 3) a treatment as usual (TAU) assessment-only control condition. 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 acceptability and feasibility.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DuoPACT | Active comparator | Behavioral: DuoPACTA 6-session HIV medication adherence support program for couples. |
| Life Steps | Active comparator | Behavioral: Life StepsA 3-session HIV medication adherence support program for individuals. |
| Treatment as usual (TAU) | No intervention | –HIV positive individuals will continue to follow their current HIV treatment plan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Gay male couple.
- One or both partners must be HIV positive and on antiretroviral medications.
Key exclusion criteria (1 listed)
- Must be able to consent to and follow study protocol.
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 |
|---|---|---|
| DuoPACTIntervention sessions are administered weekly by a counselor. | Behavioural | DuoPACT |
| Life StepsIntervention sessions are administered weekly by a counselor. | Behavioural | Life Steps |
Primary outcome
Satisfaction with the intervention
Time frame: 3 months
All participants are assessed post intervention to evaluate intervention satisfaction and acceptability.
1 secondary outcome
Feasibility
Time frame: 3 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 15 Feb 2024.
- Individual participant dataSharing planned: No
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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 Life Steps 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 2 inclusion and 1 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 15 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?
Satisfaction with the intervention (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2024.