HIV/AIDSCHAMPSNCT02310893
Effectiveness of Peer Navigation and Contingency Management on Retention in HIV Care
A study testing Combined Contingency Management and Peer Navigation, Contingency Management and Peer Navigation in people with HIV/AIDS, run by University of California, Los Angeles at 6 sites in United States.
Trial summary
Consistent treatment with anti-retroviral therapy (ART) suppresses viral load (VL), prolonging life and improving quality of life for HIV+ persons. Suppressing VL benefits communities by reducing transmission to others. 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?
- Combined Contingency Management and Peer Navigation, Contingency Management and Peer Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 579 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2016to Jan 2020
- 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
- Diagnosed HIV+
- Age 18 years or older
- English or Spanish speaking
- Residence in Los Angeles County
- prescribed ART in prior 24 months
- < 3 visits in prior 12 months or have detectable viral load, as identified in the Ryan White CaseWatch database
Who cannot join
- Not meeting any of the criteria identified above
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Center for Health Justice
Los Angeles, California, 90012
Los Angeles Sheriff's Department
Los Angeles, California, 90012
AltaMed Health Services Corporation
Los Angeles, California, 90022
Oasis Clinic
Los Angeles, California, 90059
Olive View Medical Center
Sylmar, California, 91342
Northeast Valley Health Corporation
Van Nuys, California, 91401
About this study
Consistent treatment with anti-retroviral therapy (ART) suppresses viral load (VL), prolonging life and improving quality of life for HIV+ persons. Suppressing VL benefits communities by reducing transmission to others. Mere availability of ART and care, however, is insufficient; the benefits of ART depend upon HIV+ persons' continuous visits to the health care provider, regular monitoring and regular delivery of medications, - known as retention in HIV care. In spite of national efforts, up to a quarter of HIV+ persons, especially low-income minorities are out of care. Innovative interventions are therefore urgently needed to maximize engagement and retention in HIV care, self-reported adherence, as well as HIV-1 RNA viral load suppression. In pursuit of these aims, the proposed study will assess outcomes of the following interventions in comparison to usual care: 1) contingency management (CM) only; 2) peer navigation (PN) only; and 3) a combined approach that integrates both CM and PN (CA) which the investigators hypothesize to be most effective in improving HIV clinical outcomes.
- Conditions
- HIV/AIDS
- Being tested
- Combined Contingency Management and Peer Navigation, Contingency Management, Peer Navigation
- 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.
Combined Contingency Management and Peer NavigationBehavioural
Contingency ManagementBehavioural
Peer NavigationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management only | Active comparator | Participants assigned to this arm will receive payments for attending regular HIV medical appointments at the clinic and filling prescribed HIV medications at the pharmacy Receives: Behavioral: Contingency Management |
| Peer Navigation only | Active comparator | Participants in this arm will be assigned a peer navigator to assist them in accessing and remaining in HIV care Receives: Behavioral: Peer Navigation |
| Combined Contingency Management and Peer Navigation | Experimental | Participants in this arm will be assigned a peer navigator to assist them in accessing and remaining in HIV care and will be eligible to receive incentives for attending HIV care visits/refilling prescriptions. Receives: Behavioral: Combined Contingency Management and Peer Navigation |
| Usual care | No intervention | Participants in this arm will receive the care that they would usually get in their clinic in the absence of this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in retention-in-care behaviors over 12 months
Using a 2x2 factorial design, to examine the effect of the three interventions -- peer navigation, contingency management, combined approach and usual care -- and evaluate how well they improve retention in HIV care
Measured: Basline, follow-ups at month 2, 6, 12
Change in HIV RNA viral load suppression and medication adherence over 12 months
Using the same design, to examine the effects of the PN, CM and, CA interventions on HIV RNA viral load suppression and self-reported adherence
Measured: Basline, follow-ups at month 2, and 12
Secondary outcomes (1)
Cost effectiveness
A secondary aim is to examine the cost-offset and potential cost-effectiveness of each intervention compared with usual care
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startJan 2016
- Primary completionDec 2019
- Study completionJan 2020
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, Los AngelesThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 579 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Cunningham, MD, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310893
- Sponsor's protocol ID
- 1R01MH103076-01A1
- Acronym
- CHAMPS
- Status last verified
- Nov 2020
- First submitted
- 18 Jul 2014
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Peer Navigation and Contingency Management on Retention in HIV Care
- ClinicalTrials.gov ID
- NCT02310893
- Acronym / sponsor ID
- CHAMPS / 1R01MH103076-01A1
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 8 Dec 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.
Consistent treatment with anti-retroviral therapy (ART) suppresses viral load (VL), prolonging life and improving quality of life for HIV+ persons. Suppressing VL benefits communities by reducing transmission to others. Mere availability of ART and care, however, is insufficient; the benefits of ART depend upon HIV+ persons' continuous visits to the health care provider, regular monitoring and regular delivery of medications, - known as retention in HIV care. In spite of national efforts, up to a quarter of HIV+ persons, especially low-income minorities are out of care. Innovative interventions are therefore urgently needed to maximize engagement and retention in HIV care, self-reported adherence, as well as HIV-1 RNA viral load suppression. In pursuit of these aims, the proposed study will assess outcomes of the following interventions in comparison to usual care: 1) contingency management (CM) only; 2) peer navigation (PN) only; and 3) a combined approach that integrates both CM and PN (CA) which the investigators hypothesize to be most effective in improving HIV clinical outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Contingency Management only | Active comparator | Behavioral: Contingency ManagementParticipants assigned to this arm will receive payments for attending regular HIV medical appointments at the clinic and filling prescribed HIV medications at the pharmacy |
| Peer Navigation only | Active comparator | Behavioral: Peer NavigationParticipants in this arm will be assigned a peer navigator to assist them in accessing and remaining in HIV care |
| Combined Contingency Management and Peer Navigation | Experimental | Behavioral: Combined Contingency Management and Peer NavigationParticipants in this arm will be assigned a peer navigator to assist them in accessing and remaining in HIV care and will be eligible to receive incentives for attending HIV care visits/refilling prescriptions. |
| Usual care | No intervention | –Participants in this arm will receive the care that they would usually get in their clinic in the absence of this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed HIV+
- Age 18 years or older
- English or Spanish speaking
- Residence in Los Angeles County
- prescribed ART in prior 24 months
Key exclusion criteria (1 listed)
- Not meeting any of the criteria identified above
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 |
|---|---|---|
| Combined Contingency Management and Peer Navigation | Behavioural | Combined Contingency Management and Peer Navigation |
| Contingency Management | Behavioural | Contingency Management only |
| Peer Navigation | Behavioural | Peer Navigation only |
Primary outcome
Change in retention-in-care behaviors over 12 months
Time frame: Basline, follow-ups at month 2, 6, 12
Using a 2x2 factorial design, to examine the effect of the three interventions -- peer navigation, contingency management, combined approach and usual care -- and evaluate how well they improve retention in HIV care
Change in HIV RNA viral load suppression and medication adherence over 12 months
Time frame: Basline, follow-ups at month 2, and 12
Using the same design, to examine the effects of the PN, CM and, CA interventions on HIV RNA viral load suppression and self-reported adherence
1 secondary outcome
Cost effectiveness
Time frame: 5 years
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 17 Nov 2020.
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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.
William Cunningham, MD, MPH principal investigator
University of California, Los Angeles
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Contingency Management and Peer Navigation, Contingency Management and Peer Navigation in people with HIV/AIDS, run by University of California, Los Angeles at 6 sites 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 6 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 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 in retention-in-care behaviors over 12 months (time frame: Basline, follow-ups at month 2, 6, 12). The study lists 2 primary outcomes in all. 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 17 Nov 2020.