HIV-infection/AidsLINK LANCT01406626
Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care
A study testing Peer Navigator in people with HIV-infection/Aids, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will implement a peer navigation intervention to improve linkage to and retention in HIV care for inmates released from L.A. county jail into the community. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV-infection/Aids
- What is being tested?
- Peer Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Oct 2016
- 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
- Age 18 or older
- Men or TGW diagnosed HIV-positive
- English or bilingual Spanish speaking
- Selected for the TCM program (control condition) prior to LINK LA enrollment
- Residing in LA County upon release
- Eligible for ART or incarcerated on ART.
Who cannot join
- Inability to give informed consent
- Parole hold or planned transfer to prison
- Stay in jail <5 days.
Trial locations and contacts
1 site in 1 country.
About this study
This study will implement a peer navigation intervention to improve linkage to and retention in HIV care for inmates released from L.A. county jail into the community.
Read the detailed description
The proposed study has two Primary Specific Aims:
- To examine individual-level and structural-level barriers to HIV care after release from jail, using formative semi-structured interviews with ex-inmates, case managers, and HIV care providers; and to use the information we obtain to inform the adaptation and tailoring of an intervention designed to improve linkage with and retention to HIV care for HIV+ ex-inmates (Complete);
- Using a two-group experimental RCT design, to test the adapted peer navigation intervention condition for HIV+ inmates upon release from jail compared to a usual care condition, and to evaluate the intervention's effectiveness at improving linkage with and retention in HIV care, self-reported ART adherence, and HIV RNA viral load suppression;
The intervention is hypothesized to result in greater linkage to care, a greater proportion completing at least three HIV care visits per year, increased self-reported ART adherence, and decreased levels of HIV RNA viral load compared to the usual care control group.
Secondary Aims of the study include assessing the potential moderating effects of substance abuse, the potential mediating effects of substance abuse treatment, and the program's effects on recidivism, and costs.
Active substance abuse is hypothesized to moderate the effect of the intervention, such that the intervention will be less effective among participants who report substance use.
- Conditions
- HIV-infection/Aids
- Being tested
- Peer Navigator
- Keywords
- HIV, AIDS, Peer navigation, Viral load, Corrections
- 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.
Peer NavigatorBehavioural
Peer navigation intervention to improve linkage to and retention in HIV care and suppress viral load for underserved HIV+ persons in Los Angeles
| Study group | Role | What they receive |
|---|---|---|
| Peer Navigation Intervention Arm | Experimental | Subjects will receive the following peer navigation services:
1) 10 Navigator meetings: Navigators will meet with participants in person to teach linkage/retention skills and knowledge
2a) 2 Navigator accompaniment sessions: the peer navigator will accompany participants to HIV care appointment. Before and after the appointment, participants and navigators will review linkage and retention skills/knowledge and things that make it hard or easy for him/her to get regular HIV care
2b) Optional peer navigator accompaniment sessions: If the participant requests, the peer navigator will provide accompaniment to supportive HIV care appointments (one per month max)
3) 14 peer navigator care calls: During these calls, navigators and participants will talk about any problems that could make it difficult to get regular HIV care. Receives: Behavioral: Peer Navigator |
| Usual Care | No intervention | Participants assigned to the control arm will receive the transitional case management (TCM) services that are currently offered at the jail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage to HIV Care
Number of HIV+ ex jail inmates accessing HIV care
Measured: 12 months
Retention in Treatment
This assesses whether or not the HIV+ ex jail inmates were retained in their HIV care after first accessing care.
Measured: 12 months
Adherence to Treatment
How adherent the HIV+ ex jail inmates are to their treatment regiment, by self-report.
Measured: 12 months
Viral Load
HIV+ ex jail inmates' viral load
Measured: 12 months
Secondary outcomes (1)
Costs
Cost of the intervention and HIV care
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startDec 2012
- Primary completionOct 2016
- Study completionOct 2016
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-infection/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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Los Angeles County Department of Public Health
- Responsible party
- Sponsor
- Investigators
- William E Cunningham, MD, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406626
- Sponsor's protocol ID
- R01DA030781
- Acronym
- LINK LA
- Status last verified
- Nov 2020
- First submitted
- 28 Jul 2011
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cunningham WE, Weiss RE, Nakazono T, Malek MA, Shoptaw SJ, Ettner SL, Harawa NT. Effectiveness of a Peer Navigation Intervention to Sustain Viral Suppression Among HIV-Positive Men and Transgender Women Released From Jail: The LINK LA Randomized Clinical Trial. JAMA Intern Med. 2018 Apr 1;178(4):542-553. doi: 10.1001/jamainternmed.2018.0150.
PubMed 29532059
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care
- ClinicalTrials.gov ID
- NCT01406626
- Acronym / sponsor ID
- LINK LA / R01DA030781
- Conditions
- HIV-infection/Aids
- Keywords
- HIV, AIDS, Peer navigation, Viral load, Corrections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Los Angeles County Department of Public Health
- Study start
- Dec 2012 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Aug 2011 (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 study will implement a peer navigation intervention to improve linkage to and retention in HIV care for inmates released from L.A. county jail into the community.
Detailed description
The proposed study has two Primary Specific Aims:
- To examine individual-level and structural-level barriers to HIV care after release from jail, using formative semi-structured interviews with ex-inmates, case managers, and HIV care providers; and to use the information we obtain to inform the adaptation and tailoring of an intervention designed to improve linkage with and retention to HIV care for HIV+ ex-inmates (Complete);
- Using a two-group experimental RCT design, to test the adapted peer navigation intervention condition for HIV+ inmates upon release from jail compared to a usual care condition, and to evaluate the intervention's effectiveness at improving linkage with and retention in HIV care, self-reported ART adherence, and HIV RNA viral load suppression;
The intervention is hypothesized to result in greater linkage to care, a greater proportion completing at least three HIV care visits per year, increased self-reported ART adherence, and decreased levels of HIV RNA viral load compared to the usual care control group.
Secondary Aims of the study include assessing the potential moderating effects of substance abuse, the potential mediating effects of substance abuse treatment, and the program's effects on recidivism, and costs.
Active substance abuse is hypothesized to moderate the effect of the intervention, such that the intervention will be less effective among participants who report substance use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Navigation Intervention Arm | Experimental | Behavioral: Peer NavigatorSubjects will receive the following peer navigation services: 1) 10 Navigator meetings: Navigators will meet with participants in person to teach linkage/retention skills and knowledge 2a) 2 Navigator accompaniment sessions: the peer navigator will accompany participants to HIV care appointment. Before and after the appointment, participants and navigators will review linkage and retention skills/knowledge and things that make it hard or easy for him/her to get regular HIV care 2b) Optional peer navigator accompaniment sessions: If the participant requests, the peer navigator will provide accompaniment to supportive HIV care appointments (one per month max) 3) 14 peer navigator care calls: During these calls, navigators and participants will talk about any problems that could make it difficult to get regular HIV care. |
| Usual Care | No intervention | –Participants assigned to the control arm will receive the transitional case management (TCM) services that are currently offered at the jail |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or older
- Men or TGW diagnosed HIV-positive
- English or bilingual Spanish speaking
- Selected for the TCM program (control condition) prior to LINK LA enrollment
- Residing in LA County upon release
Key exclusion criteria (3 listed)
- Inability to give informed consent
- Parole hold or planned transfer to prison
- Stay in jail <5 days.
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 |
|---|---|---|
| Peer NavigatorPeer navigation intervention to improve linkage to and retention in HIV care and suppress viral load for underserved HIV+ persons in Los Angeles | Behavioural | Peer Navigation Intervention Arm |
Primary outcome
Linkage to HIV Care
Time frame: 12 months
Number of HIV+ ex jail inmates accessing HIV care
Retention in Treatment
Time frame: 12 months
This assesses whether or not the HIV+ ex jail inmates were retained in their HIV care after first accessing care.
Adherence to Treatment
Time frame: 12 months
How adherent the HIV+ ex jail inmates are to their treatment regiment, by self-report.
Viral Load
Time frame: 12 months
HIV+ ex jail inmates' viral load
1 secondary outcome
Costs
Time frame: 12 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 18 Nov 2020.
- Derived from this study: PubMed 29532059Cunningham WE, Weiss RE, Nakazono T, Malek MA, Shoptaw SJ, Ettner SL, Harawa NT. Effectiveness of a Peer Navigation Intervention to Sustain Viral Suppression Among HIV-Positive Men and Transgender Women Released From Jail: The LINK LA Randomized Clinical Trial. JAMA Intern Med. 2018 Apr 1;178(4):542-553. doi: 10.1001/jamainternmed.2018.0150.
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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 E Cunningham, MD, MPH principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Navigator in people with HIV-infection/Aids, run by University of California, Los Angeles 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 6 inclusion and 3 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 18 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 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?
Linkage to HIV Care (time frame: 12 months). The study lists 4 primary outcomes in all. 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 NCT01406626, 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 18 Nov 2020.