Testing and Linkage to Care for Injecting Drug Users in Kenya (TLCIDU Kenya)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01557998 |
|
Recruitment Status
:
Active, not recruiting
First Posted
: March 20, 2012
Last Update Posted
: January 17, 2018
|
Sponsor:
Yale University
Collaborators:
New York University School of Medicine
Kenya National AIDS & STI Control Programme
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
Interventions for injecting drug users (IDUs) in sub-Saharan African have been almost entirely absent, despite the fact that in countries like Kenya they contribute a growing proportion of incident HIV infections. This study will leverage a historic decision in Kenya to launch needle exchange program (NSP) and related services for this most-at-risk population (MARP). The investigators will use this NSP/MARP platform to seek out IDUs, deliver rapid HIV testing, point of care CD4 count and link to ART using peer case managers, and evaluate community viral load impact using a stepped wedge cluster-randomized design. Lessons learned will have important applicability throughout sub-Saharan African.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infection | Behavioral: Point of Care CD4 count and peer case management | Not Applicable |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 8800 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Testing and Linkage to Care for IDUs in Kenya |
| Study Start Date : | March 2012 |
| Estimated Primary Completion Date : | April 30, 2018 |
| Estimated Study Completion Date : | April 30, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
|
No Intervention: Control
IDUs in the control arm will receive the behavioral survey, follow-up interviews, health education and training sessions on how to recruit peers, the rapid HIV test, and the point of care CD4 test but will not be assigned a peer case manager.
|
|
|
Experimental: CD4 and Peer Case Management
HIV-positives will receive prevention with positives (PwP) counseling and point of care CD4 counts. Those with CD4 <500/μL will be assigned a peer case manager to link the person to ART at study-participating HIV clinics, support ART and PwP adherence and care retention.
|
Behavioral: Point of Care CD4 count and peer case management
HIV-positives will receive prevention with positives (PwP) counseling and point of care CD4 counts. Those with CD4 <500/μL will be assigned a peer case manager to link the person to ART at study-participating HIV clinics, support ART and PwP adherence and care retention.
|
Primary Outcome Measures
:
- Linkage to care and time to ART [ Time Frame: Data collection done in 5 waves separated by 6 months ]Use of rapid CD4 assays to reduce time from HIV diagnosis to ART initiation
- Community viral load before and after the TLC-IDU initiation [ Time Frame: Data collection done in 5 waves separated by 6 months ]Community viral load will be ascertained by collecting specimens from randomly-selected HIV-positives at each of the NASCOP NSP-IDU service sites. This sampling will be done in waves over time, to document changes in infectivity (median viral load).
- Retention in Care [ Time Frame: Data collection done in 5 waves separated by 6 months ]HIV-positives will receive prevention with positives (PwP) counseling and point of care CD4 counts. Those with CD4 <500/μL will be assigned a peer case manager to link the person to ART at study-participating HIV clinics, support ART and PwP adherence and care retention.
Secondary Outcome Measures
:
- Modeling HIV transmission dynamics [ Time Frame: End of study (will occur in year 5 of the study) ]Conduct mathematical modeling to estimate community viral load in IDU injecting and sexual networks, and to assess potential population-level impact of the TLC-IDU intervention on Ro, numbers of infections averted, and quality-adjusted life expectancy.
- Assess the incremental cost-effectiveness ratio of the TLC-IDU model [ Time Frame: End of study (will occur in year 5 of the study) ]The expectation is that utilizing MARP/NSP services will result in a reduction in median community viral load and in forward HIV transmission. Cost per quality adjusted life year saved and HIV infection averted will be favorable as compared with the alternative of no specific seek, test, treat and retain program directed to IDUs.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
The intervention phase with stepped wedge rollout of TLC-IDU-MARP sites Inclusion Criteria:
- subjects will be adults (≥18 year olds)
- attend NSP/MARP service sites
- live in Nairobi (Central Province) or coastal Mombasa (Coast Province including Malindi), Kenya
- are IDUs that ever injected any non-prescribed drugs
- are IDUs that have used any non-prescribed drugs within the past 12 months
- for viral load testing, individuals must have tested HIV+
Exclusion Criteria:
- subjects are not adults (<18 years old)
- do not attend NSP/MRP sites
- do not live in Nairobi (Central Province) or coastal Mombasa (Coast Province including Malindi), Kenya
- are not IDUs
- for viral load testing, individuals who tested HIV-
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557998
Locations
| Kenya | |
| National AIDS/STD Control Programme (NASCOP) | |
| Nairobi, Kenya | |
Sponsors and Collaborators
Yale University
New York University School of Medicine
Kenya National AIDS & STI Control Programme
National Institute on Drug Abuse (NIDA)
Investigators
| Principal Investigator: | Ann Kurth, PhD, CNM | Yale University School of Nursing | |
| Principal Investigator: | Peter Cherutich, PhD, MBchB, MPH | NASCOP, MoH Kenya |
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT01557998 History of Changes |
| Other Study ID Numbers: |
1512016965 1R01DA032080 ( U.S. NIH Grant/Contract ) |
| First Posted: | March 20, 2012 Key Record Dates |
| Last Update Posted: | January 17, 2018 |
| Last Verified: | January 2018 |
Keywords provided by Yale University:
|
Test and linkage to care Injecting drug user (IDU) Prevention with positives ART adherence |
point of care CD4 counts Peer case management Conditional cash transfer |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |