Testing and Linkage to Care for Injecting Drug Users in Kenya (TLC-IDU Kenya)
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| First Received Date ICMJE | February 20, 2012 | ||||||||
| Last Updated Date | March 16, 2012 | ||||||||
| Start Date ICMJE | March 2012 | ||||||||
| Estimated Primary Completion Date | April 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01557998 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Testing and Linkage to Care for Injecting Drug Users in Kenya | ||||||||
| Official Title ICMJE | Testing and Linkage to Care for IDUs in Kenya | ||||||||
| 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. |
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| Detailed Description | The purpose of the study will be to leverage the GoK's first-ever needle and syringe program, to implement the HIV seek, test, treat, and retain paradigm among IDUs, whose parenteral and sexual transmission networks amplify HIV epidemics. Study innovations include: (1) use of a stepped wedge trial design; (2) intent to track community viral load in a low-income country setting; (3) use of rapid CD4 assays to reduce time from HIV diagnosis to ART initiation; and (4) use of conditional cash transfers to support peer case management of participant HIV treatment retention. Aim 1: Evaluate seek test treat retain using a stepped wedge cluster-randomized design. Clusters will be the planned NSP service sites. The investigators will initiate respondent-driven sampling (RDS) to reach IDUs in Nairobi and coastal Mombasa (including Malindi) for baseline HIV-1 prevalence determination, then collect waves of study data as service sites roll out, including behavioral data. Teams will do rapid HIV testing and refer for addiction/mental health and other services (e.g., OST). HIV-positives will receive prevention with positives (PwP) counseling and point of care CD4 counts. Those with CD4 <350/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. Both peer case managers and subjects will receive small conditional cash transfers for subject's adherence to HIV care visits. Primary study outcomes will include time to successful linkage to care, time to ART, and community viral load before and after TLC-IDU initiation. '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). With individual viral loads collected per site per time step (for a n= of at least 1800 viral loads in total across all sites and timewaves) the investigators will have good power to detect log10 viral load changes of 0.23 and hazard ratios of ~1.5 when comparing pre- and post-intervention period using linear mixed effects analysis. Aim 1: Research hypothesis: Staggered rollout of a planned NSP/MARP program can be utilized to collect pre- and post intervention data that will allow assessment of impact on community viral load. Linkage to care will be higher, time to ART initiation will be reduced, and retention in care will be higher during time periods with the TLC-IDU services as compared to time periods with standard of care. Aim 2: 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. Aim 2: Research hypothesis: HIV transmission dynamics models can use parameters from Aim 1 data waves, with sensitivity analyses identifying those parameters with largest impact on effect estimation and stability. Aim 3: Assess the incremental cost-effectiveness ratio of the TLC-IDU model, using a national payer perspective. This study will provide among the world's first data regarding implementation of the seek, test, treat and retain paradigm with IDUs in sub-Saharan Africa. It will demonstrate the degree to which a combination of structural, biomedical and behavioral interventions can reduce infectivity. Partnership with Kenya's national HIV program will allow lessons learned from this study to inform other countries considering how best to address the growing IDU contribution to the HIV epidemic in this high-HIV-burden region. Aim 3: Research hypothesis: 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | HIV Infection | ||||||||
| Intervention ICMJE | 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 <350/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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 4500 | ||||||||
| Estimated Completion Date | April 2015 | ||||||||
| Estimated Primary Completion Date | April 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | The intervention phase with stepped wedge rollout of TLC-IDU-MARP sites Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Kenya | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01557998 | ||||||||
| Other Study ID Numbers ICMJE | 1R01DA032080 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Ann Kurth, New York University | ||||||||
| Study Sponsor ICMJE | New York University | ||||||||
| Collaborators ICMJE | New York University School of Medicine | ||||||||
| Investigators ICMJE |
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| Information Provided By | New York University | ||||||||
| Verification Date | March 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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