Computerized Counseling to Promote Positive Prevention and HIV Health in Kenya (CARE+ Kenya)
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ClinicalTrials.gov Identifier: NCT01015989 |
Recruitment Status
: Unknown
Verified February 2012 by Ann Kurth, New York University.
Recruitment status was: Recruiting
First Posted
: November 18, 2009
Last Update Posted
: February 22, 2012
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Tracking Information | ||||
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First Submitted Date ICMJE | November 17, 2009 | |||
First Posted Date ICMJE | November 18, 2009 | |||
Last Update Posted Date | February 22, 2012 | |||
Study Start Date ICMJE | January 2011 | |||
Estimated Primary Completion Date | February 2012 (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 NCT01015989 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 | Computerized Counseling to Promote Positive Prevention and HIV Health in Kenya | |||
Official Title ICMJE | Computerized Counseling to Promote Positive Prevention and HIV Health in Kenya | |||
Brief Summary | The purpose of this study is to see if a computerized counseling tool helps patients reduce their sexual transmission risk and improve their antiretroviral adherence. | |||
Detailed Description | Helping people living with HIV to remain healthy and reduce transmission to sexual partners ('positive prevention') can be accomplished by behavioral counseling and supporting adherence to infectivity-reducing antiretroviral therapy (ART). Positive prevention and ART adherence approaches that are not staff-dependent are urgently needed in Africa, the region hardest hit by HIV and decimated health workforce. Interactive health communication tools offer one approach. We will adapt a computerized counseling intervention found to be efficacious in reducing HIV-1 viral load and risk behaviors in the US ('CARE+') with the largest HIV provider in Kenya, the Academic Model for the Prevention and Treatment of HIV/AIDS (AMPATH). Aim 1: Adapt a theoretically driven computerized counseling intervention for use in Kenya ('CARE+_Kenya'). Conduct in-depth interviews with n≤ 50 urban and rural AMPATH patients to understand HIV support needs, and two staff focus groups to assess counseling practices and beliefs about computer use. Modify intervention content; translate and record audio into local Kiswahili. Adapt skill-building videos (e.g., on secondary prevention, HIV disclosure, ART adherence, reproductive health). Conduct software usability testing with n=20 patients and n=8 staff. Perform 3-day test-retest reliability assessment to establish psychometric performance of measures. Aim 2: Establish biological and behavioral efficacy of CARE+_Kenya. Longitudinal randomized controlled trial (RCT) in one urban and one rural AMAPATH clinic. Randomly assign HIV-positive adults with any missed ART or unprotected sex in last 6 months, >1 sex partner in last year, or sexually transmitted infection (STI)diagnosis in last 3 years, to intervention (n=125) or risk-assessment control (n=125) for baseline, 3, 6, and 9 month sessions. HIV transmission risk will be measured by self-reported unprotected sex with HIV negative/unknown partner, and trends in Chlamydia trachomatis, Neisseria gonorrhoeae, and T. vaginalis. ART adherence will be measured by HIV-1 viral load, electronic monitoring, pharmacy refill, self-report, and clinic attendance. Aim 3: Establish cost-effectiveness of CARE+_Kenya. At baseline, follow 100 patients at each of the two clinics to evaluate standard of care counseling, and collect time-spent and facility data to determine costs and unmet counseling need. Conduct economic evaluation to compare CARE+_Kenya vs. standard of care. If the RCT shows that the intervention reduces viral load and transmission risk behaviors, we will use a Bernoulli transmission dynamics model to estimate number of secondary HIV infections prevented; then create a cost-effectiveness model to calculate 2 incremental cost-effectiveness ratios: 1) cost per HIV infection averted, and 2) cost per daily adjusted life year saved. If CARE+_Kenya is efficacious and efficient, we will develop a proposal for a cluster-randomized trial to assess translational effectiveness of CARE+_Kenya throughout the AMPATH system. This is directly responsive to PA-08-107's call for innovative, integrated interventions that leverage ART roll-out infrastructure in international settings to benefit people living with HIV. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
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Condition ICMJE | HIV Infections | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* 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 | Unknown status | |||
Estimated Enrollment ICMJE |
250 | |||
Original Enrollment ICMJE | Not Provided | |||
Estimated Study Completion Date | June 2013 | |||
Estimated Primary Completion Date | February 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Kenya | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01015989 | |||
Other Study ID Numbers ICMJE | 1R01MH085577( U.S. NIH Grant/Contract ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Ann Kurth, New York University | |||
Study Sponsor ICMJE | New York University | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | New York University | |||
Verification Date | February 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |