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Computerized Counseling to Promote Positive Prevention and HIV Health in Kenya (CARE+ Kenya)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by New York University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Indiana University
Moi University
Information provided by (Responsible Party):
Ann Kurth, New York University
ClinicalTrials.gov Identifier:
NCT01015989
First received: November 17, 2009
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Other: CARE+ Kenya brief computer risk assessment session
Other: CARE+ Kenya computer counseling session
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Computerized Counseling to Promote Positive Prevention and HIV Health in Kenya

Resource links provided by NLM:


Further study details as provided by New York University:

Primary Outcome Measures:
  • ART adherence will be measured by HIV-1 viral load, electronic monitoring, pharmacy refill, self-report, and clinic attendance [ Time Frame: Every 3 months up to 9 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Every 3 months up to 9 months ] [ Designated as safety issue: No ]
  • We will conduct economic evaluation to compare CARE+ Kenya vs. standard of care. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Qualitative exit interviews with patients [ Time Frame: At end of study ] [ Designated as safety issue: No ]
  • Two focus groups with providers [ Time Frame: At end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: January 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CARE+ Kenya brief computer risk assessment session (control) Other: CARE+ Kenya brief computer risk assessment session
The computer will ask patients questions about taking HIV medicine. The computer will also ask patients questions about sexual and substance use activities. We will repeat the session every 3 months up to 9 months total.
Active Comparator: Full CARE+ Spanish computer-counseling group Other: CARE+ Kenya computer counseling session
The computer will ask patients questions about taking HIV medicine. The computer will also ask patients questions about sexual and substance use activities. The computer will let patients look at short videos on various HIV medicine and HIV risk reduction topics and will then help patients create a health plan. Patients will get an anonymous print out at the end of the session and can choose to share with health care provider. There are questions about depression, suicide, or domestic violence. If a patient's answers indicate that they may be depressed, suicidal, or currently in an abusive relationship, we will refer them to a health worker at the clinic. We will repeat the session every 3 months up to 9 months total.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Seen for care including ART at the clinics
  • Able to understand spoken Kiswahili or English
  • Reported less than "perfect" ART adherence/any missed dose or pill counts that indicate non-adherence with medication or delay in pharmacy refill; unprotected sex in the last 6 months, or >1 sex partner in last year, or any STI diagnosis in last 3 years
  • Able to give consent (i.e., no evidence of inebriation or psychosis)

Exclusion Criteria:

  • Not fluent in Kiswahili or English
  • Has a thought disorder that precludes participation
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015989

Contacts
Contact: Ann Kurth, PhD 212-998-5316 akurth@nyu.edu
Contact: Stephen Macharia, BA stphn_mchr@yahoo.com

Locations
Kenya
AMPATH at Burnt Forest Health Centre Recruiting
Burnt Forest, Rift Valley, Kenya
Contact: Abraham Siika, MD    0721-280785    amsiika@africaonline.co.ke   
AMPATH Module 1 Recruiting
Eldoret, Kenya
Contact: Abraham Siika, MD         
Sponsors and Collaborators
New York University
Indiana University
Moi University
Investigators
Principal Investigator: Ann Kurth, PhD NYU
  More Information

No publications provided

Responsible Party: Ann Kurth, Professor, New York University
ClinicalTrials.gov Identifier: NCT01015989     History of Changes
Other Study ID Numbers: 1R01MH085577
Study First Received: November 17, 2009
Last Updated: February 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York University:
HIV treatment
ART adherence
Using new technology to improve adherence
CARE+
HIV-1 viral loads

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014