Trial record 19 of 44 for:    " January 23, 2013":" February 22, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Ssewamala, PhD, Columbia University
ClinicalTrials.gov Identifier:
NCT01790373
First received: February 11, 2013
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

The goal of Suubi+Adherence is to examine the impact and cost associated with an innovative intervention to increase adherence to HIV treatment for HIV-infected adolescents. Multiple intervention studies by our team in Rakai and Masaka Districts of southern Uganda with AIDS-orphaned adolescents have revealed that if given an opportunity to participate in economic empowerment interventions, youth and their caregivers take full advantage of these interventions to save and invest in their future, show improvements in family financial outcomes, future aspirations, health functioning, sexual-risk taking behaviors, and mental health. The Suubi+Adherence study capitalizes on this prior work, positing that economic empowerment may be a missing, yet critical ingredient to HIV treatment adherence interventions for adolescents and young people. Suubi+Adherence incorporates an economic empowerment design, with a savings-led income generating component, to promote economic stability, and apply it to adherence to HIV treatment regimens for HIV-positive adolescents in a region of southern Uganda with the highest HIV incidence and prevalence in the country.


Condition Intervention
HIV
Behavioral: Suubi+Adherence
Behavioral: Bolstered Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Official Title: Suubi+Adherence: Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Change from baseline to follow-up assessments of adherence to HIV treatment [ Time Frame: Every year for five years ] [ Designated as safety issue: No ]
    Adherence to HIV treatment regimen outcomes for HIV-positive adolescents, including participants' ability to access and refill prescribed HIV antiretroviral therapy and adhere to prescribed daily HIV medication routines.


Secondary Outcome Measures:
  • Protective Health Behaviors [ Time Frame: Every year for five years ] [ Designated as safety issue: No ]
    Using a series of standardized and pre-tested instruments, potential mechanisms of protective health behaviors, knowledge, and beliefs, including: 1) financial/economic stability, 2) sexual risk-taking behavior, 3) personal beliefs about HIV medication, 4) hopelessness, 5) future plans and aspirations, and 6) adherence self-efficacy, will be measured during a structured interview at baseline and at every subsequent follow-up assessment.

  • Cost-Effectiveness Analyses [ Time Frame: Every year for five years ] [ Designated as safety issue: No ]
    Cost-effectiveness analyses measure the cost of achieving an agreed upon benefit, such as an additional year of schooling, employment, or a reduction in a disease. Costs will be measured on a per person basis. The costs of the intervention will include all program costs. Research costs will not be included.


Estimated Enrollment: 736
Study Start Date: February 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Suubi+Adherence

Suubi+Adherence intervention arm provides:

  • Matched savings accounts/child development accounts (CDAs) for the adolescents held in a local bank.
  • Financial education and workshops on asset-building, future planning, and protection from risks
  • Mentorship from a young adult/near-peer
  • Family-based microenterprise development training

Bolstered Standard of Care: Adherence Counseling Practices

-Four to six counseling sessions to review HIV, ART, resistance, and adherence.

Medical Standard of Care:

-Pediatric ART initiation and monitoring followed by all public clinics, and outlined in National Department of Health Guidelines for pediatric HIV care in Uganda

Psychosocial Standard of Care:

-Psychosocial support provided by lay counselors trained in standardized ART adherence counseling

Behavioral: Suubi+Adherence
  • Matched savings accounts/child development accounts (CDAs) for the adolescents held in a local bank.
  • Financial education and workshops on asset-building, future planning, and protection from risks
  • Mentorship from a young adult/near-peer
  • Family-based microenterprise development training
  • Medical Event Monitoring System

Bolstered Standard of Care: Adherence Counseling Practices

-Four to six counseling sessions to review HIV, ART, resistance, and adherence.

Medical Standard of Care:

-Pediatric ART initiation and monitoring followed by all public clinics, and outlined in National Department of Health Guidelines for pediatric HIV care in Uganda

Psychosocial Standard of Care:

-Psychosocial support provided by lay counselors trained in standardized ART adherence counseling

Active Comparator: Bolstered Standard of Care

Bolstered Standard of Care: Adherence Counseling Practices

-Four to six counseling sessions to review HIV, ART, resistance, and adherence.

Medical Standard of Care:

-Pediatric ART initiation and monitoring followed by all public clinics, and outlined in National Department of Health Guidelines for pediatric HIV care in Uganda

Psychosocial Standard of Care:

-Psychosocial support provided by lay counselors trained in standardized ART adherence counseling

Behavioral: Bolstered Standard of Care

-Medical Event Monitoring System

Bolstered Standard of Care: Adherence Counseling Practices

-Four to six counseling sessions to review HIV, ART, resistance, and adherence.

Medical Standard of Care:

-Pediatric ART initiation and monitoring followed by all public clinics, and outlined in National Department of Health Guidelines for pediatric HIV care in Uganda

Psychosocial Standard of Care:

-Psychosocial support provided by lay counselors trained in standardized ART adherence counseling


  Eligibility

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HIV-positive adolescents confirmed by medical report
  • Prescribed antiretroviral therapy
  • Enrolled in care at one of 32 medical clinics within study region
  • 11-16 years of age
  • Living within a family (not necessarily with biological parent(s))

Exclusion Criteria:

  • Not HIV-positive
  • HIV-positive but not prescribed antiretroviral therapy
  • Not enrolled in care at one of 32 medical clinics within study region
  • Younger than 11 years and older than 16 years
  • Not living within a family
  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: NCT01790373

Contacts
Contact: Fred M Ssewamala, MSW, PhD 212-851-2250 fs2114@columbia.edu
Contact: Vilma P Ilic, MSW 212-851-2224 vpi2101@columbia.edu

Locations
United States, New York
Columbia University School of Social Work Not yet recruiting
New York, New York, United States, 10027
Contact: Vilma P Ilic, MSW    212-851-2224    vpi2101@columbia.edu   
Principal Investigator: Fred M Ssewamala, MSW, PhD         
Uganda
International Center for Child Health and Asset Development Recruiting
Masaka, Uganda
Contact: Abel Mwebembezi, MS    +256-793-888-711    ablemwebembez@yahoo.com   
Contact: Vilma P Ilic, MSW    +256-793-888-705    vpi2101@columbia.edu   
Principal Investigator: Fred M Ssewamala, MSW, PhD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Fred M Ssewamala, MSW, PhD Columbia University
  More Information

No publications provided

Responsible Party: Fred Ssewamala, PhD, Associate Professor, Columbia University
ClinicalTrials.gov Identifier: NCT01790373     History of Changes
Other Study ID Numbers: AAAK3852, 1R01HD074949-01
Study First Received: February 11, 2013
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board
Uganda: Higher Degrees, Research and Ethics Committee
Uganda: Uganda National Council for Science and Technology

Keywords provided by Columbia University:
Suubi
Adolescents
Poverty
Economic empowerment interventions
Adherence to HIV antiretroviral therapy
Wisepill
HIV/AIDS infected Children
Medical event monitoring system
Uganda

ClinicalTrials.gov processed this record on August 28, 2014