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

This study is currently recruiting participants.
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

February 11, 2013
March 13, 2014
February 2013
August 2017   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01790373 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence
Suubi+Adherence: Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
HIV
  • 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

  • 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

  • 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

    Intervention: Behavioral: Suubi+Adherence
  • 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

    Intervention: Behavioral: Bolstered Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
736
August 2017
August 2017   (final data collection date for primary outcome measure)

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
Both
11 Years to 16 Years
Yes
Contact: Fred M Ssewamala, MSW, PhD 212-851-2250 fs2114@columbia.edu
Contact: Vilma P Ilic, MSW 212-851-2224 vpi2101@columbia.edu
United States,   Uganda
 
NCT01790373
AAAK3852, 1R01HD074949-01
No
Fred Ssewamala, PhD, Columbia University
Columbia University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Fred M Ssewamala, MSW, PhD Columbia University
Columbia University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP