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Strengthening Families Living With HIV in Kenya

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Active, not recruiting

Conditions

Trust
Adherence, Medication
PTSD
Depression, Anxiety
Hiv
ART

Treatments

Behavioral: Kuja Pamoja - HIV

Study type

Interventional

Funder types

Other

Identifiers

NCT04588883
19-0241

Details and patient eligibility

About

This study seeks to use a group-based microfinance/internal lending model to develop social capital among people with HIV in Kenya. This will create a context to deliver validated curriculum targeting intimate partner violence, positive parenting, agriculture, small business entrepreneurship, group-interpersonal therapy, and other determinants of well-being and ART adherence among people with HIV. The primary outcomes are viral suppression, ART adherence, and common mental disorders.

Full description

It is anticipated that involvement in an internal savings and lending program will create social capital among people with HIV and their guardians (in case of adolescents w HIV). This social capital accrual will be leveraged to support and disseminate social skills (i.e. positive parenting, conflict resolution), economic skills (i.e. entrepreneurship, farming), and health skills (i.e. ART adherence, retention in care to produce viral suppression). The overall outcome is improved social, health, and economic well-being.

Enrollment

843 patients

Sex

All

Ages

13+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Criteria for inclusion of subjects include:

  • testing positive for HIV, confirmed by the Ministry of Health clinics
  • being at or older than 13 years of age
  • initiating care at a qualified Ministry of Health clinic in the catchment area, or intending to initiate care at such a clinic (see below for definition)
  • Any gender, age (13+ years), and comorbid disease states
  • Provide informed consent if adult, emancipated minor or mature minor
  • Provide assent if minor with guardian, who must provide informed consent

Qualified clinical locations include

  • those with accessible and usable public land to convene weekly meetings,
  • no current program targeting families with HIV known to the Ministry of Health

Exclusion criteria

  • Refusal to participate
  • Current participation in a similar program
  • Residing in a location with a similar program targeting patients with HIV
  • Not covered by inclusion criteria.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

843 participants in 1 patient group

Intervention Arm
Experimental group
Description:
Patients, adults and adolescents, will be recruited from patient registries at 7 government operated HIV clinics in Meru County, Kenya. Patients will complete validated questionnaires at baseline, 1.5 year and 3 years into a novel adaptation of a community empowerment program. The program utilizes savings- and internal-lending/group-based microfinance process to facilitate exchange of savings amongst patients and adolescent guardians. A byproduct of this process is the development of social capital, which will be used to facilitate education, peer learning, and collective problem solving to improve determinants of well-being and clinical adherence among participants. Expected outcomes include improved viral suppression, ART adherence, clinical attendance, and mental health.
Treatment:
Behavioral: Kuja Pamoja - HIV

Trial contacts and locations

1

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Central trial contact

Michael Goodman, DrPH

Data sourced from clinicaltrials.gov

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