Clinical trial NCT04588883: Strengthening Families Living With HIV in Kenya
Official title: Strengthening Families Living With HIV in Kenya
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: ART
Hiv
Trust
Depression, Anxiety
PTSD
Adherence, Medication
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 843
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Viral Suppression
timeFrame: Change from baseline to 3 years
measure: Anti-retroviral therapy Adherence
timeFrame: Change from baseline to 3 years
measure: Depression
timeFrame: Change from baseline to 3 years
measure: Anxiety
timeFrame: Change from baseline to 3 years
measure: Post-Traumatic Stress Disorder
timeFrame: Change from baseline to 3 years
Secondary outcomes:
measure: Group entitativity
timeFrame: Change from baseline to 3 years
measure: Intimate partner violence
timeFrame: Change from baseline to 3 years
measure: Food insecurity
timeFrame: Change from baseline to 3 years
measure: Social trust
timeFrame: Change from baseline to 3 years
measure: Expectations of mutual support
timeFrame: Change from baseline to 3 years.
measure: Child-guardian conflict
timeFrame: Change from baseline to 3 years.
Other outcomes:
Locations:
city: Maua
country: Kenya
facility: Meru County Department of Health
state: Meru County
Study officials:
affiliation: The University of Texas Medical Branch, Galveston
name: Michael L Goodman, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Sodzo Kenya
name: Stanley Gitari, MPH
role: STUDY_DIRECTOR
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citation: Straus MA, Hamby SL, Finkelhor D, Moore DW, Runyan D. Identification of child maltreatment with the Parent-Child Conflict Tactics Scales: development and psychometric data for a national sample of American parents. Child Abuse Negl. 1998 Apr;22(4):249-70. doi: 10.1016/s0145-2134(97)00174-9.