Strengthening Families Living With HIV in Kenya

Study Overview
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Brief Summary
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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
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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.

Official Title
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Strengthening Families Living With HIV in Kenya

Conditions
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ART, Hiv, Trust, Depression, Anxiety, PTSD, Adherence, Medication

Intervention / Treatment
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* Behavioral: Kuja Pamoja - HIV


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>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. | Behavioral: Kuja Pamoja - HIV<br>* Information has been provided in the treatment arm description.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Suppression | Viral suppression is measured as an undetectable viral load using standard clinic procedures. | Change from baseline to 3 years | 
| Anti-retroviral therapy Adherence | Anti-retroviral therapy (ART) adherence will be measured by patient report using the adherence portions of the AIDS Clinical Trial Group (ACTG) Adherence tool and by refill history. | Change from baseline to 3 years | 
| Depression | Depression will be measured using the Beck's Depression Inventory. Higher scores mean more depressive symptoms present. | Change from baseline to 3 years | 
| Anxiety | Anxiety will be measured using the Generalized Anxiety Disorder (GAD7) instrument. Higher score means more anxiety symptoms present. | Change from baseline to 3 years | 
| Post-Traumatic Stress Disorder | Post-traumatic stress disorder (PTSD) will be measured using the PTSD symptom scale. Higher scores mean more PTSD symptoms present. | Change from baseline to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group entitativity | Social cohesion (operationalized as group entitativity) will be measured using the Generalized Entitativity Measure (GEM). Higher score on this visual analogue scale means higher group entitativity. | Change from baseline to 3 years | 
| Intimate partner violence | Family violence will be measured using the Conflict Tactics Scale (CTS-2). Higher scale scores mean more conflict present; higher violence/coercive subscale scores mean more violence and coercion present. | Change from baseline to 3 years | 
| Food insecurity | Food security will be measured using the Household Food Insecurity Scale instrument. Higher scale scores mean higher food insecurity. | Change from baseline to 3 years | 
| Social trust | Social trust will be measured using a single validated item. This is a binary outcome with 1=presence of trust between respondent and other similar aged people with HIV. | Change from baseline to 3 years | 
| Expectations of mutual support | Expectation of mutual support will be measured using the a single validated item. Higher score means higher expectation of mutual support between respondent and other similar-aged people with HIV. | Change from baseline to 3 years. | 
| Child-guardian conflict | Child-guardian conflict will be measured using the Conflict Tactics Scale for children (CTS2-pc). Higher scale score means more conflict present; higher violence subscale scores mean more violent conflicts used. | Change from baseline to 3 years. |