Adherence, Medication, ART, Depression, Anxiety, Hiv, PTSD, Trust
Conditions
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.
Interventions
BEHAVIORALKuja Pamoja - HIV
Information has been provided in the treatment arm description.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Suppression | Change from baseline to 3 years | Viral suppression is measured as an undetectable viral load using standard clinic procedures. |
| Anti-retroviral therapy Adherence | Change from baseline to 3 years | 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. |
| Depression | Change from baseline to 3 years | Depression will be measured using the Beck's Depression Inventory. Higher scores mean more depressive symptoms present. |
| Anxiety | Change from baseline to 3 years | Anxiety will be measured using the Generalized Anxiety Disorder (GAD7) instrument. Higher score means more anxiety symptoms present. |
| Post-Traumatic Stress Disorder | Change from baseline to 3 years | Post-traumatic stress disorder (PTSD) will be measured using the PTSD symptom scale. Higher scores mean more PTSD symptoms present. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Group entitativity | Change from baseline to 3 years | 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. |
| Child-guardian conflict | Change from baseline to 3 years. | 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. |
| Intimate partner violence | Change from baseline to 3 years | 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. |
| Food insecurity | Change from baseline to 3 years | Food security will be measured using the Household Food Insecurity Scale instrument. Higher scale scores mean higher food insecurity. |
| Social trust | Change from baseline to 3 years | 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. |
| Expectations of mutual support | Change from baseline to 3 years. | 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. |
Countries
Kenya
Outcome results
None listed