Hiv Clinical Trial
Official title:
Strengthening Families Living With HIV in Kenya
Verified date | February 2024 |
Source | The University of Texas Medical Branch, Galveston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 810 |
Est. completion date | February 25, 2025 |
Est. primary completion date | February 25, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Kenya | Meru County Department of Health | Maua | Meru County |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston |
Kenya,
Chesney MA, Ickovics JR, Chambers DB, Gifford AL, Neidig J, Zwickl B, Wu AW. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient Care Committee & Adherence Working Group — View Citation
Foa, E. B., Riggs, D. S., Dancu, C. V., & Rothbaum, B. O. (1993). Reliability and validity of a brief instrument for assessing post-traumatic stress disorder. Journal of traumatic stress, 6(4), 459-473.
Gaertner, L., & Schopler, J. (1998). Perceived ingroup entitativity and intergroup bias: An interconnection of self and others. European Journal of Social Psychology, 28(6), 963-980.
Knack, S., and Keefer, P. (1997) Does social capital have an economic payoff? A cross-country investigation. The Quarterly Journal of Economics, 112(4), 1251-1288.
Poortinga W. Social relations or social capital? Individual and community health effects of bonding social capital. Soc Sci Med. 2006 Jul;63(1):255-70. doi: 10.1016/j.socscimed.2005.11.039. Epub 2006 Jan 19. — View 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. — View Citation
Straus, M. A., Hamby, S. L., Boney-McCoy, S., & Sugarman, D. B. (1996). The revised conflict tactics scales (CTS2) development and preliminary psychometric data. Journal of family issues, 17(3), 283-316.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Viral Suppression | Viral suppression is measured as an undetectable viral load using standard clinic procedures. | Change from baseline to 3 years | |
Primary | 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 | |
Primary | Depression | Depression will be measured using the Beck's Depression Inventory. Higher scores mean more depressive symptoms present. | Change from baseline to 3 years | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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. | |
Secondary | 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. |
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