Strengthening Families Living With HIV in Kenya

Hiv Clinical Trial

Official title:

Strengthening Families Living With HIV in Kenya

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04588883
• Other study ID #: 19-0241
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: February 25, 2025

Study information

• Verified date: February 2024
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Kuja Pamoja - HIV
Information has been provided in the treatment arm description.

Locations

Country	Name	City	State
Kenya	Meru County Department of Health	Maua	Meru County

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

Kenya, 

References & Publications (7)

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.

Outcome

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.