Strengthening Families Living With HIV in Kenya

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.

Study Overview

• Status: Active, not recruiting
• Conditions: PTSD; Hiv; Adherence, Medication; Depression, Anxiety; ART; Trust
• Intervention / Treatment: Behavioral: Kuja Pamoja - HIV

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.

• Study Type: Interventional
• Enrollment (Actual): 810
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Goodman, DrPH; Phone Number: 7132926588; Email: migoodma@utmb.edu

Study Locations

• Kenya
  • Meru County
    • Maua, Meru County, Kenya
      • Meru County Department of Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention Arm; 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; Information has been provided in the treatment arm description.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Michael L Goodman, DrPH, The University of Texas Medical Branch, Galveston; Study Director: Stanley Gitari, MPH, Sodzo Kenya

Publications and helpful links

General Publications

• 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.
• 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.
• 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 of the Outcomes Committee of the Adult AIDS Clinical Trials Group (AACTG). AIDS Care. 2000 Jun;12(3):255-66. doi: 10.1080/09540120050042891.
• 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.
• 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. Erratum In: Child Abuse Negl 1998 Nov;22(11):1177.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Estimated): February 25, 2025
• Study Completion (Estimated): February 25, 2025

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 19-0241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be made openly available following acceptance for publication of all main analyses.
• IPD Sharing Time Frame: Data will be available following publication of baseline, 1.5 year and 3 year data panels.
• IPD Sharing Access Criteria: Interested researchers must send requests to corresponding author, including study questions, statistical plan for analysis and evidence of competence in performing proposed statistical tests.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No