Strengthening Families Living With HIV in Kenya

NCT04588883 | Completed

• 1 other identifier: 19-0241
• Study Type: interventional
• Target: 843
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Group entitativity

  Change from baseline to 3 years

• Intimate partner violence

  Change from baseline to 3 years

• Food insecurity

  Change from baseline to 3 years

• Social trust

  Change from baseline to 3 years

• Expectations of mutual support

  Change from baseline to 3 years.

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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

Interventions

Kuja Pamoja - HIV BEHAVIORAL

Information has been provided in the treatment arm description.

Intervention Arm

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Refusal to participate
• Current participation in a similar program
• Residing in a location with a similar program targeting patients with HIV

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

Meru County Department of Health

Maua, Meru County, Kenya

Location

Related Publications (7)

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 10928201 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 16427171 RESULT

• 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.

  PMID: 9589178 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic; Medication Adherence

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Michael L Goodman, DrPH

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

• Stanley Gitari, MPH

  Sodzo Kenya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 19, 2020
• Study Start: September 28, 2021
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Data will be available following publication of baseline, 1.5 year and 3 year data panels.
• 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.

Locations

KE (1)