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Completed

NCT Number: NCT04588883

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.

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Key information

Conditions

ART Acquired Immunodeficiency Syndrome Adherence, Medication Anxiety Disorders Behavior Behavioral Symptoms Blood-Borne Infections Communicable Diseases Depression Depression, Anxiety Genital Diseases HIV HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Medication Adherence Mental Disorders PTSD Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Treatment Adherence and Compliance Trust Urogenital Diseases Virus Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meru County Department of Health

Maua, Meru County, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kuja Pamoja - HIV

Behavioral

Information has been provided in the treatment arm description.

Primary outcomes

  1. Viral Suppression

    Time frame: Change from baseline to 3 years

    Viral suppression is measured as an undetectable viral load using standard clinic procedures.

  2. Anti-retroviral therapy Adherence

    Time frame: 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.

  3. Depression

    Time frame: Change from baseline to 3 years

    Depression will be measured using the Beck's Depression Inventory. Higher scores mean more depressive symptoms present.

  4. Anxiety

    Time frame: Change from baseline to 3 years

    Anxiety will be measured using the Generalized Anxiety Disorder (GAD7) instrument. Higher score means more anxiety symptoms present.

  5. Post-Traumatic Stress Disorder

    Time frame: 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 outcomes

  1. Group entitativity

    Time frame: 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.

  2. Intimate partner violence

    Time frame: 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.

  3. Food insecurity

    Time frame: 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.

  4. Social trust

    Time frame: 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.

  5. Expectations of mutual support

    Time frame: 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.

  6. Child-guardian conflict

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 19, 2020
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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