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ARTNCT04588883

Strengthening Families Living With HIV in Kenya

A study testing Kuja Pamoja - HIV in people with ART and Hiv, run by The University of Texas Medical Branch, Galveston at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 13 years and olderHealthy volunteers can take part
Conditions the study is for
ART, Hiv, Trust
What is being tested?
Kuja Pamoja - HIV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
843 participants
Where
1 siteKenya
Study dates
28 Sep 2021to 15 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • Meru County Department of Health

    Maua, Meru County

Other trials in Kenya

About this study

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.

Read the 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.

Being tested
Kuja Pamoja - HIV
Medical subject headings
Acquired Immunodeficiency Syndrome, Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kuja Pamoja - HIVBehavioural

    Information has been provided in the treatment arm description.

Study groups in NCT04588883
Study groupRoleWhat they receive
Intervention ArmExperimentalPatients, 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.
Receives: Behavioral: Kuja Pamoja - HIV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Viral Suppression

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

    Measured: Change from baseline to 3 years

  2. 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.

    Measured: Change from baseline to 3 years

  3. Depression

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

    Measured: Change from baseline to 3 years

  4. Anxiety

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

    Measured: Change from baseline to 3 years

  5. Post-Traumatic Stress Disorder

    Post-traumatic stress disorder (PTSD) will be measured using the PTSD symptom scale. Higher scores mean more PTSD symptoms present.

    Measured: Change from baseline to 3 years

Secondary outcomes (6)

  1. 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.

    Measured: Change from baseline to 3 years

  2. 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.

    Measured: Change from baseline to 3 years

  3. Food insecurity

    Food security will be measured using the Household Food Insecurity Scale instrument. Higher scale scores mean higher food insecurity.

    Measured: Change from baseline to 3 years

  4. 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.

    Measured: Change from baseline to 3 years

  5. 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.

    Measured: Change from baseline to 3 years.

  6. 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.

    Measured: Change from baseline to 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start28 Sep 2021
  3. Primary completion15 Jul 2025
  4. Study completion15 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
843 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04588883
Sponsor's protocol ID
19-0241
Status last verified
Dec 2025
First submitted
15 Sep 2020
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified data will be made openly available following acceptance for publication of all main analyses.

Publications

  • 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.

    PubMed 10928201

  • 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.

  • 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.

    PubMed 16427171

  • 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.

    PubMed 9589178

Questions about this trial

What is this clinical trial studying?

A study testing Kuja Pamoja - HIV in people with ART and Hiv, run by The University of Texas Medical Branch, Galveston at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Viral Suppression (time frame: Change from baseline to 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04588883, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.

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