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Strengthening Families Living With HIV in Kenya

Primary Purpose

ART, Hiv, Trust

Status

Recruiting

Phase

Not Applicable

Locations

Kenya

Study Type

Interventional

Intervention

Kuja Pamoja - HIV

About this trial

This is an interventional supportive care trial for ART

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Meru County Department of HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Viral Suppression

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

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.

Depression

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

Anxiety

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

Post-Traumatic Stress Disorder

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

Secondary Outcome Measures

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.

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.

Food insecurity

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

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.

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.

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.

Full Information

NCT ID

NCT04588883

First Posted

September 15, 2020

Last Updated

January 25, 2023

Sponsor

The University of Texas Medical Branch, Galveston

1. Study Identification

Unique Protocol Identification Number

NCT04588883

Brief Title

Strengthening Families Living With HIV in Kenya

Official Title

Strengthening Families Living With HIV in Kenya

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 28, 2021 (Actual)

Primary Completion Date

February 25, 2025 (Anticipated)

Study Completion Date

February 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Medical Branch, Galveston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

810 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Arm

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Kuja Pamoja - HIV

Intervention Description

Information has been provided in the treatment arm description.

Primary Outcome Measure Information:

Title

Viral Suppression

Description

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

Time Frame

Change from baseline to 3 years

Title

Anti-retroviral therapy Adherence

Description

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.

Time Frame

Change from baseline to 3 years

Title

Depression

Description

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

Time Frame

Change from baseline to 3 years

Title

Anxiety

Description

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

Time Frame

Change from baseline to 3 years

Title

Post-Traumatic Stress Disorder

Description

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

Time Frame

Change from baseline to 3 years

Secondary Outcome Measure Information:

Title

Group entitativity

Description

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.

Time Frame

Change from baseline to 3 years

Title

Intimate partner violence

Description

Time Frame

Change from baseline to 3 years

Title

Food insecurity

Description

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

Time Frame

Change from baseline to 3 years

Title

Social trust

Description

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.

Time Frame

Change from baseline to 3 years

Title

Expectations of mutual support

Description

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.

Time Frame

Change from baseline to 3 years.

Title

Child-guardian conflict

Description

Time Frame

Change from baseline to 3 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Goodman, DrPH

Phone

7132926588

migoodma@utmb.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael L Goodman, DrPH

Organizational Affiliation

The University of Texas Medical Branch, Galveston

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stanley Gitari, MPH

Organizational Affiliation

Sodzo Kenya

Official's Role

Study Director

Facility Information:

Facility Name

Meru County Department of Health

City

Maua

State/Province

Meru County

Country

Kenya

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stanley Gitari, MPH

Phone

+254719264322

sg0719264322@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

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.

Results Reference

result

Citation

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.

Results Reference

result

PubMed Identifier

10928201

Citation

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.

Results Reference

result

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.

Results Reference

result

Citation

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.

Results Reference

result

PubMed Identifier

16427171

Citation

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.

Results Reference

result

PubMed Identifier

9589178

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. doi: 10.1016/s0145-2134(97)00174-9. Erratum In: Child Abuse Negl 1998 Nov;22(11):1177.

Results Reference

result

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Strengthening Families Living With HIV in Kenya

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