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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kuja Pamoja - HIV | Behavioral | Information has been provided in the treatment arm description. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Criteria for inclusion of subjects include:
Qualified clinical locations include
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael L Goodman, DrPH | The University of Texas Medical Branch, Galveston | Principal Investigator |
| Stanley Gitari, MPH | Sodzo Kenya | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meru County Department of Health | Maua | Meru County | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 10928201 | 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. | |
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Deidentified data will be made openly available following acceptance for publication of all main analyses.
Data will be available following publication of baseline, 1.5 year and 3 year data panels.
Interested researchers must send requests to corresponding author, including study questions, statistical plan for analysis and evidence of competence in performing proposed statistical tests.
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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. |
| 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. |
| 16427171 | 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. |
| 9589178 | 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. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |