<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04417127</url>
  </required_header>
  <id_info>
    <org_study_id>R01MH118075</org_study_id>
    <secondary_id>R01MH118075</secondary_id>
    <nct_id>NCT04417127</nct_id>
  </id_info>
  <brief_title>Harambee: Integrated Community-based HIV/NCD Care &amp; Microfinance Groups in Kenya</brief_title>
  <official_title>Harambee: Integrated Community-based HIV/NCD Care &amp; Microfinance Groups in Kenya</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Moi University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Purdue University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Academic Model Providing Access to Healthcare (AMPATH)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Brown University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this project is to demonstrate the effectiveness and longer-term&#xD;
      sustainability of a differentiated care delivery model for improving HIV treatment outcomes.&#xD;
      The central hypothesis is that the integration of community-based HIV and NCD care with group&#xD;
      microfinance will improve retention in care and rates of viral suppression (VS) among people&#xD;
      living with HIV (PLHIV) in Kenya via two mechanisms: improved household economic status and&#xD;
      easier access to care.&#xD;
&#xD;
      The specific aims are as follows:&#xD;
&#xD;
        1. To evaluate the extent to which integrated community-based HIV care with group&#xD;
           microfinance affects retention in care and VS among n=900 PLHIV in rural western Kenya&#xD;
           using a cluster randomized intervention design of n=40 existing (fully HIV+)&#xD;
           microfinance groups to receive either: (A) integrated community-based HIV and NCD care&#xD;
           or (B) standard care. Data from the two trial arms will be augmented with a matched&#xD;
           contemporaneous control group of n=300 patients receiving standard care and not involved&#xD;
           in microfinance (group C), comparing outcomes in groups A, B and C. The hypothesize is&#xD;
           that A &gt; B &gt; C in terms of viral suppression and retention in care.&#xD;
&#xD;
        2. To identify specific mechanisms through which microfinance and integrated&#xD;
           community-based care impact VS. Using a mixed methods approach, the study will&#xD;
           characterize the mechanisms of effect on patient outcomes. Investigators will conduct&#xD;
           quantitative mediation analysis to examine two main mediating pathways (household&#xD;
           economic conditions and easier access to care), as well as exploratory mechanisms (food&#xD;
           security, social support, HIV- related stigma). Investigators will also use qualitative&#xD;
           methods and multi-stakeholder panels to contextualize implementation of the&#xD;
           intervention.&#xD;
&#xD;
        3. To assess the cost-effectiveness of microfinance and integrated community-based care&#xD;
           delivery to maximize future policy and practice relevance of this promising intervention&#xD;
           strategy. The working hypothesis is that the differentiated model will be cost-effective&#xD;
           in terms of cost per HIV suppressed person-time, cost per patient retained in care, and&#xD;
           cost per disability-adjusted life year saved.&#xD;
&#xD;
      The main expected outcomes will be rigorous evidence of effectiveness, mechanisms and&#xD;
      cost-effectiveness of a differentiated model for achieving the last key step in the HIV care&#xD;
      continuum. These results are expected to have an important positive impact in terms of&#xD;
      improved, high-quality services that address known individual and structural barriers to care&#xD;
      and promote long-term sustainability of care for PLHIV in rural settings with high HIV&#xD;
      prevalence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 26, 2020</start_date>
  <completion_date type="Anticipated">April 24, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 24, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Aim 1: Cluster randomized trial where 40 existing microfinance (MF) groups with n=900 members are randomized in a 1:1 ratio to receive either integrated community-based care (ICB) (Study Arm A) or standard care (Study Arm B). The ICB intervention will be delivered during regular MF group meetings monthly during trial months 1-6 and quarterly during months 7-18. The intervention will include (1) clinical teams visits with vital signs screening, consultations, medication distribution (ART and other chronic/acute medications), POC laboratory testing (creatinine, blood glucose, hemoglobin A1C, viral load); (2) peer support; (3) referrals to facilities as needed. Members of MF groups randomized to Study Arm B will continue to receive care at an AMPATH facility. Study Arm C will include n=300 participants who receive standard care at an AMPATH facility and are not involved in MF. Aim 2: Mediation analyses with n=50 trial participants. Aim 3: Cost-effectiveness analyses with n=5 budget staff.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Viral Suppression</measure>
    <time_frame>Between baseline and 18 months</time_frame>
    <description>HIV viral load less than 400 copies/mL at 18 months as compared to baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retention in Care</measure>
    <time_frame>Between baseline and 18 months</time_frame>
    <description>Proportion of scheduled visits that were attended during the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Systolic Blood Pressure (SBP)</measure>
    <time_frame>Between baseline and 18 months</time_frame>
    <description>Change in systolic blood pressure at 18 months as compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glycated hemoglobin (HbA1c)</measure>
    <time_frame>Between baseline and 18 months</time_frame>
    <description>Change in HbA1c level at 18 months as compared to baseline</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">1215</enrollment>
  <condition>HIV/AIDS</condition>
  <condition>Noncommunicable Diseases</condition>
  <condition>Hypertension</condition>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Microfinance with Integrated Community-based Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 microfinance groups with n=450 participants will be randomized to receive the ICB intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Microfinance with Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 microfinance groups with n=450 participants will be randomized to continue to receive standard of care from an AMPATH-supported rural health facility.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care without Microfinance</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>n=300 participants who receive care at an AMPATH health facility and who are not involved in microfinance will serve as matched contemporaneous controls. These participants will be actively followed over the 18-months of the trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Integrated Community-Based (ICB) Care</intervention_name>
    <description>The intervention will include the following components: (1) integrated care visits by clinical team occurring monthly during months 1-6 of the trial, and then quarterly for the remaining months (7-18), which include vital signs screening, consultation with a clinical officer, medication distribution (ART and other chronic and acute medications), and point- of-care (POC) laboratory testing (creatinine, blood glucose and hemoglobin A1C, and viral load as it becomes available); (2) peer support for promoting ART adherence during every monthly MF meeting; (3) referrals to facilities for emergency or acute care needs that are not feasible to address in the community. Integrated care refers to delivery of primary, HIV and NCD-related care, incorporating a focus on both chronic and acute needs.</description>
    <arm_group_label>Microfinance with Integrated Community-based Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Microfinance</intervention_name>
    <description>Group microfinance uses a client-driven model that involves community savings groups where members mobilize and manage their own savings, provide interest-bearing loans to group members, offer a limited form of financial insurance, and contribute to a social fund that is used for income-generating activities and in cases of emergency or welfare issues of group members.&#xD;
For this study, group microfinance will refer to existing, active AMPATH Group Integrated Savings for Empowerment (GISE) microfinance groups with a majority of group members who are AMPATH HIV patients and have disclosed their HIV status. Groups will be considered active if the group was formed at least 6 months prior to study baseline, is consistently meeting as scheduled, and is actively engaging in saving and loaning.</description>
    <arm_group_label>Microfinance with Integrated Community-based Care</arm_group_label>
    <arm_group_label>Microfinance with Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older at study baseline&#xD;
&#xD;
          -  HIV-positive&#xD;
&#xD;
          -  Have received any care through AMPATH since 2010&#xD;
&#xD;
          -  Initiated ART at least 6 months prior to study baseline&#xD;
&#xD;
          -  Have participated in at least one microfinance group meeting in the prior 12 months at&#xD;
             study baseline (for Study Arms A &amp; B)&#xD;
&#xD;
          -  Willing and able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently participating in the BIGPIC study&#xD;
&#xD;
          -  Unable to provide informed consent for participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Moi University/ Moi Teaching and Referral Hospital</name>
      <address>
        <city>Eldoret</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <reference>
    <citation>Kafu C, Wachira J, Omodi V, Said J, Pastakia SD, Tran DN, Onyango JA, Aburi D, Wilson-Barthes M, Galarraga O, Genberg BL. Integrating community-based HIV and non-communicable disease care with microfinance groups: a feasibility study in Western Kenya. Pilot Feasibility Stud. 2022 Dec 28;8(1):266. doi: 10.1186/s40814-022-01218-6.</citation>
    <PMID>36578093</PMID>
  </reference>
  <reference>
    <citation>Genberg BL, Wilson-Barthes MG, Omodi V, Hogan JW, Steingrimsson J, Wachira J, Pastakia S, Tran DN, Kiragu ZW, Ruhl LJ, Rosenberg M, Kimaiyo S, Galarraga O. Microfinance, retention in care, and mortality among patients enrolled in HIV care in East Africa. AIDS. 2021 Oct 1;35(12):1997-2005. doi: 10.1097/QAD.0000000000002987.</citation>
    <PMID>34115646</PMID>
  </reference>
  <reference>
    <citation>Genberg BL, Wachira J, Steingrimsson JA, Pastakia S, Tran DNT, Said JA, Braitstein P, Hogan JW, Vedanthan R, Goodrich S, Kafu C, Wilson-Barthes M, Galarraga O. Integrated community-based HIV and non-communicable disease care within microfinance groups in Kenya: study protocol for the Harambee cluster randomised trial. BMJ Open. 2021 May 18;11(5):e042662. doi: 10.1136/bmjopen-2020-042662.</citation>
    <PMID>34006540</PMID>
  </reference>
  <reference>
    <citation>Tran DN, Ching J, Kafu C, Wachira J, Koros H, Venkataramani M, Said J, Pastakia SD, Galarraga O, Genberg BL. Interruptions to HIV Care Delivery During Pandemics and Natural Disasters: A Qualitative Study of Challenges and Opportunities From Frontline Healthcare Providers in Western Kenya. J Int Assoc Provid AIDS Care. 2023 Jan-Dec;22:23259582231152041. doi: 10.1177/23259582231152041.</citation>
    <PMID>36718505</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brown University</investigator_affiliation>
    <investigator_full_name>Omar Galarraga, PhD</investigator_full_name>
    <investigator_title>ASSOCIATE PROFESSOR</investigator_title>
  </responsible_party>
  <keyword>HIV, Noncommunicable Diseases, microfinance, differentiated care, mobile care, telemedicine, task-shifting</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Noncommunicable Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Materials generated under this project will be disseminated according to University and NIH policies regarding data sharing. Aggregate-level data collected in this collaboration will ultimately be available for public use. Opportunities for secondary analyses will be available following completion of the three-year project and publication of the main study findings. These findings will be available to the public through scientific meetings and peer-reviewed journals, as well as through a structured policy dissemination process.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04417127
org study id: R01MH118075
secondary id: R01MH118075
nct id: NCT04417127
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this project is to demonstrate the effectiveness and longer-term
      sustainability of a differentiated care delivery model for improving HIV treatment outcomes.
      The central hypothesis is that the integration of community-based HIV and NCD care with group
      microfinance will improve retention in care and rates of viral suppression (VS) among people
      living with HIV (PLHIV) in Kenya via two mechanisms: improved household economic status and
      easier access to care.

      The specific aims are as follows:

        1. To evaluate the extent to which integrated community-based HIV care with group
           microfinance affects retention in care and VS among n=900 PLHIV in rural western Kenya
           using a cluster randomized intervention design of n=40 existing (fully HIV+)
           microfinance groups to receive either: (A) integrated community-based HIV and NCD care
           or (B) standard care. Data from the two trial arms will be augmented with a matched
           contemporaneous control group of n=300 patients receiving standard care and not involved
           in microfinance (group C), comparing outcomes in groups A, B and C. The hypothesize is
           that A > B > C in terms of viral suppression and retention in care.

        2. To identify specific mechanisms through which microfinance and integrated
           community-based care impact VS. Using a mixed methods approach, the study will
           characterize the mechanisms of effect on patient outcomes. Investigators will conduct
           quantitative mediation analysis to examine two main mediating pathways (household
           economic conditions and easier access to care), as well as exploratory mechanisms (food
           security, social support, HIV- related stigma). Investigators will also use qualitative
           methods and multi-stakeholder panels to contextualize implementation of the
           intervention.

        3. To assess the cost-effectiveness of microfinance and integrated community-based care
           delivery to maximize future policy and practice relevance of this promising intervention
           strategy. The working hypothesis is that the differentiated model will be cost-effective
           in terms of cost per HIV suppressed person-time, cost per patient retained in care, and
           cost per disability-adjusted life year saved.

      The main expected outcomes will be rigorous evidence of effectiveness, mechanisms and
      cost-effectiveness of a differentiated model for achieving the last key step in the HIV care
      continuum. These results are expected to have an important positive impact in terms of
      improved, high-quality services that address known individual and structural barriers to care
      and promote long-term sustainability of care for PLHIV in rural settings with high HIV
      prevalence.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Aim 1: Cluster randomized trial where 40 existing microfinance (MF) groups with n=900 members are randomized in a 1:1 ratio to receive either integrated community-based care (ICB) (Study Arm A) or standard care (Study Arm B). The ICB intervention will be delivered during regular MF group meetings monthly during trial months 1-6 and quarterly during months 7-18. The intervention will include (1) clinical teams visits with vital signs screening, consultations, medication distribution (ART and other chronic/acute medications), POC laboratory testing (creatinine, blood glucose, hemoglobin A1C, viral load); (2) peer support; (3) referrals to facilities as needed. Members of MF groups randomized to Study Arm B will continue to receive care at an AMPATH facility. Study Arm C will include n=300 participants who receive standard care at an AMPATH facility and are not involved in MF. Aim 2: Mediation analyses with n=50 trial participants. Aim 3: Cost-effectiveness analyses with n=5 budget staff.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Viral Suppression
time frame: Between baseline and 18 months
description: HIV viral load less than 400 copies/mL at 18 months as compared to baseline
measure: Retention in Care
time frame: Between baseline and 18 months
description: Proportion of scheduled visits that were attended during the study period
measure: Change in Systolic Blood Pressure (SBP)
time frame: Between baseline and 18 months
description: Change in systolic blood pressure at 18 months as compared to baseline
measure: Change in glycated hemoglobin (HbA1c)
time frame: Between baseline and 18 months
description: Change in HbA1c level at 18 months as compared to baseline
arm group label: Microfinance with Integrated Community-based Care
arm group type: Experimental
description: 20 microfinance groups with n=450 participants will be randomized to receive the ICB intervention.
arm group label: Microfinance with Standard of Care
arm group type: Active Comparator
description: 20 microfinance groups with n=450 participants will be randomized to continue to receive standard of care from an AMPATH-supported rural health facility.
arm group label: Standard of Care without Microfinance
arm group type: No Intervention
description: n=300 participants who receive care at an AMPATH health facility and who are not involved in microfinance will serve as matched contemporaneous controls. These participants will be actively followed over the 18-months of the trial.
intervention type: Other
intervention name: Integrated Community-Based (ICB) Care
description: The intervention will include the following components: (1) integrated care visits by clinical team occurring monthly during months 1-6 of the trial, and then quarterly for the remaining months (7-18), which include vital signs screening, consultation with a clinical officer, medication distribution (ART and other chronic and acute medications), and point- of-care (POC) laboratory testing (creatinine, blood glucose and hemoglobin A1C, and viral load as it becomes available); (2) peer support for promoting ART adherence during every monthly MF meeting; (3) referrals to facilities for emergency or acute care needs that are not feasible to address in the community. Integrated care refers to delivery of primary, HIV and NCD-related care, incorporating a focus on both chronic and acute needs.
arm group label: Microfinance with Integrated Community-based Care
intervention type: Other
intervention name: Microfinance
description: Group microfinance uses a client-driven model that involves community savings groups where members mobilize and manage their own savings, provide interest-bearing loans to group members, offer a limited form of financial insurance, and contribute to a social fund that is used for income-generating activities and in cases of emergency or welfare issues of group members.
For this study, group microfinance will refer to existing, active AMPATH Group Integrated Savings for Empowerment (GISE) microfinance groups with a majority of group members who are AMPATH HIV patients and have disclosed their HIV status. Groups will be considered active if the group was formed at least 6 months prior to study baseline, is consistently meeting as scheduled, and is actively engaging in saving and loaning.
arm group label: Microfinance with Integrated Community-based Care
arm group label: Microfinance with Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Kenya
citation: Kafu C, Wachira J, Omodi V, Said J, Pastakia SD, Tran DN, Onyango JA, Aburi D, Wilson-Barthes M, Galarraga O, Genberg BL. Integrating community-based HIV and non-communicable disease care with microfinance groups: a feasibility study in Western Kenya. Pilot Feasibility Stud. 2022 Dec 28;8(1):266. doi: 10.1186/s40814-022-01218-6.
PMID: 36578093
citation: Genberg BL, Wilson-Barthes MG, Omodi V, Hogan JW, Steingrimsson J, Wachira J, Pastakia S, Tran DN, Kiragu ZW, Ruhl LJ, Rosenberg M, Kimaiyo S, Galarraga O. Microfinance, retention in care, and mortality among patients enrolled in HIV care in East Africa. AIDS. 2021 Oct 1;35(12):1997-2005. doi: 10.1097/QAD.0000000000002987.
PMID: 34115646
citation: Genberg BL, Wachira J, Steingrimsson JA, Pastakia S, Tran DNT, Said JA, Braitstein P, Hogan JW, Vedanthan R, Goodrich S, Kafu C, Wilson-Barthes M, Galarraga O. Integrated community-based HIV and non-communicable disease care within microfinance groups in Kenya: study protocol for the Harambee cluster randomised trial. BMJ Open. 2021 May 18;11(5):e042662. doi: 10.1136/bmjopen-2020-042662.
PMID: 34006540
citation: Tran DN, Ching J, Kafu C, Wachira J, Koros H, Venkataramani M, Said J, Pastakia SD, Galarraga O, Genberg BL. Interruptions to HIV Care Delivery During Pandemics and Natural Disasters: A Qualitative Study of Challenges and Opportunities From Frontline Healthcare Providers in Western Kenya. J Int Assoc Provid AIDS Care. 2023 Jan-Dec;22:23259582231152041. doi: 10.1177/23259582231152041.
PMID: 36718505
responsible party type: Principal Investigator
investigator affiliation: Brown University
investigator full name: Omar Galarraga, PhD
investigator title: ASSOCIATE PROFESSOR
mesh term: Noncommunicable Diseases
sharing ipd: No
ipd description: Materials generated under this project will be disseminated according to University and NIH policies regarding data sharing. Aggregate-level data collected in this collaboration will ultimately be available for public use. Opportunities for secondary analyses will be available following completion of the three-year project and publication of the main study findings. These findings will be available to the public through scientific meetings and peer-reviewed journals, as well as through a structured policy dissemination process.