Mfangano Island Healthy Networks Impact Study (MIHNIS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Organic Health Response
Microclinic International
Kenya Medical Research Institute
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01912521
First received: July 23, 2013
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

This pilot study is a non-randomized controlled cohort study evaluating the impact of social network-based HIV education on antiretroviral therapy (ART) adherence, clinical outcomes, food security, social support, HIV knowledge, and risk behaviors among people living with HIV/AIDS, as well as members of their associated social support networks. The intervention, known as the Mfangano Health Net Microclinic Pilot Program, consists of a 6-month education program on HIV biology, interpersonal communication and community mobilization for both HIV positive individuals and their self-selected social network members selected irrespective of HIV status. Investigators hypothesize that participation in the microclinic program will improve ART adherence, cluster of differentiation 4 (CD4) count, social support, HIV knowledge and food insecurity and will reduce HIV-related stigma, as compared to participants in control communities.


Condition Intervention
HIV
Behavioral: Mfangano Health Net Microclinic Program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mfangano Island Healthy Networks Impact Study

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • ART Adherence [ Time Frame: change from baseline to 6-months ] [ Designated as safety issue: No ]
    biologic (drug levels measured in small hair samples) and self-reported antiretroviral medication adherence (using AIDS Clinical Trials Group adherence questionnaire)


Secondary Outcome Measures:
  • Stigma [ Time Frame: change from baseline to 6-months ] [ Designated as safety issue: No ]
    stigma as measured by Parallel HIV/AIDS Stigma Scale (Attributed Stigma Attitudes)

  • Social support [ Time Frame: change from baseline to 6-months ] [ Designated as safety issue: No ]
    Social support as measured by Duke-University of North Carolina (UNC) Functional Social Support Scale

  • HIV knowledge [ Time Frame: change from baseline to 6-months ] [ Designated as safety issue: No ]
    HIV knowledge as measured by HIV Knowledge Questionnaire ("HIV-KQ-18")

  • Missed appointments [ Time Frame: change from baseline to 6-months ] [ Designated as safety issue: No ]
    adherence to appointments / missed appointments captured in patient chart review

  • CD4 count [ Time Frame: change from baseline to 6-months ] [ Designated as safety issue: No ]
    CD4 count measured by patient chart review

  • Food security [ Time Frame: change from baseline to 6-months ] [ Designated as safety issue: No ]
    Food security measured by Household Food Insecurity Access scale

  • ART adherence 18-month [ Time Frame: change from baseline to 18-months ] [ Designated as safety issue: No ]
    biologic (drug levels measured in small hair samples) and self-reported antiretroviral medication adherence (using AIDS Clinical Trials Group adherence questionnaire)

  • Stigma 18-month [ Time Frame: change from baseline to 18-months ] [ Designated as safety issue: No ]
    stigma as measured by Parallel HIV/AIDS Stigma Scale (Attributed Stigma Attitudes)

  • Social support 18-month [ Time Frame: change from baseline to 18-months ] [ Designated as safety issue: No ]
    Social support as measured by Duke-University of North Carolina (UNC) Functional Social Support Scale

  • HIV knowledge 18-month [ Time Frame: change from baseline to 18-months ] [ Designated as safety issue: No ]
    HIV knowledge as measured by HIV Knowledge Questionnaire ("HIV-KQ-18")

  • Missed appointments 18-month [ Time Frame: change from baseline to 18-months ] [ Designated as safety issue: No ]
    adherence to appointments / missed appointments captured in patient chart review

  • CD4 count 18-month [ Time Frame: change from baseline to 18-months ] [ Designated as safety issue: No ]
    CD4 count measured by patient chart review

  • Food security 18-month [ Time Frame: change from baseline to 18-months ] [ Designated as safety issue: No ]
    Food security measured by Household Food Insecurity Access scale


Enrollment: 883
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
This arm is eligible for participation in the Mfangano Health Net Microclinic Program, a social network-based educational program.
Behavioral: Mfangano Health Net Microclinic Program
Educational program in which HIV positive individuals are invited to recruit their social networks to form 'microclinic' groups. These groups participate in a 6-month educational curriculum composed of information on HIV biology, interpersonal communication strategies and community mobilization. At the conclusion of the program, participants are encouraged to disclose their HIV status to members of their group through a facilitated disclosure process.
No Intervention: Comparison
This arm is not eligible for participation in the intervention. Participants still have access to usual care at the Sena Health Center or their health facility of choice.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV positive patient on ART at Sena Health Center or member of patient's social network
  • Resident of Mfangano Island
  • 18 years of age or older
  • conversant in DhoLuo or English languages

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01912521

Locations
Kenya
Ekialo Kiona Center
Kitawi Beach, Mfangano Island, Nyanza, Kenya
Sponsors and Collaborators
University of California, San Francisco
Organic Health Response
Microclinic International
Kenya Medical Research Institute
Investigators
Principal Investigator: Craig R Cohen, MD University of California, San Francisco
Principal Investigator: Elizabeth Bukusi, MBChB, M.Med Kenya Medical Research Institute
Principal Investigator: Charles R Salmen, MSc, MD Candidate University of California, San Francisco
Principal Investigator: Matthew D Hickey, MD Candidate University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01912521     History of Changes
Other Study ID Numbers: MIHNIS
Study First Received: July 23, 2013
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board
Kenya: Ethical Review Committee

Keywords provided by University of California, San Francisco:
HIV
Stigma
Social support
Social network
Kenya

ClinicalTrials.gov processed this record on April 17, 2014