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Mfangano Island Healthy Networks Impact Study (MIHNIS)

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ClinicalTrials.gov Identifier: NCT01912521
Recruitment Status : Completed
First Posted : July 31, 2013
Last Update Posted : July 30, 2014
Sponsor:
Collaborators:
Organic Health Response
Microclinic International
Kenya Medical Research Institute
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV Behavioral: Mfangano Health Net Microclinic Program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 883 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mfangano Island Healthy Networks Impact Study
Study Start Date : November 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Antiretroviral therapy (ART) Adherence [ Time Frame: change from baseline to 6-months ]
    change in ART drug levels measured in small hair samples from baseline to 6 months

  2. Disengagement from care [ Time Frame: From time of study enrollment to first instance of 90-day gap in care, censorship (death, transfer outside study area) or end of study (up to 22 months) ]
    Incidence of missing a clinic appointment by ≥90 days without having first transferred care to another clinic or died.


Secondary Outcome Measures :
  1. Stigma [ Time Frame: change from baseline to 6-months ]
    stigma as measured by Parallel HIV/AIDS Stigma Scale (Attributed Stigma Attitudes)

  2. Social support [ Time Frame: change from baseline to 6-months ]
    Social support as measured by Duke-University of North Carolina (UNC) Functional Social Support Scale

  3. HIV knowledge [ Time Frame: change from baseline to 6-months ]
    HIV knowledge as measured by HIV Knowledge Questionnaire ("HIV-KQ-18")

  4. Time in care [ Time Frame: From time of study enrollment until study closure (22 months) or censorship (death or transfer of care to facility outside study area) ]
    Proportion of time eligible for HIV care that patient is adherent to clinic appointment schedules. Calculated by subtracting the sum of all gaps in care from the total time eligible for care, and dividing by total time eligible for care. Gaps in care are defined as the number of days between a missed appointment and subsequent return to any clinic in the study area to access HIV care.

  5. ART adherence - end of study [ Time Frame: change from baseline to end of study (22 months) ]
    change in ART drug levels measured in small hair samples from baseline to end of study


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01912521     History of Changes
Other Study ID Numbers: MIHNIS
First Posted: July 31, 2013    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014

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