Mfangano Island Healthy Networks Impact Study (MIHNIS)

This study has been completed.

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, 2014

Last verified: July 2014

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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

Primary Outcome Measures:

Antiretroviral therapy (ART) Adherence [ Time Frame: change from baseline to 6-months ] [ Designated as safety issue: No ]
change in ART drug levels measured in small hair samples from baseline to 6 months
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) ] [ Designated as safety issue: No ]
Incidence of missing a clinic appointment by ≥90 days without having first transferred care to another clinic or died.

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")
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) ] [ Designated as safety issue: No ]
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.
ART adherence - end of study [ Time Frame: change from baseline to end of study (22 months) ] [ Designated as safety issue: No ]
change in ART drug levels measured in small hair samples from baseline to end of study


Enrollment:	883
Study Start Date:	November 2011
Study Completion Date:	December 2013
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.

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 (Adult, Senior)
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:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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, 2014
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 September 29, 2016

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