Mfangano Island Healthy Networks Impact Study

NCT ID: NCT01912521

Last Updated: 2014-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

883 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

This arm is eligible for participation in the Mfangano Health Net Microclinic Program, a social network-based educational program.

Group Type EXPERIMENTAL

Mfangano Health Net Microclinic Program

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organic Health Response

OTHER

Sponsor Role collaborator

Microclinic International

OTHER

Sponsor Role collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Craig R Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Elizabeth Bukusi, MBChB, M.Med

Role: PRINCIPAL_INVESTIGATOR

Kenya Medical Research Institute

Charles R Salmen, MSc, MD Candidate

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Matthew D Hickey, MD Candidate

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Ekialo Kiona Center

Kitawi Beach, Mfangano Island, Nyanza, Kenya

Site Status

Countries

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Kenya

Other Identifiers

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MIHNIS

Identifier Type: -

Identifier Source: org_study_id

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