Mfangano Island Healthy Networks Impact Study (MIHNIS)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01912521

First Posted: July 31, 2013

Last Update Posted: July 30, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Organic Health Response

Microclinic International

Kenya Medical Research Institute

Information provided by (Responsible Party):

University of California, San Francisco

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 Intervention Model: Single Group Assignment Masking: None (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 ]
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) ]
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 ]
stigma as measured by Parallel HIV/AIDS Stigma Scale (Attributed Stigma Attitudes)
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
HIV knowledge [ Time Frame: change from baseline to 6-months ]
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) ]
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) ]
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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


Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01912521 History of Changes
Other Study ID Numbers:	MIHNIS
First Submitted:	July 23, 2013
First Posted:	July 31, 2013
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

To Top