Mfangano Island Healthy Networks Impact Study (MIHNIS)

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Mfangano Health Net Microclinic Program

• Study Type: Interventional
• Enrollment (Actual): 883
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Nyanza
    • Kitawi Beach, Mfangano Island, Nyanza, Kenya
      • Ekialo Kiona Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiretroviral therapy (ART) Adherence	change in ART drug levels measured in small hair samples from baseline to 6 months	change from baseline to 6-months
Disengagement from care	Incidence of missing a clinic appointment by ≥90 days without having first transferred care to another clinic or died.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stigma	stigma as measured by Parallel HIV/AIDS Stigma Scale (Attributed Stigma Attitudes)	change from baseline to 6-months
Social support	Social support as measured by Duke-University of North Carolina (UNC) Functional Social Support Scale	change from baseline to 6-months
HIV knowledge	HIV knowledge as measured by HIV Knowledge Questionnaire ("HIV-KQ-18")	change from baseline to 6-months
Time in care	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.	From time of study enrollment until study closure (22 months) or censorship (death or transfer of care to facility outside study area)
ART adherence - end of study	change in ART drug levels measured in small hair samples from baseline to end of study	change from baseline to end of study (22 months)

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Kenya Medical Research Institute; Organic Health Response; Microclinic International
• Investigators: Principal Investigator: Elizabeth Bukusi, MBChB, M.Med, Kenya Medical Research Institute; Principal Investigator: Matthew D Hickey, MD Candidate, University of California, San Francisco; Principal Investigator: Charles R Salmen, MSc, MD Candidate, University of California, San Francisco; Principal Investigator: Craig R Cohen, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 23, 2013
• First Submitted That Met QC Criteria: July 29, 2013
• First Posted (Estimate): July 31, 2013

Study Record Updates

• Last Update Posted (Estimate): July 30, 2014
• Last Update Submitted That Met QC Criteria: July 29, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: HIV; Kenya; Stigma; Social network; Social support
• Other Study ID Numbers: MIHNIS