Mfangano Island Healthy Networks Impact Study

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Mfangano Health Net Microclinic Program

• Registration Number: NCT01912521
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-31
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 883

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

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Exclusion Criteria

• none

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Antiretroviral therapy (ART) Adherence	change from baseline to 6-months	change in ART drug levels measured in small hair samples from baseline to 6 months
Disengagement from care	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

Name	Time	Method
Social support	change from baseline to 6-months	Social support as measured by Duke-University of North Carolina (UNC) Functional Social Support Scale
HIV knowledge	change from baseline to 6-months	HIV knowledge as measured by HIV Knowledge Questionnaire ("HIV-KQ-18")
Time in care	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	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
Stigma	change from baseline to 6-months	stigma as measured by Parallel HIV/AIDS Stigma Scale (Attributed Stigma Attitudes)

Trial Locations

Locations (1)

Ekialo Kiona Center; 🇰🇪 Kitawi Beach, Mfangano Island, Nyanza, Kenya