Mfangano Island Healthy Networks Impact Study

Study Overview
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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.

Official Title
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Mfangano Island Healthy Networks Impact Study

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Mfangano Health Net Microclinic Program


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| No Intervention: Comparison<br>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?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Stigma, Social support, Social network, Kenya