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Mfangano Island Healthy Networks Impact Study

Mfangano Island Healthy Networks Impact Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01912521
Acronym
MIHNIS
Enrollment
883
Registered
2013-07-31
Start date
2011-11-30
Completion date
2013-12-31
Last updated
2014-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV, Stigma, Social support, Social network, Kenya

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.

Interventions

BEHAVIORALMfangano 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.

Sponsors

Organic Health Response
CollaboratorOTHER
Microclinic International
CollaboratorOTHER
Kenya Medical Research Institute
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Antiretroviral therapy (ART) Adherencechange from baseline to 6-monthschange in ART drug levels measured in small hair samples from baseline to 6 months
Disengagement from careFrom 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

MeasureTime frameDescription
HIV knowledgechange from baseline to 6-monthsHIV knowledge as measured by HIV Knowledge Questionnaire (HIV-KQ-18)
Stigmachange from baseline to 6-monthsstigma as measured by Parallel HIV/AIDS Stigma Scale (Attributed Stigma Attitudes)
ART adherence - end of studychange from baseline to end of study (22 months)change in ART drug levels measured in small hair samples from baseline to end of study
Time in careFrom 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.
Social supportchange from baseline to 6-monthsSocial support as measured by Duke-University of North Carolina (UNC) Functional Social Support Scale

Countries

Kenya

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026