Mfangano Island Healthy Networks Impact Study | NCT01912521 | Trialant

Mfangano Island Healthy Networks Impact Study | NCT01912521 | Trialant

Sponsor/Collaborators Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	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
Comparison	No Intervention	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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mfangano Health Net Microclinic Program	Behavioral	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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
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	Principal Investigator