Mfangano Island Healthy Networks Impact Study (MIHNIS)
|ClinicalTrials.gov Identifier: NCT01912521|
Recruitment Status : Completed
First Posted : July 31, 2013
Last Update Posted : July 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Mfangano Health Net Microclinic Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||883 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mfangano Island Healthy Networks Impact Study|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
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.
- Antiretroviral therapy (ART) Adherence [ Time Frame: change from baseline to 6-months ]change in ART drug levels measured in small hair samples from baseline to 6 months
- Disengagement from care [ Time Frame: 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.
- Stigma [ Time Frame: change from baseline to 6-months ]stigma as measured by Parallel HIV/AIDS Stigma Scale (Attributed Stigma Attitudes)
- Social support [ Time Frame: change from baseline to 6-months ]Social support as measured by Duke-University of North Carolina (UNC) Functional Social Support Scale
- HIV knowledge [ Time Frame: change from baseline to 6-months ]HIV knowledge as measured by HIV Knowledge Questionnaire ("HIV-KQ-18")
- Time in care [ Time Frame: 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 [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912521
|Ekialo Kiona Center|
|Kitawi Beach, Mfangano Island, Nyanza, Kenya|
|Principal Investigator:||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|