Mfangano Island Healthy Networks Impact Study (MIHNIS)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Mfangano Island Healthy Networks Impact Study|
- Antiretroviral therapy (ART) Adherence [ Time Frame: change from baseline to 6-months ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]stigma as measured by Parallel HIV/AIDS Stigma Scale (Attributed Stigma Attitudes)
- Social support [ Time Frame: change from baseline to 6-months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]change in ART drug levels measured in small hair samples from baseline to end of study
|Study Start Date:||November 2011|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|