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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
883
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.
Ekialo Kiona Center
Kitawi Beach, Mfangano Island, Nyanza, Kenya
Antiretroviral therapy (ART) Adherence
change in ART drug levels measured in small hair samples from baseline to 6 months
Time frame: 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.
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)
Stigma
stigma as measured by Parallel HIV/AIDS Stigma Scale (Attributed Stigma Attitudes)
Time frame: change from baseline to 6-months
Social support
Social support as measured by Duke-University of North Carolina (UNC) Functional Social Support Scale
Time frame: change from baseline to 6-months
HIV knowledge
HIV knowledge as measured by HIV Knowledge Questionnaire ("HIV-KQ-18")
Time frame: 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.
Time frame: 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
Time frame: change from baseline to end of study (22 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.