Clinical trial NCT01912521: Mfangano Island Healthy Networks Impact Study
Official title: Mfangano Island Healthy Networks Impact Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Stigma
Social support
Social network
Kenya
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Organic Health Response
name: Microclinic International
name: Kenya Medical Research Institute
First posted: 2013-07-31
Enrollment: 883
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Antiretroviral therapy (ART) Adherence
timeFrame: change from baseline to 6-months
measure: Disengagement from care
timeFrame: 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: Stigma
timeFrame: change from baseline to 6-months
measure: Social support
timeFrame: change from baseline to 6-months
measure: HIV knowledge
timeFrame: change from baseline to 6-months
measure: Time in care
timeFrame: From time of study enrollment until study closure (22 months) or censorship (death or transfer of care to facility outside study area)
measure: ART adherence - end of study
timeFrame: change from baseline to end of study (22 months)
Other outcomes:
Locations:
city: Kitawi Beach, Mfangano Island
country: Kenya
facility: Ekialo Kiona Center
state: Nyanza
Study officials:
affiliation: University of California, San Francisco
name: Craig R Cohen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenya Medical Research Institute
name: Elizabeth Bukusi, MBChB, M.Med
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Charles R Salmen, MSc, MD Candidate
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Matthew D Hickey, MD Candidate
role: PRINCIPAL_INVESTIGATOR
References: