Mfangano Island Healthy Networks Impact Study

HIV Clinical Trial

— MIHNIS  

Official title:

Mfangano Island Healthy Networks Impact Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912521
• Other study ID #: MIHNIS
• Status: Completed
• Phase: N/A
• First received: July 23, 2013
• Last updated: July 29, 2014
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardKenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 883
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
Kenya	Ekialo Kiona Center	Kitawi Beach, Mfangano Island	Nyanza

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Kenya Medical Research Institute, Microclinic International, Organic Health Response

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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)	No
Secondary	Stigma	stigma as measured by Parallel HIV/AIDS Stigma Scale (Attributed Stigma Attitudes)	change from baseline to 6-months	No
Secondary	Social support	Social support as measured by Duke-University of North Carolina (UNC) Functional Social Support Scale	change from baseline to 6-months	No
Secondary	HIV knowledge	HIV knowledge as measured by HIV Knowledge Questionnaire ("HIV-KQ-18")	change from baseline to 6-months	No
Secondary	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.	From time of study enrollment until study closure (22 months) or censorship (death or transfer of care to facility outside study area)	No
Secondary	ART adherence - end of study	change in ART drug levels measured in small hair samples from baseline to end of study	change from baseline to end of study (22 months)	No