Mfangano Island Healthy Networks Impact Study

NCT01912521 | Completed

• 1 other identifier: MIHNIS
• Study Type: interventional
• Target: 883
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; Stigma; Social support; Social network; Kenya

Outcome Measures

Primary Outcomes (2)

• 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

• 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)

Secondary Outcomes (5)

• Stigma

  change from baseline to 6-months

• Social support

  change from baseline to 6-months

• HIV knowledge

  change from baseline to 6-months

• Time in care

  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 from baseline to end of study (22 months)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Comparison

NO INTERVENTION

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.

Interventions

Mfangano Health Net Microclinic Program BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV positive patient on ART at Sena Health Center or member of patient's social network
• Resident of Mfangano Island
• years of age or older
• conversant in DhoLuo or English languages

You may not qualify if:

• none

Sponsors & Collaborators

• University of California, San Francisco: lead
• Organic Health Response: collaborator
• Microclinic International: collaborator
• Kenya Medical Research Institute: collaborator

Study Sites (1)

Ekialo Kiona Center

Kitawi Beach, Mfangano Island, Nyanza, Kenya

Location

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 31, 2013
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 30, 2014

Record last verified: 2014-07

Locations

KE (1)