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Completed

NCT Number: NCT01912521

Mfangano Island Healthy Networks Impact Study

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.

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Key information

Conditions

HIV Behavior Social Behavior Social Stigma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ekialo Kiona Center

Kitawi Beach, Mfangano Island, Nyanza, Kenya

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Antiretroviral therapy (ART) Adherence

    Time frame: change from baseline to 6-months

    change in ART drug levels measured in small hair samples from baseline to 6 months

  2. 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)

    Incidence of missing a clinic appointment by ≥90 days without having first transferred care to another clinic or died.

Secondary outcomes

  1. Stigma

    Time frame: change from baseline to 6-months

    stigma as measured by Parallel HIV/AIDS Stigma Scale (Attributed Stigma Attitudes)

  2. Social support

    Time frame: change from baseline to 6-months

    Social support as measured by Duke-University of North Carolina (UNC) Functional Social Support Scale

  3. HIV knowledge

    Time frame: change from baseline to 6-months

    HIV knowledge as measured by HIV Knowledge Questionnaire ("HIV-KQ-18")

  4. 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)

    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.

  5. ART adherence - end of study

    Time frame: change from baseline to end of study (22 months)

    change in ART drug levels measured in small hair samples from baseline to end of study

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Kenya Medical Research Institute
  • Microclinic International
  • Organic Health Response

Registry information

Acronym: MIHNIS

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 31, 2013
Registry last updated
Jul 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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