HIVMIHNISNCT01912521
Mfangano Island Healthy Networks Impact Study
A study testing Mfangano Health Net Microclinic Program in people with HIV, run by University of California, San Francisco at 1 site in Kenya.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Mfangano Health Net Microclinic Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 883 participants
- Where
- 1 siteKenya
- Study dates
- Nov 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- HIV
- Being tested
- Mfangano Health Net Microclinic Program
- Keywords
- HIV, Stigma, Social support, Social network, Kenya
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mfangano Health Net Microclinic ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This arm is eligible for participation in the Mfangano Health Net Microclinic Program, a social network-based educational program. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiretroviral therapy (ART) Adherence
change in ART drug levels measured in small hair samples from baseline to 6 months
Measured: 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.
Measured: 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
stigma as measured by Parallel HIV/AIDS Stigma Scale (Attributed Stigma Attitudes)
Measured: change from baseline to 6-months
Social support
Social support as measured by Duke-University of North Carolina (UNC) Functional Social Support Scale
Measured: change from baseline to 6-months
HIV knowledge
HIV knowledge as measured by HIV Knowledge Questionnaire ("HIV-KQ-18")
Measured: 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.
Measured: 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
Measured: change from baseline to end of study (22 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 883 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Organic Health Response, Microclinic International, Kenya Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Craig R Cohen, MD, Principal investigator, University of California, San FranciscoElizabeth Bukusi, MBChB, M.Med, Principal investigator, Kenya Medical Research InstituteCharles R Salmen, MSc, MD Candidate, Principal investigator, University of California, San FranciscoMatthew D Hickey, MD Candidate, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912521
- Sponsor's protocol ID
- MIHNIS
- Acronym
- MIHNIS
- Status last verified
- Jul 2014
- First submitted
- 23 Jul 2013
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mfangano Island Healthy Networks Impact Study
- ClinicalTrials.gov ID
- NCT01912521
- Acronym / sponsor ID
- MIHNIS / MIHNIS
- Conditions
- HIV
- Keywords
- HIV, Stigma, Social support, Social network, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 883 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Organic Health Response, Microclinic International, Kenya Medical Research Institute
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mfangano Health Net Microclinic ProgramThis arm is eligible for participation in the Mfangano Health Net Microclinic Program, a social network-based educational 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mfangano Health Net Microclinic ProgramEducational 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. | Behavioural | Intervention |
Primary outcome
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
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.
5 secondary outcomes
Stigma
Time frame: change from baseline to 6-months
Social support
Time frame: change from baseline to 6-months
HIV knowledge
Time frame: change from baseline to 6-months
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)
ART adherence - end of study
Time frame: change from baseline to end of study (22 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig R Cohen, MD principal investigator
University of California, San Francisco
Elizabeth Bukusi, MBChB, M.Med principal investigator
Kenya Medical Research Institute
Charles R Salmen, MSc, MD Candidate principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mfangano Health Net Microclinic Program in people with HIV, run by University of California, San Francisco at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antiretroviral therapy (ART) Adherence (time frame: change from baseline to 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2014.