HIVNCT02474992
The Kanyakla Study: a Microclinic Social Network Intervention for Promoting Engagement and Retention in HIV Care
A study testing Microclinic in people with HIV, run by University of California, San Francisco at 1 site in Kenya.
Trial summary
The purpose of this randomized controlled trial is to compare a social network-based behavioral intervention known as microclinics to standard HIV clinical care alone in helping patients receiving HIV care on Mfangano, Remba and Ringiti Islands, Kenya remain adherent to clinic appointments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Microclinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteKenya
- Study dates
- Jan 2016to Jun 2019
- 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
- Must be currently receiving combination antiretroviral therapy (cART) or co-trimoxozole prophylaxis from one of the eligible study clinics:
- Is currently in care at study baseline, defined as having ≥1 medical care visit to receive medications (cART or prophylaxis) during the six months preceeding initiation of study enrollment, OR
- Initiates pre-ART or ART care for the first time at a study clinic during the six month study recruitment period, OR
- Transfers from a clinic outside the study area and receives pre-ART or ART care for the first time from a study clinic during the six month recruitment period
- Participants become eligible for study inclusion on the 4th day following a missed clinic appointment, provided the patient has not transferred care to another clinic prior to the 4th day, moved outside the study area or died. Participants who miss a study visit by >3 days but return to clinic before recruitment takes place are still eligible for study enrollment. Missed visits must have occurred within the previous 90 days at the time of eligibility assessment to meet this inclusion criteria.
- Must currently reside on Mfangano, Remba or Ringiti Island.
- Must be conversant with one of the commonly spoken languages within the study area (i.e. DhoLuo, Swahili or English; prior experience indicates that this represents >99% of the adult population).
- Must be ≥18 years of age as of the date of study eligibility.
Who cannot join
- Eligible participants who reside in the Mfangano East sub-location will be excluded from participation in this study. Many of these patients have already participated in the microclinic intervention as part of the Mfangano Island Healthy Network Impact Study.
- Participants planning on moving permanently out of the study area within the next six months will be excluded.
- Participants who, should they be randomized to the intervention arm, would be unwilling to participate in a microclinic will be excluded from study enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this randomized controlled trial is to compare a social network-based behavioral intervention known as microclinics to standard HIV clinical care alone in helping patients receiving HIV care on Mfangano, Remba and Ringiti Islands, Kenya remain adherent to clinic appointments. The study is designed to evaluate the effectiveness of microclinics on reducing gaps in clinical care, HIV viral load and HIV-related stigma, compared to standard HIV clinical care alone. By doing this research study, the investigators hope to learn whether microclinics are a useful social strategy for improving delivery of HIV treatment in rural Kenya.
- Conditions
- HIV
- Being tested
- Microclinic
- Keywords
- HIV, Social network, Social support, Disclosure, Stigma, 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.
MicroclinicBehavioural
Also called Kanyakla
Individuals randomized to this arm will be invited to recruit members of their social network to form a health team, or microclinic. These groups will proceed through a discussion-based health education curriculum led by local community health workers. Topics will include HIV biology, medications, the importance of social support, and community outreach for reducing HIV stigma. The curriculum will conclude with an opportunity for all group members to disclose their HIV status to one another.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This arm is eligible for participation in the Microclinic intervention, a social network-based educational program. Receives: Behavioral: Microclinic |
| Comparison | No intervention | This arm is not eligible for participation in the intervention during the first twelve months of the study. Following collection of the primary study endpoints, this arm will also be invited to participate in a Microclinic group. Participants in this arm will still have access to standard HIV care at the facility of their choice. At time of recruitment into the study, prior to randomization, all eligible participants will be counseled on the importance of returning to their clinic for ongoing HIV care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disengagement from care
Incidence of 90-day absence from care following a missed appointment
Measured: 12 months
Disengagement from 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: 12 months
Secondary outcomes (3)
Virologic suppression
Proportion of patients who are virologically suppressed 12 months after randomization
Measured: 12 months
HIV-related stigma
Reduction in stigma as compared to baseline, measured by the Earnshaw HIV Stigma Framework
Measured: 12 months
Re-engagement in care
Incidence of re-engagement in care following missed visit at time of study enrollment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 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, MPH, Principal investigator, University of California, San FranciscoElizabeth A Bukusi, MBChB, M.Med, PhD, Principal investigator, Kenya Medical Research InstituteMatthew D Hickey, MD, Principal investigator, University of California, San FranciscoCharles R Salmen, MD, MPhil, Principal investigator, Organic Health Response
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474992
- Sponsor's protocol ID
- OHR006
- Status last verified
- Aug 2019
- First submitted
- 16 Jun 2015
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Zoughbie DE, Huddleston D, Watson K, Ding EL. HIV Social-network intervention more effective in older populations in Kenya. BMC Public Health. 2024 Nov 9;24(1):3098. doi: 10.1186/s12889-024-20315-0.
PubMed 39516844Hickey MD, Ouma GB, Mattah B, Pederson B, DesLauriers NR, Mohamed P, Obanda J, Odhiambo A, Njoroge B, Otieno L, Zoughbie DE, Ding EL, Fiorella KJ, Bukusi EA, Cohen CR, Geng EH, Salmen CR. The Kanyakla study: Randomized controlled trial of a microclinic social network intervention for promoting engagement and retention in HIV care in rural western Kenya. PLoS One. 2021 Sep 13;16(9):e0255945. doi: 10.1371/journal.pone.0255945. eCollection 2021.
PubMed 34516557
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Kanyakla Study: a Microclinic Social Network Intervention for Promoting Engagement and Retention in HIV Care
- ClinicalTrials.gov ID
- NCT02474992
- Acronym / sponsor ID
- OHR006
- Conditions
- HIV
- Keywords
- HIV, Social network, Social support, Disclosure, Stigma, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Organic Health Response, Microclinic International, Kenya Medical Research Institute
- Study start
- Jan 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 18 Jun 2015 (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.
The purpose of this randomized controlled trial is to compare a social network-based behavioral intervention known as microclinics to standard HIV clinical care alone in helping patients receiving HIV care on Mfangano, Remba and Ringiti Islands, Kenya remain adherent to clinic appointments. The study is designed to evaluate the effectiveness of microclinics on reducing gaps in clinical care, HIV viral load and HIV-related stigma, compared to standard HIV clinical care alone. By doing this research study, the investigators hope to learn whether microclinics are a useful social strategy for improving delivery of HIV treatment in rural Kenya.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MicroclinicThis arm is eligible for participation in the Microclinic intervention, a social network-based educational program. |
| Comparison | No intervention | –This arm is not eligible for participation in the intervention during the first twelve months of the study. Following collection of the primary study endpoints, this arm will also be invited to participate in a Microclinic group. Participants in this arm will still have access to standard HIV care at the facility of their choice. At time of recruitment into the study, prior to randomization, all eligible participants will be counseled on the importance of returning to their clinic for ongoing HIV care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must be currently receiving combination antiretroviral therapy (cART) or co-trimoxozole prophylaxis from one of the eligible study clinics:
- Participants become eligible for study inclusion on the 4th day following a missed clinic appointment, provided the patient has not transferred care to another clinic prior to the 4th day, moved outside the study area or died. Participants who miss a study visit by >3 days but return to clinic before recruitment takes place are still eligible for study enrollment. Missed visits must have occurred within the previous 90 days at the time of eligibility assessment to meet this inclusion criteria.
- Must currently reside on Mfangano, Remba or Ringiti Island.
- Must be conversant with one of the commonly spoken languages within the study area (i.e. DhoLuo, Swahili or English; prior experience indicates that this represents >99% of the adult population).
- Must be ≥18 years of age as of the date of study eligibility.
Key exclusion criteria (3 listed)
- Eligible participants who reside in the Mfangano East sub-location will be excluded from participation in this study. Many of these patients have already participated in the microclinic intervention as part of the Mfangano Island Healthy Network Impact Study.
- Participants planning on moving permanently out of the study area within the next six months will be excluded.
- Participants who, should they be randomized to the intervention arm, would be unwilling to participate in a microclinic will be excluded from study enrollment.
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 |
|---|---|---|
| MicroclinicAlso: KanyaklaIndividuals randomized to this arm will be invited to recruit members of their social network to form a health team, or microclinic. These groups will proceed through a discussion-based health education curriculum led by local community health workers. Topics will include HIV biology, medications, the importance of social support, and community outreach for reducing HIV stigma. The curriculum will conclude with an opportunity for all group members to disclose their HIV status to one another. | Behavioural | Intervention |
Primary outcome
Disengagement from care
Time frame: 12 months
Incidence of 90-day absence from care following a missed appointment
Disengagement from care
Time frame: 12 months
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.
3 secondary outcomes
Virologic suppression
Time frame: 12 months
HIV-related stigma
Time frame: 12 months
Re-engagement in care
Time frame: 12 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 8 Aug 2019.
- Derived from this study: PubMed 39516844Zoughbie DE, Huddleston D, Watson K, Ding EL. HIV Social-network intervention more effective in older populations in Kenya. BMC Public Health. 2024 Nov 9;24(1):3098. doi: 10.1186/s12889-024-20315-0.
- Derived from this study: PubMed 34516557Hickey MD, Ouma GB, Mattah B, Pederson B, DesLauriers NR, Mohamed P, Obanda J, Odhiambo A, Njoroge B, Otieno L, Zoughbie DE, Ding EL, Fiorella KJ, Bukusi EA, Cohen CR, Geng EH, Salmen CR. The Kanyakla study: Randomized controlled trial of a microclinic social network intervention for promoting engagement and retention in HIV care in rural western Kenya. PLoS One. 2021 Sep 13;16(9):e0255945. doi: 10.1371/journal.pone.0255945. eCollection 2021.
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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, MPH principal investigator
University of California, San Francisco
Elizabeth A Bukusi, MBChB, M.Med, PhD principal investigator
Kenya Medical Research Institute
Matthew D Hickey, MD 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 Microclinic 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 8 inclusion and 3 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 8 Aug 2019. 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?
Disengagement from care (time frame: 12 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?
On the ClinicalTrials.gov record for NCT02474992, which also lists 2 linked publications.
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 8 Aug 2019; AzTrials last refreshed its copy on 30 Oct 2026.