Medication AdherenceShikamanaNCT02301533
Provider and Peer Support Intervention to Improve ART Adherence Among Kenyan Men Who Have Sex With Men
A study testing Shikamana Intervention in people with Medication Adherence, run by University of Washington at 1 site in Kenya.
Trial summary
Antiretroviral therapy (ART) can improve health, prevent complications due to HIV infection, and prevent HIV transmission by making people less infectious. Men who have sex with men (MSM) are at high risk for transmitting HIV, but face stigma and discrimination that can make ART adherence difficult. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Shikamana Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteKenya
- Study dates
- Jun 2015to Oct 2016
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- 18 years or older
- Live or work in or around Mtwapa
- Kenyan nationality
- Engaged in any sex (manual, oral, anal) with a man during the past 12 months
- Documented HIV-1-infection
Show all 10Show fewer
- Eligible for ART by current Kenyan guidelines
- Able to communicate in Swahili or English
- Willing to undergo randomization and participate in study procedures as outlined in the consent
- Not planning to move from area during the next 12 months To enhance study feasibility, we will recruit up to 30 men with prior ART experience. We will collect data on the duration of ART at the time of study enrolment.
Who cannot join
- Inability to understand the research, as assessed during informed consent
- Refusal to consider ART initiation
Trial locations and contacts
1 site in 1 country.
About this study
Antiretroviral therapy (ART) can improve health, prevent complications due to HIV infection, and prevent HIV transmission by making people less infectious. Men who have sex with men (MSM) are at high risk for transmitting HIV, but face stigma and discrimination that can make ART adherence difficult. Our goal is to find out if an intervention involving provider counselling and support from an MSM peer will improve ART adherence and engagement in care among Kenyan MSM. This study will be carried out in the KEMRI clinic in Mtwapa with 70 MSM patient participants who reside in this area, identified through our outreach and testing programs in Mtwapa. Six providers and five peers who are trained for the intervention will also be consented in order to collect data on their feedback and help monitor the study. Our intervention consists of support from a trained peer with experience taking ART and enhanced counselling from providers that is aimed to motivate patients to improve and maintain their health. In an initial pilot test, we will implement our intervention with 10 MSM starting ART for the first time. After any needed revisions to research procedures and training, we will next conduct a small randomized controlled trial with 60 MSM patient participants to determine feasibility, acceptability, tolerability, and safety, and estimate an initial effect size for the adherence intervention. The 60 patient participants will be randomized to our intervention or to standard counselling care, and will be followed for 6 months to evaluate their ART adherence and retention in care. Providers and peers will give feedback at regular project meetings and in in-depth interviews after the pilot test and after the RCT. The work proposed for this project will be carried out over 2 years, from June 1, 2014 through May 31, 2016.
Read the detailed description
Although men who have sex with men (MSM) are at very high risk for HIV globally, this group has only recently become an important focus of national HIV/AIDS programs in sub-Saharan Africa. While it is clear that antiretroviral therapy (ART) can reduce AIDS-related morbidity and mortality and prevent sexual transmission from HIV-infected MSM, this group faces significant stigma that can impede engagement in care. Based on qualitative research conducted in 2013-2014 in coastal Kenya, we have developed an intervention called "Shikamana" (a Kiswahili word meaning "to form a bond or stick together") to improve HIV treatment engagement, ART adherence, and clinical outcomes in this group. We now propose a 2-year study to pilot test and conduct an initial evaluation of this intervention. Our specific aims are to: 1) pilot test our evidence-based intervention for MSM and ensure that the intervention is feasible and acceptable to patient, peer, and provider participants; and 2) implement a small randomized controlled trial (RCT) of the resulting multi-component intervention versus standard care with 60 MSM patient participants. Ten patient participants will be followed in the pilot test for 3 months each, with monthly measurement of ART adherence, baseline and month 3 measurement of adherence correlates, and feedback from participants and staff on the intervention procedures. After fine-tuning of the intervention based on the pilot test, we will follow 60 MSM patient participants for 6 months each, with monthly measurement of ART adherence, baseline and quarterly measurement of adherence correlates, viral load testing at month 3 and month 6 as a biomarker of treatment success, and feedback from participants and staff on the intervention procedures. Findings from this formative 2-year study will provide qualitative data on the feasibility, acceptability, tolerability, safety, and quantitative data on preliminary effect sizes to test this intervention and its components in a fully powered RCT including a larger, more diverse sample of MSM from multiple sites in sub-Saharan Africa.
- Conditions
- Medication Adherence
- Being tested
- Shikamana Intervention, Standard Care
- Keywords
- HIV infection, antiretroviral therapy, adherence, men who have sex with men
- Medical subject headings
- Medication Adherence, HIV Infections, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shikamana InterventionBehavioural
See arm description
Standard CareBehavioural
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Shikamana Intervention | Experimental | The Shikamana Intervention consists of provider support (modified Next Step Counseling) and peer support (trained peer navigator) to promote adherence to antiretroviral therapy Receives: Behavioral: Shikamana Intervention |
| Standard Care | Other | The standard care arm will receive adherence counseling per standard Kenyan Ministry of Health guidelines, along with the recommendation to disclose to a family member or friend in order to obtain support Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Any adverse events, such as confidentiality breaches, as a result of study participation
Measured: assessed at month 6 in each arm
Secondary outcomes (2)
MEMS adherence
Adherence to antiretroviral therapy, measured by MEMS Caps
Measured: assessed at months 3 and 6 in each arm
plasma viral load
plasma HIV-1 RNA level
Measured: assessed at months 3 and 6 in each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startJun 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Susan Graham, University of Washington
- Investigators
- Susan M Graham, MD MPH PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301533
- Sponsor's protocol ID
- 44022
- Other IDs
- 1R34MH099946
- Acronym
- Shikamana
- Status last verified
- Jul 2017
- First submitted
- 13 Nov 2014
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Study data will be available after publication of the main study manuscripts. Researchers requesting access to data/resources will be asked to submit a request in writing describing their qualifications including their certification by their local IRB, analytic plans and other uses of the data/resources, and plans to secure the confidentiality and safety of the data. Given the sensitive nature of the data we are collecting, including HIV diagnosis and mental health status, we will not create a public access file.
Publications
Graham SM, Micheni M, Kombo B, Van Der Elst EM, Mugo PM, Kivaya E, Aunon F, Kutner B, Sanders EJ, Simoni JM. Development and pilot testing of an intervention to promote care engagement and adherence among HIV-positive Kenyan MSM. AIDS. 2015 Dec;29 Suppl 3(0 3):S241-9. doi: 10.1097/QAD.0000000000000897.
PubMed 26562813
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provider and Peer Support Intervention to Improve ART Adherence Among Kenyan Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT02301533
- Acronym / sponsor ID
- Shikamana / 44022
- Conditions
- Medication Adherence
- Keywords
- HIV infection, antiretroviral therapy, adherence, men who have sex with men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, National Institute of Mental Health (NIMH)
- Study start
- Jun 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Nov 2014 (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.
Antiretroviral therapy (ART) can improve health, prevent complications due to HIV infection, and prevent HIV transmission by making people less infectious. Men who have sex with men (MSM) are at high risk for transmitting HIV, but face stigma and discrimination that can make ART adherence difficult. Our goal is to find out if an intervention involving provider counselling and support from an MSM peer will improve ART adherence and engagement in care among Kenyan MSM. This study will be carried out in the KEMRI clinic in Mtwapa with 70 MSM patient participants who reside in this area, identified through our outreach and testing programs in Mtwapa. Six providers and five peers who are trained for the intervention will also be consented in order to collect data on their feedback and help monitor the study. Our intervention consists of support from a trained peer with experience taking ART and enhanced counselling from providers that is aimed to motivate patients to improve and maintain their health. In an initial pilot test, we will implement our intervention with 10 MSM starting ART for the first time. After any needed revisions to research procedures and training, we will next conduct a small randomized controlled trial with 60 MSM patient participants to determine feasibility, acceptability, tolerability, and safety, and estimate an initial effect size for the adherence intervention. The 60 patient participants will be randomized to our intervention or to standard counselling care, and will be followed for 6 months to evaluate their ART adherence and retention in care. Providers and peers will give feedback at regular project meetings and in in-depth interviews after the pilot test and after the RCT. The work proposed for this project will be carried out over 2 years, from June 1, 2014 through May 31, 2016.
Detailed description
Although men who have sex with men (MSM) are at very high risk for HIV globally, this group has only recently become an important focus of national HIV/AIDS programs in sub-Saharan Africa. While it is clear that antiretroviral therapy (ART) can reduce AIDS-related morbidity and mortality and prevent sexual transmission from HIV-infected MSM, this group faces significant stigma that can impede engagement in care. Based on qualitative research conducted in 2013-2014 in coastal Kenya, we have developed an intervention called "Shikamana" (a Kiswahili word meaning "to form a bond or stick together") to improve HIV treatment engagement, ART adherence, and clinical outcomes in this group. We now propose a 2-year study to pilot test and conduct an initial evaluation of this intervention. Our specific aims are to: 1) pilot test our evidence-based intervention for MSM and ensure that the intervention is feasible and acceptable to patient, peer, and provider participants; and 2) implement a small randomized controlled trial (RCT) of the resulting multi-component intervention versus standard care with 60 MSM patient participants. Ten patient participants will be followed in the pilot test for 3 months each, with monthly measurement of ART adherence, baseline and month 3 measurement of adherence correlates, and feedback from participants and staff on the intervention procedures. After fine-tuning of the intervention based on the pilot test, we will follow 60 MSM patient participants for 6 months each, with monthly measurement of ART adherence, baseline and quarterly measurement of adherence correlates, viral load testing at month 3 and month 6 as a biomarker of treatment success, and feedback from participants and staff on the intervention procedures. Findings from this formative 2-year study will provide qualitative data on the feasibility, acceptability, tolerability, safety, and quantitative data on preliminary effect sizes to test this intervention and its components in a fully powered RCT including a larger, more diverse sample of MSM from multiple sites in sub-Saharan Africa.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shikamana Intervention | Experimental | Behavioral: Shikamana InterventionThe Shikamana Intervention consists of provider support (modified Next Step Counseling) and peer support (trained peer navigator) to promote adherence to antiretroviral therapy |
| Standard Care | Other | Behavioral: Standard CareThe standard care arm will receive adherence counseling per standard Kenyan Ministry of Health guidelines, along with the recommendation to disclose to a family member or friend in order to obtain support |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male
- 18 years or older
- Live or work in or around Mtwapa
- Kenyan nationality
- Engaged in any sex (manual, oral, anal) with a man during the past 12 months
Key exclusion criteria (2 listed)
- Inability to understand the research, as assessed during informed consent
- Refusal to consider ART initiation
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 |
|---|---|---|
| Shikamana InterventionSee arm description | Behavioural | Shikamana Intervention |
| Standard CareSee arm description | Behavioural | Standard Care |
Primary outcome
Adverse events
Time frame: assessed at month 6 in each arm
Any adverse events, such as confidentiality breaches, as a result of study participation
2 secondary outcomes
MEMS adherence
Time frame: assessed at months 3 and 6 in each arm
plasma viral load
Time frame: assessed at months 3 and 6 in each arm
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 13 Jul 2017.
- Background: PubMed 26562813Graham SM, Micheni M, Kombo B, Van Der Elst EM, Mugo PM, Kivaya E, Aunon F, Kutner B, Sanders EJ, Simoni JM. Development and pilot testing of an intervention to promote care engagement and adherence among HIV-positive Kenyan MSM. AIDS. 2015 Dec;29 Suppl 3(0 3):S241-9. doi: 10.1097/QAD.0000000000000897.
- Individual participant dataSharing planned: Yes. Study data will be available after publication of the main study manuscripts. Researchers requesting access to data/resources will be asked to submit a request in writing describing their qualifications including their certification by their local IRB, analytic plans and other uses of the data/resources, and plans to secure the confidentiality and safety of the data. Given the sensitive nature of the data we are collecting, including HIV diagnosis and mental health status, we will not create a public access file.
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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.
Susan M Graham, MD MPH PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shikamana Intervention in people with Medication Adherence, run by University of Washington 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 10 inclusion and 2 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 13 Jul 2017. 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?
Adverse events (time frame: assessed at month 6 in each arm). 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 NCT02301533, which also lists 1 linked publication.
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 13 Jul 2017.