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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02301533 |
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Date of registration:
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13/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Provider and Peer Support Intervention to Improve ART Adherence Among Kenyan Men Who Have Sex With Men
Shikamana |
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Scientific title:
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Provider and Peer Support Intervention to Improve ART Adherence Among Kenyan Men Who Have Sex With Men |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02301533 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Susan M Graham, MD MPH PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Washington |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- Inability to understand the research, as assessed during informed consent
- Refusal to consider ART initiation
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Medication Adherence
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Intervention(s)
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Behavioral: Standard Care
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Behavioral: Shikamana Intervention
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Primary Outcome(s)
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Adverse events
[Time Frame: assessed at month 6 in each arm]
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Secondary Outcome(s)
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MEMS adherence
[Time Frame: assessed at months 3 and 6 in each arm]
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plasma viral load
[Time Frame: assessed at months 3 and 6 in each arm]
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Secondary ID(s)
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1R34MH099946
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44022
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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