Identifying efficient linkage strategies for men (IDEaL): a study protocol for an individually randomised control trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11320%2F23%3A10472208" target="_blank" >RIV/00216208:11320/23:10472208 - isvavai.cz</a>
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=4fNupS.w_B" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=4fNupS.w_B</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1136/bmjopen-2022-070896" target="_blank" >10.1136/bmjopen-2022-070896</a>
Alternative languages
Result language
angličtina
Original language name
Identifying efficient linkage strategies for men (IDEaL): a study protocol for an individually randomised control trial
Original language description
Introduction Men in sub-Saharan Africa are less likely than women to initiate antiretroviral therapy (ART) and more likely to have longer cycles of disengagement from ART programmes. Treatment interventions that meet the unique needs of men are needed, but they must be scalable. We will test the impact of various interventions on 6-month retention in ART programmes among men living with HIV who are not currently engaged in care (never initiated ART and ART clients with treatment interruption). Methods and analysis We will conduct a programmatic, individually randomised, non-blinded, controlled trial. 'Non-engaged' men will be randomised 1:1:1 to either a low-intensity, high-intensity or stepped arm. The low-intensity intervention includes one-time male-specific counseling+facility navigation only. The high-intensity intervention offers immediate outside-facility ART initiation+male-specific counselling+facility navigation for follow-up ART visits. In the stepped arm, intervention activities build in intensity over time for those who do not re-engage in care with the following steps: (1) one-time male-specific counselling+facility navigation ->(2) ongoing male mentorship+facility navigation ->(3) outside-facility ART initiation+male-specific counselling+facility navigation for follow-up ART visits. Our primary outcome is 6-month retention in care. Secondary outcomes include cost-effectiveness and rates of adverse events. The primary analysis will be intention to treat with all eligible men in the denominator and all men retained in care at 6 months in the numerator. The proportions achieving the primary outcome will be compared with a risk ratio, corresponding 95% CI and p value computed using binomial regression accounting for clustering at facility level. Ethics and dissemination The Institutional Review Board of the University of California, Los Angeles and the National Health Sciences Research Council in Malawi have approved the trial protocol. Findings will be disseminated rapidly in national and international forums and in peer-reviewed journals and are expected to provide urgently needed information to other countries and donors.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
10103 - Statistics and probability
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2023
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
BMJ Open
ISSN
2044-6055
e-ISSN
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Volume of the periodical
13
Issue of the periodical within the volume
7
Country of publishing house
GB - UNITED KINGDOM
Number of pages
8
Pages from-to
e070896
UT code for WoS article
001042144500016
EID of the result in the Scopus database
2-s2.0-85164540687