Identifying efficient linkage strategies for men (IDEaL): a study protocol for an individually randomised control trial
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 imp...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/7/e070896.full |
| _version_ | 1827172644313628672 |
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| author | Sam Phiri Khumbo Phiri Lawrence C Long Thomas J Coates Risa M Hoffman Michal Kulich Julie Hubbard Kathryn Dovel Brooke E Nichols Kelvin Balakasi Elijah Chikuse Augustine T Choko |
| author_facet | Sam Phiri Khumbo Phiri Lawrence C Long Thomas J Coates Risa M Hoffman Michal Kulich Julie Hubbard Kathryn Dovel Brooke E Nichols Kelvin Balakasi Elijah Chikuse Augustine T Choko |
| author_sort | Sam Phiri |
| collection | DOAJ |
| 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.Trial registration number NCT05137210.Date and version 5 May 2023; version 3. |
| first_indexed | 2024-03-12T15:23:21Z |
| format | Article |
| id | doaj.art-02d7275352274b8eafbd174f4f10b786 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2025-03-21T03:27:02Z |
| publishDate | 2023-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-02d7275352274b8eafbd174f4f10b7862024-07-31T21:25:10ZengBMJ Publishing GroupBMJ Open2044-60552023-07-0113710.1136/bmjopen-2022-070896Identifying efficient linkage strategies for men (IDEaL): a study protocol for an individually randomised control trialSam Phiri0Khumbo Phiri1Lawrence C Long2Thomas J Coates3Risa M Hoffman4Michal Kulich5Julie Hubbard6Kathryn Dovel7Brooke E Nichols8Kelvin Balakasi9Elijah Chikuse10Augustine T Choko11Department of Implementation Science, Partners in Hope, Lilongwe, MalawiDepartment of Implementation Science, Partners in Hope, Lilongwe, MalawiDepartment of Global Health, Boston University School of Public Health, Boston, Massachusetts, USADivision of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USADivision of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USADepartment of Probability and Statistics, Faculty of Mathematics and Physics, Charles University, Prague, CzechiaDivision of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USADepartment of Implementation Science, Partners in Hope, Lilongwe, MalawiDepartment of Medical Microbiology, Amsterdam University Medical Center, Amsterdam, The NetherlandsDepartment of Implementation Science, Partners in Hope, Lilongwe, MalawiDepartment of Implementation Science, Partners in Hope, Lilongwe, MalawiClinical Research Programme, Malawi Liverpool Wellcome Programme, Blantyre, MalawiIntroduction 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.Trial registration number NCT05137210.Date and version 5 May 2023; version 3.https://bmjopen.bmj.com/content/13/7/e070896.full |
| spellingShingle | Sam Phiri Khumbo Phiri Lawrence C Long Thomas J Coates Risa M Hoffman Michal Kulich Julie Hubbard Kathryn Dovel Brooke E Nichols Kelvin Balakasi Elijah Chikuse Augustine T Choko Identifying efficient linkage strategies for men (IDEaL): a study protocol for an individually randomised control trial BMJ Open |
| title | Identifying efficient linkage strategies for men (IDEaL): a study protocol for an individually randomised control trial |
| title_full | Identifying efficient linkage strategies for men (IDEaL): a study protocol for an individually randomised control trial |
| title_fullStr | Identifying efficient linkage strategies for men (IDEaL): a study protocol for an individually randomised control trial |
| title_full_unstemmed | Identifying efficient linkage strategies for men (IDEaL): a study protocol for an individually randomised control trial |
| title_short | Identifying efficient linkage strategies for men (IDEaL): a study protocol for an individually randomised control trial |
| title_sort | identifying efficient linkage strategies for men ideal a study protocol for an individually randomised control trial |
| url | https://bmjopen.bmj.com/content/13/7/e070896.full |
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