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A secondary analysis using individual patient data of two pragmatic cluster-randomized control trials evaluating 3 monthly and 6 monthly community-based multimonth dispensing of antiretroviral treatment in Southern Africa
Thesis (MSc)--Stellenbosch University, 2021.
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| Format: | Thesis |
| Language: | en_ZA |
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Stellenbosch : Stellenbosch University
2021
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| _version_ | 1867613902641037312 |
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| access_status_str | Open Access |
| author | Lopes, John |
| author2 | Fatti, Geoffrey |
| author_browse | Fatti, Geoffrey Lopes, John |
| author_facet | Fatti, Geoffrey Lopes, John |
| author_sort | Lopes, John |
| collection | Thesis |
| dc_rights_str_mv | Stellenbosch University |
| description | Thesis (MSc)--Stellenbosch University, 2021. |
| format | Thesis |
| id | oai:scholar.sun.ac.za:10019.1/124194 |
| institution | Stellenbosch University (South Africa) |
| language | en_ZA |
| last_indexed | 2026-06-10T12:43:31.605Z |
| license_str | Other — see source repository |
| provenance_str_mv | Harvested via OAI-PMH from SUNScholar — Stellenbosch University Repository |
| publishDate | 2021 |
| publishDateRange | 2021 |
| publishDateSort | 2021 |
| publisher | Stellenbosch : Stellenbosch University |
| publisherStr | Stellenbosch : Stellenbosch University |
| record_format | dspace |
| source_str | SUNScholar — Stellenbosch University Repository |
| spelling | oai:scholar.sun.ac.za:10019.1/124194 A secondary analysis using individual patient data of two pragmatic cluster-randomized control trials evaluating 3 monthly and 6 monthly community-based multimonth dispensing of antiretroviral treatment in Southern Africa Lopes, John Fatti, Geoffrey Lombard, Carl J. Stellenbosch University. Faculty of Medicine and Health Sciences. Dept. of Global Health. Epidemiology and Biostatistics. Differentiated service delivery Antiretroviral treatment Multi-month dispensing UCTD Thesis (MSc)--Stellenbosch University, 2021. ENGLISH SUMMARY: Randomized evidence of the effectiveness of community-based multi-month dispensing (MMD) of antiretroviral treatment (ART) is lacking, particularly for 6 months MMD with only annual clinical consultations. Data from two cluster randomized trials (CRTs) were pooled to compare community-based MMD of ART versus non-inferior to standard-of-care facility-based MMD. Methods: Adult people living with HIV (PLHIV) stable on ART for ≥6 months with viral load suppression (VLS) at baseline was included. Community-based 3 monthly (3MC) and 6 monthly (6MC) ART refill dispensing were compared to control facility-based 3 monthly (3MF). Twelve months retention-in-care (primary outcome) was evaluated by intention-to-treat using individual-level regression analyses, with a prespecified non-inferiority margin of -3.25% risk difference (RD). Secondary outcomes evaluated after 12 months were; (1) retention within the study arm (2) VLS, (3) number of unscheduled facility visits, and after 18 months; (4) attrition in ART care. Results: Data pooling yielded a total of 10136 participants with relatively balanced characteristics across the arms, except for age and district. Retention after 12 months was noninferior in the adjusted analysis (3MC: RD=0.3, 95% CI: -0.8 to 1.4 vs 3MF, 6MC: RD=-0.2, 95 % CI: -1.4 to 1.0 vs 3MF). VLS was high (≥97.9%) with no differences between the arms, risk ratio (RR) of 1.0 for 3MC (95 % CI: 1.0 to 1.0, p=0.885) and 6MC (95 % CI: 1.0 to 1.0, p=0.186) compared to 3MF. The incidence rate ratio (IRR) for unscheduled visits showed no difference between 3MC (IRR=0.6, 95 % CI: 0.2 to 2.1, p=0.383) and 6MC (IRR=1.0, 95 % CI: 0.4 to 2.5, p=0.974) compared to 3MF. Participant attrition (0-18 months) for Zimbabwe showed no differences between the arms, facility location or healthcare level. Conclusion: Community-based MMD of ART at 3 and 6 monthly refills for PLHIV stable on ART is safe to scale-up, without increased unscheduled facility visits or compromise in VLS. AFRIKAANSE OPSOMMING: Geen opsomming beskikbaar. Masters 2021-06-10T02:29:09Z 2022-02-22T10:15:33Z 2022-02-23T03:00:10Z 2021-03 Thesis http://hdl.handle.net/10019.1/124194 en_ZA Stellenbosch University 72 pages application/pdf Stellenbosch : Stellenbosch University |
| spellingShingle | Differentiated service delivery Antiretroviral treatment Multi-month dispensing UCTD Lopes, John A secondary analysis using individual patient data of two pragmatic cluster-randomized control trials evaluating 3 monthly and 6 monthly community-based multimonth dispensing of antiretroviral treatment in Southern Africa |
| title | A secondary analysis using individual patient data of two pragmatic cluster-randomized control trials evaluating 3 monthly and 6 monthly community-based multimonth dispensing of antiretroviral treatment in Southern Africa |
| title_full | A secondary analysis using individual patient data of two pragmatic cluster-randomized control trials evaluating 3 monthly and 6 monthly community-based multimonth dispensing of antiretroviral treatment in Southern Africa |
| title_fullStr | A secondary analysis using individual patient data of two pragmatic cluster-randomized control trials evaluating 3 monthly and 6 monthly community-based multimonth dispensing of antiretroviral treatment in Southern Africa |
| title_full_unstemmed | A secondary analysis using individual patient data of two pragmatic cluster-randomized control trials evaluating 3 monthly and 6 monthly community-based multimonth dispensing of antiretroviral treatment in Southern Africa |
| title_short | A secondary analysis using individual patient data of two pragmatic cluster-randomized control trials evaluating 3 monthly and 6 monthly community-based multimonth dispensing of antiretroviral treatment in Southern Africa |
| title_sort | secondary analysis using individual patient data of two pragmatic cluster randomized control trials evaluating 3 monthly and 6 monthly community based multimonth dispensing of antiretroviral treatment in southern africa |
| topic | Differentiated service delivery Antiretroviral treatment Multi-month dispensing UCTD |
| url | http://hdl.handle.net/10019.1/124194 |
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