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A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients' economic outcomes in Eswatini
Since 2015, the World Health Organisation (WHO) recommends immediate initiation of antiretroviral therapy (ART) for all HIV-positive patients. Epidemiological evidence points to important health benefits of immediate ART initiation; however, the policy’s impact on the economic aspects of patients�...
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| Published in: | eLife 2020-08, Vol.9 |
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| creator | Steinert, Janina Isabel Khan, Shaukat Mlambo, Khudzie Walsh, Fiona J Mafara, Emma Lejeune, Charlotte Wong, Cebele Hettema, Anita Ogbuoji, Osondu Vollmer, Sebastian De Neve, Jan-Walter Mazibuko, Sikhathele Okello, Velephi Bärnighausen, Till Geldsetzer, Pascal |
| description | Since 2015, the World Health Organisation (WHO) recommends immediate initiation of antiretroviral therapy (ART) for all HIV-positive patients. Epidemiological evidence points to important health benefits of immediate ART initiation; however, the policy’s impact on the economic aspects of patients' lives remains unknown.
We conducted a stepped-wedge cluster-randomised controlled trial in Eswatini to determine the causal impact of immediate ART initiation on patients’ individual- and household-level economic outcomes. Fourteen healthcare facilities were non-randomly matched into pairs and then randomly allocated to transition from the standard of care (ART eligibility at CD4 counts of |
| doi_str_mv | 10.7554/eLife.58487 |
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We conducted a stepped-wedge cluster-randomised controlled trial in Eswatini to determine the causal impact of immediate ART initiation on patients’ individual- and household-level economic outcomes. Fourteen healthcare facilities were non-randomly matched into pairs and then randomly allocated to transition from the standard of care (ART eligibility at CD4 counts of <350 cells/mm3 until September 2016 and <500 cells/mm3 thereafter) to the ‘Early Initiation of ART for All’ (EAAA) intervention at one of seven timepoints. Patients, healthcare personnel, and outcome assessors remained unblinded. Data were collected via standardised paper-based surveys with HIV-positive adults who were neither pregnant nor breastfeeding. Outcomes were patients’ time use, employment status, household expenditures, and household living standards.
A total sample of 3019 participants were interviewed over the duration of the study. The mean number of participants approached at each facility per time step varied from 4 to 112 participants. Using mixed-effects negative binomial regressions accounting for time trends and clustering at the level of the healthcare facility, we found no significant difference between study arms for any economic outcome. Specifically, the EAAA intervention had no significant effect on non-resting time use (RR = 1.00 [CI: 0.96, 1.05, p=0.93]) or income-generating time use (RR = 0.94, [CI: 0.73,1.20, p=0.61]). Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93 [CI: 0.82, 1.04, p=0.21] and 0.92 [CI: 0.79, 1.06, p=0.26], respectively. We also found no significant treatment effect on households’ asset ownership and living standards (RR = 0.96, [CI 0.92, 1.00, p=0.253]). Lastly, there was no evidence of heterogeneity in effect estimates by patients’ sex, age, education, timing of HIV diagnosis and ART initiation.
Our findings do not provide evidence that should discourage further investments into scaling up immediate ART for all HIV patients.
Funded by the Dutch Postcode Lottery in the Netherlands, Alexander von Humboldt-Stiftung (Humboldt-Stiftung), the Embassy of the Kingdom of the Netherlands in South Africa/Mozambique, British Columbia Centre of Excellence in Canada, Doctors Without Borders (MSF USA), National Center for Advancing Translational Sciences of the National Institutes of Health and Joachim Herz Foundation.
NCT02909218 and NCT03789448.</description><identifier>ISSN: 2050-084X</identifier><identifier>EISSN: 2050-084X</identifier><identifier>DOI: 10.7554/eLife.58487</identifier><identifier>PMID: 32831169</identifier><language>eng</language><publisher>England: eLife Sciences Publications, Ltd</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Anti-HIV Agents - administration & dosage ; Anti-HIV Agents - therapeutic use ; antiretroviral treatment ; Economic Status - statistics & numerical data ; Employment - statistics & numerical data ; Epidemiology and Global Health ; Eswatini ; Female ; health economics ; Health Facilities ; healthcare expenditures ; HIV Infections - drug therapy ; HIV Infections - economics ; HIV/AIDS ; Humans ; Male ; Medicine ; Middle Aged ; randomized controlled trial ; Time-to-Treatment - statistics & numerical data ; Young Adult</subject><ispartof>eLife, 2020-08, Vol.9</ispartof><rights>2020, Steinert et al.</rights><rights>2020, Steinert et al 2020 Steinert et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c377t-8fc9c52f6a52b705b4cf0a9eea5a39d01fe121108fd6dea5c2a1036dbbf9a0093</citedby><cites>FETCH-LOGICAL-c377t-8fc9c52f6a52b705b4cf0a9eea5a39d01fe121108fd6dea5c2a1036dbbf9a0093</cites><orcidid>0000-0002-8878-5505 ; 0000-0003-2282-1005 ; 0000-0003-0090-8249 ; 0000-0001-7120-0075</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7529454/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7529454/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,37013,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32831169$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Steinert, Janina Isabel</creatorcontrib><creatorcontrib>Khan, Shaukat</creatorcontrib><creatorcontrib>Mlambo, Khudzie</creatorcontrib><creatorcontrib>Walsh, Fiona J</creatorcontrib><creatorcontrib>Mafara, Emma</creatorcontrib><creatorcontrib>Lejeune, Charlotte</creatorcontrib><creatorcontrib>Wong, Cebele</creatorcontrib><creatorcontrib>Hettema, Anita</creatorcontrib><creatorcontrib>Ogbuoji, Osondu</creatorcontrib><creatorcontrib>Vollmer, Sebastian</creatorcontrib><creatorcontrib>De Neve, Jan-Walter</creatorcontrib><creatorcontrib>Mazibuko, Sikhathele</creatorcontrib><creatorcontrib>Okello, Velephi</creatorcontrib><creatorcontrib>Bärnighausen, Till</creatorcontrib><creatorcontrib>Geldsetzer, Pascal</creatorcontrib><title>A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients' economic outcomes in Eswatini</title><title>eLife</title><addtitle>Elife</addtitle><description>Since 2015, the World Health Organisation (WHO) recommends immediate initiation of antiretroviral therapy (ART) for all HIV-positive patients. Epidemiological evidence points to important health benefits of immediate ART initiation; however, the policy’s impact on the economic aspects of patients' lives remains unknown.
We conducted a stepped-wedge cluster-randomised controlled trial in Eswatini to determine the causal impact of immediate ART initiation on patients’ individual- and household-level economic outcomes. Fourteen healthcare facilities were non-randomly matched into pairs and then randomly allocated to transition from the standard of care (ART eligibility at CD4 counts of <350 cells/mm3 until September 2016 and <500 cells/mm3 thereafter) to the ‘Early Initiation of ART for All’ (EAAA) intervention at one of seven timepoints. Patients, healthcare personnel, and outcome assessors remained unblinded. Data were collected via standardised paper-based surveys with HIV-positive adults who were neither pregnant nor breastfeeding. Outcomes were patients’ time use, employment status, household expenditures, and household living standards.
A total sample of 3019 participants were interviewed over the duration of the study. The mean number of participants approached at each facility per time step varied from 4 to 112 participants. Using mixed-effects negative binomial regressions accounting for time trends and clustering at the level of the healthcare facility, we found no significant difference between study arms for any economic outcome. Specifically, the EAAA intervention had no significant effect on non-resting time use (RR = 1.00 [CI: 0.96, 1.05, p=0.93]) or income-generating time use (RR = 0.94, [CI: 0.73,1.20, p=0.61]). Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93 [CI: 0.82, 1.04, p=0.21] and 0.92 [CI: 0.79, 1.06, p=0.26], respectively. We also found no significant treatment effect on households’ asset ownership and living standards (RR = 0.96, [CI 0.92, 1.00, p=0.253]). Lastly, there was no evidence of heterogeneity in effect estimates by patients’ sex, age, education, timing of HIV diagnosis and ART initiation.
Our findings do not provide evidence that should discourage further investments into scaling up immediate ART for all HIV patients.
Funded by the Dutch Postcode Lottery in the Netherlands, Alexander von Humboldt-Stiftung (Humboldt-Stiftung), the Embassy of the Kingdom of the Netherlands in South Africa/Mozambique, British Columbia Centre of Excellence in Canada, Doctors Without Borders (MSF USA), National Center for Advancing Translational Sciences of the National Institutes of Health and Joachim Herz Foundation.
NCT02909218 and NCT03789448.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anti-HIV Agents - administration & dosage</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>antiretroviral treatment</subject><subject>Economic Status - statistics & numerical data</subject><subject>Employment - statistics & numerical data</subject><subject>Epidemiology and Global Health</subject><subject>Eswatini</subject><subject>Female</subject><subject>health economics</subject><subject>Health Facilities</subject><subject>healthcare expenditures</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - economics</subject><subject>HIV/AIDS</subject><subject>Humans</subject><subject>Male</subject><subject>Medicine</subject><subject>Middle Aged</subject><subject>randomized controlled trial</subject><subject>Time-to-Treatment - statistics & numerical data</subject><subject>Young Adult</subject><issn>2050-084X</issn><issn>2050-084X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>DOA</sourceid><recordid>eNpVkdtrFDEUhwdRbKl98l3ypiBTc53Li7CUahcWClLFt3AmOdmmzE7GJGPpf2_cbUsbAklOPr5cflX1ntGzVin5BTfe4ZnqZNe-qo45VbSmnfz9-tn8qDpN6ZaW1squY_3b6kjwTjDW9MfVsiIp4zyjre_QbpFEmGzY-YSW5OhhJGEi-QaJ381gMgmOIMTxnqx-XBM_-ewh-4KUfrn-Vc9lhVNOHwmaMBWPIWHJJuwwFZpcpLsCTP5d9cbBmPD0YTypfn67uD6_rDdX39fnq01tRNvmunOmN4q7BhQfWqoGaRyFHhEUiN5S5pBxxmjnbGNL0XBgVDR2GFwPlPbipFofvDbArZ6j30G81wG83hdC3GqI2ZsRNW2Es8o522IjBefQUC4GAdKVz6UgiuvrwTUvww6tKc-MML6QvtyZ_I3ehr-6VbyXShbBpwdBDH8WTFmXbzY4jjBhWJLmUjRdSxtOC_r5gJoYUorono5hVP_PXe9z1_vcC_3h-c2e2MeUxT9lXKtc</recordid><startdate>20200824</startdate><enddate>20200824</enddate><creator>Steinert, Janina Isabel</creator><creator>Khan, Shaukat</creator><creator>Mlambo, Khudzie</creator><creator>Walsh, Fiona J</creator><creator>Mafara, Emma</creator><creator>Lejeune, Charlotte</creator><creator>Wong, Cebele</creator><creator>Hettema, Anita</creator><creator>Ogbuoji, Osondu</creator><creator>Vollmer, Sebastian</creator><creator>De Neve, Jan-Walter</creator><creator>Mazibuko, Sikhathele</creator><creator>Okello, Velephi</creator><creator>Bärnighausen, Till</creator><creator>Geldsetzer, Pascal</creator><general>eLife Sciences Publications, Ltd</general><general>eLife Sciences Publications Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-8878-5505</orcidid><orcidid>https://orcid.org/0000-0003-2282-1005</orcidid><orcidid>https://orcid.org/0000-0003-0090-8249</orcidid><orcidid>https://orcid.org/0000-0001-7120-0075</orcidid></search><sort><creationdate>20200824</creationdate><title>A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients' economic outcomes in Eswatini</title><author>Steinert, Janina Isabel ; Khan, Shaukat ; Mlambo, Khudzie ; Walsh, Fiona J ; Mafara, Emma ; Lejeune, Charlotte ; Wong, Cebele ; Hettema, Anita ; Ogbuoji, Osondu ; Vollmer, Sebastian ; De Neve, Jan-Walter ; Mazibuko, Sikhathele ; Okello, Velephi ; Bärnighausen, Till ; Geldsetzer, Pascal</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c377t-8fc9c52f6a52b705b4cf0a9eea5a39d01fe121108fd6dea5c2a1036dbbf9a0093</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anti-HIV Agents - administration & dosage</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>antiretroviral treatment</topic><topic>Economic Status - statistics & numerical data</topic><topic>Employment - statistics & numerical data</topic><topic>Epidemiology and Global Health</topic><topic>Eswatini</topic><topic>Female</topic><topic>health economics</topic><topic>Health Facilities</topic><topic>healthcare expenditures</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - economics</topic><topic>HIV/AIDS</topic><topic>Humans</topic><topic>Male</topic><topic>Medicine</topic><topic>Middle Aged</topic><topic>randomized controlled trial</topic><topic>Time-to-Treatment - statistics & numerical data</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Steinert, Janina Isabel</creatorcontrib><creatorcontrib>Khan, Shaukat</creatorcontrib><creatorcontrib>Mlambo, Khudzie</creatorcontrib><creatorcontrib>Walsh, Fiona J</creatorcontrib><creatorcontrib>Mafara, Emma</creatorcontrib><creatorcontrib>Lejeune, Charlotte</creatorcontrib><creatorcontrib>Wong, Cebele</creatorcontrib><creatorcontrib>Hettema, Anita</creatorcontrib><creatorcontrib>Ogbuoji, Osondu</creatorcontrib><creatorcontrib>Vollmer, Sebastian</creatorcontrib><creatorcontrib>De Neve, Jan-Walter</creatorcontrib><creatorcontrib>Mazibuko, Sikhathele</creatorcontrib><creatorcontrib>Okello, Velephi</creatorcontrib><creatorcontrib>Bärnighausen, Till</creatorcontrib><creatorcontrib>Geldsetzer, Pascal</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>eLife</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Steinert, Janina Isabel</au><au>Khan, Shaukat</au><au>Mlambo, Khudzie</au><au>Walsh, Fiona J</au><au>Mafara, Emma</au><au>Lejeune, Charlotte</au><au>Wong, Cebele</au><au>Hettema, Anita</au><au>Ogbuoji, Osondu</au><au>Vollmer, Sebastian</au><au>De Neve, Jan-Walter</au><au>Mazibuko, Sikhathele</au><au>Okello, Velephi</au><au>Bärnighausen, Till</au><au>Geldsetzer, Pascal</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients' economic outcomes in Eswatini</atitle><jtitle>eLife</jtitle><addtitle>Elife</addtitle><date>2020-08-24</date><risdate>2020</risdate><volume>9</volume><issn>2050-084X</issn><eissn>2050-084X</eissn><abstract>Since 2015, the World Health Organisation (WHO) recommends immediate initiation of antiretroviral therapy (ART) for all HIV-positive patients. Epidemiological evidence points to important health benefits of immediate ART initiation; however, the policy’s impact on the economic aspects of patients' lives remains unknown.
We conducted a stepped-wedge cluster-randomised controlled trial in Eswatini to determine the causal impact of immediate ART initiation on patients’ individual- and household-level economic outcomes. Fourteen healthcare facilities were non-randomly matched into pairs and then randomly allocated to transition from the standard of care (ART eligibility at CD4 counts of <350 cells/mm3 until September 2016 and <500 cells/mm3 thereafter) to the ‘Early Initiation of ART for All’ (EAAA) intervention at one of seven timepoints. Patients, healthcare personnel, and outcome assessors remained unblinded. Data were collected via standardised paper-based surveys with HIV-positive adults who were neither pregnant nor breastfeeding. Outcomes were patients’ time use, employment status, household expenditures, and household living standards.
A total sample of 3019 participants were interviewed over the duration of the study. The mean number of participants approached at each facility per time step varied from 4 to 112 participants. Using mixed-effects negative binomial regressions accounting for time trends and clustering at the level of the healthcare facility, we found no significant difference between study arms for any economic outcome. Specifically, the EAAA intervention had no significant effect on non-resting time use (RR = 1.00 [CI: 0.96, 1.05, p=0.93]) or income-generating time use (RR = 0.94, [CI: 0.73,1.20, p=0.61]). Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93 [CI: 0.82, 1.04, p=0.21] and 0.92 [CI: 0.79, 1.06, p=0.26], respectively. We also found no significant treatment effect on households’ asset ownership and living standards (RR = 0.96, [CI 0.92, 1.00, p=0.253]). Lastly, there was no evidence of heterogeneity in effect estimates by patients’ sex, age, education, timing of HIV diagnosis and ART initiation.
Our findings do not provide evidence that should discourage further investments into scaling up immediate ART for all HIV patients.
Funded by the Dutch Postcode Lottery in the Netherlands, Alexander von Humboldt-Stiftung (Humboldt-Stiftung), the Embassy of the Kingdom of the Netherlands in South Africa/Mozambique, British Columbia Centre of Excellence in Canada, Doctors Without Borders (MSF USA), National Center for Advancing Translational Sciences of the National Institutes of Health and Joachim Herz Foundation.
NCT02909218 and NCT03789448.</abstract><cop>England</cop><pub>eLife Sciences Publications, Ltd</pub><pmid>32831169</pmid><doi>10.7554/eLife.58487</doi><orcidid>https://orcid.org/0000-0002-8878-5505</orcidid><orcidid>https://orcid.org/0000-0003-2282-1005</orcidid><orcidid>https://orcid.org/0000-0003-0090-8249</orcidid><orcidid>https://orcid.org/0000-0001-7120-0075</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adult Aged Aged, 80 and over Anti-HIV Agents - administration & dosage Anti-HIV Agents - therapeutic use antiretroviral treatment Economic Status - statistics & numerical data Employment - statistics & numerical data Epidemiology and Global Health Eswatini Female health economics Health Facilities healthcare expenditures HIV Infections - drug therapy HIV Infections - economics HIV/AIDS Humans Male Medicine Middle Aged randomized controlled trial Time-to-Treatment - statistics & numerical data Young Adult |
| title | A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients' economic outcomes in Eswatini |
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