Rashida A Ferrand|Victoria Simms|Ethel Dauya|Tsitsi Bandason|Grace McHugh|Hilda Mujuru|Prosper Chonzi|Joanna Busza|Katharina Kranzer|Shungu Munyati|Helen A. Weiss|Richard Hayes
The effect of community-based support for caregivers on the risk of virological failure in children and adolescents with HIV in Harare, Zimbabwe (ZENITH): an open-label, randomised controlled trial
Biomedical Research and Training Institute|London School of Hygiene & Tropical Medicine|London School of Hygiene & Tropical Medicine|Biomedical Research and Training Institute|Biomedical Research and Training Institute|Biomedical Research and Training Institute|University of Zimbabwe|London School of Hygiene & Tropical Medicine|Research Center Borstel - Leibniz Lung Center|London School of Hygiene & Tropical Medicine|Biomedical Research and Training Institute|London School of Hygiene & Tropical Medicine|London School of Hygiene & Tropical Medicine
h3backgroundh3 children adolescents poorer hiv treatment outcomes adults aimed assess effect communitybased support caregivers hivinfected children adolescents key mediators children engaging care treatment outcomes h3methodsh3 openlabel randomised contolled trial recruited children aged 615 years newlydiagnosed hiv attending primary healthcare clinics harare zimbabwe children randomly assigned receive decentralised primary healthcare clinicbased hiv care control group according national guidelines 18 months decentralised care plus structured support visits trained community health workers intervention group according national guidelines 18 months primary outcomes proportion participants died hiv viral load 400 copies per ml higher 12 months antiretroviral therapy art initiation among started art within 6 months enrolment proportion missed two scheduled clinic visits 18 months postenrolment among participants analyses completecase modifiedintentiontotreat trial registered pan african clinical trials registry number pactr201212000442288 h3findingsh3 january 2013 january 2015 470 participants tested hivpositive seven study primary healthcare clinics screened eligibility 334 eligible children adolescents 166 randomly assigned intervention group 168 control group median age participants 11 years iqr 813 178 53 girls among 238 participants started art within 6 months enrolment proportion died viral load 400 copiesml higher 12 months postart initiation significantly lower intervention group control group 31 33 94 participants ivsi 42 49 86 participants respectively adjusted odds ratio aor 046 95 ci 023089 p002 proportion children missing two scheduled visits similar intervention group control group 27 17 155 ivsi 30 18 165 aor 092 95 ci 049174 p079 one participant withdrew trial 240 days enrolment 12 died followup five intervention group seven control group h3interpretationh3 communitybased support caregivers high potential scalability could substantial effect hiv virological suppression children adolescents group disproportionately poor treatment outcomes h3fundingh3 wellcome trust