CROI 2020 Abstract eBook

Abstract eBook

Oral Abstracts

131LB DIFFERENTIATED CARE FOR POSTPARTUM ART IN SOUTH AFRICAN WOMEN LIVING WITH HIV: AN RCT Jasantha Odayar 1 , Maia Lesosky 1 , Thokozile R. Malaba 1 , Siti Kabanda 1 , Joanna Allerton 1 , Nai-Chung Hu 1 , Elton E. Mukonda 1 , Stephanie Fourie 2 , Shahieda Jacobs 2 , David Huang 2 , Cathy D. Kalombo 2 , Nei-Yuan M. Hsiao 3 , Landon Myer 1 , for the Postpartum Adherence Clubs for Antiretroviral Therapy (PACART) Trial 1 University of Cape Town, Cape Town, South Africa, 2 Western Cape Provincial Department of Health, Cape Town, South Africa, 3 National Health Laboratory Service, Cape Town, South Africa Background: Differentiated service delivery (DSD) models are used increasingly to deliver ART in high-burden settings but there are few data on DSD models for postpartumwomen, who are at high risk of non-adherence and elevated viral load (VL). Methods: From Jan’16 to Sept’17 we enrolled consecutive postpartumwomen who initiated ART (TFV+XTC+EFV) during pregnancy and met local DSD eligibility (clinically stable with VL<400 c/mL) at a large urban primary care antenatal clinic (NCT03200054). Women were randomised to be referred to (i) a community-based “Adherence Club” (AC, the local DSD model: lay health worker-led groups of 20-30 patients with 2-4 monthly ART dispensing at a community venue) or (ii) routine primary health care clinics (PHC; the local standard with nurse/doctor-led care). Outcomes were measured through Nov’19 with study visits and batched VL separate from care in either arm at 3, 6, 12, 18 and 24m postpartum. Endpoints were time to VL>1000 c/mL (primary) and >50 c/mL (secondary) by intention-to-treat; per protocol analyses were restricted to women who attended the allocated service within 3m of referral. Results: Overall 412 women were randomised at a median of 10d postpartum (IQR, 6-20d; at enrolment median age 27y; median duration of prenatal ART 21w; 100% VL<1000 and 88%<50 c/mL); baseline characteristics did not differ by arm. Attendance at the allocated service within 3m of referral per protocol was higher in AC (77%) vs PHC (68%); 90% completed the final study visit at 24m postpartumwith no difference by arm. For the primary endpoint, 16% and 29% of women in AC experienced a cumulative incidence of VL>1000 c/ mL by 12m and 24m, compared to 23% and 37% in PHC, respectively (HR=0.71; 95%CI=0.50-1.01; p=0.056; Figure). For the secondary endpoint, 32% and 44% of women in AC had VL>50 c/mL by 12m and 24m, compared to 42% and 56% in PHC, respectively (HR=0.69; 95%CI=0.52-0.92; p=0.009). Findings were unchanged in per protocol analyses and across a priori demographic and clinical subgroups. Infant HIV testing, MTCT, breastfeeding duration, family planning use, and other outcomes were similar between AC and PHC arms. Conclusion: Postpartum referral to DSD models such as “Adherence Clubs” is associated with an approximately 30% reduction in elevated VL and may be an important part of strategies to improve women’s virologic outcomes on ART.

Background: Despite WHO recommendations for early infant virologic diagnostic testing (EID) of HIV-exposed infants (HEI), in 2017, only 50% of HEI in 21 high-priority countries received an EID test in the first 2 months of life. This study builds on a Unitaid-funded, 9-country point-of-care (POC) EID implementation project that sought to improve access to EID and reduce turnaround time from sample collection to results availability. Methods: This randomized stepped-wedge trial evaluated the effect of POC EID compared to standard-of-care conventional central lab-based testing on timely receipt of results in HEI. The study was conducted over two years, in two countries, Kenya and Zimbabwe. In each country, 18 health facilities were randomly selected from the list of project sites to serve as study sites. Study sites were randomized to one of four time points to transition from conventional EID testing to POC EID testing. HIV-exposed infants were eligible for inclusion if they presented for EID testing at the 4-8 week time-point recommended by the WHO. The study was powered to detect at least a 50% increase in the proportion of caregivers receiving HIV test results by 12 weeks of infant age after introduction of POC, assuming a design effect of 2. Results: In Zimbabwe, caregivers with infants tested under POC EID were 4.56 (95% CI: 4.5, 4.6) times more likely to receive the infant HIV test results by 12 weeks of age compared to conventional EID. In Kenya, caregivers with infants tested under POC EID were 1.29 (95% CI: 1.27, 1.3) times more likely to receive the infant HIV test results within 12 weeks of age compared to conventional EID. POC EID significantly reduced the turn-around-time between sample collection and return of infant HIV test results to caregiver by an average of 8.41 weeks (95% CI: 8.87, 7.95) in Zimbabwe and 3.29 weeks (95% CI: 3.55, 3.03). For HIV-infected infants, POC EID significantly reduced the time between sample collection and infant antiretroviral therapy (ART) initiation by an average of 7.97 weeks (95% CI: 3.62, 12.32) in Zimbabwe and 2.43 weeks (95% CI: 1.34 , 3.52) in Kenya. Conclusion: POC EID improved return of results by 12 weeks of age, turnaround time to receipt of results, as well as rapid initiation on ART for infected infants. Even where conventional lab-based EID systems had been strengthened, as in Kenya, POC EID had significant benefit in providing results to caregivers quickly.

Oral Abstracts

133 A RANDOMIZED TRIAL OF POINT-OF-CARE EARLY INFANT HIV DIAGNOSIS IN ZAMBIA Carla J. Chibwesha 1 , Katie Mollan 1 , Catherine Ford 2 , Aaron Shibemba 3 , Pooja Saha 1 , Benjamin H. Chi 1 , Lloyd Mulenga 3 , Mildred Lusaka 2 , Felistas Mbewe 2 , Jeffrey S. Stringer 1 1 University of North Carolina at Chapel Hill, Chapel Hill, NC, USA, 2 University of North Carolina in Zambia, Lusaka, Zambia, 3 University Teaching Hospital, Lusaka, Zambia Background: Early infant HIV diagnosis (EID) requires molecular methods historically limited to central labs. As a result, many HIV-exposed infants either have no access to EID or must wait months for a result. Point of care (POC) EID offers a potential solution. Methods: We conducted a POC EID trial at 6 clinics in Lusaka, Zambia. HIV- exposed infants were randomly allocated between 4-12 weeks of life to: (a) POC EID – same-day testing with Alere q or (b) Offsite EID – testing of dried heel prick samples at a central lab with Roche COBAS. The trial provided a safety net by testing an archived sample if off-site EID results did not return within 4 weeks. HIV-infected infants were referred for immediate antiretroviral therapy (ART). Our primary outcome was defined as being alive, in care, and virally suppressed (viral load <200 copies/mL) at 12 months.

132 POC EID VS CENTRAL LAB TESTING: RESULTS FROM A STEP-WEDGE RCT IN KENYA AND ZIMBABWE Emma Sacks 1 , Rhoderick Machekano 1 , Bernard Ochuka 1 , Haurovi Mafaune 1 , Addmore Chadambuka 1 , Collins Otieno 2 , Agnes Mahomva 3 , George Githuka 4 , Jean-Francois Lemaire 1 , Flavia Bianchi 1 , Jennifer Cohn 1 1 Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC, USA, 2 African Society for Laboratory Medicine, Gaborone, Botswana, 3 Zimbabwe Ministry of Health and Child Care, Harare, Zimbabwe, 4 Ministry of Health, Nairobi, Kenya

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CROI 2020