CROI 2019 Abstract eBook
wk, p=0.004). There were no grade 3 or higher adverse effects attributed to DMPA. Conclusion: DMPA, when given with EFV-based ART and RIF-based TB therapy, was safe and well tolerated. MPA clearance was higher than in controls, leading to sub-therapeutic concentrations of MPA in some women at 10 and 12 weeks post-dose, though progesterone levels typically associated with ovulation were not observed. It may be prudent to dose DMPA more frequently than every 12 weeks in women on EFV with HIV-associated TB taking RIF.
TB at SOC than CBI sites (61% vs 92%, p=0.07). The yield of child contacts per adult TB case was higher at CBI than SOC sites (0.40 vs. 0.20, p=0.06). Conclusion: The number of child contacts identified was similar across study arms, but more child contacts per adult TB case were identified and subsequently screened at CBI compared with SOC sites. However, the yield of child TB contacts requires further optimization as there are many missed opportunities to diagnose or prevent TB. Additional research is needed to enhance the definition of child household contacts and overcome barriers to CCM that impede identification and screening of child TB contacts in high TB/ HIV burden settings.
79 IMPROVING CHILD TUBERCULOSIS CONTACT MANAGEMENT IN LESOTHO Yael Hirsch-Moverman 1 , Andrea Howard 1 , Limakatso Lebelo 1 , Koen Frederix 2 , Aprielle Wills 1 , Anneke Hesseling 3 , Joanne E. Mantell 4 , Sharon Nachman 5 , Llang Maama-Maime 6 , Wafaa M. El-Sadr 1 1 ICAP at Columbia University, New York, NY, USA, 2 ICAP at Columbia University– Lesotho, Maseru, Lesotho, 3 Stellenbosch University, Cape Town, South Africa, 4 New York State Psychiatric Institute, New York, NY, USA, 5 Stony Brook University, Stony Brook, NY, USA, 6 Ministry of Health, Maseru, Lesotho Background: Child TB contact management (CCM), including identification and screening of HIV-negative children <5 years and HIV-positive children regardless of age, who live in households with adult TB patients, is a proven strategy for preventing progression to TB and TB case finding. However, CCM implementation is suboptimal in high TB/HIV burden settings, such as Lesotho. The PREVENT Study was a cluster randomized trial to evaluate the effectiveness of a community-based intervention (CBI) to improve CCM in Lesotho. Methods: Ten clinics were randomized to CBI or standard of care (SOC). CBI addressed the complex provider-, patient-, and caregiver-related barriers to childhood TB prevention through several interventions: nurse training and mentorship; health education for caregivers and patients by village health workers (VHW); adherence support with weekly messages and facility-based VHWwho supervised community-based VHW; and multidisciplinary team meetings, where programmatic data were reviewed. Routine program data were abstracted from TB registers and cards for all adult TB cases >18 years registered during the study period, and their child contacts. The primary outcome was the yield (number) of child contacts identified and screened per adult TB case. Generalized linear mixed models were used to test for differences between study arms. Results: From 01/17-06/18, 1017 new adult TB patients were recorded in the TB register, 505 at CBI and 512 at SOC sites; >70%were HIV co-infected. At CBI, 99% of TB cards were located and contact section was completed for 99% of TB cases compared with 91% and 67%, respectively, at SOC sites (Figure). Overall, per adult TB cases, 220/505 child contacts were identified at CBI and 170/512 child contacts at SOC sites (p=0.16). Fewer identified children were screened for
80LB SAFETY & PK OF WEEKLY RIFAPENTINE/ISONIAZID (3HP) IN ADULTS WITH HIV ON DOLUTEGRAVIR Kelly E. Dooley 1 , Gavin Churchyard 2 , Radojka M. Savic 3 , Akshay Gupte 1 , Mark A. Marzinke 1 , Nan Zhang 3 , Vinodh Edward 2 , Lisa Wolf 1 , Modulakgotla Sebe 2 , Morongwe Likoti 2 , Mark Fyvie 4 , Innocent Shibambo 4 , Trevor Beattie 2 , Richard E. Chaisson 1 , for the DOLPHIN Study Team 1 Johns Hopkins University School of Medicine, Baltimore, MD, USA, 2 The Aurum Institute, Johannesburg, South Africa, 3 University of California San Francisco, San Francisco, CA, USA, 4 Vx Pharma, Pretoria, South Africa Background: Short-course preventive therapy with 12 once-weekly rifapentine/isoniazid doses (3HP) could transform TB control, but drug interactions with antiretrovirals may pose implementation challenges. In a previous trial, 3HP administered with dolutegravir (DTG) resulted in serious adverse events (AE) in 2/4 healthy subjects (fever, hypotension, elevated transaminases); the study was halted. We conducted a Phase I/II study of 3HP and DTG in adults with HIV to characterize safety, drug interactions, and viral suppression. Methods: HIV infected adults with undetectable viral load on efavirenz (EFV)- based regimens were recruited into 3 groups. All received DTG in place of EFV for 8 weeks, then began 3HP; after 3HP completion, all participants were followed 4 more weeks. Viral loads were measured at baseline and weeks 11 and 24. Groups 1A (n=12) and 1B (n=18) had intensive DTG PK sampling performed at week 8 (pre-HP), then weeks 11 and 16 following the 3rd and 8th doses of HP. Group 2 (n=30) were treated with the same schedule and had sparse DTG PK sampling at weeks 8, 11 and 16. Primary endpoints were 1) grade >3 AE and 2) population PK parameters of DTG with or without HP. An independent Study Monitoring Committee recommended release of results following its second review. Results: Of the 60 participants who received 3HP, 43 (70%) were female, median (IQR) age was 40 (35-48) years, all were black African, median (IQR) CD4 was 683 (447-935) cells/mm3, and median (IQR) BMI was 28.9 (24.0-32.9) kg/m2. All participants received ≥6 HP doses at the time of this report. Three
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