1 University of Washington, Global Health, Seattle, WA, United States, 2 Kenya Medical Research Institute, Nairobi, Kenya, 3 Makerere University, Kampala, Uganda, 4 Kabwohe Clinical Research Center (KCRC), Kabwohe, Uganda, 5 Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya, 6 Fred Hutchinson Cancer Research Center, Seattle, WA, United States, 7 Massachusetts General Hospital, Boston, MA, United States Background: Pre-exposure prophylaxis (PrEP) and anti- retroviral therapy (ART) have high efficacy for HIV prevention among heterosexual African HIV discordant couples. Assessing initiation and adherence to antiretroviral-based HIV prevention strategies outside of clinical trial settings is a priority. Methods: Enrollment of high-risk HIV discordant couples into an open-label PrEP and ART demonstration project in Kenya and Uganda began in November 2012. Without PrEP and ART, anticipated HIV incidence in this cohort would be ‡ 5% per year. ART is offered per national guidelines and PrEP is offered as a ‘bridge’ to ART, provided between study enrollment and the time when the HIV-infected partner is likely to have achieved viral suppression. ART adherence is assessed through biannual HIV RNA measurements and MEMS caps are used to assess PrEP adherence. Results: As of April 2014, 714 high risk couples were enrolled, 67% with an HIV infected woman, and 42% with an HIV in- fected partner eligible to initiate ART. At enrollment, 96% of HIV uninfected participants initiated PrEP and 92% of ART- eligible participants planned to start ART. To date, 51% of couples have had ‡ 6 months of expected follow-up and retention through 6 months is 88% for HIV uninfected and 93% for in- fected participants. Among HIV uninfected participants on PrEP, 77% took ‡ 80% of expected PrEP doses by MEMS be- tween enrollment and their 6 month clinic visit. Travel and re- lationship dissolution are common reasons for missing PrEP doses, reported at 27% and 18% of visits with missed doses. Among HIV infected participants initiating ART at enrollment, 85% had a plasma HIV RNA concentration < 400 copies/ml by the 6 month visit. Six months after enrollment, 85% of couples were using PrEP and/or ART: 45% PrEP only, 14% ART only, and 26% both PrEP and ART. Conclusions: PrEP and ART initiation and early adherence are high among high-risk African HIV discordant couples partici- pating in an open-label demonstration project of PrEP and ART for HIV prevention. OA28.02 Evaluation of a Risk Score Tool to Identify Higher-risk HIV-1 Serodiscordant Couples for Antiretroviral- based HIV-1 Prevention Elizabeth M. Irungu 1 , Renee Heffron 2 , Nelly Mugo 2,3 , Kenneth Ngure 2,4 , Elly Katabira 5 , Nulu Bulya 5 , Elizabeth Bukusi 2,3 , Josephine Odoyo 3 , Stephen Asiimwe 6 , Edna Tindimwebwa 6 , Deborah Donnell 2,7 , Connie Celum 2 , Jared M. Baeten 2 , Part- ners Demonstration Project Team 1 Kenyatta National Hospital, Nairobi, Kenya, 2 University of Washington, Seattle, WA, United States, 3 Kenya Medical Re- search Institute, Nairobi, Kenya, 4 Jomo Kenyatta University of Agriculture and Technology, Ruiru, Kenya, 5 Makerere Uni- versity, Kampala, Uganda, 6 Kabwohe Clinical Research Center (KCRC), Kabwohe, Uganda, 7 Fred Hutchinson Cancer Re- search Center, Seattle, WA, United States Background: Antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) significantly reduce HIV transmission within heterosexual HIV serodiscordant couples. To maximize impact and minimize costs, ART and PrEP interventions should be of- fered to couples at highest risk of HIV transmission. Methods: The Partners Demonstration Project is an open-label, prospective cohort study of PrEP and ART for HIV prevention among high risk HIV serodiscordant couples in Kenya and Uganda. We evaluated the feasibility of using a validated em- piric risk score (Kahle et al. JAIDS 2013) that uses a combina- tion of variables (age, number of children, male circumcision status, plasma HIV levels, condom use, marital status) to iden- tify couples at highest risk for HIV transmission. Results: Since November 2012, 1217 couples have screened and 714 enrolled. Of the screened couples, 274 (23%) scored 0–4 (anticipated HIV incidence of £ 2% per year), 493 (41%) scored 5–6 (anticipated HIV incidence of *5% per year) and 450 (37%) scored ‡ 7 (anticipated HIV incidence of ‡ 7% per year). Couples scoring ‡ 5 were eligible for enrollment and 76% en- tered the study. The median age of the HIV uninfected partner was 29.5 [IQR 26, 36] years and the HIV seronegative partner was male in 67% of partnerships. Over half (57%) had no children, 92% had unprotected sex in the month prior to screening and 34% of HIV susceptible men were uncircumcised. Among HIV infected members of the couples, the median CD4 count was 436 [IQR 274,634] cells/mm 3 and 41.3% had a plasma viral load > 50,000 copies/ml. Conclusions: An empiric risk score derived from observational analyses of African HIV serodiscordant couples identified higher risk HIV discordant couples for a demonstration project of PrEP and ART for HIV prevention. Three-quarters of the higher risk couples who were eligible have enrolled. Risk scores could be useful for recruitment of higher risk persons and couples into future HIV prevention trials and demonstra- tion projects. OA28.03 Facing the Realities of HIV Universal Test and Treat: Early Lessons Learned from the Delivery of the HPTN071/ PopART Study Intervention in Zambia Kwame Shanaube 1 , Sam Griffith 2 , Musonda Simwinga 1 , Ephraim Sakala 1 , Chepela Ngulube 1 , Sandra Simbeza 1 , Martin Mutonyi 1 , Sarah Fidler 3 , Richard Hayes 4 , Helen Ayles 1,5 , HPTN071-PopART study Team 1 ZAMBART Project, Lusaka, Zambia, 2 FHI 360, Science Fa- cilitation Department, Washington, NC, United States, 3 Im- perial College, Department of Infectious Disease Epidemiology, London, United Kingdom, 4 London School of Hygiene & Tropical Medicine, Department of Infectious Disease Epide- miology, London, United Kingdom, 5 London School of Hy- giene & Tropical Medicine, Department of Clinical Research, London, United Kingdom Background: The HPTN071 (PopART) is a 5-year community randomized study of a combination HIV prevention package in 21 communities in Zambia and South Africa. HPTN071 is one of the first studies to evaluate a combined HIV prevention package (including universal HIV testing and ART for all HIV + indi- viduals irrespective of CD4 count (UTT)) on HIV incidence at community-level. Methods: 21 communities were randomly assigned to one of three study arms. The study intervention consists of door to door A72