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Background Effective interventions to reduce HIV incidence in sub-Saharan Africa are urgently needed. Mathematical modelling and the HIV Prevention Trials Network (HPTN) 052 trial results suggest that universal HIV testing combined with immediate antiretroviral treatment (ART) should substantially reduce incidence and may eliminate HIV as a public health problem. We describe the rationale and design of a trial to evaluate this hypothesis. Methods/Design A rigorously-designed trial of universal testing and treatment (UTT) interventions is needed because: i) it is unknown whether these interventions can be delivered to scale with adequate uptake; ii) there are many uncertainties in the models such that the population-level impact of these interventions is unknown; and ii) there are potential adverse effects including sexual risk disinhibition, HIV-related stigma, over-burdening of health systems, poor adherence, toxicity, and drug resistance. In the HPTN 071 (PopART) trial, 21 communities in Zambia and South Africa (total population 1.2 m) will be randomly allocated to three arms. Arm A will receive the full PopART combination HIV prevention package including annual home-based HIV testing, promotion of medical male circumcision for HIV-negative men, and offer of immediate ART for those testing HIV-positive; Arm B will receive the full package except that ART initiation will follow current national guidelines; Arm C will receive standard of care. A Population Cohort of 2,500 adults will be randomly selected in each community and followed for 3 years to measure the primary outcome of HIV incidence. Based on model projections, the trial will be well-powered to detect predicted effects on HIV incidence and secondary outcomes. Discussion Trial results, combined with modelling and cost data, will provide short-term and long-term estimates of cost-effectiveness of UTT interventions. Importantly, the three-arm design will enable assessment of how much could be achieved by optimal delivery of current policies and the costs and benefits of extending this to UTT. Trial registration ClinicalTrials.gov NCT01900977. [ABSTRACT FROM AUTHOR]

Background In order to maximize the benefits of HIV care and treatment investments in sub-Saharan Africa, programs can broaden to target other diseases amenable to screening and efficient management. We nested cervical cancer screening into family planning clinics at select sites also receiving PEPFAR support for antiretroviral therapy (ART) rollout. This was done using visual inspection with acetic acid (VIA) by maternal child health nurses. We report on achievements and obstacles in the first year of the program in rural Mozambique. Methods VIA was taught to clinic nurses and hospital physicians, with a regular clinical feedback loop for quality evaluation and retraining. Cryotherapy using carbon dioxide as the refrigerant was provided at clinics; loop electrosurgical excision procedure (LEEP) and surgery were provided at the provincial hospital for serious cases. No pathology services were available. Results Nurses screened 4651 women using VIA in Zambézia Province in year one of the program, more than double the Ministry of Health service target. VIA was judged positive for squamous intraepithelial lesions in 8% ( n=380) of the women (9% if age ≥30 years ( n=3154) and 7% if age <30 years ( n=1497); p=0.02). Of the 380 VIA-positive women, 4% ( n=16) had lesions (0.3% of 4651 total screened) requiring referral to Quelimane Provincial Hospital. Fourteen (88%) of these 16 women were seen at the hospital, but records were inadequate to judge outcomes. Of women screened, 2714 (58%) either had knowledge of their HIV status prior to VIA or were subsequently sent for HIV testing, of which 583 (21%) were HIV positive. Conclusions Screening and clinical services were successfully provided on a large scale for the first time ever in these rural clinics. However, health manpower shortages, equipment problems, poor paper record systems and a limited ability to follow-up patients inhibited the quality of the cervical cancer screening services. Using prior HIV investments, chronic disease screening and management for cervical cancer is feasible even in severely resource-constrained rural Africa. [ABSTRACT FROM AUTHOR]