All testing strategies had relatively low per client costs. Hospital-based HCT most readily identified HIV-infected individuals eligible for treatment, whereas home-based strategies more efficiently reached populations with low rates of prior testing and HIV-infected people with higher CD4 cell counts. Multiple HCT strategies with different costs and efficiencies can be used to meet the UNAIDS/WHO call for universal HCT access by 2010.

for the CONSERVE Group IMPORTANCE Extenuating circumstances can trigger unplanned changes to randomized trials and introduce methodological, ethical, feasibility, and analytical challenges that can potentially compromise the validity of findings. Numerous randomized trials have required changes in response to the COVID-19 pandemic, but guidance for reporting such modifications is incomplete.OBJECTIVE As a joint extension for the CONSORT and SPIRIT reporting guidelines, CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances) aims to improve reporting of trial protocols and completed trials that undergo important modifications in response to extenuating circumstances. EVIDENCE A panel of 37 international trial investigators, patient representatives, methodologists and statisticians, ethicists, funders, regulators, and journal editors convened to develop the guideline. The panel developed CONSERVE following an accelerated, iterative process between June 2020 and February 2021 involving (1) a rapid literature review of multiple databases (OVID Medline, OVID EMBASE, and EBSCO CINAHL) and gray literature sources from 2003 to March 2021; (2) consensus-based panelist meetings using a modified Delphi process and surveys; and (3) a global survey of trial stakeholders.FINDINGS The rapid review yielded 41 673 citations, of which 38 titles were relevant, including emerging guidance from regulatory and funding agencies for managing the effects of the COVID-19 pandemic on trials. However, no generalizable guidance for all circumstances in which trials and trial protocols might face unanticipated modifications were identified. The CONSERVE panel used these findings to develop a consensus reporting guidelines following 4 rounds of meetings and surveys. Responses were received from 198 professionals from 34 countries, of whom 90% (n = 178) indicated that they understood the concept definitions and 85.4% (n = 169) indicated that they understood and could use the implementation tool. Feedback from survey respondents was used to finalize the guideline and confirm that the guideline's core concepts were applicable and had utility for the trial community. CONSERVE incorporates an implementation tool and checklists tailored to trial reports and trial protocols for which extenuating circumstances have resulted in important modifications to the intended study procedures. The checklists include 4 sections capturing extenuating circumstances, important modifications, responsible parties, and interim data analyses.CONCLUSIONS AND RELEVANCE CONSERVE offers an extension to CONSORT and SPIRIT that could improve the transparency, quality, and completeness of reporting important modifications to trials in extenuating circumstances such as COVID-19.

BackgroundHIV prevalence among female sex workers (FSWs) in high burden countries in sub-Saharan Africa varies between 24 and 72%, however their access to HIV services remains limited. This study explored FSWs’ perspectives of the barriers and opportunities to HIV service access in Uganda.MethodsThe cross-sectional qualitative study was conducted between October and December 2013. Twenty-four focus group discussions were conducted with 190 FSWs in 12 districts. Data were analysed using manifest content analysis, using Atlas.ti software, based on the socio-ecological model.ResultsFSWs indicated that HIV services were available and these included condoms, HIV testing and treatment, and management of sexually transmitted infections. However, access to HIV services was affected by several individual, societal, structural, and policy related barriers. Individual level factors included limited awareness of some prevention services, fears, and misconceptions while societal stigma was prominent. Structural and policy level barriers included inconvenient hours of operation of the clinics, inflexible facility based distribution of condoms, interuptions in the supply of condoms and other commodities, and limited package of services with virtually no access to lubricants, HIV pre- and post-exposure prophylaxis, and support following client perpetrated violence. Policies such as partner testing and involvement at antenatal care, and using only one facility for antiretroviral drug refills hindered HIV service uptake and retention in care. FSWs had major concerns with the quality of services especially discrimination and rude remarks from providers, denial or delay of services, and potential for breach of confidentiality. However, some FSWs reported positive experiences including interface with friendly providers and participated in formal and informal FSW groups, which supported them to access health services.ConclusionDespite availability of services, FSWs faced major challenges in access to services. Comprehensive multilevel interventions targeting individual, societal, structural and policy level barriers are required to increase access to HIVservices among FSWs in Uganda. Policy and institutional adjustments should emphasize quality friendly services and expanding the package of services to meet the needs of FSWs.

BackgroundIn 2012, Uganda started implementing lifelong antiretroviral therapy (ART) for prevention of mother to child transmission (PMTCT) in line with the WHO 2012 guidelines. This study explored experiences of HIV infected pregnant and breastfeeding women regarding barriers and facilitators to uptake and adherence to lifelong ART.MethodsThis was a cross-sectional qualitative study conducted in three districts (Masaka, Mityana and Luwero) in Uganda, between February and May 2014. We conducted in-depth interviews with 57 pregnant and breastfeeding women receiving care in six health facilities, who had been on lifelong ART for at least 6 months. Data analysis was done using a content thematic approach with Atlas-ti software.ResultsInitiation of lifelong ART was done the same day the mother tested HIV positive. Several women felt the counselling was inadequate and had reservations about taking ART for life. The main motivation to initiate and adhere to ART was the desire to have an HIV-free baby. Adherence was a challenge, ranging from not taking the drugs at the right time, to completely missing doses and clinic appointments. Support from their male partners and peer family support groups enhanced good adherence. Fear to disclose HIV status to partners, drug related factors (side effects and the big size of the tablet), and HIV stigma were major barriers to ART initiation and adherence. Transition from antenatal care to HIV chronic care clinics was a challenge due to fear of stigma and discrimination.ConclusionsIn order to maximize the benefits of lifelong ART, adequate preparation of women before ART initiation and on-going support through family support groups and male partner engagement are critical, particularly after birth and cessation of breastfeeding.

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