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Background: Following the World Health Organization's (WHO) 2015 guidelines recommending initiation of antiretroviral therapy (ART) irrespective of CD4 count for all people living with HIV (PLHIV), many countries in sub-Saharan Africa have adopted this strategy to reach epidemic control. As the number of PLHIV on ART rises, maintenance of viral suppression on ART for over 90% of PLHIV remains a challenge to government health systems in resource-limited high HIV burden settings. Non facility-based antiretroviral therapy (ART) delivery for stable HIV+ patients may increase sustainable ART coverage in resource-limited settings. Within the HPTN 071 (PopART) trial, two models, home-based delivery (HBD) or adherence clubs (AC), were offered to assess whether they achieved similar viral load suppression (VLS) to standard of care (SoC). In this paper, we describe the trial design and discuss the methodological issues and challenges. Methods: A three-arm cluster randomized non-inferiority trial, nested in two urban HPTN 071 trial communities in Zambia, randomly allocated 104 zones to SoC (35), HBD (35), or AC (34). ART and adherence support were delivered 3-monthly at home (HBD), adherence clubs (AC), or clinic (SoC). Adult HIV+ patients defined as "stable" on ART were eligible for inclusion. The primary endpoint was the proportion of PLHIV with virological suppression (≤ 1000 copies HIV RNA/ml) at 12 months (± 3months) after study entry across all three arms. Viral load measurement was done at the routine government laboratories in accordance with national guidelines, annually. The study was powered to determine if either of the community-based interventions would yield a viral suppression rate drop compared to SoC of no more than 5% in its absolute value. Both community-based interventions were delivered by community HIV providers (CHiPs). An additional qualitative study using observations, interviews with PLHIV, and FGDs with community HIV providers was nested in this study to complement the quantitative data. Discussion: This trial was designed to provide rigorous randomized evidence of safety and efficacy of non-facility-based delivery of ART for stable PLHIV in high-burden resource-limited settings. This trial will inform policy regarding best practices and what is needed to strengthen scale-up of differentiated models of ART delivery in resource-limited settings. Trial registration: ClinicalTrials.gov NCT03025165. Registered on 19 January 2017 [ABSTRACT FROM AUTHOR]

Background: Health-related stigma is a complex phenomenon, the experience of which intersects with those of other adversities arising from a diversity of social inequalities and oppressive identities like gender, sexuality, and poverty – a concept called "intersectionality". Understanding this intersectionality between health-related stigma and other forms of social marginalization can provide a fuller and more comprehensive picture of stigma associated with health conditions. The main objective of this paper is to build upon the concept of intersectionality in health-related stigma by exploring the convergence of experiences of stigma and other adversities across the intersections of health and other forms of social oppressions among people living with stigmatized health conditions in Indonesia. Methods: This qualitative study interviewed 40 people affected by either of four stigmatizing health conditions (HIV, leprosy, schizophrenia, and diabetes) in Jakarta and West Java, Indonesia between March and June 2018. Data was analyzed thematically using an integrative inductive-deductive framework approach. Results: The main intersectional inequalities identified by the participants were gender and socioeconomic status (n = 21), followed by religion (n = 13), age (n = 11), co-morbidity (n = 9), disability (n = 6), and sexuality (n = 4). Based on these inequalities/identities, the participants reported of experiencing oppression because of prevailing social norms, systems, and policies (macro-level), exclusion and discrimination from societal actors (meso-level), and self-shame and stigma (micro-level). While religion and age posed adversities that negatively affected participants in macro and meso levels, they helped mitigate the negative experiences of stigma in micro level by improving self-acceptance and self-confidence. Conclusion: This study uncovered how the experience of health-related stigma intersects with other oppressions originating from the various social inequalities in an individual's life. The findings highlight the importance of acknowledging and understanding the multi-dimensional aspect of lives of people living with stigmatized health conditions, and warrant integrated multi-level and cross-cutting stigma reduction interventions to address the intersectional oppressions they experience. [ABSTRACT FROM AUTHOR]

Background: Dropout is a common problem in longitudinal clinical trials and cohort studies, and is of particular concern when dropout occurs for reasons that may be related to the outcome of interest. This paper reviews common parametric models to account for dropout and introduces a Bayesian semi-parametric varying coefficient model for exponential family longitudinal data with non-ignorable dropout.Methods: To demonstrate these methods, we present results from a simulation study and estimate the impact of drug use on longitudinal CD4 + T cell count and viral load suppression in the Women's Interagency HIV Study. Sensitivity analyses are performed to consider the impact of model assumptions on inference. We compare results between our semi-parametric method and parametric models to account for dropout, including the conditional linear model and a parametric frailty model. We also compare results to analyses that fail to account for dropout.Results: In simulation studies, we show that semi-parametric methods reduce bias and mean squared error when parametric model assumptions are violated. In analyses of the Women's Interagency HIV Study data, we find important differences in estimates of changes in CD4 + T cell count over time in untreated subjects that report drug use between different models used to account for dropout. We find steeper declines over time using our semi-parametric model, which makes fewer assumptions, compared to parametric models. Failing to account for dropout or to meet parametric assumptions of models to account for dropout could lead to underestimation of the impact of hard drug use on CD4 + cell count decline in untreated subjects. In analyses of subjects that initiated highly active anti-retroviral treatment, we find that the estimated probability of viral load suppression is lower in models that account for dropout.Conclusions: Non-ignorable dropout is an important consideration when analyzing data from longitudinal clinical trials and cohort studies. While methods that account for non-ignorable dropout must make some unavoidable assumptions that cannot be verified from the observed data, many methods make additional parametric assumptions. If these assumptions are not met, inferences can be biased, making more flexible methods with minimal assumptions important. [ABSTRACT FROM AUTHOR]

Background: Community health workers (CHWs) are increasingly engaged to address human resource shortages and fill primary healthcare gaps. In Eswatini, a cadre of CHWs called Rural Health Motivators (RHM) was introduced in 1976 to respond to key public health challenges. However, the emergence of health needs, particularly HIV/TB, has been met with inadequate programme amendments, and the role of RHMs has become marginalised following the addition of other CHWs supported by non-governmental organisations. This study was implemented to understand the role of RHMs in decentralised HIV/TB activities. In this paper, we explore the findings in relation to the recognition of RHMs and the programme.Methods: This exploratory qualitative study utilised individual in-depth interviews, group and focus group discussions, participatory methods (utilising a game format) and observations. Participants were purposively selected and comprised RHM programme implementers, community stakeholders and local and non-governmental personnel. Data collection took place between August and September 2019. Interviews were conducted in English or siSwati and transcribed. SiSwati interviews were translated directly into English. All interviews were audio-recorded, manually coded and thematically analysed. Data was validated through methodical triangulation.Results: Suboptimal organisational structure and support, primarily insufficient training and supervision for activities were factors identified through interviews and observation activities. Significant confusion of the RHM role was observed, with community expectations beyond formally endorsed tasks. Community participants expressed dissatisfaction with receiving health information only, preferring physical assistance in the form of goods. Additionally, gender emerged as a significant influencing factor on the acceptability of health messages and the engagement of RHMs with community members. Expectations and structurally limiting factors shape the extent to which RHMs are recognised as integral to the health system, at all social and organisational levels.Conclusions: Findings highlight the lack of recognition of RHMs and the programme at both community and national levels. This, along with historical neglect, has hindered the capacity of RHMs to successfully contribute to positive health outcomes for rural communities. Renewed attention and support mechanisms for this cadre are needed. Clarification of the RHM role in line with current health challenges and clearer role parameters is essential. [ABSTRACT FROM AUTHOR]

Background: Homelessness is a global issue and HIV, hepatitis C and tuberculosis are known to be prevalent in this group. Homeless populations face significant barriers to care. We aim to summarise evidence of treatment initiation and completion for homeless populations with these infections, and their associated factors, through a systematic review and meta-analysis. Methods: We will search MEDLINE, Embase and CINAHL for all study types and conference abstracts looking at either (1) treatment initiation in a cohort experiencing homelessness with at least one of HIV, hepatitis C, active tuberculosis and/or latent tuberculosis infection (LTBI); (2) treatment completion for those who initiated treatment. We will perform a meta-analysis of the proportion of those with each infection who initiate and complete treatment, as well as analysis of individual and health system factors that may affect adherence levels. We will evaluate the quality of research papers using the Newcastle-Ottawa scale. Discussion: Given the political emphasis on global elimination of these diseases, and the current lack of understanding of effective and equitable treatment adherence strategies in homeless populations, this review will provide insight to policy-makers and service providers aiming to improve homeless healthcare. Systematic review registration: PROSPERO CRD42019153150 [ABSTRACT FROM AUTHOR]

Background: The 'Primary HIV Prevention among Pregnant and Lactating Ugandan Women' (PRIMAL) randomized controlled trial aimed to assess an enhanced counseling strategy linked to extended postpartum repeat HIV testing and enhanced counseling among 820 HIV-negative pregnant and lactating women aged 18-49 years and 410 of their male partners to address the first pillar of the WHO Global Strategy for the Prevention of Mother-to-Child HIV transmission (PMTCT). This paper presents findings of qualitative studies aimed at evaluating participants' and service providers' perceptions on the acceptability and feasibility of the intervention and at understanding the effects of the intervention on risk reduction, couple communication, and emotional support from women's partners.Methods: PRIMAL Study participants were enrolled from two antenatal care clinics and randomized 1:1 to an intervention or control arm. Both arms received repeat sexually transmitted infections (STI) and HIV testing at enrolment, labor and delivery, and at 3, 6, 12, 18 and 24 months postpartum. The intervention consisted of enhanced quarterly counseling on HIV risk reduction, couple communication, family planning and nutrition delivered by study counselors through up to 24 months post-partum. Control participants received repeat standard post-test counseling. Qualitative data were collected from intervention women participants, counsellors and midwives at baseline, midline and end of the study through 18 focus group discussions and 44 key informant interviews. Data analysis followed a thematic approach using framework analysis and a matrix-based system for organizing, reducing, and synthesizing data.Results: At baseline, FGD participants mentioned multiple sexual partners and lack of condom use as the main risks for pregnant and lactating women to acquire HIV. The main reasons for having multiple sexual partners were 1) the cultural practice not to have sex in the late pre-natal and early post-natal period; 2) increased sexual desire during pregnancy; 3) alcohol abuse; 4) poverty; and 5) conflict in couples. Consistent condom use at baseline was limited due to lack of knowledge and low acceptance of condom use in couples. The majority of intervention participants enrolled as couples felt enhanced counselling improved understanding, faithfulness, mutual support and appreciation within their couple. Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use. Participants stressed the importance of providing counselling services to all couples.Conclusion: This study shows that enhanced individual and couple counselling linked to extended repeat HIV and STI testing and focusing on HIV prevention, couple communication, family planning and nutrition is a feasible and acceptable intervention that could enhance risk reduction programs among pregnant and lactating women.Trial Registration: ClinicalTrials.gov registration number NCT01882998, date of registration 21st June 2013. [ABSTRACT FROM AUTHOR]

Background: There is a need for acceptable and feasible HIV testing options to ensure people living with HIV know their status so they can access care. Pharmacist-provided HIV point-of-care testing (POCT) may overcome testing barriers, including privacy concerns, testing wait times, and improve accessibility. In the APPROACH study, we aimed to develop and assess an HIV POCT program in community pharmacies for future scale up and evaluation. This paper describes the program uptake, participant and pharmacist experiences, and implementation factors.Methods: A pharmacist-provided HIV POCT program was offered in 4 pharmacies in two Canadian provinces. A mixed methods design incorporated self-report questionnaire data, participant telephone interviews, pharmacist focus groups, workload analysis, and situational analysis to assess the uptake, acceptability and feasibility of the HIV POCT program.Results: Over the 6-month pilot, 123 HIV tests were performed. One new case of HIV was identified; this participant was linked with confirmatory testing and HIV care. Participants were predominantly male (76%), with a mean age of 35 years. This was the first HIV test for 27% participants, and 75% were at moderate to very high risk of undiagnosed HIV infection, by Denver HIV Risk Score. Questionnaires and telephone interviews showed participants were very satisfied with the program; 99% agreed HIV POCT should be routinely offered in pharmacies and 78% were willing to pay for the service. Participants felt the pharmacy was convenient, discreet, and that the pharmacist was supportive and provided education about how to reduce their future risk. Pharmacists felt prepared, confident, and expressed professional satisfaction with offering HIV POCT. Community and public health supports, clear linkage to care plans to refer participants with positive HIV POCT results, and provision of counselling tools were important enabling factors for the program. Pharmacist remuneration, integration with existing healthcare systems, and support for ongoing promotion of HIV POCT availability in pharmacies were identified as needs for future scale-up and sustainability.Conclusions: A successful model of pharmacy-based POCT, including linkage to care, was developed. Further research is needed to determine the effectiveness and cost-effectiveness of this approach in finding new diagnoses and linking them with care.Trial Registration: Retrospectively registered with clinicaltrials.gov (NCT03210701) on July 6, 2017. [ABSTRACT FROM AUTHOR]

The SWI/SNF chromatin remodeling complex is an essential regulator of transcription of cellular genes. HIV-1 infection induces exit of a core component of SWI/SNF, Ini1, into the cytoplasm and its association with the viral pre-integration complex. Several recent papers published in EMBO Journal, Journal of Biological Chemistry, and Retrovirology provide new information regarding possible functions of Ini1 and SWI/SNF in HIV life cycle. It appears that Ini1 has an inhibitory effect on pre-integration steps of HIV replication, but also contributes to stimulation of Tat-mediated transcription. This stimulation involves displacement of the nucleosome positioned at the HIV promoter. [ABSTRACT FROM AUTHOR]

Background: The treatment of mental health issues among people living with HIV (PLH) in Botswana is yet to be addressed. A recent study revealed that depressive symptoms are highly prevalent in a sample of PLH in Botswana. Based on empirical findings of a study that investigated intervention targets for PLH in Botswana, a self-help program with coaching in booklet format in the Setswana and English languages was developed, composed of cognitive behavioral techniques, coping skills interventions, and goal adjustment training. We will investigate the program for effectiveness in the treatment of depressive symptoms among PLH. Additionally, we will investigate treatment moderators and mediators. This paper describes the study protocol.Methods/design: A randomized controlled trial will be conducted to compare the booklet self-help program with coaching with an attention-only control condition, by including pre-test, post-test, and follow-up assessments. We aim to enroll 200 participants with mild to moderate depressive symptoms into the study. The self-help program contains the following main components: activation, relaxation, changing maladaptive cognitions, and the attainment of new personal goals. This content is covered over six lessons to be completed in a maximum of 8 weeks. It uses a combination of psycho-education, assignments, and exercises. The participants will work on the program 1-2 h every week for 6 weeks (maximum 8 weeks). Coaches will offer support and motivate the participants. For both groups, depressive symptoms and possible mediators will be measured three times during the intervention, and at pre-test, post-test, and follow-up.Discussion: If the intervention is found to effectively treat depressive symptoms, it will be implemented and thus help improve the psychological health of PLH in Botswana.Trial Registration: Netherlands Trial Register, NTR7428 . Registered on 23 August 2018. [ABSTRACT FROM AUTHOR]

Background: Antiretroviral drugs are a very effective therapy against HIV infection. However, the high mutation rate of HIV permits the emergence of variants that can be resistant to the drug treatment. Predicting drug resistance to previously unobserved variants is therefore very important for an optimum medical treatment. In this paper, we propose the use of weighted categorical kernel functions to predict drug resistance from virus sequence data. These kernel functions are very simple to implement and are able to take into account HIV data particularities, such as allele mixtures, and to weigh the different importance of each protein residue, as it is known that not all positions contribute equally to the resistance. Results: We analyzed 21 drugs of four classes: protease inhibitors (PI), integrase inhibitors (INI), nucleoside reverse transcriptase inhibitors (NRTI) and non-nucleoside reverse transcriptase inhibitors (NNRTI). We compared two categorical kernel functions, Overlap and Jaccard, against two well-known noncategorical kernel functions (Linear and RBF) and Random Forest (RF). Weighted versions of these kernels were also considered, where the weights were obtained from the RF decrease in node impurity. The Jaccard kernel was the best method, either in its weighted or unweighted form, for 20 out of the 21 drugs. Conclusions: Results show that kernels that take into account both the categorical nature of the data and the presence of mixtures consistently result in the best prediction model. The advantage of including weights depended on the protein targeted by the drug. In the case of reverse transcriptase, weights based in the relative importance of each position clearly increased the prediction performance, while the improvement in the protease was much smaller. This seems to be related to the distribution of weights, as measured by the Gini index. All methods described, together with documentation and examples, are freely available at https://bitbucket.org/elies_ramon/catkern. [ABSTRACT FROM AUTHOR]

Background: Heterosexual men in South Africa are a large key population to exposure to HIV, yet preferences for HIV pre-exposure prophylaxis (PrEP) among this population have not, to date, been investigated in the literature. This paper aims to explore HIV prevention preferences among heterosexual men in urban South Africa, as well as to examine the demand and characteristics of men who favour long-acting injectable (LAI) PrEP over condoms and oral PrEP.Methods: Data were collected among 178 self-reported HIV-negative heterosexual men, who were given example products and information before being asked which they preferred. Multivariate logistic regression was used to analyse which characteristics were associated with product choice.Results: 48% (n = 85) of participants preferred LAI PrEP, while 33% (n = 58) and 20% (n = 35) chose oral PrEP and condoms respectively. Having children (marginal effect = 0.22; 95% CI [0.01, 0.44]) or having higher risk attitude scores (marginal effect = 0.03; 95% CI [0.01, 0.06]) was significantly associated with a choice of LAI PrEP, while those who had unprotected anal intercourse (marginal effect = - 0.42; 95% CI [- 0.57, - 0.27]) and those who were concerned with protection against other sexually transmitted infections over HIV (marginal effect = - 0.42; 95% CI [- 0.60, - 0.24]) appeared less likely to prefer LAI PrEP.Conclusions: The results suggested a relatively high demand and theoretical acceptability for LAI PrEP among heterosexual men in urban South Africa, but there appeared to be fewer distinct predictors for the willingness to use LAI PrEP compared to studies conducted among gay and bisexual men and women. Nevertheless, the findings contribute to the mapping of the demand and determinants of heterosexual men's preferences for novel antiretroviral-based prevention in sub-Saharan Africa, and the data could aid in the differentiated design of future HIV prevention strategies using LAI PrEP in conjunction with other methods. [ABSTRACT FROM AUTHOR]

Background: HIV disproportionately infects women in many regions. Zimbabwe is one of the countries, most heavily affected. Unequal gender power relations between men and women can increase women's vulnerability to HIV. The aim of this paper was to determine the relationship between gender power and HIV sero-status among postpartum women in Zimbabwe.Methodology: A cross-sectional survey was conducted among 2042 women aged 15-49 years, attending postnatal-care at six public primary health care clinics in low-income urban communities of Harare in 2011. Women were asked about relationship power factors using an interviewer-administered questionnaire. The questionnaire included adapted WHO multi-country study items, which measure partner violence perpetrated against women. HIV status data were based on rapid HIV diagnostic tests done during earlier antenatal visits. The analysis was restricted to women with known HIV test results (n = 1951). Multivariable logistic regression analyses were performed to assess the predictors of HIV and relationship power factors.Results: HIV prevalence was 15.3% (n = 299/1951). Three quarters of the women (76.9%, n = 1438/1871) reported some level of relationship control in their current/most recent intimate relationship. HIV positive women reported higher levels of control by the male partner in their intimate relationships. In adjusted models, the study found a significant association between relationship-control by the male partner and women's HIV status (AOR 1.11, 95% CI 1.01-1.22), and the decision-making dimensions of relationship power. Although there were indications of high male partner control in participants' intimate relationships, some women still had agency, as they were able to make independent decisions to fall pregnant. These women were less likely to be HIV positive (AOR 0.54, 95% CI 0.29-1.00). Having a partner who ever refused use of a family planning method was associated with increased odds of having a positive HIV status among the postpartum women (AOR 1.88, 95% CI 1.20-2.90).Conclusion: Unequal gender power relations continue to be a risk factor for heterosexual transmission of HIV. This suggests that prevention efforts have not successfully resulted in gender equality. HIV prevention interventions should address gender power dynamics to help curb the disproportionate HIV burden among women. [ABSTRACT FROM AUTHOR]

Background: As in non-infected subjects, statins and aspirin have a pivotal preventive role in reducing the cardiovascular related morbidity and mortality in HIV infected patients. The persistence of immune activation in these subjects, could contribute to accelerate atherosclerosis, therefore, these treatments that reduce inflammation could provide additional cardiovascular protection. However the current guidelines for the use of these drugs in general population are dissimilar, with important differences between American and European ones. Aim of the present position paper is to provide recommendations aimed to overcome the actual differences and limitations among the current ones and to adapt them to the needs of HIV infected patients. Results: We propose to adopt the new ACC/AHA guidelines, simple to use and cost effective, to use the ASCVD score that seems to estimate more accurately the cardiovascular risk among these patients. We suggest to start statin therapy in all patients with a calculated 10-year risk of a cardiovascular event of 10% or greater. Rosuvastatin and atorvastatin should be preferred. LDL-C target may be adopted. Aspirin should be always associated with a statin, in secondary prevention, while in primary prevention it should be reserved only to patients with ≥ 20% 10-year risk particularly adherent to treatments, and with low risk of bleeding. We suggest to start with a dose of 100 mg/day. Finally, management of antiplatelet agents or novel oral anticoagulants may include selecting antiretrovirals with a lower potential for drug interactions or choosing agents least likely to interact with antiretrovirals. Conclusions: As demonstrated in surveys, HIV physicians are generally highly committed regarding CVD and autonomous in prescribing statins and ASA. Consequently, in the light of the previously discussed discrepancies among the different guidelines and of the incomplete indications regarding HIV-positive persons, the present suggestions could overcome the actual differences and limitations among the current ones. [ABSTRACT FROM AUTHOR]

Background: Reinforcement learning (RL) provides a promising technique to solve complex sequential decision making problems in health care domains. However, existing studies simply apply naive RL algorithms in discovering optimal treatment strategies for a targeted problem. This kind of direct applications ignores the abundant causal relationships between treatment options and the associated outcomes that are inherent in medical domains.Methods: This paper investigates how to integrate causal factors into an RL process in order to facilitate the final learning performance and increase explanations of learned strategies. A causal policy gradient algorithm is proposed and evaluated in dynamic treatment regimes (DTRs) for HIV based on a simulated computational model.Results: Simulations prove the effectiveness of the proposed algorithm for designing more efficient treatment protocols in HIV, and different definitions of the causal factors could have significant influence on the final learning performance, indicating the necessity of human prior knowledge on defining a suitable causal relationships for a given problem.Conclusions: More efficient and robust DTRs for HIV can be derived through incorporation of causal factors between options of anti-HIV drugs and the associated treatment outcomes. [ABSTRACT FROM AUTHOR]

Background: Geographic differences in HIV, syphilis and condomless sex among men who have sex with men in China remained unknown. We aimed to elucidate these spatiotemporal changing patterns in China.Methods: We conducted a spatiotemporal meta-analysis. We searched four databases for studies conducted between 2001 and 2015. We included studies that reported original data of HIV/syphilis prevalence in China, the study's area/province, and period of data collection. We grouped studies into six regions and four time periods. We examined the changing patterns of national and regional prevalence of HIV, syphilis and condomless sex.Results: Search results yielded 2119 papers, and 272 were included in the meta-analysis. The sample sizes of the studies ranged from 19 to 47,231. National HIV prevalence increased from 3.8% (95% CI 3.0-4.8) in 2001-07 to 6.6% (5.6-7.7) in 2013-15. In most regions, the rise occurred before 2010 and the HIV prevalence remained relatively stable afterwards, except for the Northwest which showed a considerable increase since 2008. National syphilis prevalence decreased from 12.3% (10.2-14.9) in 2001-07 to 7.1% (5.6-8.9) in 2013-15.Conclusions: The trends of HIV and syphilis infections have been effectively curbed in MSM in most regions of China. Continuous efforts, particularly promotion of condom use, are needed to further reduce these infections. [ABSTRACT FROM AUTHOR]

Background: Despite persistent calls for HIV care to adopt a chronic care approach, few HIV treatment services have been able to establish service arrangements that prioritise self-management. To prevent cardiovascular and other chronic disease outcomes, the HealthMap program aims to enhance routine HIV care with opportunities for self-management support. This paper outlines the systematic process that was used to design and develop the HealthMap program, prior to its evaluation in a cluster-randomised trial.Methods: Program development, planning and evaluation was informed by the PRECEDE-PROCOEDE Model and an Intervention Mapping approach and involved four steps: (1) a multifaceted needs assessment; (2) the identification of intervention priorities; (3) exploration and identification of the antecedents and reinforcing factors required to initiate and sustain desired change of risk behaviours; and finally (4) the development of intervention goals, strategies and methods and integrating them into a comprehensive description of the intervention components.Results: The logic model incorporated the program's guiding principles, program elements, hypothesised causal processes, and intended program outcomes. Grounding the development of HealthMap on a clear conceptual base, informed by the research literature and stakeholder's perspectives, has ensured that the HealthMap program is targeted, relevant, provides transparency, and enables effective program evaluation.Conclusions: The use of a systematic process for intervention development facilitated the development of an intervention that is patient centred, accessible, and focuses on the key determinants of health-related outcomes for people with HIV in Australia. The techniques used here may offer a useful methodology for those involved in the development and implementation of complex interventions. [ABSTRACT FROM AUTHOR]

High medicines prices increasingly pose challenges for universal access to treatments of communicable and non-communicable diseases. New essential medicines are often patent-protected which sustains high prices in many countries, including in low- and middle-income countries. To respond to the HIV/AIDS crisis of the late nineties and to increase access to antiretroviral treatment, certain flexibilities contained in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS flexibilities) have been clarified and in some respects strengthened at the global level. They have been applied by a number of countries to ensure access to lower-priced generic medicines to treat HIV/AIDS. Governments in the South African Development Community (SADC) have also used TRIPS flexibilities to gain access to lower-priced generic medicines. This paper documents 15 instances of the use of TRIPS flexibilities by eight SADC Member States during the period 2001–2016. Of those, six concerned least developed countries (LDCs) that declared non-enforcement of pharmaceutical patents pursuant to a new LDC transition provision. All instances occurred in the context of medicines procurement for HIV treatment. Such flexibilities can, however, also be used to overcome patent barriers to gain access to generic medicines for other diseases, including NCDs. The SADC, being a regional bloc with over 50% least developed country Members, can make use of the regional exception, a TRIPS flexibility that facilitates the production or procurement of generic medicines to the benefit of the entire region. SADC's Pharmaceutical Business Plan proposes strategies for increased collaboration and pooled procurement of medicines. [ABSTRACT FROM AUTHOR]

Background: Like other countries, Tanzania instituted mobile and outreach testing approaches to address low HIV testing rates at health facilities and enhance linkage to care. Available evidence from hard-to-reach rural settings of Mbeya region, Tanzania suggests that clients testing HIV+ at facility-based sites are more likely to link to care, and to link sooner, than those testing at mobile sites. This paper (1) describes the populations accessing HIV testing at mobile/outreach and facility-based testing sites, and (2) compares processes and dynamics from testing to linkage to care between these two testing models from the same study context. Methods: An explanatory sequential mixed-method study (a) reviewed records of all clients (n = 11,773) testing at 8 mobile and 8 facility-based testing sites over 6 months; (b), reviewed guidelines; (c) observed HIV testing sites (n = 10) and Care and Treatment Centers (CTCs) (n = 8); (d) applied questionnaires at 0, 3 and 6 months to a cohort of 1012 HIV newly-diagnosed clients from the 16 sites; and (e) conducted focus group discussions (n = 8) and in-depth qualitative interviews with cohort members (n = 10) and health care providers (n = 20). Results: More clients tested at mobile/outreach than facility-based sites (56% vs 44% of 11,733, p < 0.001). Mobile site clients were more likely to be younger and male (p < 0.001). More clients testing at facility sites were HIV positive (21.5% vs. 7.9% of 11,733, p < 0.001). All sites in both testing models adhered to national HIV testing and care guidelines. Staff at mobile sites showed more proactive efforts to support linkage to care, and clients report favouring the confidentiality of mobile sites to avoid stigma. Clients who tested at mobile/outreach sites faced longer delays and waiting times at treatment sites (CTCs). Conclusions: Rural mobile/outreach HIV testing sites reach more people than facility based sites but they reach a different clientèle which is less likely to be HIV +ve and appears to be less "linkage-ready". Despite more proactive care and confidentiality at mobile sites, linkage to care is worse than for clients who tested at facility-based sites. Our findings highlight a combination of (a) patient-level factors, including stigma; and (b) well-established procedures and routines for each step between testing and initiation of treatment in facility-based sites. Long waiting times at treatment sites are a further barrier that must be addressed. [ABSTRACT FROM AUTHOR]

Background: There is scanty or inconclusive evidence on which cervical cancer screening tool is effective and suitable for human immunodeficiency virus (HIV)-seropositive women. The aim of this review was to assess, synthesise and document published evidence relating to the available cervical cancer screening modalities for HIV-seropositive women in developing countries. This paper did not review the issue of human papillomavirus (HPV) prophylactic vaccine on HIV-seropositive women. Methods: Five electronic databases were systematically searched from inception to January 2018 for relevant published original research examining cervical cancer prevention modalities for HPV infection, abnormal cytology and direct visualisation of the cervix amongst HIV-seropositive women in developing countries. Extra studies were identified through reference list and citation tracking. Results: Due to methodological and clinical heterogeneity, a narrative synthesis was presented. Of the 2559 articles, 149 underwent full-text screening and 25 were included in the review. Included studies were of moderate quality, and no exclusions were made based on quality or bias. There is no standard cervical cancer screening test or programme for HIV-seropositive women and countries screening according to available resources and expertise. The screening methods used for HIV-seropositive women are the same for HIV-negative women, with varying clinical performance and accuracy. The main cervical cancer screening methods described for HIV-seropositive women are HPV deoxyribonucleic acid/messenger RNA (DNA/mRNA) testing (n = 16, 64.0%), visual inspection with acetic acid (VIA) (n = 13, 52.0%) and Pap smear (n = 11, 44.0%). HPV testing has a better accuracy/efficiency than other methods with a sensitivity of 80.0–97.0% and specificity of 51.0–78.0%. Sequential screening using VIA or visual inspection with Lugol's iodine (VILI) and HPV testing has shown better clinical performance in screening HIV-seropositive women. Conclusion: Although cervical cancer screening exists in almost all developing countries, what is missing is both opportunistic and systematic organised population-based screenings. Cervical cancer screening programmes need to be integrated into already existing HIV services to enable early detection and treatment. There is a need to offer opportunistic and coordinated screening programmes that are provider-initiated to promote early identification of cervical precancerous lesions. Systematic review registration: PROSPERO CRD42018095702 [ABSTRACT FROM AUTHOR]

Background: Although HIV prevalence in Cambodia has declined to 0.6% among the general population, the prevalence remains high among female sex workers (14.0%) and men who have sex with men (2.3%). Over the past 10 years, the number of people who use drugs (PWUDs) has increased considerably. PWUDs, especially people who inject drugs (PWIDs), who have multiple sex partners or unprotected sex contribute to a higher HIV prevalence. This paper aims to estimate the prevalence of HIV across PWUD groups and to identify factors associated with HIV infection.Methods: Respondent-driven sampling (RDS) was used to recruit 1626 consenting PWUDs in 9 provinces in 2012. Questionnaires and blood specimens were collected. HIV prevalence estimates were calculated using RDSAT 7.1. Individual weightings for HIV were generated with RDSAT and used for a weighted analysis in STATA 13. Multivariate logistic regression was used to identify the independent factors associated with HIV prevalence.Results: Most of the PWUDs were men (82.0%), and 7.3% were PWIDs. Non-PWIDs, especially users of amphetamine-type stimulants (ATS), represented the larger proportion of the participants (81.5%). The median age for of the PWUDs was 24.0 years (IQR: 20-29). The HIV prevalence among the PWUDs was 5.1% (95% CI: 4.1-6.2), 24.8%, among PWIDs and 4.0% among non-PWIDs. The HIV prevalence among female PWIDs was 37.5, and 22.5% among male PWIDs. Four factors were independently associated with HIV infection: female sex, with AOR = 7.8 (95% CI: 3.00-20.35); age groups 21-29 and older (AOR = 10.3, 95% CI: 1.2-20.4); and using drugs for ≥12 months (AOR = 4.0, 95% CI: 1.38-11.35). Finally, injecting drugs remained a strong predictor of HIV infection, with an AOR = 4.1 (95% CI: 1.53-10.96).Conclusion: HIV prevalence remains high among PWIDs. Harm reduction efforts, such as needle and syringe provision programs, must improve their coverage. Innovative strategies are needed to reach sub-groups of PWUDs, especially women who inject drugs. Furthermore, the large proportion of non-PWIDs, especially ATS users, should not be ignored. Therefore, combined HIV prevention and harm reduction programs should integrate ATS users. [ABSTRACT FROM AUTHOR]

Background: Long-distance truck drivers in Africa are particularly at risk of HIV acquisition and offering self-testing could help increase testing coverage in this hard-to-reach population. The aims of this study are twofold: (1) to examine the preference structures of truck drivers in Kenya regarding HIV testing service delivery models and what they mean for the roll-out of HIV self-testing, and (2) to compare the preference data collected from a hypothetical discrete choice experiment with the actual choices made by participants in the intervention arm of a randomised controlled trial (RCT) who were offered HIV testing choices.Methods: Using data from 150 truck drivers, this paper examines whether the stated preferences regarding HIV testing in a discrete choice experiment predict the actual test selected when offered HIV testing choices. Conditional logit models were used for main effects analysis and stratified models were run by HIV testing choices made in the trial to assess if the attributes preferred differed by test chosen.Results: The strongest driver of stated preference among all participants was cost. However, two preferences diverged between those who actually chose self-testing in the RCT and those who chose a provider administered test: the type of test (p < 0.001) and the type of counselling (p = 0.003). Self-testers preferred oral-testing to finger-prick testing (OR 1.26 p = 0.005), while non-self-testers preferred finger-prick testing (OR 0.56 p < 0.001). Non-self-testers preferred in-person counselling to telephonic counselling (OR 0.64 p < 0.001), while self-testers were indifferent to type of counselling. Preferences in both groups regarding who administered the test were not significant.Conclusions: We found stated preference structures helped explain the actual choices participants made regarding the type of HIV testing they accepted. Offering oral testing may be an effective strategy for increasing willingness to test among certain groups of truck drivers. However, the importance of in-person counselling and support, and concern that an oral test cannot detect HIV infection may mean that continuing to offer finger-prick testing at roadside wellness centres will best align with the preferences of those already attending these facilities. More research is needed to explore whether who administers the HIV test (provider versus self) makes any difference.Trial Registration: This trial is registered with the Registry for International Development Impact Evaluations ( RIDE ID#55847d64a454f ). [ABSTRACT FROM AUTHOR]

Background: Health services for adolescents are increasingly recognised as a priority in low- and middle-income countries (LMICs). The Adolescent and Youth Friendly Service (AYFS) approach has been promoted in South Africa by the National Department of Health and partners, as a means of standardising the quality of adolescent health services in the country. The objective of this paper is to detail the evaluation of AYFS against defined standards to inform initiatives for strengthening these services.Methods: A cross-sectional assessment of AYFS was carried out in 14 healthcare facilities in a sub-district of Gauteng Province and 16 in a sub-district in North West Province, South Africa. Data on adolescent care and service management systems were collected through interviews with healthcare providers, non-clinical staff and document review. Responses were scored using a tool based on national and World Health Organisation criteria for ten AYFS standards.Results: Mean scores for the ten standards showed substantial variation across facilities in the two sub-Districts, with Gauteng Province scoring lower than the North West for 9 standards. The sub-district median for Gauteng was 38% and the North West 48%. In both provinces standards related to the general service delivery, such as Standards 4 and 5, scored above 75%. Assessment of services specifically addressing sexual, reproductive and mental health (Standard 3) showed that almost all these services were scored above 50%. Exploration of services related to psycho-social and physical assessments (Standard 8) demonstrated differences in the healthcare facilities' management of adolescents' presenting complaints and their comprehensive management including psycho-social status and risk profile. Additionally, none of the facilities in either sub-district was able to meet the minimum criteria for the five standards required for AYFS recognition.Conclusion: Facilities had the essential components for general service delivery in place, but adolescent-specific service provision was lacking. AYFS is a government priority, but additional support for facilities is needed to achieve the agreed standards. Meeting these standards could make a major contribution to securing adolescents' health, especially in preventing unintended pregnancies and HIV as well as improving psycho-social management. [ABSTRACT FROM AUTHOR]

Background: Adolescents living with HIV experience worse HIV care outcomes compared to adults, especially during transition from pediatric to adult care. However, data regarding adolescents are limited. This paper describes and compares characteristics of male and female adolescents living with HIV preparing for transition from pediatric to adult care in Cambodia.Methods: This cross-sectional study was conducted in August 2016 among 328 adolescents aged 15-17, randomly selected from 11 antiretroviral therapy (ART) clinics. Data were collected using a structured questionnaire, and descriptive analyses were conducted to compare characteristics of male and female adolescents.Results: Of total, 55.2% were male, and 40.8% were living with parents. Majority (82.6%) got HIV infection from their mothers. Overall, adolescents had received ART for an average of 8.4 years, and HIV care for 9.5 years. Additionally, 82.4% were on first line ART regimen. Mean CD4 count from the most recent test was 672 cells/mm3, and viral load was 7686 copies/mL. Overall, 95.6% were adherent to ART on Visual Analogue Scale. About half (50.7%) had never disclosed their HIV status to anyone, while the remaining had disclosed it to their siblings (24.2%), friends (13.0%), schoolteachers (2.4%), or other (5.8%). A fifth reported having had boy or girlfriends, but few (2.1%) had ever had sexual intercourse. Females were more likely to have been engaged in sexual intercourse, and none reported having used a condom in their last intercourse. Few participants reported having ever used tobacco (1.8%), or any kind of illicit drugs (0.9%), but almost a fifth (20.7%) had a history of alcohol use. The majority (82.1%) were aware that they were receiving ART. HIV-related knowledge was suboptimal among the sample.Conclusions: This study provides a snapshot of immunological, virological, adherence, and disclosure outcomes that should be tracked during and following healthcare transition to evaluate the effectiveness of the transition program. Findings showed high ART adherence, low likelihood of disclosure outside of family circles, sub-optimal condom use, and poor knowledge of HIV. To provide individualized support for healthcare transition, pediatric and adult clinics need to ensure that these characteristics are taken into account. [ABSTRACT FROM AUTHOR]

Background: The rollout of universal, lifelong treatment for all HIV-positive pregnant and breastfeeding women ("Option B+") has rapidly increased the number of women initiating antiretroviral treatment (ART) and requiring ART care postpartum. In a pilot project in South Africa, eligible postpartum women were offered the choice of referral to the standard of care, a local primary health care clinic, or a community-based model of differentiated ART services, the adherence club (AC). ACs have typically enrolled only non-pregnant and non-postpartum adults; postpartum women had not previously been referred directly from antenatal care. There is little evidence regarding postpartum women's preferences for and experiences of differentiated models of care, or the capacity of this particular model to cater to their specific needs. This qualitative paper reports on feedback from both postpartum women and health workers who care for them on their respective experiences of the AC.Methods: One-on-one in-depth qualitative interviews were conducted with 19 (23%) of the 84 postpartum women who selected the AC and were retained at approximately 12 months postpartum, and 9 health workers who staff the AC. Data were transcribed and thematically analysed using NVivo 11.Results: Postpartum women's inclusion in the AC was acceptable for both participants and health workers. Health workers were welcoming of postpartum women but expressed concerns about prospects for longer term adherence and retention, and raised logistical issues they felt might compromise trust with AC members in general.Conclusions: Enrolling postpartum women in mixed groups with the general adult population is feasible and acceptable. Preliminary recommendations are offered and may assist in supporting the specific needs of postpartum women transitioning from antenatal ART care.Trial Registration: Number NCT02417675 clinicaltrials.gov/ct2/show/record/NCT02417675 (retrospective reg.). [ABSTRACT FROM AUTHOR]

Background: In the United States, problematic stimulant use is a prevalent and difficult to treat problem among men who have sex with men (MSM), as well as a major driver of HIV transmission through the large number of sexual partners and concomitant condomless anal sex (CAS). Evidence-based behavioral studies that address problematic stimulant use in MSM at risk for HIV infection are also lacking. In this paper, we describe the design of a behavioral intervention trial to reduce sexual risk behavior and stimulant use in HIV-uninfected MSM.Methods: This study, funded by the National Institute on Drug Abuse (NIDA), is a randomized controlled trial (RCT) testing an integrated HIV risk reduction and behavioral activation counseling intervention (IMPACT) for HIV-uninfected, stimulant using MSM in Boston, MA, and Miami, FL. Participants are randomized (2:2:1) to either (1) the IMPACT intervention; (2) a relaxation condition, an active therapy time- and intensity-matched control; or (3) a standard of care risk reduction counseling comparison. At enrollment, all participants receive an HIV test and pre- and post-test counseling. The primary outcome is the difference in the rate of change in the number of self-reported condomless anal sex acts without the protection of consistent Pre-Exposure Prophylaxis (PrEP) use, as well as reductions in stimulant use during the prior 4-months. Major assessments are conducted at baseline, 4-, 8-, and 12-month follow-up visits.Discussion: Effective and sustainable behavioral interventions are sorely needed to reduce HIV acquisition in stimulant using MSM at risk for HIV infection. In this study, we will evaluate the evidence of efficacy of the IMPACT intervention to reduce HIV acquisition in HIV-uninfected, stimulant-using MSM. If found effective, the intervention tested here holds promise for being readily integrated into real-world clinical settings.Trial Registration: ClinicalTrials.gov number NCT03175159 , registered June 5, 2017. [ABSTRACT FROM AUTHOR]

Background: Unstable settings present challenges for the effective provision of antiretroviral treatment (ART). In this paper, we summarize the experience and results of providing ART and implementing contingency plans during acute instability in the Central African Republic (CAR) and Yemen. Case presentation: In CAR, MSF has provided HIV care in three conflict-affected rural regions; these were put on hold throughout the acute phase of violence. "Run-away bags" containing 3 or 4 months of ART were distributed to patients at MSF facilities. Among 1820 HIV patients enrolled into care, 1440 (79%) initiated ART. By December 2016, 782 (54%) patients were still under ART, 354 (25%) have been lost to follow up and 182 (13%) had died. In 2013, when violence disrupted services, 683 patients were receiving ART. Between September–December 2013, 594 (87%) patients received runaway bags and by February 2014, 313 (53%) of these patients returned to the clinic. In Yemen, when violence erupted, patients received a health card that included a helpline to call in case of drug shortages in admission to emergency stocks; this was not possible in CAR due to lack of a functioning telephone network. One thousand six hundred fifty-five PLWHA have been enrolled in care and 1470 (89%) initiated ART; 1056 (72%) are still followed on ART, 126 (9%) were lost to follow up, and 288 (20%) died. In January 2011 clashes began and by April 2011 MSF medical activities were interrupted. Of the 363 patients receiving ART, 363 (100%) received emergency bags to cover 9 months and by February 2012, 354 (98%) patients returned to care. In March 2015 a new wave of conflict affected Yemen, forcing HIV activities to revert to contingency planning. Conclusions: This experience provides further evidence that provision of HIV treatment and emergency drug stocks can be successfully provided to most patients in both conflict-affected settings. [ABSTRACT FROM AUTHOR]

Background: Asset-based economic empowerment interventions, which take an integrated approach to building human, social, and economic capital, have shown promise in their ability to reduce HIV risk for young people, including adolescent girls, in sub-Saharan Africa. Similarly, community and family strengthening interventions have proven beneficial in addressing mental health and behavioral challenges of adolescents transitioning to adulthood. Yet, few programs aimed at addressing sexual risk have applied combination interventions to address economic stability and mental health within the traditional framework of health education and HIV counseling/testing. This paper describes a study protocol for a 5-year, NIMH-funded, cluster randomized-controlled trial to evaluate a combination intervention aimed at reducing HIV risk among adolescent girls in Uganda. The intervention, titled Suubi4Her, combines savings-led economic empowerment through youth development accounts (YDA) with an innovative family strengthening component delivered via Multiple Family Groups (MFG).Methods: Suubi4Her will be evaluated via a three-arm cluster randomized-controlled trial design (YDA only, YDA + MFG, Usual Care) in 42 secondary schools in the Central region of Uganda, targeting a total of 1260 girls (ages 15-17 at enrollment). Assessments will occur at baseline, 12, 24, and 36 months. This study addresses two primary outcomes: 1) change in HIV risk behavior and 2) change in mental health functioning. Secondary exploratory outcomes include HIV and STI incidence, pregnancy, educational attainment, financial savings behavior, gender attitudes, and self-esteem. For potential scale-up, cost effectiveness analysis will be employed to compare the relative costs and outcomes associated with each study arm.Conclusions: Suubi4Her will be one of the first prospective studies to examine the impact and cost of a combination intervention integrating economic and social components to reduce known HIV risk factors and improve mental health functioning among adolescent girls, while concurrently exploring mental health as a mediator in HIV risk reduction. The findings will illuminate the pathways that connect economic needs, mental health, family support, and HIV risk. If successful, the results will promote holistic HIV prevention strategies to reduce risk among adolescent girls in Uganda and potentially the broader sub-Saharan Africa region.Trial Registration: Clinical Trials NCT03307226 (Registered: 10/11/17). [ABSTRACT FROM AUTHOR]

Background: A tenth of all people who inject drugs in Kenya are women, yet their social contexts and experiences remain poorly understood. This paper reports how multiple forms of stigma are experienced by women who inject drugs in coastal Kenya and the impact that they have on their ability to access essential health services. Methods: In 2015, in-depth interviews and focus group discussions were held with 45 women who inject drugs in two coastal towns. These data were supplemented with in-depth interviews with five individual stakeholders involved in service provision to this population. Data were analyzed thematically using NVivo. Results: Women who inject drugs experience multiple stigmas, often simultaneously. These included the external stigma and self-stigma of injection drug use, external gender-related stigma of being a female injecting drug user, and the external stigma of being HIV positive (i.e., among those living with HIV). Stigma led to rejection, social exclusion, low self-esteem, and delay or denial of services at health facilities. Conclusion: HIV and harm reduction programs should incorporate interventions that address different forms of stigma among women who inject drugs in coastal Kenya. Addressing stigma will require a combination of individual, social, and structural interventions, such as collective empowerment of injecting drug users, training of healthcare providers on issues and needs of women who inject drugs, peer accompaniment to health facilities, addressing wider social determinants of stigma and discrimination, and expansion of harm reduction interventions to change perceptions of communities towards women who inject drugs. [ABSTRACT FROM AUTHOR]

Background: In 2011, a decision was made to scale up a pilot innovation involving 'adherence clubs' as a form of differentiated care for HIV positive people in the public sector antiretroviral therapy programme in the Western Cape Province of South Africa. In 2016 we were involved in the qualitative aspect of an evaluation of the adherence club model, the overall objective of which was to assess the health outcomes for patients accessing clubs through epidemiological analysis, and to conduct a health systems analysis to evaluate how the model of care performed at scale. In this paper we adopt a complex adaptive systems lens to analyse planned organisational change through intervention in a state health system. We explore the challenges associated with taking to scale a pilot that began as a relatively simple innovation by a non-governmental organisation.Results: Our analysis reveals how a programme initially representing a simple, unitary system in terms of management and clinical governance had evolved into a complex, differentiated care system. An innovation that was assessed as an excellent idea and received political backing, worked well whilst supported on a small scale. However, as scaling up progressed, challenges have emerged at the same time as support has waned. We identified a 'tipping point' at which the system was more likely to fail, as vulnerabilities magnified and the capacity for adaptation was exceeded. Yet the study also revealed the impressive capacity that a health system can have for catalysing novel approaches.Conclusions: We argue that innovation in largescale, complex programmes in health systems is a continuous process that requires ongoing support and attention to new innovation as challenges emerge. Rapid scaling up is also likely to require recourse to further resources, and a culture of iterative learning to address emerging challenges and mitigate complex system errors. These are necessary steps to the future success of adherence clubs as a cornerstone of differentiated care. Further research is needed to assess the equity and quality outcomes of a differentiated care model and to ensure the inclusive distribution of the benefits to all categories of people living with HIV. [ABSTRACT FROM AUTHOR]

Background: Implementation research (IR) facilitates health systems strengthening and optimal patient outcomes by generating evidence for scale-up of efficacious strategies in context. Thus, difficulties in generating IR evidence, particularly in limited-resource settings with wide disease prevention and treatment gaps, need to be anticipated and addressed. Nigeria is a priority country for the prevention of mother-to-child transmission of HIV (PMTCT). This paper analyses the experiences of four PMTCT IR studies in Nigeria, and proffers solutions to major challenges encountered during implementation.Studies Included and Findings: Multicentre PMTCT IR studies conducted in Nigeria during the Global Plan's assessment period (2011 to 2015) were included. Four studies were identified, namely The Baby Shower Trial, Optimizing PMTCT, MoMent and Lafiyan Jikin Mata. Major common challenges encountered were categorised as 'External' (beyond the control of study teams) and 'Internal' (amenable to rectification by study teams). External challenges included healthcare worker strikes and turnover, acts and threats of ethnic and political violence and terrorism, and multiplicity of required local ethical reviews. Internal challenges included limited research capacity among study staff, research staff turnover and travel restrictions hindering study site visits. Deliberate research capacity-building was provided to study staff through multiple opportunities before and during study implementation. Post-study employment opportunities and pathways for further research career-building are suggested as incentives for study staff retention. Engagement of study community-resident personnel minimised research staff turnover in violence-prone areas.Conclusions: The IR environment in Nigeria is extremely diverse and challenging, yet, with local experience and anticipatory planning, innovative solutions can be implemented to modulate internal challenges. Issues still remain with healthcare worker strikes and often unpredictable insecurity. There is a dire need for cooperation between institutional review boards across Nigeria in order to minimise the multiplicity of reviews for multicentre studies. External challenges need to be addressed by high-level stakeholders, given Nigeria's crucial regional and global position in the fight against the HIV epidemic. [ABSTRACT FROM AUTHOR]

Background: Increasing routine HIV testing among key populations is a public health imperative, so improving access to acceptable testing options for those in need is a priority. Despite increasing targeted distribution and uptake of HIV self-sampling kits (SSKs) among men who have sex with men in the UK, little is known about why targeted SSK interventions for black African users are not as wide-spread or well-used. This paper addresses this key gap, offering insight into why some groups may be less likely than others to adopt certain types of SSK interventions in particular contexts. These data were collected during the development phase of a larger study to explore the feasibility and acceptability of targeted distribution of SSKs to black African people.Methods: We undertook 6 focus groups with members of the public who self-identified as black African (n = 48), 6 groups with specialists providing HIV and social services to black African people (n = 53), and interviews with HIV specialist consultants and policy-makers (n = 9). Framework analysis was undertaken, using inductive and deductive analysis to develop and check themes.Results: We found three valuable components of targeted SSK interventions for this population: the use of settings and technologies that increase choice and autonomy; targeted offers of HIV testing that preserve privacy and do not exacerbate HIV stigma; and ensuring that the specific kit being used (in this case, the TINY vial) is perceived as simple and reliable.Conclusions: This unique and rigorous research offers insights into participants' views on SSK interventions, offering key considerations when targeting this population.. Given the plethora of HIV testing options, our work demonstrates that those commissioning and delivering SSK interventions will need to clarify (for users and providers) how each kit type and intervention design adds value. Most significantly, these findings demonstrate that without a strong locus of control over their own circumstances and personal information, black African people are less likely to feel that they can pursue an HIV test that is safe and secure. Thus, where profound social inequalities persist, so will inequalities in HIV testing uptake - by any means. [ABSTRACT FROM AUTHOR]

In the absence of a vaccine or a cure, identification of novel HIV-1 inhibitors remains important. A paper in Retrovirology describes a rationally designed bi-specific protein that irreversibly damages the viral envelope glycoprotein complex via a two-punch mechanism. In contrast to traditional drugs that inhibit essential steps in the viral life cycle at the cell surface or in the infected cells, this inhibitor cripples free virus in the absence of cells. [ABSTRACT FROM AUTHOR]

Background: By 1990, 94 percent of the acquired immunodeficiency syndrome (AIDS) cases in Romania were in children less than 13 years of age. The majority of the cases were identified in the city of Constanta. The purpose of this paper was to describe the current burden of pediatric human immunodeficiency virus (HIV) infection in the Constanta county.Methods: A cross-sectional study was designed to address the primary objective. Between April 1999 and March 2000, all living cases of pediatric HIV infection in the Constanta county were identified from records at the HIV hospital clinic which serves the Constanta county. Standard demographic, social, clinical, treatment and hospitalization data were collected for each study subject. Data were analyzed according to cross-sectional study design methodology.Results: Of the 762 subjects, the majority were seven to 11 years of age, lived with their parents and attended school. Only 70% of the fathers and 13% of the mothers were employed. Horizontal transmission accounted for 90% of the cases. Most of the children had moderate to severe disease as indicated by their AIDS-defining signs; 40% had AIDS. Less than half of the children were receiving antiretroviral therapy (ART). ART and children of mothers with a high school or greater education were independent predictors of long-term non-progression of HIV disease.Conclusions: This cross-sectional study demonstrated that ten years after the HIV epidemic was identified in Romania, it remains a health and economic burden. The infected children are very ill, but ART is not available for all. The proportion with vertical transmission has increased from an estimated four % to nine %. Our findings support the need to get HIV therapy to economically challenged countries such as Romania. [ABSTRACT FROM AUTHOR]