Risk Screening Tools Could Potentially Miss HIV-Positive Individuals Who Seek Testing Services: A Secondary Program Data Analysis on the Performance Characteristics of an Adolescent and Adult HIV Risk Screening Tool in Uganda.

Improving HIV testing efficiency saves financial and material resources for health. We conducted a secondary data analysis of routinely collected HIV risk-screening program data in Uganda, from October to November 2019, to determine the performance characteristics of the adolescent and adult HIV risk screening tools in public health facilities. A total of 19,854 clients had been screened for HIV testing eligibility and tested for HIV. The overall positivity rate (cluster-weighted prevalence of HIV) among those screened was 4.5% (95% CI: 4.1-4.8) versus 3.71% (95% CI: 3.06-4.50) among those not screened. The sensitivity and specificity of the risk screening tool were 91% (95% CI: 89-93) and 25% (24.2-26), respectively. With screening, the number needed to test to identify one PLHIV was reduced from 27 to 22. Although risk screening would have led to a 24.5% (4825/19,704) reduction in testing volume, 9.3% (68/732) of PLHIV would have been missed and be misclassified as not eligible for testing. The cost saving per PLHIV identified was minimally reduced by 3% from USD 69 without screening to USD 66.9 with screening. Since the treatment-adjusted prevalence of HIV is dropping globally, overzealous use of risk screening tools to determine who to test or not carries the potential of missing PLHIV due to their limited specificity. We recommend the use of scientifically validated HIV risk screening tools, and a need to explore the use of HIV self-testing as a test for tirage to minimize misclassification of people who seek HIV testing services.

The practice of pilot/feasibility studies in informing the conduct of HIV related clinical trials in sub-Saharan Africa: A scoping review.

Introduction: Pilot/feasibility studies represent a fundamental phase of the research process and play a vital role in the preliminary planning of a full size HIV clinical trial. Published HIV clinical trial protocols were reviewed to establish the extent to which the proposed HIV clinical trials are informed by a prior pilot/feasibility study. Methods: The JBI methodology for scoping reviews was followed. Six databases were systematically searched to identify articles for inclusion. Results: Thirty two (32) published HIV study protocols were included. Articles were in the English language and were published in the past 10 years (2011-2020). The review results showed that the majority of HIV-related clinical trials in sub-Saharan Africa were not informed by pilot/feasibility studies. The results further indicated that the number of HIV clinical trials informed by a pilot/feasibility study have been on the increase in the 8 years' period since 2012, a trend that indicates positive uptake of pilot studies in HIV related studies. A few select countries (South Africa, Uganda, Zimbabwe, Malawi and Kenya) comprised more than 70% of all clinical trials that were informed by a pilot/feasibility study, conducted in sub Saharan Africa. Conclusions: Although there is an increasing interest among researchers to integrate pilot/feasibility studies in HIV related research, limited countries in sub-Saharan Africa appear to have embraced this trend. Strategies that can motivate researchers to engage in a culture of incorporating pilot/feasibility studies in HIV related research should be implemented.

Emotional Reaction to the First Dose of COVID-19 Vaccine: Postvaccination Decline in Anxiety and Stress among Anxious Individuals and Increase among Individuals with Normal Prevaccination Anxiety Levels.

Although vaccination has been adopted by the WHO to limit worldwide transmission of COVID-19, people's worries about COVID-19 vaccines may suppress their desire for vaccination despite vaccine availability. This study aimed to investigate anxiety and stress symptoms among 250 Jordanians (mean age = 43.18 ± 6.34 years, 72% females) who received their first vaccine dose. The respondents completed the anxiety and stress subscales of the Depression Anxiety and Stress scale 21 (DASS-21) before and after vaccination. The respondents expressed more moderate-severe levels of stress before than after vaccination (20.8% and 13.2%, respectively). Meanwhile, 37.2% and 45.2% of the respondents expressed moderate-severe anxiety before and after vaccination, respectively. Wilcoxon signed-rank test revealed that the drop in the level of stress from before- (median (IQR) = 5 (1-8)) to after vaccination (median (IQR) = 3 (1-7)) was statistically significant (z = -3.81, p = 0.001, r = 0.17) while the increase in anxiety was not. Anxiety significantly dropped postvaccination among individuals experiencing mild to severe anxiety before vaccination. Similarly, stress and anxiety significantly increased among individuals expressing normal anxiety before vaccination (z = -3.57 and -8.24, p values = 0.001, r = 0.16 and 0.37, respectively). Age positively correlated with postvaccination anxiety among respondents with mild prevaccination anxiety, and it negatively correlated with the prevaccination level of stress in the normal-anxiety group. Gender, marital status, respondents' level of education, and history of COVID-19 infection had no significant correlation with anxiety or stress at either point of measurement. Overcoming their hesitancy to receive COVID-19 vaccines, individuals with normal levels of anxiety experienced a rise in their distress symptoms following immunization. On the contrary, vaccination seemed to desensitize anxious individuals. Policymakers need to formulate a population-specific plan to increase vaccine preparedness and promote psychological well-being over all during the pandemic.

COVID-19 may exacerbate the clinical, structural and psychological barriers to retention in care among women living with HIV in rural and peri-urban settings in Uganda.

BACKGROUND: Retention of pregnant and breastfeeding women and their infants in HIV care still remains low in Uganda. Recent literature has shown that the effects of COVID-19 mitigation measures may increase disease burden of common illnesses including HIV, Tuberculosis, Malaria and other key public health outcomes such as maternal mortality. A research program was undertaken to locate disengaged HIV positive women on option B+ and supported them to reengage in care. A 1 year follow up done following the tracing revealed that some women still disengaged from care. We aimed to establish the barriers to and facilitators for reengagement in care among previously traced women on option B+, and how these could have been impacted by the COVID-19 pandemic. METHODS: This was a cross sectional qualitative study using individual interviews conducted in June and July, 2020, a period when the COVID-19 response measures such as lockdown and restrictions on transport were being observed in Uganda. Study participants were drawn from nine peri-urban and rural public healthcare facilities. Purposive sampling was used to select women still engaged in and those who disengaged from care approximately after 1 year since they were last contacted. Seventeen participants were included. Data was analysed using the content analysis approach. RESULTS: Women reported various barriers that affected their reengagement and retention in care during the COVID-19 pandemic. These included structural barriers such as transport difficulties and financial constraints; clinical barriers which included unsupportive healthcare workers, short supply of drugs, clinic delays, lack of privacy and medicine side effects; and psychosocial barriers such as perceived or experienced stigma and non-disclosure of HIV sero-status. Supportive structures such as family, community-based medicine distribution models, and a friendly healthcare environment were key facilitators to retention in care among this group. The COVID-19 pandemic was reported to exacerbate the barriers to retention in care. CONCLUSIONS: COVID-19 may exacerbate barriers to retention in HIV care among those who have experienced previous disengagement. We recommend community-based models such as drop out centres, peer facilitated distribution and community outreaches as alternative measures for access to ART during the COVID-19 pandemic.

Facilitated transition in HIV drug trial closure: A conceptual model for HIV post-trial care.

Within the HIV clinical trial field, there are gaps in existing ethical regulations in relation to post-trial care. There is need to develop post-trial care guidelines that are flexible and sensitive to local contexts and to the specific needs of different groups of participants, particularly in low income contexts. Evidence regarding HIV trial closure and post-trial care is required to underpin the development of appropriate policies in this area. This article reports research from Uganda that develops a new model of 'Facilitated Transition' to conceptualize the transition process of HIV positive trial participants from 'research' to 'usual care' health facilities after trial conclusion. This was a qualitative grounded theory study that included 21 adult HIV positive post-trial participants and 22 research staff, undertaken between October 2014 and August 2015. The findings showed that trial closure is a complex process for HIV positive participants which includes three phases: the pre-closure, trial-closure, and post-trial phases. The model highlights a range of different needs of research participants and suggests specific and person-centred interventions that can be delivered at different phases with the aim of improving health outcomes and experiences for trial participants in low income settings during trial closure. Further research needs to be done to verify the model in other contexts and for other conditions.

Moving to Another World: Understanding the Impact of Clinical Trial Closure on Research Participants Living With HIV in Uganda.

Despite an increasing need for clinical trials involving people living with HIV (PLWH), little is known about how PLWH experience trial closure, particularly in low-income countries, where the majority of trials take place. We sought to explore the impact of trial closure on PLWH in Uganda. This was an interpretive, grounded theory study using in-depth interviews, conducted between October 2014 and August 2015. Adult participants (N = 23) from 3 trials were included. The findings indicated that trial closure was represented as "moving to another world" and was an emotional transition, linked to a loss of quality care in the research environment, the need to find alternative health facilities, fear of experiencing unwanted side effects, a desire to receive trial feedback, and difficulties linking to posttrial care. We concluded that PLWH leaving trials in a resource-limited setting required holistic care to facilitate their transition back to "usual care."

The views and experiences of nurses and midwives in the provision and management of provider-initiated HIV testing and counseling: a systematic review of qualitative evidence.

BACKGROUND: Global progress towards HIV prevention and care is contingent upon increasing the number of those aware of their status through HIV testing. Provider-initiated HIV testing and counseling is recommended globally as a strategy to enhance uptake of HIV testing and is primarily conducted by nurses and midwives. Research shows that provider-initiated HIV testing and counseling implementation is sub-optimal. The reasons for this are unclear. OBJECTIVES: The review aimed to explore nurses' and midwives' views and experiences of the provision and management of provider-initiated HIV testing and counseling. TYPES OF PARTICIPANTS: All cadres of nurses and midwives were considered, including those who undertake routine HIV testing as part of a diverse role and those who are specifically trained as HIV counselors. Types of phenomenon of interest: The review sought to understand the views and experiences of the provision and management of provider-initiated HIV testing and counseling (including perceptions, opinions, beliefs, practices and strategies related to HIV testing and its implementation in practice). CONTEXT: The review included only provider-initiated HIV testing and counseling. It excluded all other models of HIV testing. The review included all countries and all healthcare settings. Types of studies: This review considered all forms of qualitative study design and methodology. Qualitative elements of a mixed method study were included if they were presented separately within the publication. SEARCH STRATEGY: A three-step search strategy was utilized. Eight databases were searched for papers published from 1996 to October 2014, followed by hand searching of reference lists. Only studies published in the English language were considered. METHODOLOGICAL QUALITY: Methodological quality was assessed using the Qualitative Assessment and Review Instrument developed by the Joanna Briggs Institute. DATA EXTRACTION: Qualitative findings were extracted using the Joanna Briggs Institute Qualitative Assessment and Review Instrument. DATA SYNTHESIS: Qualitative research findings were pooled using a pragmatic meta-aggregative approach and the Joanna Briggs Institute Qualitative Assessment and Review Instrument software. RESULTS: This review included 21 publications from 18 research studies, representing a wide range of countries and healthcare settings. There were 245 findings which were aggregated into 12 categories and five synthesized findings. 1. Nurses/midwives are supportive of provider-initiated HIV testing and counseling if it is perceived to enhance patient care and to align with perceived professional roles. 2. Nurses'/midwives' ability to perform provider-initiated HIV testing and counseling well requires an appropriate infrastructure and adequate human and material resources. 3. At the organizational level, nurses'/midwives' engagement with provider-initiated HIV testing and counseling is facilitated by an inclusive management structure, alongside the provision of ongoing training and clinical supervision. Provider-initiated HIV testing and counseling is hindered by difficulties in fitting it into existing workloads and routines. 4. Nurses/midwives perceive that good quality care in provider-initiated HIV testing and counseling involves finding a balance between public health needs and individual patient needs. Good care requires time and the ability to apply a patient centred approach. 5. The emotional work involved in provider-initiated HIV testing and counseling can be stressful. Nurses/Midwives may require support to deal with complex moral and ethical issues. CONCLUSIONS: This review shows that provider-initiated HIV testing and counseling is supported by nurses/midwives who strive to implement it according to principles of good care and a patient centered approach. Nurses/midwives face multiple operational, infra-structural, resource and ethical challenges in the implementation of provider-initiated HIV testing and counseling. IMPLICATIONS FOR PRACTICE: The implementation process for provider-initiated HIV testing and counseling would benefit from using a quality improvement framework. Nurses/midwives undertaking provider-initiated HIV testing and counseling require management support, ongoing training and adequate infrastructure/resources. Additional guidance is required on legal/ethical issues in testing of children and in third party disclosure. IMPLICATIONS FOR RESEARCH: Operational research is required to determine an optimal skill mix and optimal methods of integrating provider-initiated HIV testing and counseling into existing work routines.

Participant views and experiences of participating in HIV research in sub-Saharan Africa: a qualitative systematic review.

BACKGROUND: Human immunodeficiency virus clinical trials are increasingly being conducted in sub-Saharan Africa. There is a tension between the pressure to increase levels of research participation and the need to ensure informed consent and protection of participants' rights. Researchers need to be aware of the particular ethical issues that underpin Human immunodeficiency virus research conduct in low income settings. This necessitates hearing from those who have participated in research and who have direct experience of the research process. OBJECTIVES: This review aimed to synthesize and present the best available evidence in relation to Human immunodeficiency virus research participation in sub-Saharan Africa, based on the views and experiences of research participants. TYPES OF PARTICIPANTS: The review included studies whose participants were current or former adult Human immunodeficiency virus research participants from sub-Saharan African countries. PHENOMENON OF INTEREST: Views, experiences, attitudes, understandings, perceptions and perspectives of Human immunodeficiency virus research participants in sub-Saharan Africa. Types of studies: This review considered studies that focused on qualitative data, including, but not limited to, designs such as phenomenology, ethnography, grounded theory, action research and feminist research. SEARCH STRATEGY: A three-step search strategy was utilized. Seven databases (CINAHL, Ovid MEDLINE (R) 1946, ASSIA, PsychInfo, Web of Science, EMBASE, and African Index Medicus) were searched with no limitation to years of publication, followed by hand searching of reference lists. Only studies published in the English language were considered. METHODOLOGICAL QUALITY: Methodological quality was assessed using the Qualitative Assessment and Review Instrument developed by the Joanna Briggs Institute. DATA EXTRACTION: Qualitative findings were extracted using the Joanna Briggs Institute Qualitative Assessment and Review Instrument. DATA SYNTHESIS: Qualitative research findings were pooled using a pragmatic meta-aggregative approach and the Joanna Briggs Institute Qualitative Assessment and Review Instrument software. RESULTS: Twenty-one studies were included in the review. One hundred and thirty-six findings were extracted from included studies and clustered into 14 categories based on similarities in meaning. These were further synthesized into five synthesized findings, set out below; i) Individuals are motivated to participate in Human immunodeficiency virus research due to a range of perceived benefits for themselves and others. ii) Participation in research can be associated with considerable fear and uncertainty. iii) Participation in Human immunodeficiency virus research is strongly influenced by social relationships (e.g. support or disapproval of family or friends) and social-economic and domestic factors (such as time or finances). iv). The meanings of research programs and processes are constructed within a context of existing lay beliefs, experiences and social relations associated with Human immunodeficiency virus and biomedical interventions in general. This means that local people may understand research and its processes very differently to health professionals. v) Participants' research experiences and their continued participation in Human immunodeficiency virus research are influenced by the research clinic context and the nature of their interactions with research staff. CONCLUSIONS: Individuals are generally willing to participate in Human immunodeficiency virus research. However their understanding of the process can be limited, and the experience may may cause anxiety or have negative consequences. Furthermore longer-term participation may become problematic due to socio-economic pressure or social commitments. IMPLICATIONS FOR PRACTICE: The review suggests a need to develop better ways to explain research processes and to support participants, when/if they encounter problems. There is also a need to engage better with communities in order to educate them about HIV research programs. IMPLICATIONS FOR RESEARCH: All the included studies focused on experiences around research enrolment and participation (retention); however there is a complete evidence gap on experiences of trial closure.