HIV Point-of-care Testing Research Articles

Exploring the Acceptability of HIV Testing in the UK Dental Setting: A Qualitative Study.

HIV point of care testing (POCT) is a common approach to expanding testing into non-specialised settings. Dental services have untapped potential to screen for health conditions including HIV. However, the perspectives of UK dental patients, dental professionals, and people with HIV are unknown. Ten focus groups were undertaken with dental patients, professionals, and people with HIV. The Framework method was used to analyse the qualitative data. Six themes were generated from the focus group data. The themes explored perceptions of HIV, the purpose, appropriateness, and acceptability of HIV testing in dental settings, and new processes that would need to be established in order to successfully implement point of care HIV testing in UK dental settings. Training needs were identified including communication skills and updates to current knowledge about HIV. HIV testing in dental settings is generally acceptable to dental patients, dental professionals, and PWH. However, of concern were logistical challenges and the risk of patients surprised at being offered an HIV test during a visit to the dentist. Nonetheless, the public health benefits of the intervention were well understood, i.e., early detection of HIV and initiation of treatment to improve health outcomes. Dental teams were able to generate novel solutions that could help to overcome contextual and logistical challenges to implementing HIV testing in dental settings.

True and false positive HIV point of care test results in a prospective multinational study of at-risk African women: implications for large-scale repeat HIV testing in HIV prevention programs.

Accurate HIV point of care testing is the cornerstone of prevention and treatment efforts globally, though false (both negative and positive) results are expected to occur. We assessed the spectrum of true and false positive HIV results in a large prospective study of HIV incidence in African women using three contraceptive methods tested longitudinally in Eswatini, Kenya, South Africa, and Zambia. HIV serologic testing was conducted quarterly using two parallel rapid HIV tests. When one or both tests were positive, additional confirmatory testing was conducted, including HIV enzyme immunoassay (EIA) and ribonucleic acid (RNA). 7730 women contributed 48,234 visits: true positive results occurred at 412 visits (0.9%) and false positives at 96 visits (0.2%). Of 412 women with HIV seroconversion, 10 had discordant (i.e., one negative and one positive) rapid tests and 13 had undetectable HIV RNA levels. Of 62 women with false positive rapid HIV results, most had discordant rapid testing but six (9.7%) had dually-positive rapid results and four (6.5%) had false positive or indeterminate EIA results. The positive predictive value of dual positive rapid results was 98.3%. Although the majority of rapid test results were accurate, false positive results were expected and occurred in this population of initially HIV seronegative individuals tested repeatedly and prospectively. When HIV infection occurred, not all cases had textbook laboratory results. Our findings highlight the importance of confirmatory testing, particularly for individuals undergoing repeat testing and in settings where the point prevalence is expected to be low.

Point of care HIV testing in dental settings in high-income countries: A mixed-methods systematic review.

Expanding HIV testing beyond specialized services has been a key strategic approach to eliminating the transmission of HIV. In recent years, dental settings have been identified as offering an opportunity for delivering point of care HIV testing (POCT) interventions. Intervention components and implementation strategies have varied across studies and there is uncertainty about the prevalence of undiagnosed HIV in the dental patient population. Therefore, this systematic review aimed to synthesize the HIV testing outcomes of intervention studies, identify the core components of POCT interventions implemented in dental settings; and understand the barriers and facilitators to intervention implementation. A mixed-methods systematic review was undertaken. Two authors reviewed abstracts and full papers for inclusion and appraised the studies using the Mixed Methods Appraisal Tool. A convergent integrated mixed methods study design underpinned the synthesis. Outcomes were presented using descriptive statistics. Intervention components were mapped to the Template for Intervention Description and Replication (TIDieR) checklist. Barriers and facilitators were described using a narrative thematic analysis. POCT was offered to 22 146 dental patients, 62.5% accepted POCT. Intervention studies that reported higher uptake of testing utilized a dedicated dental or researcher staff member to provide testing, integrated testing and provided results within the routine dental appointment and adopted a provider-initiated universal approach to offering testing. Six themes emerged that were pertinent to the barriers and facilitators to HIV testing in dental setting. POCT uptake in dental settings was comparable with other non-specialized health settings. Key to the operationalization of the intervention were perceptions about its value and relevance to the dental patient population, attitudes toward the intervention, logistical barriers to its implementation, the risk of HIV testing stigma to the patient-practitioner relationship and maximising the fit of the intervention within the constraints of the dental setting.

A clinical utility evaluation of dual HIV/Syphilis point-of-care tests in non-clinical settings for screening for HIV and syphilis in men who have sex with men

BackgroundDual point-of-care tests (POCTs) for the simultaneous detection of antibodies to HIV and syphilis have been developed. Since community-based organisations (CBO) are effective providers of HIV and syphilis testing among men who have sex with men (MSM), evaluation of the utility of these dual tests at CBO testing services is a high priority. The aim of this study is to determine the feasibility of performing dual HIV-syphilis POCT testing among both users and providers at these non-clinical sites.MethodsThis evaluation assessed the utility of two lateral flow immunochromatographic antibody technologies for dual screening for HIV/syphilis among MSM seeking testing in four CBO testing services in Spain, Slovenia, Latvia, and Ukraine. The study’s conceptual framework divides the concept of feasibility into two inter-related domains, acceptability, and usability and further breaks it down into six subdomains: learnability, willingness, suitability, satisfaction, efficacy, and effectiveness. The feasibility analysis was performed by calculating the median score in 3 stages (for individual questions, subdomains, and domains), using a summated scores method.ResultsThe final sample included 844 participants, 60 of which were found to be HIV test positive (7.1%) and 61 (7.2%) positive on testing for syphilis. There was a small difference (1.1%) when comparing the results of the two dual POCTs under evaluation to the tests routinely used at each site. The inter-rater agreement showed a high concordance between two independent readings. The analysis of the feasibility for the users of the services indicated good satisfaction, suitability, and willingness. In addition, among 18 providers the total mean score showed good acceptability and usability, good willingness, easy learnability, high suitability, and good efficacy, but lower satisfaction and effectiveness. The operational characteristics of both dual study POCTs were well evaluated by providers.ConclusionsThe introduction of dual HIV and syphilis POCTs in CBO testing services for screening of MSM is feasible, with a high acceptability and usability both for users and providers. Implementation of dual POCTs for HIV and syphilis in CBO testing services is an opportunity for scaling up integrated HIV/syphilis testing for MSM.

The Cascade of Care for Early Infant Diagnosis in Zimbabwe: Point of Care HIV Testing at Birth and 6-8 Weeks.

Routine birth testing of HIV-exposed infants (HEI) using point of care (POC) nucleic acid testing may allow for earlier diagnosis and treatment of infants living with HIV, but more data are needed on retention in care for those diagnosed at birth and re-testing for those with a negative HIV birth test. POC birth testing (within 48 hours of birth) was offered to all HEI born at 10 public maternities in Zimbabwe from November 2018 to July 2019. Data were abstracted from routine registers, including information on re-testing at 6-8 weeks for infants testing HIV-negative at birth and 6-month retention in care among infants diagnosed with HIV at birth. Of 2854 eligible HEIs, 2806 (98.3%) received POC HIV birth testing. Thirty-nine infants with HIV were identified (1.4%), and 23 (59%) were started on antiretroviral therapy (ART). Twenty infants (51%) remained on ART at 6 months. Of the 2694 infants who tested negative at birth, 1229 (46.5%) had a documented retest at 6-8 weeks. 7 (0.6%) of those infants tested HIV-positive. The uptake of POC birth testing was high in study facilities, but low rates of ART initiation after a positive birth test, despite high retention on ART through 6 months, diminish the impact of POC birth testing and must be addressed. Among infants who tested negative at birth, rates of testing at 6-8 weeks of life (46%) were slightly lower than national rates of testing at the same age without a birth test (56%) during the study period. Improving infant HIV testing rates at 6-8 weeks, regardless of birth testing, should be a priority.

1345. The Cascade of Care for Early Infant Diagnosis in Zimbabwe: Point of Care HIV Testing at Birth and 6-8 weeks

Abstract Background Routine birth testing of HIV exposed infants (HEI) using point of care (POC) nucleic acid testing may allow for earlier diagnosis and treatment of HIV-infected infants than current methods, but more data are needed on retention in care for those diagnosed as HIV-positive at birth and on re-testing for those with a negative HIV test at birth. Methods POC birth testing (within 48 hours of birth) was offered to all HEI born at ten public maternities in Zimbabwe from November 2018 to July 2019. Data from routine registers, including information on re-testing at 6–8 weeks for infants testing HIV-negative at birth and six-month retention in care among infants testing HIV-positive at birth. Results Of 2,854 eligible HEI, 2,806 (98.3%) received a POC HIV birth test. We identified 39 HIV-infected infants (1.4%), and 23 (59%) were started on ART. Of those, 20 infants (87%) remained on ART at six months. Of the 2,694 infants who tested negative at birth, 1,229 (46.5%) had a documented re-test at 6-8 weeks, and 7 (0.6%) of those infants tested positive. Conclusion Uptake of POC birth testing was high in the 10 study facilities. However, ART initiation for HIV-positive infants was low. Among infants initiated on ART, most but not all continued ART at 6 months. Among infants who tested negative at birth, rates of testing at 6-8 weeks of life were similar to national rates of testing at the same age without a birth test (56%). Improving infant HIV testing rates at 6-8 weeks, regardless of birth testing, should be a priority. Additionally, insuring that HIV-positive newborns are started and retained on ART is critical for preventing morbidity and mortality among HIV-infected infants. Disclosures All Authors: No reported disclosures.

1028. Performance and Patient Acceptability Evaluation of the Chembio DPP® HIV-Syphilis Assay in an Emergency Department

BackgroundEmergency departments (EDs) serve as sentinel settings for diagnosing sexually transmitted infections (STIs), including HIV and syphilis. We aimed to assess performance and patient acceptability of a point-of-care (POC) test, the Chembio Dual Path Platform (DPP®) HIV-Syphilis Assay, in an urban ED in Baltimore.Methods170 patients were enrolled via convenience sampling from Oct 2019 – March 2020 and Jan 2021 – June 2021. Patients eligible were < 70 yrs, men who have sex with men, pregnant without care, had STI concerns, or history of drug use. Subjects received standard of care (SOC) HIV and syphilis testing under institutional laboratory algorithms. Subjects were then tested with the finger-stick POC test and completed a survey, both before and after the POC test to assess subjects’ attitudes about the POC test.ResultsComparing the SOC and POC results, 165/170 (97.1%) were test concordant. 3 syphilis POC results were false negative, but reported successful treatment over 10 years prior to enrollment (treponemal antibody remains after treatment). 1 HIV result was false negative and 1 was false positive. Overall the sensitivity and specificity of the HIV POC test were 96.8% (95%CI: 83.3%, 99.9%) and 99.3% (95% CI: 96.1%, 100%), and for syphilis were 85.7% (95%Cl: 63.7%, 97.0%) or 100% (95%CI: 81.5%, 100%), if excluding 3 persons having been successfully treated, and 100% (95% CI: 97.6%, 100%) respectively.The pre-test survey found 67% and 77% of participants were comfortable with a finger-stick test and agreed the POC test result would be as good as the SOC test result, which increased to 96% and 86% in the post-test, respectively, (p< 0.05). At post-test, 86% reported they would feel confident to perform this test at home and 81% would use it at least once per year if it were available. 97% reported they were more likely to seek treatment if receiving a positive result during their ED visit and 91% reported it would reduce their stress/anxiety if receiving a negative test result in the ED.ConclusionOur findings demonstrated satisfactory performance and high patient acceptability of the Chembio DPP® HIV-Syphilis Assay. Given the test is FDA approved, implementation studies are needed to determine whether adoption of this POC test will benefit patients and be consistent with ED workflows.Disclosures Richard E. Rothman, PhD, MD, Chem bio (Grant/Research Support)

Acceptability and facilitators of and barriers to point-of-care HIV testing in a homeless-focused service in Gloucestershire: a qualitative evaluation.

Late HIV diagnosis increases the risks of onward transmission, morbidity and mortality. Rapid point-of-care testing (POCT) reaches people who have never been tested and people living with HIV who are undiagnosed. This study explored the acceptability and feasibility of HIV POCT from the perspectives of service providers and users. A pilot study introduced HIV POCT to one service in Gloucestershire, England. Eleven semi-structured interviews with service users and a focus group with three service providers were conducted. The Theoretical Framework of Acceptability and the Theoretical Domains Framework were used to design the topic guide and analysis. Acceptability of HIV POCT was high. Seven facilitators were identified (e.g. understanding the test purpose and process), alongside two potential barriers, one relevant to service providers and users (anxiety) and the other to service users (stigma). To maximize the benefits of implementation of HIV POCT, health care providers require appropriate training and supervision to offer and administer POCT.

Could use of informal healthcare providers increase uptake of HIV testing? Qualitative results from southwestern Uganda

BackgroundUganda is an HIV-endemic country with prevalence of around 6%, and has yet to reach the 95–95–95 UNAIDS benchmarks for HIV epidemic control. It has previously been reported that approximately 80% of people in sub-Saharan Africa use informal health-care providers such as traditional healers. Collaboration with informal healthcare providers has been proposed as a strategy to increase testing uptake. In this study, we use data from a parent cluster-randomised trial and aim to assess acceptability and implementation of a programme that uses informal health-care providers to deliver point-of-care HIV testing. MethodsWe analysed qualitative data from a parent cluster-randomised trial in which traditional healers delivered oral swab point-of care HIV tests to adults of unknown HIV serostatus (clinicaltrials.gov NCT#03718871). We invited traditional healers aged 18 years or older who were practising within 10 km of Mbarara township, southwestern Uganda, to participate in the trial. We recruited a purposive sample of trial participants to complete a qualitative interview. We included patients who had received care from participating healers, were aged 18 years or older, were sexually active, self-reported not receiving an HIV test in the previous 12 months, and had not previously been diagnosed with HIV infection. Interviews explored experiences of participating in the trial and perceptions of healers delivering HIV testing. Interviews were audio-recorded, conducted in the local language, then translated and transcribed into English. Following a content-analysis approach, transcripts were independently reviewed by two authors to develop a coding scheme and framework that explains outcomes of the parent trial. FindingsBetween Nov 26, 2019, and May 14, 2020, we conducted 124 interviews with 17 traditional healers and 107 trial participants. Half the participant group were women (n=62, 50%) and approximately one-third of healers were women (n=6, 35%). Responses from patients and providers showed that the intervention programme mitigated existing barriers to HIV testing. First, healer-delivered HIV testing overcame structural barriers that impeded receiving tests at clinical facilities. Underlying impoverishment and rural locations limited use of clinical testing, as transportation costs to facilities were frequently prohibitive. Healers were located in villages, where their services were easier to access. Second, patients perceived traditional healers as trustworthy and confidential. Participant responses underscored a preference for receiving an HIV test from a healer, rather than from biomedical settings, where HIV testing was described as stigmatising. Additionally, traditional healers reported increased respect from community members for offering HIV testing and expressed a desire to continue to offer HIV testing and counselling. InterpretationUse of informal health-care providers to administer HIV testing is not only feasible but also well accepted in an area where traditional healers are frequently used for health care. Healers should be considered key stakeholders in the effort to increase uptake of HIV testing and achieving HIV epidemic control. Further research should consider whether results are generalisable beyond rural Uganda. FundingNational Institutes of Mental Health (K23MH111409 PI: [RS]).

The Geography of Emergency Department-Based HIV Testing in South Africa: Can Patients Link to Care?

Background: Emergency Departments (EDs) can serve as clinical sites for identification of new HIV infections and their entry into care. We examined if HIV-positive patients who present to EDs in South Africa are able to successfully link to care. Methods: We conducted a one-year longitudinal prospective cohort study in four hospitals across the Eastern Cape, South Africa between July 2016 and July 2018. All adult, non-critical patients presenting to the ED were systematically approached, asked about their HIV status, and, if unknown, offered a point-of-care (POC) HIV test. All HIV-positive patients were further consented to participate in a follow-up study to assess subsequent linkage to care and distance from “home” to ED. Linkage to care was defined as self-reported linkage (telephonic) or evidence of repeated CD4/viral load testing in the National Health Laboratory System (NHLS) at either 6- or 12-months post index ED visit. Findings: A total of 983 patients consented to participate in the study. In the 12 months following their ED visit, 34∙1% of patients demonstrated linkage to care (335/983), 23∙8% did not link to care (234/983), and 42∙1% (414/983) were lost to follow-up. Though not statistically significant, a higher percentage of young men and those presenting with a trauma-related complaint did not link to care. A considerable proportion of patients (105/454, 23∙2%,) resided 50 or more km from their index ED sites, though there was not a significant difference in linkage to care rate between those who lived closer or further from the ED. Interpretation: Innovative implementation strategies are required to overcome patient-level factors and structural barriers within the health system to improve HIV care linkage to care for both known HIV-positive and newly diagnosed HIV-positive ED patients. Strategies should consider the use of facilitated linkage using case management approaches and same day ART initiation, amongst others. Funding Information: This research was supported by the South African Medical Research Council, the Division of Intramural Research, the National Institute of Allergy and Infectious Diseases, National Institutes of Health, and the Johns Hopkins Center for Global Health. The funding bodies had no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript. Declaration of Interests: The authors have nothing to disclose. Ethics Approval Statement: The study was approved by the Johns Hopkins University School of Medicine Institutional Review Board (IRB00105801), the Human Research Ethics Committees (HREC) of University of Cape Town (Ref 856/2015), and the Walter Sisulu University HREC (Ref 069/15). Written consent was obtained from all participants for the collection of demographic data and POC HIV testing.

The contribution of HIV point-of-care tests in early HIV diagnosis: community-based HIV testing monitoring in Catalonia, 1995 to 2018.

BackgroundCommunity-based HIV testing services combined with the use of point-of-care tests (POCT) have the potential to improve early diagnosis through increasing availability, accessibility and uptake of HIV testing.AimTo describe community-based HIV testing activity in Catalonia, Spain, from 1995 to 2018, and to evaluate the impact of HIV POCT on the HIV continuum of care.MethodsA community-based network of voluntary counselling and testing services in Catalonia, Spain has been collecting systematic data on activity, process and results since 1995. A descriptive analysis was performed on pooled data, describing the data in terms of people tested and reactive screening test results.ResultsBetween 1995 and 2018, 125,876 HIV tests were performed (2.1% reactive). Since the introduction of HIV POCT in 2007, a large increase in the number of tests performed was observed, reaching 14,537 tests alone in 2018 (1.3% reactive). Men who have sex with men (MSM), as a proportion of all people tested, has increased greatly over time reaching 74.7% in 2018. The highest percentage of reactive tests was found in people who inject drugs followed by MSM. The contribution of community-based HIV testing to the overall total notified cases in the Catalonia HIV registry has gradually increased, reaching 37.9% in 2018, and 70% of all MSM cases. In 2018, the percentage of individuals with a reactive screening test who were linked to care was 89.0%.ConclusionOur study reinforces the important role that community-based HIV POCT has on the diagnosis of HIV in key populations.

Implementation planning for community-based point-of-care HIV testing for infants: Recommendations from community leaders in Kenya.

BackgroundEarly infant diagnosis (EID) establishes the presence of HIV infection in HIV-exposed infants and children younger than 18 months of age. EID services are hospital-based, and thus fail to capture HIV-exposed infants who are not brought to the hospital for care. Point-of-care (POC) diagnostic systems deployed in the community could increase the proportion tested and linked to treatment, but little feasibility and acceptability data is available.MethodsSemi-structured interviews (n = 74) were conducted by a Kenyan team with community members (Community Health Workers/Volunteers [CHW/CHV], Traditional Birth Attendants [TBAs], community leaders) and parents of HIV-exposed infants at four study sites in Kenya to elicit feedback on the acceptability and feasibility of community-based POC HIV testing.ResultsParticipants described existing community health resources that could be leveraged to support integration of community-based POC HIV testing; however, the added demand placed on CHW/CHV could pose a challenge. Participants indicated that other potential barriers (concerns about confidentiality, disclosure, and HIV stigma) could be overcome with strong engagement from trusted community leaders and health providers, community sensitization, and strategic location and timing of testing. These steps were seen to improve acceptability and maximize the recognized benefits (rapid results, improved reach) of community-based testing.ConclusionCommunity members felt that with strategic planning and engagement, community-based POC HIV testing could be a feasible and acceptable strategy to overcome the existing barriers of hospital-based EID.

Programmatic evaluation of feasibility and efficiency of at birth and 6-week, point of care HIV testing in Kenyan infant.

BackgroundTesting infants at birth and with more efficient point of care (POC) HIV diagnostic can streamline EID and expedite infant ART initiation. We evaluated the implementation of at birth and 6-week POC testing to assess the effectiveness and feasibility when implemented by existing hospital staff in Kenya.MethodsFour government hospitals were randomly assigned to receive a GeneXpert HIV-1 Qual (n = 2) or Alere m-PIMA (n = 2) machine for POC testing. All HIV-exposed infants enrolled were eligible to receive POC testing at birth and 6-weeks of age. The primary outcome was repeat POC testing, defined as testing both at birth and 6-weeks of age. Secondary outcomes included predictors of repeat POC testing, POC efficiency (turnaround times of key services), and operations (failed POC results, missed opportunities).ResultsOf 626 enrolled infants, 309 (49.4%) received repeat POC testing, 115 (18.4%) were lost to follow up after an at-birth test, 120 (19.2%) received POC testing at 6-weeks only, 80 (12.8%) received no POC testing, and 2 (0.3%) received delayed POC testing (>12 weeks of age). Three (0.4%) were identified as HIV-positive. Of the total 853 POC tests run at birth (n = 424) or 6-weeks (n = 429), 806 (94.5%) had a valid result documented and 792 (98.3%) results had documented maternal notification. Mean time from sample collection to notification was 1.08 days, with 751 (94.8%) notifications on the same day as sample collection. Machine error rates at birth and 6-weeks were 8.5% and 2.5%, respectively. A total of 198 infants presented for care (48 at birth; 150 at 6-weeks) without receiving a POC test, representing missed opportunities for testing.DiscussionAt birth POC testing can streamline infant HIV diagnosis, expedite ART initiation and can be implemented by existing hospital staff. However, maternal disengagement and missed opportunities for testing must be addressed to realize the full benefits of at birth POC testing.

Consolidating strategic information to monitor progress against the UNAIDS 90\u201390\u201390 targets: evaluating the operational feasibility of an electronic HIV testing register in Cape Town, South Africa

BackgroundHIV diagnosis in South Africa is based on a point-of-care testing (PoCT) algorithm with paper-based record-keeping. Aggregated testing data are reported routinely. To facilitate improved HIV case-based surveillance, the Western Cape Province implemented a unique pilot intervention to digitise PoCT results, at an individual level, and generate an electronic register using the newly developed Provincial Health Data Centre (PHDC). We describe the intervention (phased) and present an evaluation of the operational feasibility of the intervention. We also offer implementation insights into establishing electronic capture of individual level testing data.MethodsCross-sectional analyses were conducted on records of all patients attending a local Community Health Centre who had an HIV-PoCT during the study period. Data from the intervention were linked to the PHDC using a unique identifier and compared with aggregate data from the paper-based register. Correlation coefficients were calculated to quantify the correlation between the two monthly datasets. To support an understanding of the findings, the Department of Health project management team generated reflections on the implementation process, which were then grouped thematically into implementation lessons.ResultsIn total, 11,337 PoCT records were digitised (70% (7954) during Phase I; and 30% (3383) during Phase II). Linkage of forms to the PHDC was 96% in Phase I and 98% in Phase II. Comparison with aggregate data showed high correlation during Phase I, but notable divergence during Phase II. Divergence in Phase II was due to stringent data quality requirements and high clinical staff turnover. Factors supporting implementation success in Phase I included direct oversight of data capturing by a manager with clinical and operational insight. Implementation challenges included operational, health system, and high cost-related issues.ConclusionsWe demonstrate that rapid digitisation of HIV PoCT data, without compromising currently collected aggregate data, is operationally feasible, and can contribute to person-level longitudinal HIV case-based surveillance. To take to scale, we will need to improve PoCT platforms and clerical and administrative systems. Although we highlight challenges, we demonstrate that electronic HIV testing registers can successfully replace manual registers and improve efforts to monitor and evaluate HIV testing strategies.

"We Need it the Same Day": A Qualitative Study of Caregivers and Community Members' Perspectives Toward the Use of Point-of-Care Early Infant Diagnosis.

Only half of the infants tested for HIV ever receive results, leading to low uptake of treatment and increased mortality and morbidity rates. Point-of-care (POC) nucleic acid diagnostic machines allow for the possibility of same-day results. In Kenya and Zimbabwe, as part of an evaluation comparing standard of care with POC testing for early infant diagnosis, a qualitative substudy was undertaken to understand the acceptability of POC among caregivers of HIV-exposed infants and community members. Kenya and Zimbabwe. In Kenya, 74 interviews were conducted with caregivers, and 6 focus group discussions were conducted with male and female community members and elders. In Zimbabwe, we conducted 85 interviews and 8 focus group discussions. Data were collected in 2 rounds: 1 before the introduction of POC platforms and 1 after the platforms had been in use for at least 3 months. Interviews were conducted in local languages, and content analysis and constant comparison were used to identify key themes. Reduced time to receive test results lowered caregiver anxiety about the child's HIV status and allowed families to put children on treatment earlier. Printed POC results were seen by some as more trustworthy than conventional handwritten results, believing this reduced the chance of human error; a few distrusted HIV results were generated too quickly. Community awareness of POC was lower among caregivers of HIV-exposed infants. Caregivers are generally very accepting of receiving POC HIV test results; however, additional sensitization among influential community members about the benefits of POC testing is needed.

Utility of digitising point of care HIV test results to accurately measure, and improve performance towards, the UNAIDS 90-90-90 targets.

IntroductionHigh rates of pre-treatment loss to care among persons diagnosed with HIV persist. Linkage to care can be improved through active digitally-based surveillance. Currently, record-keeping for HIV diagnoses in South Africa is paper-based. Aggregated testing data are reported routinely, and only discordant findings result in a specimen being tested at a laboratory and digitised. The Western Cape Province in South Africa has a Provincial Health Data Centre (PHDC) where person-level routine electronic data are consolidated in a single database, leveraging the existence of a unique patient identifier. To facilitate improved HIV surveillance, a pre-carbonated point-of-care test (PoCT) form was piloted, where one copy was routed to a central point and digitised for PHDC inclusion.MethodsWe evaluated the utility of the intervention using cross-sectional and retrospective cohort analyses, as well as comparisons with aggregate data. Data were linked to the Patient Master Index of the PHDC using unique identifiers. Prior evidences of HIV within the PHDC were used to differentiate newly diagnosed patients and those retesting, as well as linkage to care and treatment.ResultsFrom May 2017 to June 2018, 11337 digitised point-of-care HIV testing records were linked to the PHDC. Overall, 96% of records in the aggregate dataset were digitised, with 97% linked to the PHDC. Of those tested, 79% were female (median age 27 years). Linkage demonstrated that 51.3% (95% CI 48.4–54.1%) of patients testing HIV-positive were retesting. Of those newly diagnosed, 81% (95% CI 77.9–84.3%) were linked to HIV care and 25% (95% CI 21.6–28.7%) were initiated on antiretroviral therapy immediately.ConclusionDigitisation of PoCT results provides individuated HIV testing data to assist in linkage to care and in differentiating newly diagnosed patients from positive patients retesting. Actionable and accurate data can improve the measurement of performance towards the UNAIDS 90-90-90 targets.

Training student pharmacists to facilitate human immunodeficiency virus point-of-care testing

Background and purpose: The advent of HIV point-of-care testing (POCT) has increased ease of access to HIV testing in the outpatient setting. As community pharmacy continues to expand, it is crucial that student pharmacists are exposed to POCT in the classroom so they are prepared for more intensive training as a pharmacist as they could be providing POCT in future practice. Our objective was to train student pharmacists to perform HIV POCT and educate patients on results and implications of testing.Educational activity and setting: Following a didactic HIV lecture, second-year student pharmacists learned to utilize the OraQuick ADVANCE Rapid HIV-½ Antibody Test in a one-hour workshop. Participants were then assessed using a 4-point Likert type scale during an individual, 10-min skills lab on their ability to provide POCT using sample kits and interpret simulated results. Data were analyzed using descriptive statistics.Findings: Forty-one students participated. Students showed competency when performing HIV POCT, as 92.7% of students were able to describe the test, and 97.6% of students were able to interpret the results correctly. Students scored a mean of 46.2 points overall (maximum of 50).Summary: Results suggest training student pharmacists to perform HIV POCT may better prepare them to administer the test and counsel patients on results in an outpatient setting. Future studies should examine the differences in the ability to perform POCT between pharmacists who received training as students and those who did not.

Expanding access to HIV testing through Canadian community pharmacies: findings from the APPROACH study

BackgroundThere 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.MethodsA 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.ResultsOver 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.ConclusionsA 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 registrationRetrospectively registered with clinicaltrials.gov (NCT03210701) on July 6, 2017.

Increasing the Offer, Shifting the Offer: Patients' Perspectives on Routinely Offering HIV Counseling and POC Testing in the Health Services Program of an Urban Community Health Centre.

Objectives: Canadian epidemiologic data demonstrate the fallibility of established HIV testing approaches to reach, diagnose, and link to care a significant portion of the population thereby contributing to missed opportunities to reduce onward HIV transmission. Increasing and diversifying entry points to accessing HIV testing may be a successful strategy to reach people who remain undiagnosed. We sought to determine the perspectives of patients on the acceptability of an offer of routine non-targeted provider-initiated HIV counseling and point-of-care (POC) testing in the health services program of a Community Health Centre in downtown Ottawa, the capital of Canada.Methods: Patients aged 18 years and over accessing the Health Services Program for scheduled clinical appointments were approached by research staff with the offer of a POC HIV test with pre- and post-test counseling. All patients accepting the offer and those declining the offer were offered the opportunity to complete an Acceptability Questionnaire.Results: Questionnaire responses from eligible patients over four consecutive weeks in 2018 strongly endorse the acceptability of an offer of an HIV test in the context of their scheduled health services appointment for a separate clinical condition. This contention held both for those patients accepting the offer and proceeding to testing and for those patients declining the offer.Conclusions: The perspectives of the patients in our study demonstrate that a routine offer of non-targeted provider-initiated HIV counseling and POC testing was considered not only to be an acceptable, but also an appropriate and welcome intervention in a community health services program. These results suggest the potential for actively engaging more individuals—including those less likely to be engaged through a targeted testing approach—in the documented benefits of the HIV care and treatment cascade by increasing the HIV test offer through routine provider initiation. In addition, at the population level, shifting the offer through venue diversification, similarly shows potential for reducing engagement in ongoing HIV transmission behaviors and practices attributed to those unaware of their HIV positive status. Both outcomes fundamental to the goal of eliminating AIDS by 2030.

Prospective Evaluation of HIV Testing Technologies in a Clinical Setting: Protocol for Project DETECT

BackgroundHIV testing guidelines provided by the Centers for Disease Control and Prevention (CDC) are continually changing to reflect advancements in new testing technology. Evaluation of existing and new point-of-care (POC) HIV tests is crucial to inform testing guidelines and provide information to clinicians and other HIV test providers. Characterizing the performance of POC HIV tests using unprocessed specimens can provide estimates for the window period of detection, or the time from HIV acquisition to test positivity, which allows clinicians and other HIV providers to select the appropriate POC HIV tests for persons who may be recently infected with HIV.ObjectiveThis paper describes the protocols and procedures used to evaluate the performance of the newest POC tests and determine their sensitivity during early HIV infection.MethodsProject DETECT is a CDC-funded study that is evaluating POC HIV test performance. Part 1 is a cross-sectional, retrospective study comparing behavioral characteristics and HIV prevalence of the overall population of the Public Health–Seattle & King County (PHSKC) Sexually Transmitted Disease (STD) Clinic to Project DETECT participants enrolled in part 2. Part 2 is a cross-sectional, prospective study evaluating POC HIV tests in real time using unprocessed whole blood and oral fluid specimens. A POC nucleic acid test (NAT) was added to the panel of HIV tests in June 2018. Part 3 is a longitudinal, prospective study evaluating seroconversion sensitivity of POC HIV tests through serial follow-up testing. For comparison, HIV-1 RNA and HIV-1/HIV-2 antigen/antibody tests are also performed for participants enrolled in part 2 or 3. A behavioral survey that collects information about demographics, history of HIV testing, STD history, symptoms of acute HIV infection, substance use, sexual behaviors in the aggregate and with recent partners, and use of pre-exposure prophylaxis and antiretroviral therapy is completed at each part 2 or 3 visit.ResultsBetween September 2015 and March 2019, there were 14,990 Project DETECT–eligible visits (part 1) to the PHSKC STD Clinic resulting in 1819 part 2 Project DETECT study visits. The longitudinal study within Project DETECT (part 3) enrolled 27 participants with discordant POC test results from their part 2 visit, and 10 (37%) were followed until they had fully seroconverted with concordant positive POC test results. Behavioral survey data and HIV test results, sensitivity, and specificity will be presented elsewhere.ConclusionsStudies such as Project DETECT are critical for evaluating POC HIV test devices as well as describing characteristics of persons at risk for HIV acquisition in the United States. HIV tests in development, including POC NATs, will provide new opportunities for HIV testing programs.International Registered Report Identifier (IRRID)RR1-10.2196/16332