Accuracy of and preferences for blood-based versus oral-fluid-based HIV self-testing in Malawi: a cross-sectional study.

BACKGROUND: HIV self-testing (HIVST) can use either oral-fluid or blood-based tests. Studies have shown strong preferences for self-testing compared to facility-based services. Despite availability of low-cost blood-based HIVST options, to date, HIVST implementation in sub-Saharan Africa has largely been oral-fluid-based. We investigated whether users preferred blood-based (i.e. using blood sample derived from a finger prick) or oral fluid-based HIVST in rural and urban Malawi. METHODS: At clinics providing HIV testing services (n = 2 urban; n = 2 rural), participants completed a semi-structured questionnaire capturing sociodemographic data before choosing to test using oral-fluid-based HVST, blood-based HIVST or provider-delivered testing. They also completed a self-administered questionnaire afterwards, followed by a confirmatory test using the national algorithm then appropriate referral. We used simple and multivariable logistic regression to identify factors associated with preference for oral-fluid or blood-based HIVST. RESULTS: July to October 2018, N = 691 participants enrolled in this study. Given the choice, 98.4% (680/691) selected HIVST over provider-delivered testing. Of 680 opting for HIVST, 416 (61.2%) chose oral-fluid-based HIVST, 264 (38.8%) chose blood-based HIVST and 99.1% (674/680) reported their results appropriately. Self-testers who opted for blood-based HIVST were more likely to be male (50.3% men vs. 29.6% women, p < 0.001), attending an urban facility (43% urban vs. 34.6% rural, p = 0.025) and regular salary-earners (49.5% regular vs. 36.8% non-regular, p = 0.012). After adjustment, only sex was found to be associated with choice of self-test (adjusted OR 0.43 (95%CI: 0.3-0.61); p-value < 0.001). Among 264 reporting blood-based HIVST results, 11 (4.2%) were HIV-positive. Blood-based HIVST had sensitivity of 100% (95% CI: 71.5-100%) and specificity of 99.6% (95% CI: 97.6-100%), with 20 (7.6%) invalid results. Among 416 reporting oral-fluid-based HIVST results 18 (4.3%) were HIV-positive. Oral-fluid-based HIVST had sensitivity of 88.9% (95% CI: 65.3-98.6%) and specificity of 98.7% (95% CI: 97.1-99.6%), with no invalid results. CONCLUSIONS: Offering both blood-based and oral-fluid-based HIVST resulted in high uptake when compared directly with provider-delivered testing. Both types of self-testing achieved high accuracy among users provided with a pre-test demonstration beforehand. Policymakers and donors need to adequately plan and budget for the sensitisation and support needed to optimise the introduction of new quality-assured blood-based HIVST products.

Lessons learned from implementation of four HIV self-testing (HIVST) distribution models in Zambia: applying the Consolidated Framework for Implementation Research to understand impact of contextual factors on implementation.

BACKGROUND: Although Zambia has integrated HIV-self-testing (HIVST) into its Human Immunodeficiency Virus (HIV) regulatory frameworks, few best practices to optimize the use of HIV self-testing to increase testing coverage have been documented. We conducted a prospective case study to understand contextual factors guiding implementation of four HIVST distribution models to inform scale-up in Zambia. METHODS: We used the qualitative case study method to explore user and provider experiences with four HIVST distribution models (two secondary distribution models in Antenatal Care (ANC) and Antiretroviral Therapy (ART) clinics, community-led, and workplace) to understand factors influencing HIVST distribution. Participants were purposefully selected based on their participation in HIVST and on their ability to provide rich contextual experience of the distribution models. Data were collected using observations (n = 31), group discussions (n = 10), and in-depth interviews (n = 77). Data were analyzed using the thematic approach and aligned to the four Consolidated Framework for Implementation Research (CFIR) domains. RESULTS: Implementation of the four distribution models was influenced by an interplay of outer and inner setting factors. Inadequate compensation and incentives for distributors may have contributed to distributor attrition in the community-led and workplace HIVST models. Stockouts, experienced at the start of implementation in the secondary-distribution and community-led distribution models often disrupted distribution. The existence of policy and practices aided integration of HIVST in the workplace. External factors complimented internal factors for successful implementation. For instance, despite distributor attrition leading to excessive workload, distributors often multi-tasked to keep up with demand for kits, even though distribution points were geographically widespread in the workplace, and to a less extent in the community-led models. Use of existing communication platforms such as lunchtime and safety meetings to promote and distribute kits, peers to support distributors, reduction in trips by distributors to replenish stocks, increase in monetary incentives and reorganisation of stakeholder roles proved to be good adaptations. CONCLUSION: HIVST distribution was influenced by a combination of contextual factors in variable ways. Understanding how the factors interacted in real world settings informed adaptations to implementation devised to minimize disruptions to distribution.

Experience of social harms among female sex workers following HIV self-test distribution in Malawi: results of a cohort study.

BACKGROUND: In Malawi, female sex workers (FSW) have high HIV incidence and regular testing is suggested. HIV self-testing (HIVST) is a safe and acceptable alternative to standard testing services. This study assessed; whether social harms were more likely to be reported after HIVST distribution to FSW by peer distributors than after facility-based HIV testing and whether FSW regretted HIVST use or experienced associated relationship problems. METHODS: Peer HIVST distributors, who were FSW, were recruited in Blantyre district, Malawi between February and July 2017. Among HIVST recipients a prospective cohort was recruited. Interviews were conducted at baseline and at end-line, 3 months later. Participants completed daily sexual activity diaries. End-line data were analysed using logistic regression to assess whether regret or relationship problems were associated with HIVST use. Sexual activity data were analysed using Generalised Estimating Equations to assess whether HIVST use was temporally associated with an increase in social harms. RESULTS: Of 265 FSW recruited and offered HIVST, 131 completed both interviews. Of these, 31/131(23.7%) reported initial regret after HIVST use, this reduced to 23/131(17.6%) at the 3-month follow-up. Relationship problems were reported by 12/131(9.2%). Regret about HIVST use was less commonly reported in those aged 26-35 years compared to those aged 16-25 years (OR immediate regret-0.40 95% CI 0.16-1.01) (OR current regret-0.22 95% CI 0.07 - 0.71) and was not associated with the HIVST result. There was limited evidence that reports of verbal abuse perpetrated by clients in the week following HIVST use were greater than when there was no testing in the preceding week. There was no evidence for increases in any other social harms. There was some evidence of coercion to test, most commonly initiated by the peer distributor. CONCLUSIONS: Little evidence was found that the peer distribution model was associated with increased levels of social harms, however programmes aimed at reaching FSW need to carefully consider possible unintended consequences of their service delivery approaches, including the potential for peer distributors to coerce individuals to test or disclose their test results and alternative distribution models may need to be considered.

Association of same-sex criminalisation laws and national HIV policies with HIV testing in African MSM: an ecological single-level and multilevel cross-sectional study of sub-Saharan African countries.

BACKGROUND: HIV incidence among men who have sex with men (MSM) in sub-Saharan Africa (SSA) remains high compared with the general population. Many countries in the region still criminalise consensual homosexual relationships, and some are yet to adopt WHO-recommended interventions for MSM into national HIV policies. This study examines how HIV testing of adult MSM in SSA varies according to the legal climate and presence of targeted HIV policy using data from the cross-sectional 2019 Global LGBTI Internet Survey study. METHODS: Using data from 3191 MSM in 44 SSA countries, we assessed associations of legal climate and HIV policy with ever and recent HIV testing using linear ecological and logistic multilevel analyses. From the single-level analysis, we can compare our findings to previously reported data, then, extending to a two-level multilevel analysis, we account for the hierarchical structure of the population and simultaneously adjust for differences in context and composition in each country. We then test the sensitivity of our analyses to excluding countries from the model. RESULTS: We find evidence that legalised same-sex relationships were associated with increased odds of ever testing (OR=2.00, 95% CI 1.04, 3.82) in multilevel analyses. We also find evidence of an association of targeted HIV policies with increased odds of ever testing (OR=2.49, 95% CI 1.12, 5.52). We did not find evidence of an association of the legal climate (OR=1.01, 95% CI 0.69, 1.46) and targeted HIV policies (OR=1.26, 95% CI 0.78, 2.04) with recent testing. CONCLUSIONS: This study suggests elimination of discriminatory laws and policies might be important for increasing HIV status awareness of MSM, an important first step in epidemic control. Additionally, we highlight heterogeneity between South Africa and other SSA countries, which has implications for studying SSA countries as a homogeneous group.

Costs of distributing HIV self-testing kits in Eswatini through community and workplace models.

BACKGROUND: This study evaluates the implementation and running costs of an HIV self-testing (HIVST) distribution program in Eswatini. HIVST kits were delivered through community-based and workplace models using primary and secondary distribution. Primary clients could self-test onsite or offsite. This study presents total running economic costs of kit distribution per model between April 2019 and March 2020, and estimates average cost per HIVST kit distributed, per client self-tested, per client self-tested reactive, per client confirmed positive, and per client initiating antiretroviral therapy (ART). METHODS: Distribution data and follow-up phone interviews were analysed to estimate implementation outcomes. Results were presented for each step of the care cascade using best-case and worst-case scenarios. A top-down incremental cost-analysis was conducted from the provider perspective using project expenditures. Sensitivity and scenario analyses explored effects of economic and epidemiological parameters on average costs. RESULTS: Nineteen thousand one hundred fifty-five HIVST kits were distributed to 13,031 individuals over a 12-month period, averaging 1.5 kits per recipient. 83% and 17% of kits were distributed via the community and workplace models, respectively. Clients reached via the workplace model were less likely to opt for onsite testing than clients in the community model (8% vs 29%). 6% of onsite workplace testers tested reactive compared to 2% of onsite community testers. Best-case scenario estimated 17,458 (91%) clients self-tested, 633 (4%) received reactive-test results, 606 (96%) linked to confirmatory testing, and 505 (83%) initiated ART. Personnel and HIVST kits represented 60% and 32% of total costs, respectively. Average costs were: per kit distributed US$17.23, per client tested US$18.91, per client with a reactive test US$521.54, per client confirmed positive US$550.83, and per client initiating ART US$708.60. Lower rates for testing, reactivity, and linkage to care in the worst-case scenario resulted in higher average costs along the treatment cascade. CONCLUSION: This study fills a significant evidence gap regarding costs of HIVST provision along the client care cascade in Eswatini. Workplace and community-based distribution of HIVST accompanied with effective linkage to care strategies can support countries to reach cascade objectives.

Effectiveness and cost-effectiveness of a transdiagnostic intervention for alcohol misuse and psychological distress in humanitarian settings: study protocol for a randomised controlled trial in Uganda.

BACKGROUND: The war in South Sudan has displaced more than four million people, with Uganda hosting the largest number of South Sudanese refugees. Research in Uganda has shown elevated levels of alcohol misuse and psychological distress among these refugees. The World Health Organization (WHO) has developed a trans-diagnostic scalable psychological intervention called Problem Management Plus (PM +) to reduce psychological distress among populations exposed to adversities. Our study aims to evaluate the effectiveness and cost-effectiveness of the CHANGE intervention, which builds on PM + , to also address alcohol misuse through problem-solving therapy and selected behavioural strategies for dealing with alcohol use disorders. We hypothesise that the CHANGE intervention together with enhanced usual care (EUC) will be superior to EUC alone in increasing the percentage of days abstinent. METHODS: A parallel-arm individually randomised controlled trial will be conducted in the Rhino Camp and Imvepi settlements in Uganda. Five hundred adult male South Sudanese refugees with (i) elevated levels of alcohol use (between 8 and 20 on the Alcohol Use Disorder Identification Test [AUDIT]); and (ii) psychological distress (> 16 on the Kessler Psychological Distress Scale) will be randomly assigned 1:1 to EUC or CHANGE and EUC. CHANGE will be delivered by lay healthcare providers over 6 weeks. Outcomes will be assessed at 3 and 12 months post-randomisation. The primary outcome is the percentage of days abstinent, measured by the timeline follow-back measure at 3 months. Secondary outcomes include percentage of days abstinent at 12 months and alcohol misuse (measured by the AUDIT), psychological distress (i.e. depression, anxiety, posttraumatic stress disorder), functional disability, perpetration of intimate partner violence, and health economic indicators at 3 and 12 months. A mixed-methods process evaluation will investigate competency, dose, fidelity, feasibility, and acceptability. Primary analyses will be intention-to-treat. DISCUSSION: CHANGE aims to address alcohol misuse and psychological distress with male refugees in a humanitarian setting. If it is proven to be effective, it can help fill an important under-researched gap in humanitarian service delivery. TRIAL REGISTRATION: ISRCTN ISRCTN10360385. Registered on 30 January 2023.

Is Internalised Homonegativity associated with HIV testing and HIV risk behaviours of men who have sex with men: a multilevel cross-sectional study of sub-Saharan African countries.

OBJECTIVES: This study assessed the associations of Internalised Homonegativity (IH) with HIV testing and risk behaviours of adult men who have sex with men (MSM) in sub-Saharan Africa (SSA) and effect modification by the legal climate. DESIGN: We used data from the cross-sectional 2019 Global Lesbian, Gay, Bisexual, Transgender and Intersex (LGBTI+) Internet survey study. SETTING AND PARTICIPANTS: Overall, the 2019 Global LGBTI Internet Survey collected data from 46 SSA countries. In this secondary analysis, we included data from 3191 MSM in 44 SSA countries as there were no eligible MSM responses in the 2 countries excluded. OUTCOME MEASURES: Our response variables were self-reported binary indicators of ever tested for HIV, recently tested in the past 6 months (from those who reported ever testing), transactional sex (paying for and being paid for sex in the past 12 months), and unprotected anal sex (that is without a condom or pre-exposure prohylaxis (PrEP)) with a non-steady partner (in the past 3 months). RESULTS: Our findings showed high levels of IH (range 1-7) in MSM across SSA (mean (SD)=5.3 (1.36)). We found that MSM with higher IH levels were more likely to have ever (adjusted OR (aOR) 1.18, 95% CI 1.03 to 1.35) and recently tested (aOR 1.19, 95% CI 1.07 to 1.32) but no evidence of an association with paying for sex (aOR 1.00, 95% CI 0.89 to 1.12), selling sex (aOR 1.06, 95% CI 0.95 to 1.20) and unprotected sex (aOR 0.99, 95% CI 0.89 to 1.09). However, we observed that a favourable legal climate modifies the associations of IH and paying for sex (aOR 0.75, 95% CI 0.60 to 0.94). Increasing levels of IH had a negative association with paying for sex in countries where same-sex relationships are legal. We found no associations of IH with unprotected anal sex in the population surveyed. CONCLUSIONS: We confirm that IH is widespread across SSA but in countries that legalise same-sex relationships, MSM were less likely to engage in transactional sex compared with those in countries where homosexuality is criminalised.

Effect of the Mamás del Río programme on essential newborn care: a three-year before-and-after outcome evaluation of a community-based, maternal and neonatal health intervention in the Peruvian Amazon.

Background: Despite remarkable progress in maternal and neonatal health, regional inequalities persist in Peru. In rural areas of Amazonian Loreto, access to quality care is difficult, home births are frequent, and neonatal mortality is high. We conducted a prospective before-and-after study to assess the effect after implementation and over time of a community-based intervention on essential newborn care (ENC). Methods: Mamás del Río consists of tablet-enhanced educational home visits by Community health workers (CHW) to pregnant women and mothers of newborns, with supportive training on ENC of traditional birth attendants and facility staff. The study area comprised 79 rural communities of three districts in Loreto. Primary outcomes were ENC practices in home births, secondary outcomes were ENC in facility births as well as healthcare seeking, measured at baseline before and at year 2 and year 3 after intervention implementation. Community censuses included questionnaires to women aged 15-49 years with a live birth. We calculated prevalence of outcomes at each time point and estimated adjusted prevalence differences (PD) between time points using post-estimation based on logistic regression. Findings: Following implementation early 2019, 97% of communities had a trained CHW. At year 2 follow-up, 63% (322/530) of women received a CHW visit during pregnancy. Seven out of nine ENC indicators among home births improved, with largest adjusted prevalence differences in immediate skin-to-skin contact (50% [95% CI: 42-58], p < 0.0001), colostrum feeding (45% [35-54], p < 0.0001), and cord care (19% [10-28], p = 0.0001). Improvements were maintained at year 3, except for cord care. At year 2, among facility births only three ENC indicators improved, while more women gave birth in a facility. Sensitivity analyses showed ENC prevalence was similar before compared to after onset of Covid-19 lockdown. Interpretation: ENC practices in home births improved consistently and changes were sustained over time, despite the onset of the Covid-19 pandemic. A community-based approach for behaviour-change in home-based newborn care appears effective. Process evaluation of mechanisms will help to explain observed effects and understand transferability of findings. Funding: Grand Challenges Canada and Peruvian National Council of Science and Technology.

Do community measures impact the effectiveness of a community led HIV testing intervention. Secondary analysis of an HIV self-testing intervention in rural communities in Zimbabwe.

BACKGROUND: There is a growing body of evidence for the role that communities can have in producing beneficial health outcomes. There is also an increasing recognition of the effectiveness and success of community-led interventions to promote public health efforts. This study investigated whether and how community-level measures facilitate a community-led intervention to achieve improved HIV outcomes. METHODS: This is a secondary analysis of survey data from a cluster randomised trial in 40 rural communities in Zimbabwe. The survey was conducted four months after the intervention was initiated. Communities were randomised 1:1 to either paid distribution arm, where HIV self-test (HIVST) kits were distributed by a paid distributor, or community-led whereby members of the community were responsible for organising and conducting the distribution of HIVST kits. We used mixed effects logistic regression to assess the effect of social cohesion, problem solving, and HIV awareness on HIV testing and prevention. RESULTS: We found no association between community measures and the three HIV outcomes (self-testing, new HIV diagnosis and linkage to VMMC or confirmatory testing). However, the interaction analyses highlighted that in high social cohesion communities, the odds of new HIV diagnosis was greater in the community-led arm than paid distribution arm (OR 2.06 95% CI 1.03-4.19). CONCLUSION: We found some evidence that community-led interventions reached more undiagnosed people living with HIV in places with high social cohesion. Additional research should seek to understand whether the effect of social cohesion is persistent across other community interventions and outcomes. TRIAL REGISTRATION: PACTR201607001701788.

Effect and cost-effectiveness of human-centred design-based approaches to increase adolescent uptake of modern contraceptives in Nigeria, Ethiopia and Tanzania: Population-based, quasi-experimental studies.

Around half of adolescent pregnancies in low- and middle-income countries are unintended, contributing to millions of unsafe abortions per year. Adolescents 360 (A360), a girl-centred initiative, aimed to increase voluntary uptake of modern contraceptives among adolescents in Nigeria, Ethiopia and Tanzania. We evaluated the effectiveness and cost-effectiveness of A360 in increasing modern contraceptive use in selected geographies. We used before-and-after cross-sectional studies of adolescent girls in four settings. Two Nigerian settings had purposefully selected comparison areas. Baseline and endline household surveys were conducted. The primary study outcome was modern contraceptive prevalence rate (mCPR). Secondary outcomes mapped onto the A360 Theory of Change. Interpretation was aided by a process evaluation along with secular mCPR trends and self-reported A360 exposure data. Incremental design and implementation costs were calculated from implementer systems, site visits, surveys, and interviews. mCPR change was modelled into maternal disability-adjusted life years (DALY) averted to calculate incremental cost-effectiveness ratios. In Oromia, Ethiopia, mCPR increased by 5% points (95% CI 1-10; n = 1,697). In Nigeria, there was no evidence of an effect of A360 on mCPR in Nasarawa (risk ratio: 0·96, 95% CI: 0·76-1·21; n = 5,414) or in Ogun (risk ratio: 1·08, 95% CI: 0·92-1·26; n = 3,230). In Mwanza, Tanzania, mCPR decreased by 9% points (-17 to -0.3; n = 1,973). Incremental cost per DALY averted were $30,855 in Oromia, $111,416 in Nasarawa, $30,114 in Ogun, and $25,579 in Mwanza. Costs per DALY averted were 14-53 times gross domestic product per capita. A360 did not lead to increased adolescent use of modern contraceptives at a population level, except in Oromia, and was not cost-effective. This novel adolescent-centred design approach showed some promise in addressing the reproductive health needs of adolescents, but must be accompanied by efforts to address the contextual drivers of low modern contraceptive use.

Coach-Supported Versus Self-guided Digital Training Course for a Problem-solving Psychological Intervention for Nonspecialists: Protocol for a Pre-Post Nested Randomized Controlled Trial.

BACKGROUND: Psychosocial interventions delivered by nonspecialists can be effective at reducing common adolescent mental health problems in low-resource settings. However, there is a lack of evidence on resource-efficient methods for building capacity to deliver these interventions. OBJECTIVE: The objective of this study is to evaluate the effects of a digital training (DT) course, delivered in a self-guided format or with coaching, on nonspecialists' competency to deliver a problem-solving intervention intended for adolescents with common mental health problems in India. METHODS: We will conduct a pre-post study with a nested parallel, 2-arm, individually randomized controlled trial. The study aims to recruit 262 participants, randomized 1:1 to receive either a self-guided DT course or a DT course with weekly individualized coaching provided remotely by telephone. In both arms, the DT will be accessed over 4 to 6 weeks. Participants will be nonspecialists (ie, without prior practice-based training in psychological therapies) recruited from among university students and affiliates of nongovernmental organizations in Delhi and Mumbai, India. RESULTS: Outcomes will be assessed at baseline and 6 weeks post randomization using a knowledge-based competency measure that incorporates a multiple-choice quiz format. The primary hypothesis is that self-guided DT will lead to increased competency scores among novices with no prior experience of delivering psychotherapies. The secondary hypothesis is that digital training with coaching will have an incremental effect on competency scores compared with DT alone. The first participant was enrolled on April 4, 2022. CONCLUSIONS: The study will address an evidence gap on the effectiveness of training methods for nonspecialist providers of adolescent mental health interventions in low-resource settings. The findings from this study will be used to support wider efforts to scale up evidence-based mental health interventions for young people. TRIAL REGISTRATION: ClinicalTrials.gov NCT05290142; https://clinicaltrials.gov/ct2/show/NCT05290142. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41981.

Prevalence of essential newborn care in home and facility births in the Peruvian Amazon: analysis of census data from programme evaluation in three remote districts of the Loreto region.

Background: Essential newborn care (ENC) covers optimal breastfeeding, thermal care, and hygienic cord care. These practices are fundamental to save newborn lives. Despite neonatal mortality remaining high in some parts of Peru, no comprehensive data on ENC is available. We sought to estimate the prevalence of ENC and assess differences between facility and home births in the remote Peruvian Amazon. Methods: We used baseline data from a household census of rural communities of three districts in Loreto region, collected as part of the evaluation of a maternal-neonatal health (MNH) programme. Women between 15 and 49 years with a live birth in the last 12 months were invited to complete a questionnaire about MNH-related care and ENC. Prevalence of ENC was calculated for all births and disaggregated by place of birth. Adjusted prevalence differences (PD) were post-estimated from logistic regression models on the effect of place of birth on ENC. Findings: All 79 rural communities with a population of 14,474 were censused. Among 324 (>99%) women interviewed, 70% gave birth at home, most (93%) without skilled birth assistance. Among all births, prevalence was lowest for immediate skin-to-skin contact (24%), colostrum feeding (47%), and early breastfeeding (64%). ENC was consistently lower in home compared to facility births. After adjusting for confounders, largest PD were found for immediate skin-to-skin contact (50% [95% CI: 38-62]), colostrum feeding (26% [16-36]), and clean cord care (23% [14-32]). ENC prevalence in facilities ranged between 58 and 93%; delayed bathing was lower compared to home births (-19% [-31 to -7]). Interpretation: Low prevalence of ENC practices among home births in a setting with high neonatal mortality and difficult access to quality care in facilities suggests potential for a community-based intervention to promote ENC practices at home, along with promotion of healthcare seeking and simultaneous strengthening of routine facility care. Funding: Grand Challenges Canada and Peruvian National Council of Science, Technology, and Technology Innovation.

Developing knowledge-based psychotherapeutic competencies in non-specialist providers: A pre-post study with a nested randomised controlled trial of a coach-supported versus self-guided digital training course for a problem-solving psychological intervention in India.

We evaluated a digital learning programme for non-specialists to develop knowledge-based competencies in a problem-solving intervention for adolescents to examine the overall impact of training on knowledge-based competencies among learners; and to compare the effects of two training conditions (self-guided digital training with or without coaching) in a nested parallel, two-arm, individually randomised controlled trial. Eligible participants were 18 or older; fluent in Hindi or English; able to access digital training; and had no prior experience of delivering structured psychotherapies. 277 participants were enrolled from 31 March 2022 to 19 June 2022 of which 230 (83%) completed the study. There was a significant increase in competency score from pre-training (Mean = 7.01, SD = 3.29) to post-training (Mean = 8.88, SD = 3.80), 6 weeks after the pre-training assessment. Knowledge competency scores showed larger increase among participants randomised to the coaching arm (AMD = 1.09, 95% CI 0.26-1.92, p = 0.01) with an effect size (d) of 0.33 (95% CI 0.08-0.58). More participants completed training in the coaching arm (n = 96, 69.6%) compared to the self-guided training arm (n = 56, 40.3%). In conclusion, a coach-supported remote digital training intervention is associated with enhanced participation by learners and increased psychotherapeutic knowledge competencies.

Sensitivity and specificity of OraQuick® HIV self-test compared to a 4th generation laboratory reference standard algorithm in urban and rural Zambia.

BACKGROUND: HIV self-testing (HIVST) has the potential to increase coverage of HIV testing, but concerns exist about intended users' ability to correctly perform and interpret tests, especially in poor communities with low literacy rates. We assessed the clinical performance of the 2016 prototype OraQuick® HIV Self-Test in rural and urban communities in Zambia to assess the sensitivity and specificity of the test compared to the national HIV rapid diagnostic test (RDT) algorithm and a laboratory reference standard using 4th generation enzyme immunoassays and HIV RNA detection. METHODS: Participants were recruited from randomly selected rural and urban households and one urban health facility between May 2016 and June 2017. Participants received a brief demonstration of the self-test, and then self-tested without further assistance. The research team re-read the self-test, repeated the self-test, drew blood for the laboratory reference, and conducted RDTs following the national HIV testing algorithm (Determine™ HIV1/2 (Alere) confirmed using Unigold™ HIV1/2 (Trinity Biotech)). Selected participants (N = 85) were videotaped whilst conducting the testing to observe common errors. RESULTS: Initial piloting showed that written instructions alone were inadequate, and a demonstration of self-test use was required. Of 2,566 self-test users, 2,557 (99.6%) were able to interpret their result. Of participants who were videoed 75/84 (89.3%) completed all steps of the procedure correctly. Agreement between the user-read result and the researcher-read result was 99.1%. Compared to the RDT algorithm, user-conducted HIVST was 94.1% sensitive (95%CI: 90.2-96.7) and 99.7% specific (95%CI: 99.3-99.9). Compared to the laboratory reference, both user-conducted HIVST (sensitivity 87.5%, 95%CI: 82.70-91.3; specificity 99.7%, 95%CI: 99.4-99.9) and the national RDT algorithm (sensitivity 93.4%, 95%CI: 89.7-96.1%; specificity 100% (95%CI: 99.8-100%) had considerably lower sensitivity. CONCLUSIONS: Self-testers in Zambia who used OraQuick® HIV Self-Test achieved reasonable clinical performance compared to the national RDT algorithm. However, sensitivity of the self-test was reduced compared to a laboratory reference standard, as was the national RDT algorithm. In-person demonstration, along with the written manufacturer instructions, was needed to obtain accurate results. Programmes introducing self-care diagnostics should pilot and optimise support materials to ensure they are appropriately adapted to context.

Did you hear about HIV self-testing? HIV self-testing awareness after community-based HIVST distribution in rural Zimbabwe.

BACKGROUND: Several trials of community-based HIV self-testing (HIVST) provide evidence on the acceptability and feasibility of campaign-style distribution to reach first-time testers, men and adolescents. However, we do not know how many remain unaware of HIVST after distribution campaigns, and who these individuals are. Here we look at factors associated with never having heard of HIVST after community-based campaign-style HIVST distribution in rural Zimbabwe between September 2016 and July 2017. METHODS: Analysis of representative population-based trial survey data collected from 7146 individuals following community-based HIVST distribution to households was conducted. Factors associated with having never heard of HIVST were determined using multivariable mixed-effects logistic regression adjusted for clustered design. RESULTS: Among survey participants, 1308 (18.3%) self-reported having never heard of HIVST. Individuals who were between 20 and 60 years old {20-29 years: [aOR = 0.74, 95% CI (0.58-0.95)], 30-39 years: [aOR = 0.56, 95% CI (0.42-0.74)], 40-49 years: [aOR = 0.50, 95% CI (0.36-0.68)], 50-59 years [aOR = 0.58, 95% CI (0.42-0.82)]}, who had attained at least ordinary level education [aOR = 0.51, 95% CI (0.34-0.76)], and who had an HIV test before [aOR = 0.30, 95% CI (0.25-0.37)] were less likely to have never heard of HIVST compared with individuals who were between 16 and 19 years old, who had a lower educational level and who had never tested for HIV before, respectively. In addition, non-household heads or household head representatives [aOR = 1.21, 95% CI (1.01-1.45)] were more likely to report never having heard of HIVST compared to household head and representatives. CONCLUSIONS: Around one fifth of survey participants remain unaware of HIVST even after an intensive community-based door-to-door HIVST distribution. Of note, those least likely to have heard of self-testing were younger, less educated and less likely to have tested previously. Household heads appear to play an important role in granting or denying access to self-testing to other household members during door-to-door distribution. Differentiated distribution models are needed to ensure access to all. Trial registration PACTR, PACTR201607001701788. Registered 29 June 2016, https://pactr.samrc.ac.za/ PACTR201607001701788.

A field sentinel study investigating withering syndrome transmission dynamics in California abalones.

We examined the risk of withering syndrome (WS) rickettsia-like organism (WS-RLO) infection in sentinel red abalone (Haliotis rufescens) deployed in modules at two Southern California field sites, one adjacent to an abalone farm and one adjacent to wild abalones. WS-RLO DNA was detected in seawater near modules at the wild abalone site but not near the farm (WS-RLO DNA was detected in the farm effluent). More WS-RLO DNA was detected in tissue from abalone near the farm relative to those near wild abalones (p < 0.05). However, infection prevalence and intensity based on histology were low and similar between sites (p > 0.05) and were independent of WS-RLO DNA loads in abalone tissue and seawater. More stippled (ST)-RLO than WS-RLO were observed with more ST-RLO infections near wild abalone than near the abalone farm (p < 0.05). We demonstrate the utility of caged sentinel abalone to better understand pathogen transmission patterns in the field.

Understanding mechanisms of impact from community-led delivery of HIV self-testing: Mediation analysis of a cluster-randomised trial in Malawi.

Community HIV strategies are important for early diagnosis and treatment, with new self-care technologies expanding the types of services that can be led by communities. We evaluated mechanisms underlying the impact of community-led delivery of HIV self-testing (HIVST) using mediation analysis. We conducted a cluster-randomised trial allocating 30 group village heads and their catchment areas to the community-led HIVST intervention in addition to the standard of care (SOC) or the SOC alone. The intervention used participatory approaches to engage established community health groups to lead the design and implementation of HIVST campaigns. Potential mediators (individual perceptions of social cohesion, shared HIV concern, critical consciousness, community HIV stigma) and the outcome (HIV testing in the last 3 months) were measured through a post-intervention survey. Analysis used regression-based models to test (i) intervention-mediator effects, (ii) mediator-outcome effects, and (iii) direct and indirect effects. The survey included 972 and 924 participants in the community-led HIVST and SOC clusters, respectively. The community-led HIVST intervention increased uptake of recent HIV testing, with no evidence of indirect effects from changes in hypothesised mediators. However, standardised scores for community cohesion (adjusted mean difference [MD] 0.15, 95% CI -0.03 to 0.32, p = 0.10) and shared concern for HIV (adjusted MD 0.13, 95% CI -0.02 to 0.29, p = 0.09) were slightly higher in the community-led HIVST arm than the SOC arm. Social cohesion, community concern, and critical consciousness also apparently had a quadratic association with recent testing in the community-led HIVST arm, with a positive relationship indicated at lower ranges of each score. We found no evidence of intervention effects on community HIV stigma and its association with recent testing. We conclude that the intervention effect mostly operated directly through community-driven service delivery of a novel HIV technology rather than through intermediate effects on perceived community mobilisation and HIV stigma.

Effect of peer-distributed HIV self-test kits on demand for biomedical HIV prevention in rural KwaZulu-Natal, South Africa: a three-armed cluster-randomised trial comparing social networks versus direct delivery.

STUDY OBJECTIVE: We investigated two peer distribution models of HIV self-testing (HIVST) in HIV prevention demand creation compared with trained young community members (peer navigators). METHODS: We used restricted randomisation to allocate 24 peer navigator pairs (clusters) in KwaZulu-Natal 1:1:1: (1) standard of care (SOC): peer navigators distributed clinic referrals, pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) information to 18-30 year olds. (2) peer navigator direct distribution (PND): Peer navigators distributed HIVST packs (SOC plus two OraQuick HIVST kits) (3) incentivised peer networks (IPN): peer navigators recruited young community members (seeds) to distribute up to five HIVST packs to 18-30 year olds within their social networks. Seeds received 20 Rand (US$1.5) for each recipient who distributed further packs. The primary outcome was PrEP/ART linkage, defined as screening for PrEP/ART eligibility within 90 days of pack distribution per peer navigator month (pnm) of outreach, in women aged 18-24 (a priority for HIV prevention). Investigators and statisticians were blinded to allocation. Analysis was intention to treat. Total and unit costs were collected prospectively. RESULTS: Between March and December 2019, 4163 packs (1098 SOC, 1480 PND, 1585 IPN) were distributed across 24 clusters. During 144 pnm, 272 18-30 year olds linked to PrEP/ART (1.9/pnm). Linkage rates for 18-24-year-old women were lower for IPN (n=26, 0.54/pnm) than PND (n=45, 0.80/pnm; SOC n=49, 0.85/pnm). Rate ratios were 0.68 (95% CI 0.28 to 1.66) for IPN versus PND, 0.64 (95% CI 0.26 to 1.62) for IPN versus SOC and 0.95 (95% CI 0.38 to 2.36) for PND versus SOC. In 18-30 year olds, PND had significantly more linkages than IPN (2.11 vs 0.88/pnm, RR 0.42, 95% CI 0.18 to 0.98). Cost per pack distributed was cheapest for IPN (US$36) c.f. SOC (US$64). Cost per person linked to PrEP/ART was cheaper in both peer navigator arms compared with IPN. DISCUSSION: HIVST did not increase demand for PrEP/ART. Incentivised social network distribution reached large numbers with HIVST but resulted in fewer linkages compared with PrEP/ART promotion by peer navigators. TRIAL REGISTRATION NUMBER: NCT03751826.