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.

Secondary distribution of HIV self-test kits by HIV index and antenatal care clients: implementation and costing results from the STAR Initiative in South Africa.

BACKGROUND: Partner-delivered HIV self-testing kits has previously been highlighted as a safe, acceptable and effective approach to reach men. However, less is known about its real-world implementation in reaching partners of people living with HIV. We evaluated programmatic implementation of partner-delivered self-testing through antenatal care (ANC) attendees and people newly diagnosed with HIV by assessing use, positivity, linkage and cost per kit distributed. METHODS: Between April 2018 and December 2019, antenatal care (ANC) clinic attendees and people or those newly diagnosed with HIV clients across twelve clinics in three cities in South Africa were given HIVST kits (OraQuick Rapid HIV-1/2 Antibody Test, OraSure Technologies) to distribute to their sexual partners. A follow-up telephonic survey was administered to all prior consenting clients who were successfully reached by telephone to assess primary outcomes. Incremental economic costs of the implementation were estimated from the provider's perspective. RESULTS: Fourteen thousand four hundred seventy-three HIVST kits were distributed - 10,319 (71%) to ANC clients for their male partner and 29% to people newly diagnosed with HIV for their partners. Of the 4,235 ANC clients successfully followed-up, 82.1% (3,475) reportedly offered HIVST kits to their male partner with 98.1% (3,409) accepting and 97.6% (3,328) using the kit. Among ANC partners self-testing, 159 (4.8%) reported reactive HIVST results, of which 127 (79.9%) received further testing; 116 (91.3%) were diagnosed with HIV and 114 (98.3%) initiated antiretroviral therapy (ART). Of the 1,649 people newly diagnosed with HIV successfully followed-up; 1,312 (79.6%) reportedly offered HIVST kits to their partners with 95.8% (1,257) of the partners accepting and 95.9% (1,206) reported that their partners used the kit. Among these index partners, 297 (24.6%) reported reactive HIVST results of which 261 (87.9%) received further testing; 260 (99.6%) were diagnosed with HIV and 258 (99.2%) initiated ART. The average cost per HIVST distributed in the three cities was US$7.90, US$11.98, and US$14.81, respectively. CONCLUSIONS: Partner-delivered HIVST in real world implementation was able to affordably reach many male partners of ANC attendees and index partners of people newly diagnosed with HIV in South Africa. Given recent COVID-19 related restrictions, partner-delivered HIVST provides an important strategy to maintain essential testing services.

Examining the Use of HIV Self-Testing to Support PrEP Delivery: a Systematic Literature Review.

PURPOSE OF REVIEW: HIV self-testing (HIVST) has the potential to expand access to and uptake of HIV pre-exposure prophylaxis (PrEP) delivery. We conducted a systematic literature review to understand the evidence on HIVST use for PrEP delivery. RECENT FINDINGS: After screening 1055 records, we included eight: three randomized trials and five values and preferences studies. None measured PrEP initiation. Most studies occurred in Sub-Saharan Africa (7/8) and included different populations. One trial found that HIVST use between quarterly clinic visits as part of an adherence package with biofeedback slightly increased adherence; the other two trials found that HIVST use between or in lieu of quarterly clinic visits had no significant or non-inferior effects on adherence. HIVST to support PrEP delivery was acceptable, feasible, and preferred. HIVST use for PrEP continuation largely resulted in similar outcomes to standard-of-care delivery and was perceived acceptable and feasible. Further research is needed to optimize HIVST use within PrEP programming.

HIV Testing Uptake According to Opt-In, Opt-Out or Risk-Based Testing Approaches: a Systematic Review and Meta-Analysis.

PURPOSE OF REVIEW: Improving HIV testing uptake is essential to ending the HIV pandemic. HIV testing approaches can be opt-in, opt-out or risk-based. This systematic review examines and compares the uptake of HIV testing in opt-in, opt-out and risk-based testing approaches. RECENT FINDINGS: There remain missed opportunities for HIV testing in a variety of settings using different approaches: opt-in (a person actively accepts to be tested for HIV), opt-out (a person is informed that HIV testing is routine/standard of care, and they actively decline if they do not wish to be tested for HIV) or risk-based (using risk-based screening tools to focus testing on certain individuals or sub-populations at greater risk of HIV). It is not clear how the approach could impact HIV test uptake when adjusted for other factors (e.g. rapid testing, country-income level, test setting and population tested). We searched four databases for studies reporting on HIV test uptake. In total, 18,238 records were screened, and 150 studies were included in the review. Most studies described an opt-in approach (87 estimates), followed by opt-out (76) and risk-based (19). Opt-out testing was associated with 64.3% test uptake (I2 = 99.9%), opt-in testing with 59.8% (I2 = 99.9%) and risk-based testing with 54.4% (I2 = 99.9%). When adjusted for settings that offered rapid testing, country income level, setting and population tested, opt-out testing had a significantly higher uptake (+ 12% (95% confidence intervals: 3-21), p = 0.007) than opt-in testing. We also found that emergency department patients and hospital outpatients had significantly lower HIV test uptake than other populations.

Effect of door-to-door distribution of HIV self-testing kits on HIV testing and antiretroviral therapy initiation: a cluster randomised trial in Malawi.

INTRODUCTION: Reaching high coverage of HIV testing remains essential for HIV diagnosis, treatment and prevention. We evaluated the effectiveness and safety of door-to-door distribution of HIV self-testing (HIVST) kits in rural Malawi. METHODS: This cluster randomised trial, conducted between September 2016 and January 2018, used restricted 1:1 randomisation to allocate 22 health facilities and their defined areas to door-to-door HIVST alongside the standard of care (SOC) or the SOC alone. The study population included residents (≥16 years). HIVST kits were provided door-to-door by community-based distribution agents (CBDAs) for at least 12 months. The primary outcome was recent HIV testing (in the last 12 months) measured through an endline survey. Secondary outcomes were lifetime HIV testing and cumulative 16-month antiretroviral therapy (ART) initiations, which were captured at health facilities. Social harms were reported through community reporting systems. Analysis compared cluster-level outcomes by arm. RESULTS: Overall, 203 CBDAs distributed 273 729 HIVST kits. The endline survey included 2582 participants in 11 HIVST clusters and 2908 participants in 11 SOC clusters. Recent testing was higher in the HIVST arm (68.5%, 1768/2582) than the SOC arm (48.9%, 1422/2908), with adjusted risk difference (RD) of 16.1% (95% CI 6.5% to 25.7%). Lifetime testing was also higher in the HIVST arm (86.9%, 2243/2582) compared with the SOC arm (78.5%, 2283/2908; adjusted RD 6.3%, 95% CI 2.3% to 10.3%). Differences were most pronounced for adolescents aged 16-19 years (adjusted RD 18.6%, 95% CI 7.3% to 29.9%) and men (adjusted RD 10.2%, 95% CI 3.1% to 17.2%). Cumulative incidence of ART initiation was 1187.2 and 909.0 per 100 000 population in the HIVST and SOC arms, respectively (adjusted RD 309.1, 95% CI -95.5 to 713.7). Self-reported HIVST use was 42.5% (1097/2582), with minimal social harms reported. CONCLUSION: Door-to-door HIVST increased recent and lifetime testing at population level and showed high safety, underscoring potential for HIVST to contribute to HIV elimination goals in priority settings. TRIAL REGISTRATION NUMBER: NCT02718274.

Effect of community-led delivery of HIV self-testing on HIV testing and antiretroviral therapy initiation in Malawi: A cluster-randomised trial.

BACKGROUND: Undiagnosed HIV infection remains substantial in key population subgroups including adolescents, older adults, and men, driving ongoing transmission in sub-Saharan Africa. We evaluated the impact, safety, and costs of community-led delivery of HIV self-testing (HIVST), aiming to increase HIV testing in underserved subgroups and stimulate demand for antiretroviral therapy (ART). METHODS AND FINDINGS: This cluster-randomised trial, conducted between October 2018 and July 2019, used restricted randomisation (1:1) to allocate 30 group village head clusters in Mangochi district, Malawi to the community-led HIVST intervention in addition to the standard of care (SOC) or the SOC alone. The intervention involved mobilising community health groups to lead the design and implementation of 7-day HIVST campaigns, with cluster residents (≥15 years) eligible for HIVST. The primary outcome compared lifetime HIV testing among adolescents (15 to 19 years) between arms. Secondary outcomes compared: recent HIV testing (in the last 3 months) among older adults (≥40 years) and men; cumulative 6-month incidence of ART initiation per 100,000 population; knowledge of the preventive benefits of HIV treatment; and HIV testing stigma. Outcomes were measured through a post-intervention survey and at neighboring health facilities. Analysis used intention-to-treat for cluster-level outcomes. Community health groups delivered 24,316 oral fluid-based HIVST kits. The survey included 90.2% (3,960/4,388) of listed participants in the 15 community-led HIVST clusters and 89.2% (3,920/4,394) of listed participants in the 15 SOC clusters. Overall, the proportion of men was 39.0% (3,072/7,880). Most participants obtained primary-level education or below, were married, and reported a sexual partner. Lifetime HIV testing among adolescents was higher in the community-led HIVST arm (84.6%, 770/910) than the SOC arm (67.1%, 582/867; adjusted risk difference [RD] 15.2%, 95% CI 7.5% to 22.9%; p < 0.001), especially among 15 to 17 year olds and boys. Recent testing among older adults was also higher in the community-led HIVST arm (74.5%, 869/1,166) than the SOC arm (31.5%, 350/1,111; adjusted RD 42.1%, 95% CI 34.9% to 49.4%; p < 0.001). Similarly, the proportions of recently tested men were 74.6% (1,177/1,577) and 33.9% (507/1,495) in the community-led HIVST and SOC arms, respectively (adjusted RD 40.2%, 95% CI 32.9% to 47.4%; p < 0.001). Knowledge of HIV treatment benefits and HIV testing stigma showed no differences between arms. Cumulative incidence of ART initiation was respectively 305.3 and 226.1 per 100,000 population in the community-led HIVST and SOC arms (RD 72.3, 95% CI -36.2 to 180.8; p = 0.18). In post hoc analysis, ART initiations in the 3-month post-intervention period were higher in the community-led HIVST arm than the SOC arm (RD 97.7, 95% CI 33.4 to 162.1; p = 0.004). HIVST uptake was 74.7% (2,956/3,960), with few adverse events (0.6%, 18/2,955) and at US$5.70 per HIVST kit distributed. The main limitations include the use of self-reported HIV testing outcomes and lack of baseline measurement for the primary outcome. CONCLUSIONS: In this study, we found that community-led HIVST was effective, safe, and affordable, with population impact and coverage rapidly realised at low cost. This approach could enable community HIV testing in high HIV prevalence settings and demonstrates potential for economies of scale and scope. TRIAL REGISTRATION: Clinicaltrials.gov NCT03541382.

Implementation of different HIV self-testing models with implications for HIV testing services during the COVID-19 pandemic: study protocol for secondary data analysis of the STAR Initiative in South Africa.

INTRODUCTION: HIV self-testing (HIVST) presents a convenient, private approach that removes barriers to providing HIV testing services. The Self-Testing Africa (STAR) Initiative aims to scale up HIVST among priority and undertested populations. HIVST has the potential to help maintain testing services during the social distancing restrictions implemented to prevent the spread of COVID-19. This project evaluates linkage to confirmatory testing and treatment for HIV-positive clients for the STAR South Africa site. METHODS AND ANALYSIS: This secondary data analysis protocol aims to evaluate different HIVST distribution models from a prospective study implemented during November 2017 and December 2020 by Ezintsha, a subdivision of Wits Reproductive Health and HIV Institute. Routinely collected distribution and self-reported HIVST outcomes data will be deidentified and analysed. The main outcomes of interest are linkage to care and treatment among HIVST users who report a reactive HIVST result. Additionally, we plan to determine sociodemographic factors associated with linkage to care and treatment among HIVST users. Descriptive statistics will be used to describe the variables of interest, and modified Poisson regression with robust variance estimation will be performed to identify factors associated with linkage to care and treatment among HIVST users who report a reactive HIVST result. Risk ratios and 95% CIs for the risk ratios will be reported. ETHICS AND DISSEMINATION: The study protocol has been approved by the University of Witwatersrand Human Research Ethics Committee. The dissemination plan for the study findings will include presentations to local and international health authorities, international conferences and publications in open access journals.

Trends in knowledge of HIV status and efficiency of HIV testing services in sub-Saharan Africa, 2000-20: a modelling study using survey and HIV testing programme data.

BACKGROUND: Monitoring knowledge of HIV status among people living with HIV is essential for an effective national HIV response. This study estimates progress and gaps in reaching the UNAIDS 2020 target of 90% knowledge of status, and the efficiency of HIV testing services in sub-Saharan Africa, where two thirds of all people living with HIV reside. METHODS: For this modelling study, we used data from 183 population-based surveys (including more than 2·7 million participants) and national HIV testing programme reports (315 country-years) from 40 countries in sub-Saharan Africa as inputs into a mathematical model to examine trends in knowledge of status among people living with HIV, median time from HIV infection to diagnosis, HIV testing positivity, and proportion of new diagnoses among all positive tests, adjusting for retesting. We included data from 2000 to 2019, and projected results to 2020. FINDINGS: Across sub-Saharan Africa, knowledge of status steadily increased from 5·7% (95% credible interval [CrI] 4·6-7·0) in 2000 to 84% (82-86) in 2020. 12 countries and one region, southern Africa, reached the 90% target. In 2020, knowledge of status was lower among men (79%, 95% CrI 76-81) than women (87%, 85-89) across sub-Saharan Africa. People living with HIV aged 15-24 years were the least likely to know their status (65%, 62-69), but the largest gap in terms of absolute numbers was among men aged 35-49 years, with 701 000 (95% CrI 611 000-788 000) remaining undiagnosed. As knowledge of status increased from 2000 to 2020, the median time to diagnosis decreased from 9·6 years (9·1-10) to 2·6 years (1·8-3·5), HIV testing positivity declined from 9·0% (7·7-10) to 2·8% (2·1-3·9), and the proportion of first-time diagnoses among all positive tests dropped from 89% (77-96) to 42% (30-55). INTERPRETATION: On the path towards the next UNAIDS target of 95% diagnostic coverage by 2025, and in a context of declining positivity and yield of first-time diagnoses, disparities in knowledge of status must be addressed. Increasing knowledge of status and treatment coverage among older men could be crucial to reducing HIV incidence among women in sub-Saharan Africa, and by extension, reducing mother-to-child transmission. FUNDING: Steinberg Fund for Interdisciplinary Global Health Research (McGill University); Canadian Institutes of Health Research; Bill & Melinda Gates Foundation; Fonds the recherche du Québec-Santé; UNAIDS; UK Medical Research Council; MRC Centre for Global Infectious Disease Analysis; UK Foreign, Commonwealth & Development Office.

Expansion of HIV testing in Eswatini: stakeholder perspectives on reaching the first 90.

Achieving the United Nations' 90-90-90 goals has proven challenging in most settings and the ambitious 95-95-95 goals seem even more elusive. However, in Eswatini - a lower-middle-income country in sub-Saharan Africa with the highest HIV prevalence in the world - an estimated 92% of people living with HIV know their status. We conducted 26 in-depth interviews with stakeholders from policy, implementation, donor, local advocacy and academic sectors to elicit the facilitators and inhibitors to HIV testing uptake in Eswatini. Background data and related reports and policy documents (n = 57) were also reviewed. Essential facilitators included good governance via institutional and national budgetary commitments, which often led to swift adoption of globally recommended programs and standards. The integration of HIV testing into all points of care fostered a sense that testing was part of routine care, which reduced stigma. Challenges, however, centred on social norms that disadvantage certain groups with high ongoing HIV risk (such as key populations, adolescent girls and young women), a heavy reliance on external donor funding, and stigma that had subsided but nevertheless persisted. Amid concerns about whether the 90-90-90 targets could be achieved by 2020, the experience of Eswatini provides tangible insights into factors that have successfully influenced HIV testing uptake and may thus prove informative for other countries.

Using HIV self-testing to increase the affordability of community-based HIV testing services.

OBJECTIVES: This study estimates the costs of community-based HIV testing services (HTS) in Lesotho and assesses the potential efficiency gains achieved by adding HIV self-testing (HIVST) and then self-testing booths. DESIGN: Micro-costing analysis using longitudinal data from a real-world intervention. METHODS: We collected data prospectively on provider's costs and programmatic outcomes over three time periods of approximately 8 months each, between May 2017 and April 2019. The scope of services was extended during each period as follows: HTS only, HTS and HIVST, HTS and HIVST with individual HIVST booths wherein clients were encouraged to self-test on-site followed by on-site confirmative testing for those with reactive self-test. For each implementation period, we estimated the full financial and economic implementation costs, the incremental costs of adding HIVST onto conventional HTS and the cost per HIV positive case identified. RESULTS: Costs per HIV-positive case identified increased between period 1 (US$956) and period 2 (US$1249) then dropped in period 3 (US$813). Full versus incremental cost analyses resulted in large differences in the magnitude of costs, attributable to methods rather than resource use: for example, in period 3, the average full and incremental cost estimates for HTS were US$34.3 and US$23.5 per person tested, and for HIVST were US$37.7 and US$14.0 per kit provided, respectively. CONCLUSION: In Lesotho, adding HIVST to community-based HTS improves its overall affordability for HIV-positive case finding. The reporting of both full and incremental cost estimates increase transparency for use in priority setting, budgeting and financial planning for scale-up.

Who are the missing men? Characterising men who never tested for HIV from population-based surveys in six sub-Saharan African countries.

INTRODUCTION: We sought to characterize men who had never tested for HIV, understand factors associated with not testing, and measure survey HIV test uptake among never testers. We analysed nationally representative Demographic and Health Surveys of six African countries from 2013 to 2016: Ethiopia, Malawi, Zimbabwe, Rwanda, Lesotho and Zambia. METHODS: Eligible men were household residents or overnight visitors aged 15 to 59 years. We analysed questionnaire responses on HIV testing, known behavioural risk factors, and corresponding HIV laboratory results. We used survey-weighted logistic regression to identify factors associated with never testing for HIV. RESULTS: Approximately double the proportion of men had never tested for HIV compared to women (Malawi: 30% vs. 17%, p < 0.0001; Zimbabwe: 35% vs. 19%, p < 0.0001; Lesotho: 34% vs. 15%, p < 0.0001; Zambia: 36% vs. 20%, p < 0.0001); although, less of a differential existed in Ethiopia (54% vs. 56%, p = 0.12) and Rwanda (19% vs. 14%, p < 0.0001). When offered a test during the survey, 85% to 99% of sexually active men who reported never previously testing, accepted testing. HIV positivity ranged from <0.05% to 14% for never tested men. After adjusting for age, factors associated with never having tested for HIV were never being married (aOR range: 1.46 to 10.39), not having children (aOR: 1.36 to 3.59) and lower education (less than primary education aOR: 2.77 to 5.59). CONCLUSIONS: Although higher proportions of men than women had never tested for HIV, 85% to 99% of men did accept a test when offered. Finding opportunities to offer HIV testing to single men without children, older men who have never tested, and those disadvantaged with less schooling and employment, alongside other facility and community-based services, will be important in identifying those living with undiagnosed HIV and improving men's health.

Community-led delivery of HIV self-testing to improve HIV testing, ART initiation and broader social outcomes in rural Malawi: study protocol for a cluster-randomised trial.

BACKGROUND: Prevention of new HIV infections is a critical public health issue. The highest HIV testing gaps are in men, adolescents 15-19 years old, and adults 40 years and older. Community-based HIV testing services (HTS) can contribute to increased testing coverage and early HIV diagnosis, with HIV self-testing (HIVST) strategies showing promise. Community-based strategies, however, are resource intensive, costly and not widely implemented. A community-led approach to health interventions involves supporting communities to plan and implement solutions to improve their health. This trial aims to determine if community-led delivery of HIVST can improve HIV testing uptake, ART initiation, and broader social outcomes in rural Malawi. METHODS: The trial uses a parallel arm, cluster-randomised design with group village heads (GVH) and their defined catchment areas randomised (1:1) to community-led HIVST or continue with the standard of the care (SOC). As part of the intervention, informal community health cadres are supported to plan and implement a seven-day HIVST campaign linked to HIV treatment and prevention. Approximately 12 months after the initial campaign, intervention GVHs are randomised to lead a repeat HIVST campaign. The primary outcome includes the proportion of adolescents 15-19 years old who have tested for HIV in their lifetime. Secondary outcomes include recent testing in adults 40 years and older and men; ART initiation; knowledge of HIV prevention; and HIV testing stigma. Outcomes will be measured through cross-sectional surveys and clinic registers. Economic evaluation will determine the cost per person tested, cost per person diagnosed, and incremental cost effectiveness ratio. DISCUSSION: To the best of our knowledge, this is the first trial to assess the effectiveness of community-led HTS, which has only recently been enabled by the introduction of HIVST. Community-led delivery of HIVST is a promising new strategy for providing periodic HIV testing to support HIV prevention in rural communities. Further, introduction of HIVST through a community-led framework seems particularly apt, with control over healthcare concurrently devolved to individuals and communities. TRIAL REGISTRATION: Clinicaltrials.gov registry ( NCT03541382 ) registered 30 May 2018.

Community-led HIV testing services including HIV self-testing and assisted partner notification services in Vietnam: lessons from a pilot study in a concentrated epidemic setting.

INTRODUCTION: The HIV epidemic in Vietnam is concentrated in key populations and their partners - people who inject drugs, men who have sex with men, sex workers and partners of people living with HIV. These groups have poor access to and uptake of conventional HIV testing services (HTS). To address this gap, lay provider- and self-testing and assisted partner notification (aPN) were introduced and delivered by the community. We explored the feasibility and effectiveness of implementing aPN as part of community testing services for key populations. METHODS: Lay provider testing and self-testing was started in January 2017, and targeted key populations and their partners. Since July 2017, aPN was introduced. HTS was offered at drop-in houses or coffee shops in Thai Nguyen and Can Tho provinces. All self-testing was assisted and observed by peer educators. Both in-person and social network methods were used to mobilize key populations to test for HIV and offer HTS to partners of people living with HIV. Client-level data, including demographic information and self-reported risk behaviour, were collected on site by peer educators. RESULTS: Between January 2017 and May 2018, 3978 persons from key populations were tested through community-led HTS; 66.7% were first-time testers. Of the 3978 clients, 3086 received HTS from a lay provider and 892 self-tested in the presence of a lay provider. Overall, 245 (6.2% of tested clients) had reactive results, 231 (94.3%) were confirmed to be HIV positive; 215/231 (93.1%) initiated antiretroviral therapy (ART). Of 231 adult HIV-positive clients, 186 (80.5%) were provided voluntary aPN, and 105 of their partners were contacted and received HTS. The ratio of partners who tested for HIV per index client was 0.56. Forty-four (41.9%) partners of index clients receiving HTS were diagnosed with HIV, 97.7% initiated ART during the study period. No social harm was identified or reported. CONCLUSIONS: Including aPN as part of community-led HTS for key populations and their partners is feasible and effective, particularly for reaching first-time testers and undiagnosed HIV clients. Scale-up of aPN within community-led HTS for key populations is essential for achieving the United Nations 90-90-90 targets in Vietnam.

Retest and treat: a review of national HIV retesting guidelines to inform elimination of mother-to-child HIV transmission (EMTCT) efforts.

INTRODUCTION: High maternal HIV incidence contributes substantially to mother-to-child HIV transmission (MTCT) in some settings. Since 2006, HIV retesting during the third trimester and breastfeeding has been recommended by the World Health Organization in higher prevalence (≥5%) settings to reduce MTCT. However, many countries lack clarity on when and how often to retest pregnant and postpartum women to optimize resources and service delivery. We reviewed and characterized national guidelines on maternal retesting based on timing and frequency. METHODS: We identified 52 countries to represent variations in HIV prevalence, geography, and MTCT priority and searched available national MTCT, HIV testing and HIV treatment policies published between 2007 and 2017 for recommendations on retesting during pregnancy, labour/delivery and postpartum. Recommended retesting frequency and timing was extracted. Country HIV prevalence was classified as: very low (<1%), low (1% to 5%), intermediate (>5 to <15%) and high (≥15%). Women with unknown HIV status at delivery/postpartum were included in retesting guidelines. RESULTS AND DISCUSSION: Overall, policies from 49 countries were identified; 51% from 2015 or later and most (n = 25) were from Africa. Four countries were high HIV prevalence, seven intermediate, sixteen low and twenty-two very low. Most (n = 31) had guidance on universal voluntary opt-out HIV testing at the first antenatal care (ANC) visit. Beyond the first ANC visit, the majority (78%, n = 38) had guidance on retesting; 22 recommended retesting all women with unknown/negative status, five only if unknown HIV status, three in pregnancy based on risk and eight combining these approaches. Retesting was universally recommended during pregnancy, labour/delivery, and postpartum for all high prevalence settings and four of seven intermediate prevalence settings. Five UNAIDS priority countries for EMTCT with low/very low HIV prevalence, but high/intermediate MTCT, had no guidance on retesting. CONCLUSIONS: Retesting guidelines for pregnant and postpartum women were ubiquitous in high prevalence countries and defined in some intermediate prevalence countries, but absent in some low HIV prevalence countries with high MTCT. Countries may require additional guidance on how to optimize maternal HIV testing and whether to prioritize retesting efforts or discontinue universal retesting based on HIV incidence. Research is needed to assess country-level guideline implementation and impact.

Ability to understand and correctly follow HIV self-test kit instructions for use: applying the cognitive interview technique in Malawi and Zambia.

INTRODUCTION: The ability to achieve an accurate test result and interpret it correctly is critical to the impact and effectiveness of HIV self-testing (HIVST). Simple and easy-to-use devices, instructions for use (IFU) and other support tools have been shown to be key to good performance in sub-Saharan Africa and may be highly contextual. The objective of this study was to explore the utility of cognitive interviewing in optimizing the local understanding of manufacturers' IFUs to achieve an accurate HIVST result. METHODS: Functionally literate and antiretroviral therapy-naive participants were purposefully selected between May 2016 and June 2017 to represent intended users of HIV self-tests from urban and rural areas in Malawi and Zambia. Participants were asked to follow IFUs for HIVST. We then conducted cognitive interviews and observed participants while they attempted to complete the HIVST steps using a structured guide, which mirrored the steps in the IFU. Qualitative data were analysed using a thematic approach. RESULTS: Of a total of 61 participants, many successfully performed most steps in the IFU. Some had difficulties in understanding these and made errors, which could have led to incorrect test results, such as incorrect use of buffer and reading the results prematurely. Participants with lower levels of literacy and inexperience with standard pictorial images were more likely to struggle with IFUs. Difficulties tended to be more pronounced among those in rural settings. Ambiguous terms and translations in the IFU, unfamiliar images and symbols, and unclear order of the steps to be followed were most commonly linked to errors and lower comprehension among participants. Feedback was provided to the manufacturer on the findings, which resulted in further optimization of IFUs. CONCLUSIONS: Cognitive interviewing identifies local difficulties in conducting HIVST from manufacturer-translated IFUs. It is a useful and practical methodology to optimize IFUs and make them more understandable.

The impact and cost-effectiveness of community-based HIV self-testing in sub-Saharan Africa: a health economic and modelling analysis.

INTRODUCTION: The prevalence of undiagnosed HIV is declining in Africa, and various HIV testing approaches are finding lower positivity rates. In this context, the epidemiological impact and cost-effectiveness of community-based HIV self-testing (CB-HIVST) is unclear. We aimed to assess this in different sub-populations and across scenarios characterized by different adult HIV prevalence and antiretroviral treatment programmes in sub-Saharan Africa. METHODS: The synthesis model was used to address this aim. Three sub-populations were considered for CB-HIVST: (i) women having transactional sex (WTS); (ii) young people (15 to 24 years); and (iii) adult men (25 to 49 years). We assumed uptake of CB-HIVST similar to that reported in epidemiological studies (base case), or assumed people use CB-HIVST only if exposed to risk (condomless sex) since last HIV test. We also considered a five-year time-limited CB-HIVST programme. Cost-effectiveness was defined by an incremental cost-effectiveness ratio (ICER; cost-per-disability-adjusted life-year (DALY) averted) below US$500 over a time horizon of 50 years. The efficiency of targeted CB-HIVST was evaluated using the number of additional tests per infection or death averted. RESULTS: In the base case, targeting adult men with CB-HIVST offered the greatest impact, averting 1500 HIV infections and 520 deaths per year in the context of a simulated country with nine million adults, and impact could be enhanced by linkage to voluntary medical male circumcision (VMMC). However, the approach was only cost-effective if the programme was limited to five years or the undiagnosed prevalence was above 3%. CB-HIVST to WTS was the most cost-effective. The main drivers of cost-effectiveness were the cost of CB-HIVST and the prevalence of undiagnosed HIV. All other CB-HIVST scenarios had an ICER above US$500 per DALY averted. CONCLUSIONS: CB-HIVST showed an important epidemiological impact. To maximize population health within a fixed budget, CB-HIVST needs to be targeted on the basis of the prevalence of undiagnosed HIV, sub-population and the overall costs of delivering this testing modality. Linkage to VMMC enhances its cost-effectiveness.

Economic cost analysis of door-to-door community-based distribution of HIV self-test kits in Malawi, Zambia and Zimbabwe.

INTRODUCTION: HIV self-testing (HIVST) is recommended by the World Health Organization in addition to other testing modalities to increase uptake of HIV testing, particularly among harder-to-reach populations. This study provides the first empirical evidence of the costs of door-to-door community-based HIVST distribution in Malawi, Zambia and Zimbabwe. METHODS: HIVST kits were distributed door-to-door in 71 sites across Malawi, Zambia and Zimbabwe from June 2016 to May 2017. Programme expenditures, supplemented by on-site observation and monitoring and evaluation data were used to estimate total economic and unit costs of HIVST distribution, by input and site. Inputs were categorized into start-up, capital and recurrent costs. Sensitivity and scenario analyses were performed to assess the impact of key parameters on unit costs. RESULTS: In total, 152,671, 103,589 and 93,459 HIVST kits were distributed in Malawi, Zambia and Zimbabwe over 12, 11 and 10 months respectively. Across these countries, 43% to 51% of HIVST kits were distributed to men. The average cost per HIVST kit distributed was US$8.15, US$16.42 and US$13.84 in Malawi, Zambia and Zimbabwe, respectively, with pronounced intersite variation within countries driven largely by site-level fixed costs. Site-level recurrent costs were 70% to 92% of full costs and 20% to 62% higher than routine HIV testing services (HTS) costs. Personnel costs contributed from 26% to 52% of total costs across countries reflecting differences in remuneration approaches and country GDP. CONCLUSIONS: These early door-to-door community HIVST distribution programmes show large potential, both for reaching untested populations and for substantial economies of scale as HIVST programmes scale-up and mature. From a societal perspective, the costs of HIVST appear similar to conventional HTS, with the higher providers' costs substantially offsetting user costs. Future approaches to minimizing cost and/or maximize testing coverage could include unpaid door-to-door community-led distribution to reach end-users and integrating HIVST into routine clinical services via direct or secondary distribution strategies with lower fixed costs.

HIV self-testing: breaking the barriers to uptake of testing among men and adolescents in sub-Saharan Africa, experiences from STAR demonstration projects in Malawi, Zambia and Zimbabwe.

INTRODUCTION: Social, structural and systems barriers inhibit uptake of HIV testing. HIV self-testing (HIVST) has shown promising uptake by otherwise underserved priority groups including men, young people and first-time testers. Here, we use characteristics of HIVST kit recipients to investigate delivery to these priority groups during HIVST scale-up in three African countries. METHODS: Kit distributors collected individual-level age, sex and testing history from all clients. These data were aggregated and analysed by country (Malawi, Zambia and Zimbabwe) for five distribution models: local community-based distributor (CBD: door-to-door, street and local venues), workplace distribution (WD), integration into HIV testing services (IHTS), or public health facilities (IPHF) and during demand creation for voluntary male medical circumcision (VMMC). Used kits were collected and re-read from CBD and IHTS recipients. RESULTS: Between May 2015 and July 2017, 628,705 HIVST kits were distributed in Malawi (172,830), Zambia (190,787) and Zimbabwe (265,091). Community-based models, the first to be established, accounted for 519,658 (82.7%) of kits distributed, with 275,419 (53.0%) used kits returned. Subsequent model diversification delivered 54,453 (8.7%) test-kits through IHTS, 23,561 (3.7%) through VMMC, 21,183 (3.4%) through IPHF and 9850 (1.7%) through WD. Men took 294,508 (48.2%) kits, and 263,073 (43.1%) went to young people (16 to 24 years). A higher proportion of male self-testers (65,577; 22.3%) were first-time testers than women (54,096; 17.1%) with this apparent in Zimbabwe (16.2% vs. 11.4%), Zambia (25.4% vs. 17.7%) and Malawi (27.9% vs. 25.9%). The highest proportions of first-time testers were in young (16 to 24 years) and older (>50 years) men (country-ranges: 18.7% to 35.9% and 13.8% to 26.8% respectively). Most IHTS clients opted for HIVST in preference to standard HTS in each of 12 delivery sites, with those selecting HIVST having lower HIV prevalence, potentially due to self-selection. CONCLUSIONS: HIVST delivered at scale using several different models reached a high proportion of men, young people and first-time testers in Malawi, Zambia and Zimbabwe, some of whom may not have tested otherwise. As men and young people have limited uptake under standard facility-and community-based HIV testing, innovative male- and youth-sensitive approaches like HIVST may be essential to reaching UNAIDS fast-track targets for 2020.