Tensor-structured decomposition improves systems serology analysis.

Systems serology provides a broad view of humoral immunity by profiling both the antigen-binding and Fc properties of antibodies. These studies contain structured biophysical profiling across disease-relevant antigen targets, alongside additional measurements made for single antigens or in an antigen-generic manner. Identifying patterns in these measurements helps guide vaccine and therapeutic antibody development, improve our understanding of diseases, and discover conserved regulatory mechanisms. Here, we report that coupled matrix-tensor factorization (CMTF) can reduce these data into consistent patterns by recognizing the intrinsic structure of these data. We use measurements from two previous studies of HIV- and SARS-CoV-2-infected subjects as examples. CMTF outperforms standard methods like principal components analysis in the extent of data reduction while maintaining equivalent prediction of immune functional responses and disease status. Under CMTF, model interpretation improves through effective data reduction, separation of the Fc and antigen-binding effects, and recognition of consistent patterns across individual measurements. Data reduction also helps make prediction models more replicable. Therefore, we propose that CMTF is an effective general strategy for data exploration in systems serology.

Longitudinal Viral Load Monitoring Using Home-Collected Dried Blood Spot Specimens of MSM Living with HIV: Results from a Feasibility Pilot Study.

Novel viral load monitoring strategies are needed to help individuals maintain an undetectable viral load (UVL). In 2018, U.S. MSM living with HIV with a past detectable VL received a dried blood spot (DBS) kit at baseline and 3-month follow-up and returned specimens to a research laboratory. Of 56 consenting participants, 91% returned specimens at baseline and 77% at 3-month follow-up; 74% who returned two specimens had UVL at both time points. At-home DBS collection and longitudinal VL monitoring is feasible among U.S. MSM with fluctuating viral load. This complementary approach to clinical care could improve viral suppression maintenance.

RESUMEN: Se necesitan nuevas estrategias para evaluar los niveles de la carga viral para ayudar a las personas viviendo con VIH a mantener una carga viral indetectable (CVI). En 2018, hombres viviendo con VIH, que reportaron sexo con hombres y una carga viral detectable, recibieron dos paquetes de materiales para colectar muestras de sangre seca después de completar una evaluación basal y después de tres meses de seguimiento. Participantes devolvieron las muestras de sangre seca a un laboratorio. De 56 participantes que dieron su consentimiento a participar en el estudio, el 91% devolvió una muestra de sangre seca al inicio del estudio y el 77% a los 3 meses de seguimiento. Además, el 74% que devolvió dos muestras de sangre seca tenían CVI en ambos puntos de tiempo. La colección de sangre seca en el hogar y el monitoreo longitudinal de la carga viral de VIH es factible entre los hombres viviendo con el VIH y que tienen sexo con hombres. Los resultados de este estudio pueden proporcionar un enfoque complementario a la atención clínica para mejorar la supresión viral del VIH.

Partner Notification Services for Patients with Established and New HIV Infection Leads to Diagnosis and Linkage of HIV-Positive Partners.

Offering people living with HIV the opportunity to refer partners for HIV testing is an efficient way of identifying new HIV diagnoses. This report describes the outcomes of physician-led partner services at an urban academic center. Patients with HIV VL > 1000 copies/mL in both inpatient and outpatient settings were offered partner notification services (PNS). Of referred partners, 8.7% had a new diagnosis of HIV. New HIV+ partners were as likely to be referred by patients with existing HIV diagnoses as new diagnoses (p = 0.61), and as likely to be referred by patients interviewed while hospitalized as those in the clinic (p = 0.61).

Three-year outcome of rapid HIV testing at public health centers in Seoul, Republic of Korea: a short report.

Before 2014, the only test used for anonymous voluntary human immunodeficiency virus (HIV) screening at public health centers (PHCs) in the Republic of Korea was an enzyme-linked immunosorbent assay (ELISA), which takes around 3 days to obtain results. In 2014, to encourage voluntary anonymous HIV screening tests, the Seoul Metropolitan Government adopted a rapid HIV screening test at PHCs. The rapid HIV screening test was introduced at four PHCs in 2014 and all 25 PHCs after 2015. We compared the numbers of HIV screening tests and confirmed positive individuals before and after introduction of the rapid HIV screening test. In 2012-2013, before the introduction of rapid HIV screening test, an average of 330 HIV screening tests were performed monthly (355 in 2012 and 305 in 2013) and 69 individuals were confirmed to have HIV in 2012 and 93 in 2013. After the introduction of the rapid HIV screening test, anonymous voluntary HIV screening increased to a monthly average of 447 tests in 2014, 2099 in 2015, and 2409 in 2016. These identified 38 new cases in 2014, 116 in 2015, and 143 in 2016. Adoption of the rapid HIV screening test has increased the number of HIV screening tests and confirmed cases.

Adolescents' and caregivers' perceptions of caregiver-provided testing and HIV self-testing using oral mucosal transudate tests in Zimbabwe: a short report.

Uptake of HIV testing remains lower among children and adolescents compared to adults. This study explored adolescents' perceptions of HIV self-testing (HIVST) and caregivers' perceptions of testing their children using an oral mucosal transudate (OMT) rapid HIV test (caregiver-provided testing). We conducted 31 interviews with adolescents aged 16-18 years and caregivers of children aged 2-15 years who received an OMT test. Participants described barriers to HIV testing including lack of privacy and the potential for discrimination by community members towards children and adolescents who received an HIV test. Most participants felt caregiver-provided testing and HIVST could address these barriers through increased privacy. Some participants expressed worry about their ability to correctly perform the OMT and their anxious reactions to a positive result. Counseling and assistance from health care workers were viewed as ways to alleviate concerns. Concerns shaped participants' preferences for facility-based HIVST and caregiver-provided testing. Findings demonstrate HIVST performed by adolescents and caregiver-provided testing could increase the uptake of HIV testing. Concerns related to being able to test correctly and the availability of post-test counseling must be addressed in any future delivery mechanisms.

Difference in HIV prevalence by testing venue: results from population level survey in Uganda.

Growing demand for use of Health Facility (HF) HIV testing data, in addition to other testing data to obtain district level HIV prevalence requires understanding the comparability of these various sources. We analysed the 2011 Uganda AIDS indicator survey data to assess: the proportion of people tested for HIV across Uganda by venue of testing; HIV prevalence ratio for those tested in a HF compared to those tested in community setting; [Katz, D., Baptista, J., Azen, S. P., & Pike, M. C. (1978). Obtaining confidence intervals for the risk ratio in cohort studies. International Biometric Society, 34(3), 469-474. https://doi.org/10.2307/2530610] and factors associated with HIV positivity in each subgroup. Of the 11,685 individuals, 8978 (77.1%) had ever tested for HIV in a HF. Fifty nine per cent tested in a HF in the 12 months preceding the survey (female: 5507, 72.7% versus male: 1413, 34.9%). HIV prevalence ratio was 1.8 times among those tested in a HF compared to those tested at community setting (10.9% [95% CI: 10.0-11.7] versus 6.2% [95% CI: 5.4-7.0]). Among HF testers, older age group, previously married and having no sexual partner was associated with significantly higher HIV prevalence. Using facility testing data for planning and decisions should take into consideration the elevated and varying HIV prevalence among individuals accessing HIV testing services at HFs as well as differences in their social-demographic characteristics.

Acceptability of a tablet-based application to support early HIV testing among men in rural KwaZulu-Natal, South Africa: a mixed method study.

Uptake of HIV testing remains low among men in South Africa. As part of a trial, we assessed the acceptability of a theoretically derived and adapted tablet-based-application (EPIC-HIV1) in rural South Africa. We conducted 20 in-depth interviews with men aged ≥18 years and offered a tablet-based survey to all men aged ≥15 years who received EPIC-HIV1 (Sep-Dec 2018). We conducted a descriptive analysis of the survey and used Self-Determination Theory (SDT) to guide our thematic analysis. A total of 232/307 (75%) completed the survey, 55% of whom were aged 15-24 years. 96%[ CI: 92.8-98.2%; n = 223] found EPIC-HIV1 acceptable and 77% [95% CI: 71.8-82.6%; n = 179] found it user-friendly. 222 [96%] reported that EPIC-HIV1 motivated them to test; 83% (192/232) tested for HIV, of which 33% (64/192) were first time testers. Those who did not consent (n = 40) were more likely to have had an HIV-positive test result. Participants reported that the app boosted their confidence to test. However, they were unsure that the app would help them overcome barriers to test in local clinics. Given reach and usability, an adapted SDT male-tailored app was found to be acceptable and could encourage positive health-seeking behavioural change among men.

Evaluation of Geenius HIV-1/2 Confirmatory Assay for the confirmatory and differential diagnosis of HIV-1/HIV-2 in Japan and reliability of the Geenius Reader in the diagnosis of HIV-2.

BACKGROUND: NEW LAV BLOT I and II (LAV I and LAV II), they were only option for human immunodeficiency virus (HIV) confirmatory test, following HIV screening test using HIV Ag/Ab combination test in Japan. We evaluated the performance of Geenius HIV-1/2 Confirmatory Assay (Geenius), both as a confirmatory test and for differentiation between HIV-1 and HIV-2, in comparison with LAV I and LAV II. METHODS: Eighty-nine HIV-1-positive plasma specimens, one anti-HIV-1 low-titer performance panel, 10 seroconversion panels, and two anti-HIV-1/2 combo performance panels were tested. The results were read with the Geenius Reader and by visual reading. RESULTS: All 89 HIV-1-positive plasma specimens were identified as HIV-1-positive using Geenius; this 100% success rate was superior to that with LAV I (95.5% using WHO criteria, 98.9% using CDC criteria). The HIV-1-positive specimens showed low cross-reactivity with HIV-2 lines in Geenius. The sensitivity of Geenius for HIV-1 detection was the same as or greater than that of LAV I, but less than that of Genscreen HIV Ag-Ab ULT, in our analysis of the commercial performance and seroconversion panels. In contrast, five of the 13 HIV-2-positive specimens that had been identified as HIV-positive untypable by visual reading because of their cross-reactivity to HIV-1 lines were successfully identified by the Geenius Reader as HIV-2-positive with cross-reactivity. CONCLUSIONS: Geenius provides strong performance for HIV confirmatory tests and HIV-1 differentiation tests. However, when visual reading is used, its performance in HIV-2 differentiation is less reliable. Because HIV-2 infection has been sporadically reported in Japan, the use of the Geenius Reader is preferable to ensure more reliable HIV-1/HIV-2 differentiation.

Five Waves of an Online HIV Self-Test Giveaway in New York City, 2015 to 2018.

BACKGROUND: HIV self-tests increase HIV status awareness by providing convenience and privacy, although cost and access may limit use. Since 2015, the New York City (NYC) Health Department has conducted 5 waves of an online Home Test Giveaway. METHODS: We recruited adult cisgender men who have sex with men (MSM) and transgender and gender-nonconforming (TGNC) individuals who had sex with men, who were living in NYC, not previously HIV diagnosed, and using paid digital advertisements (4-8 weeks per wave). Eligible respondents were e-mailed a code to redeem on the manufacturer's website for a free HIV self-test and an online follow-up survey ~2 months later. For key process and outcome measures, we present means across 5 waves. RESULTS: Across the 5 waves of Home Test Giveaway, there were 28,921 responses to the eligibility questionnaire: 17,383 were eligible, 12,182 redeemed a code for a free HIV self-test, and 7935 responded to the follow-up survey (46% of eligible responses). Among eligible responses, approximately half were Latino/a (mean, 32%) or non-Latino/a, black (mean, 17%). Mean report of never testing before was 16%. Among 5903 follow-up survey responses who reported test use, 32 reported reactive results with no known previous diagnosis (0.54%), of whom 78% reported receiving confirmatory testing. Report of likelihood of recommending the Home Test Giveaway to friends was high (mean, 96%). CONCLUSIONS: We recruited diverse NYC MSM and TGNC and distributed a large number of HIV self-tests to them. Among respondents who reported newly reactive tests, the majority reported confirmatory testing. This seems to be one acceptable way to reach MSM and TGNC for HIV testing, including those who have never tested before.

Alone But Supported: A Qualitative Study of an HIV Self-testing App in an Observational Cohort Study in South Africa.

HIV self-testing has the potential to improve test access and uptake, but concerns remain regarding counselling and support during and after HIV self-testing. We investigated an oral HIV self-testing strategy together with a mobile phone/tablet application to see if and how it provided counselling and support, and how it might impact test access. This ethnographic study was nested within an ongoing observational cohort study in Cape Town, South Africa. Qualitative data was collected from study participants and study staff using 33 semi-structured interviews, one focus group discussion, and observation notes. The app provided information and guidance while also addressing privacy concerns. The flexibility and support provided by the strategy gave participants more control in choosing whom they included during testing. Accessibility concerns included smartphone access and usability issues for older and rural users. The adaptable access and support of this strategy could aid in expanding test access in South Africa.

Transgender Women's Experiences Using a Home HIV-Testing Kit for Partner-Testing.

HIV partner-testing (PT) may represent a unique and empowering HIV prevention strategy for groups that face structural and institutional barriers to HIV testing and care, including transgender women. We report on in-depth interviews (IDIs) with N = 10 transgender women who used HIV self-test kits for three months to screen potential sexual partners in a randomized controlled trial (iSUM; "I'll Show You Mine") that took place in New York City and San Juan, Puerto Rico. Participants were assigned to intervention (supplied with 10 self-test kits immediately) or control groups (received 6 test kits after 3 months). We conducted IDIs with the first N = 10 transgender women to enroll in the intervention group after three months in the study (after participants used kits with partners) to understand their experiences. Themes discussed in IDIs included: partners' reaction to HIV testing, participants' reactions to partners' test results or refusal to test, partners' own reaction to their test results, and decision-making around test use. Data were independently analyzed by two coders. Overwhelmingly, participants' experiences with PT was positive. Participants reported kits were convenient and acceptable to most partners. Transgender women felt that PT could pose additional risk for them; one woman experienced violence related to kit use. Furthermore, the availability of kits appeared to encourage participants and their partners to think about their HIV status and, in some cases, modify sexual behavior. Work suggests that HIV PT could be a viable risk-reduction strategy for transgender women.

Use of HIV Self-Testing Kits to Screen Clients Among Transgender Female Sex Workers in New York and Puerto Rico.

Transgender female sex workers (TFSW) are highly affected by HIV, with a global prevalence of 27%. HIV self-testing (HIVST) to screen sexual partners has helped men who have sex with men and female sex workers make informed sexual decisions and avoid HIV exposure. This is the first report on TFSW's experiences screening clients using HIVST. Ten TFSW were each given ten HIVST kits and returned after 3 months to complete an online questionnaire and undergo an interview. Eight of them reported using HIVST with potential partners. Among fifty potential partners who were asked in person to test, 42 (84%) were clients. Thirty-four out of fifty (68%) accepted and 16 (32%) refused. Very few violent incidents occurred, and participants felt empowered by offering HIVST to others. Nevertheless, HIVST market cost was prohibitive for future use. HIVST use with clients could be feasible for TFSW if the cost were lowered or subsidized.

Few Aggressive or Violent Incidents are Associated with the Use of HIV Self-tests to Screen Sexual Partners Among Key Populations.

Men who have sex with men and transgender women who had multiple sexual partners in the prior 3 months participated in ISUM, a randomized, controlled trial of self- and partner-testing in New York City and San Juan, PR. Only 2% of screened participants were ineligible to enroll due to anticipating they would find it very hard to avoid or handle violence. The intervention group received free rapid HIV self-test kits. During the trial, 114 (88%) of intervention participants who were assessed at follow-up used self-tests with at least one potential partner. Only 6% of participants who asked a partner in person to test reported that at least one of their partners got physically violent, some in the context of sex work. In total, 16 (2%) partners reacted violently. Post-trial, only one participant reported finding it very hard to handle violence, and none found it very hard to avoid potential violence.

Computer-Based Substance Use Reporting and Acceptance of HIV Testing Among Emergency Department Patients.

More than 10 years after the Centers for Disease Control and Prevention recommended routine HIV testing for patients in emergency departments (ED) and other clinical settings, as many as three out of four patients may not be offered testing, and those who are offered testing frequently decline. The current study examines how participant characteristics, including demographics and reported substance use, influence the efficacy of a video-based intervention designed to increase HIV testing among ED patients who initially declined tests offered by hospital staff. Data from three separate trials in a high volume New York City ED were merged to determine whether patients (N = 560) were more likely to test post-intervention if: (1) they resembled people who appeared onscreen in terms of gender or race; or (2) they reported problem substance use. Chi Square and logistic regression analyses indicated demographic concordance did not significantly increase likelihood of accepting an HIV test. However, participants who reported problem substance use (n = 231) were significantly more likely to test for HIV in comparison to participants who reported either no problem substance use (n = 190) or no substance use at all (n = 125) (x2 = 6.830, p < 0.05). Specifically, 36.4% of patients who reported problem substance use tested for HIV post-intervention compared to 30.5% of patients who did not report problem substance use and 28.8% of participants who did not report substance use at all. This may be an important finding because substance use, including heavy alcohol or cannabis use, can lead to behaviors that increase HIV risk, such as sex with multiple partners or decreased condom use.

An expanded HIV screening strategy in the Emergency Department fails to identify most patients with undiagnosed infection: insights from a blinded serosurvey.

Screening for HIV in Emergency Departments (EDs) is recommended to address the problem of undiagnosed HIV. Serosurveys are an important method for estimating the prevalence of undiagnosed HIV and can provide insight into the effectiveness of an HIV screening strategy. We performed a blinded serosurvey in an ED offering non-targeted HIV screening to determine the proportion of patients with undiagnosed HIV who were diagnosed during their visit. The study was conducted in a high-volume, urban ED and included patients who had blood drawn for clinical purposes and had sufficient remnant specimen to undergo deidentified HIV testing. Among 4752 patients not previously diagnosed with HIV, 1403 (29.5%) were offered HIV screening and 543 (38.7% of those offered) consented. Overall, undiagnosed HIV was present in 12 patients (0.25%): six among those offered screening (0.4%), and six among those not offered screening (0.2%). Among those with undiagnosed HIV, two (16.7%) consented to screening and were diagnosed during their visit. Despite efforts to increase HIV screening, more than 80% of patients with undiagnosed HIV were not tested during their ED visit. Although half of those with undiagnosed HIV were missed because they were not offered screening, the yield was further diminished because a substantial proportion of patients declined screening. To avoid missed opportunities for diagnosis in the ED, strategies to further improve implementation of HIV screening and optimize rates of consent are needed.

Acceptability of HIV self-testing is low among men who have sex with men who have not tested for HIV: a study with respondent-driven sampling in Brazil.

BACKGROUND: Brazil has many people living with HIV (PLWH) who are unaware of their serostatus. The public health system has recently added HIV self-testing (HIVST) for key populations such as men who have sex with men (MSM). This study estimates HIVST acceptability among Brazilian MSM and explores factors associated with acceptability among MSM who have never tested for HIV or who had a previous negative result. METHODS: Respondent-driven sampling (RDS) was used to recruit 4176 MSM in 12 Brazilian cities in 2016 to this biological and behavioral surveillance study. We excluded from this analysis all MSM who were aware of their positive HIV serostatus. Descriptive, bivariate and multivariate analyses were conducted. Overall proportions were weighted with Gile's estimator in RDS Analyst software and 95% confidence intervals were calculated. The analyses of HIVST acceptability were stratified by prior HIV testing (never or one or more times). RESULTS: For this analysis, 3605 MSM were included. The acceptability of HIVST was 49.1%, lower among those who had never tested for HIV (42.7%) compared to those who had a previous HIV negative test (50.1%). In the subgroup of MSM who had never tested for HIV, those who reported discrimination or who had a medical appointment in the last 12 months reported higher HIVST acceptability. Among MSM who had a previous negative HIV test, only those reporting condomless receptive anal sex reported higher HIVST acceptability. In addition, we observed that high levels of knowledge of HIV/AIDS, taking part in lesbian, gay, bisexual, and transgender nongovernmental organizations (LGBT-NGO), or complete secondary or incomplete higher undergraduate education reported higher acceptability. CONCLUSIONS: The acceptability of HIVST was low among MSM, especially among those who never tested for HIV. Given access to HIVST in Brazil, we point to the need for programs that enhance promotion of testing addressed to MSM.

Continuous quality monitoring in the field: an evaluation of the performance of the Fio Deki Reader™ for rapid HIV testing in South Africa.

BACKGROUND: Rapid diagnostic tests (RDTs) are a cornerstone of HIV diagnosis and rely on good quality processing and interpretation, particularly in the era of test and treat. The Deki Reader (Fio Corporation®, Toronto, Ontario, Canada) is a portable device designed specifically for analysing RDTs and was selected for evaluation in South Africa in the context of HIV RDT analysis. METHODS: This study consisted of a laboratory evaluation and two-part field evaluation of the Deki Reader v100, covering two RDT testing algorithms, and an evaluation of the continuous quality monitoring through the Fionet™ web portal. Based on user feedback from the field evaluation, the device underwent hardware and software redesign, and the Deki Reader v200 was evaluated in the laboratory. Ethics approval for this evaluation was obtained from the University of the Witwatersrand Human Research Ethics Committee: M150160. RESULTS: The intra- and inter-device laboratory precision of the Deki Reader v100 were 98.3 and 99.2% respectively, and 99.3 and 100% for the Deki Reader v200. The laboratory concordances compared to standard-of-care reporting were 99.5 and 98.0% for the two respective models, while sensitivity and specificity were 99.5 and 99.4% for the Deki Reader V100 and 100 and 93.1% for the Deki Reader V200 respectively. Screening and confirmatory concordances in the field were 99.3 and 96.5% under algorithm 1 and 99.7 and 100% under algorithm 2. Sensitivity and specificity for the field evaluation were 99.8 and 97.7%. Overall robustness of the device was acceptable and continuous quality monitoring through Fionet™ was feasible. CONCLUSIONS: The Deki Reader provides an option for improved and reliable quality assessment for rapid diagnosis of HIV using RDTs to enhance the quality of healthcare at the point-of-care. However, the introduction of new RDTs and modification of current algorithms necessitates ongoing and agile RDT reader adjustments, which will require cost modelling to ensure sustainability of devices implemented into national HIV programs.

Promoting routine syphilis screening among men who have sex with men in China: study protocol for a randomised controlled trial of syphilis self-testing and lottery incentive.

BACKGROUND: Men who have sex with men (MSM) bear a high burden of syphilis infection. Expanding syphilis testing to improve timely diagnosis and treatment is critical to improve syphilis control. However, syphilis testing rates remain low among MSM, particularly in low- and middle-income countries. We describe the protocol for a randomised controlled trial (RCT) to assess whether provision of syphilis self-testing services can increase the uptake of syphilis testing among MSM in China. METHODS: Four hundred forty-four high-risk MSM will be recruited online and randomized in a 1:1:1 ratio to (1) standard syphilis self-testing arm; (2) a self-testing arm program enhanced with crowdsourcing and a lottery-based incentive, and (3) a standard of care (control). Self-testing services include a free syphilis self-test kit through the mail at monthly intervals. Participants in the lottery incentive arm will additionally receive health promotion materials generated from an open crowdsourcing contest and be given a lottery draw with a 10% chance to win 100 RMB (approximately 15 US Dollars) upon confirmed completion of syphilis testing. Syphilis self-test kits have step-by-step instructions and an instructional video. This is a non-blinded, open-label, parallel RCT. Participants in each arm will be followed-up at three and 6 months through WeChat (a social media app like Facebook messenger). Confirmation of syphilis self-test use will be determined by requiring participants to submit a photo of the used test kit to study staff via secure data messaging. Both self-testing and facility-based testing will be ascertained by sending a secure photographic image of the completed kit through an existing digital platform. The primary outcome is the proportion of participants who tested for syphilis in the past 3 months. DISCUSSION: Findings from this study will provide much needed insight on the impact of syphilis self-testing on promoting routine syphilis screening among MSM. The findings will also contribute to our understanding of the safety, effectiveness and acceptability of syphilis self-testing. These findings will have important implications for self-testing policy, both in China and internationally. TRIAL REGISTRATION: ChiCTR1900022409 (10 April, 2019).

HIV self-testing alone or with additional interventions, including financial incentives, and linkage to care or prevention among male partners of antenatal care clinic attendees in Malawi: An adaptive multi-arm, multi-stage cluster randomised trial.

BACKGROUND: Conventional HIV testing services have been less comprehensive in reaching men than in reaching women globally, but HIV self-testing (HIVST) appears to be an acceptable alternative. Measurement of linkage to post-test services following HIVST remains the biggest challenge, yet is the biggest driver of cost-effectiveness. We investigated the impact of HIVST alone or with additional interventions on the uptake of testing and linkage to care or prevention among male partners of antenatal care clinic attendees in a novel adaptive trial. METHODS AND FINDINGS: An adaptive multi-arm, 2-stage cluster randomised trial was conducted between 8 August 2016 and 30 June 2017, with antenatal care clinic (ANC) days (i.e., clusters of women attending on a single day) as the unit of randomisation. Recruitment was from Ndirande, Bangwe, and Zingwangwa primary health clinics in urban Blantyre, Malawi. Women attending an ANC for the first time for their current pregnancy (regardless of trimester), 18 years and older, with a primary male partner not known to be on ART were enrolled in the trial after giving consent. Randomisation was to either the standard of care (SOC; with a clinic invitation letter to the male partner) or 1 of 5 intervention arms: the first arm provided women with 2 HIVST kits for their partners; the second and third arms provided 2 HIVST kits along with a conditional fixed financial incentive of $3 or $10; the fourth arm provided 2 HIVST kits and a 10% chance of receiving $30 in a lottery; and the fifth arm provided 2 HIVST kits and a phone call reminder for the women's partners. The primary outcome was the proportion of male partners who were reported to have tested for HIV and linked into care or prevention within 28 days, with referral for antiretroviral therapy (ART) or circumcision accordingly. Women were interviewed at 28 days about partner testing and adverse events. Cluster-level summaries compared each intervention versus SOC using eligible women as the denominator (intention-to-treat). Risk ratios were adjusted for male partner testing history and recruitment clinic. A total of 2,349/3,137 (74.9%) women participated (71 ANC days), with a mean age of 24.8 years (SD: 5.4). The majority (2,201/2,233; 98.6%) of women were married, 254/2,107 (12.3%) were unable to read and write, and 1,505/2,247 (67.0%) were not employed. The mean age for male partners was 29.6 years (SD: 7.5), only 88/2,200 (4.0%) were unemployed, and 966/2,210 (43.7%) had never tested for HIV before. Women in the SOC arm reported that 17.4% (71/408) of their partners tested for HIV, whereas a much higher proportion of partners were reported to have tested for HIV in all intervention arms (87.0%-95.4%, p < 0.001 in all 5 intervention arms). As compared with those who tested in the SOC arm (geometric mean 13.0%), higher proportions of partners met the primary endpoint in the HIVST + $3 (geometric mean 40.9%, adjusted risk ratio [aRR] 3.01 [95% CI 1.63-5.57], p < 0.001), HIVST + $10 (51.7%, aRR 3.72 [95% CI 1.85-7.48], p < 0.001), and phone reminder (22.3%, aRR 1.58 [95% CI 1.07-2.33], p = 0.021) arms. In contrast, there was no significant increase in partners meeting the primary endpoint in the HIVST alone (geometric mean 17.5%, aRR 1.45 [95% CI 0.99-2.13], p = 0.130) or lottery (18.6%, aRR 1.43 [95% CI 0.96-2.13], p = 0.211) arms. The lottery arm was dropped at interim analysis. Overall, 46 male partners were confirmed to be HIV positive, 42 (91.3%) of whom initiated ART within 28 days; 222 tested HIV negative and were not already circumcised, of whom 135 (60.8%) were circumcised as part of the trial. No serious adverse events were reported. Costs per male partner who attended the clinic with a confirmed HIV test result were $23.73 and $28.08 for the HIVST + $3 and HIVST + $10 arms, respectively. Notable limitations of the trial included the relatively small number of clusters randomised to each arm, proxy reporting of the male partner testing outcome, and being unable to evaluate retention in care. CONCLUSIONS: In this study, the odds of men's linkage to care or prevention increased substantially using conditional fixed financial incentives plus partner-delivered HIVST; combinations were potentially affordable. TRIAL REGISTRATION: ISRCTN 18421340.

Distribution of HIV Self-tests by HIV-Positive Men Who Have Sex with Men to Social and Sexual Contacts.

HIV-positive men who have sex with men (MSM) were recruited on www.Facebook.com and www.Poz.com to give HIV self-tests to their contacts. Study participants completed a baseline survey, were given two self-tests, and completed a survey 2 months later. Of 133 eligible men, 40 (30%) completed both surveys. Most participants were 30-54 years old and non-Hispanic white. Some had a detectable viral load (n = 4), had condomless anal sex with male partners of negative or unknown status (n = 17), and had met anal sex partners at gay dating websites (n = 23). Of 80 self-tests given to participants, 59 (74%) were distributed, primarily to non-Hispanic white MSM, 30-54 years old who were friends. Participants reported results from 31 distributed tests; 2 sex partners of participants had positive results. Participants indicated these two persons were unaware of their infections. Expanding recruitment websites might reach non-white MSM. Unrecognized infections were identified through online recruitment and self-test distribution via HIV-positive persons.