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Introduction The uptake of HIV testing and linkage to care remains low among men, contributing to high HIV incidence in women in South Africa. We conducted the “Home‐Based Intervention to Test and Start” (HITS) in a 2x2 factorial cluster randomized controlled trial in one of the World’s largest ongoing HIV cohorts in rural South Africa aimed at enhancing both intrinsic and extrinsic motivations for HIV testing. Methods Between February and December 2018, in the uMkhanyakude district of KwaZulu‐Natal, we randomly assigned 45 communities (clusters) (n = 13,838 residents) to one of the four arms: (i) financial incentives for home‐based HIV testing and linkage to care (R50 [$3] food voucher each); (ii) male‐targeted HIV‐specific decision support application, called EPIC‐HIV; (iii) both financial incentives and male‐targeted HIV‐specific decision support application and (iv) standard of care (SoC). EPIC‐HIV was developed to encourage and serve as an intrinsic motivator for HIV testing and linkage to care, and individually offered to men via a tablet device. Financial incentives were offered to both men and women. Here we report the effect of the interventions on uptake of home‐based HIV testing among men. Intention‐to‐treat (ITT) analysis was performed using modified Poisson regression with adjustment for clustering of standard errors at the cluster levels. Results Among all 13,838 men ≥ 15 years living in the 45 communities, the overall population coverage during a single round of home‐based HIV testing was 20.7%. The uptake of HIV testing was 27.5% (683/2481) in the financial incentives arm, 17.1% (433/2534) in the EPIC‐HIV arm, 26.8% (568/2120) in the arm receiving both interventions and 17.8% in the SoC arm. The probability of HIV testing increased substantially by 55% in the financial incentives arm (risk ratio (RR)=1.55, 95% CI: 1.31 to 1.82, p < 0.001) and 51% in the arm receiving both interventions (RR = 1.51, 95% CI: 1.21 to 1.87 p < 0.001), compared to men in the SoC arm. The probability of HIV testing did not significantly differ in the EPIC‐HIV arm (RR = 0.96, 95% CI: 0.76 to 1.20, p = 0.70). Conclusions The provision of a small financial incentive acted as a powerful extrinsic motivator substantially increasing the uptake of home‐based HIV testing among men in rural South Africa. In contrast, the counselling and testing application which was designed to encourage and serve as an intrinsic motivator to test for HIV did not increase the uptake of home‐based testing.

Introduction In South Africa, the HIV care cascade remains suboptimal. We investigated the impact of small conditional financial incentives (CFIs) and male‐targeted HIV‐specific decision‐support application (EPIC‐HIV) on the HIV care cascade. Methods In 2018, in uMkhanyakude district, 45 communities were randomly assigned to one of four arms: (i) CFI for home‐based HIV testing and linkage to care within 6 weeks (R50 [US$3] food voucher each); (ii) EPIC‐HIV which are based on self‐determination theory; (iii) both CFI and EPIC‐HIV; and (iv) standard of care. EPIC‐HIV consisted of two components: EPIC‐HIV 1, provided to men through a tablet before home‐based HIV testing, and EPIC‐HIV 2, offered 1 month later to men who tested positive but had not yet linked to care. Linking HITS trial data to national antiretroviral treatment (ART) programme data and HIV surveillance programme data, we estimated HIV status awareness after the HITS trial implementation, ART status 3 month after the trial and viral load suppression 1 year later. Analysis included all known individuals living with HIV in the study area including those who did not participated in the HITS trial. Results Among the 33,778 residents in the study area, 2763 men and 7266 women were identified as living with HIV by the end of the intervention period and included in the analysis. After the intervention, awareness of HIV‐positive status was higher in the CFI arms compared to non‐CFI arms (men: 793/908 [87.3%] vs. 1574/1855 [84.9%], RR = 1.03 [95% CI: 0.99−1.07]; women: 2259/2421 [93.3%] vs. 4439/4845 [91.6%], RR = 1.02 [95% CI: 1.00−1.04]). Three months after the intervention, no differences were found for linkage to ART between arms. One year after the intervention, only 1829 viral test results were retrieved. Viral suppression was higher but not significant in the EPIC‐HIV intervention arms among men (65/99 [65.7%] vs. 182/308 [59.1%], RR = 1.11 [95% CI: 0.88−1.40]). Conclusions Small CFIs can contribute to achieve the first step of the HIV care cascade. However, neither CFIs nor EPIC‐HIV was sufficient to increase the number of people on ART. Additional evidence is needed to confirm the impact of EPIC‐HIV on viral suppression.

Introduction WHO recommends implementing a mix of community and facility testing strategies to diagnose 95% of persons living with HIV (PLHIV). In Mozambique, a country with an estimated 506,000 undiagnosed PLHIV, use of home‐based HIV testing services (HBHTS) to help achieve the 95% target has not been evaluated. Methods HBHTS was provided at 20,000 households in the Chókwè Health Demographic Surveillance System (CHDSS), Mozambique, in annual rounds (R) during 2014 to 2019. Trends in prevalence of HIV infection, prior HIV diagnosis among PLHIV (diagnostic coverage), and undiagnosed HIV infection were assessed with three population‐based surveys conducted in R1 (04/2014 to 04/2015), R3 (03/2016 to 12/2016), and R5 (04/2018 to 03/2019) of residents aged 15 to 59 years. Counts of patients aged ≥15 years tested for HIV in CHDSS healthcare facilities were obtained from routine reports. Results During 2014 to 2019, counsellors conducted 92,512 home‐based HIV tests and newly diagnosed 3711 residents aged 15 to 59 years. Prevalence of HIV infection was stable (R1, 25.1%; R3 23.6%; R5 22.9%; p‐value, 0.19). After the first two rounds (44,825 home‐based tests; 31,717 facility‐based tests), diagnostic coverage increased from 73.8% (95% CI 70.3 to 77.2) in R1 to 93.0% (95% CI 91.3 to 94.7) in R3, and prevalence of undiagnosed HIV infection decreased from 6.6% (95% CI 5.6 to 7.5) in R1 to 1.7% (95% CI 1.2 to 2.1) in R3. After two more rounds (32,226 home‐based tests; 46,003 facility‐based tests), diagnostic coverage was 95.4% (95% CI 93.7 to 97.1) and prevalence of undiagnosed HIV infection was 1.1% (95% CI 0.7 to 1.5) in R5. Prevalence of having last tested at home was 12.7% (95% CI 11.3 to 14.0) in R1, 45.2% (95% CI 43.4 to 47.0) in R3, and 41.4% (95% CI 39.5 to 43.2) in R5, and prevalence of having last tested at a healthcare facility was 45.3% (95% CI 43.3 to 47.3) in R1, 40.1% (95% CI 38.4 to 41.8) in R3, and 45.2% (95% CI 43.3 to 47.0) in R5. Conclusions HBHTS successfully augmented facility‐based testing to achieve HIV diagnostic coverage in a high‐burden community of Mozambique. HBHTS should be considered in sub‐Saharan Africa communities striving to diagnose 95% of persons living with HIV.

Introduction Lack of universal, annual testing for human immunodeficiency virus (HIV) in health facilities suggests that expansion of HIV testing and counselling (HTC) to non‐clinical settings is critical to the achievement of national goals for prevention, care and treatment. Consideration should be given to the ability of lay counsellors to perform home‐based HTC in community settings. Methods We implemented a community cluster randomized controlled trial of home‐based HTC in Sisonke District, South Africa. Trained lay counsellors conducted door‐to‐door HIV testing using the same rapid tests used by the local health department at the time of the study (SD Bioline and Sensa). To monitor testing quality and counsellor skill, additional dry blood spots were taken and sent for laboratory‐based enzyme‐linked immunosorbent assay (ELISA) testing. Sensitivity and specificity were calculated using the laboratory result as the gold standard. Results and discussion From 3986 samples, the counsellor and laboratory results matched in all but 23 cases. In 18 cases, the counsellor judged the result as indeterminate, whereas the laboratory judged 10 positive, eight negative and three indeterminate, indicating that the counsellor may have erred on the side of caution. Sensitivity was 98.0% (95% CI: 96.3–98.9%), and specificity 99.6% (95% CI: 99.4–99.7%), for the lay counsellor field‐based rapid tests. Both measures are high, and the lower confidence bound for specificity meets the international standard for assessing HIV rapid tests. Conclusions These findings indicate that adequately trained lay counsellors are capable of safely conducting high‐quality rapid HIV tests and interpreting the results as per the kit guidelines. These findings are important given the likely expansion of community and home‐based testing models and the shortage of clinically trained professional staff.

Introduction We aimed to quantify and identify associated factors of linkage to HIV care following home‐based HIV counselling and testing (HBHCT) in the ongoing ANRS 12249 treatment‐as‐prevention (TasP) cluster‐randomized trial in rural KwaZulu‐Natal, South Africa. Methods Individuals ≥16 years were offered HBHCT; those who were identified HIV positive were referred to cluster‐based TasP clinics and offered antiretroviral treatment (ART) immediately (five clusters) or according to national guidelines (five clusters). HIV care was also available in the local Department of Health (DoH) clinics. Linkage to HIV care was defined as TasP or DoH clinic attendance within three months of referral among adults not in HIV care at referral. Associated factors were identified using multivariable logistic regression adjusted for trial arm. Results Overall, 1323 HIV‐positive adults (72.9% women) not in HIV care at referral were included, of whom 36.9% (n=488) linked to care <3 months of referral (similar by sex). In adjusted analyses (n=1222), individuals who had never been in HIV care before referral were significantly less likely to link to care than those who had previously been in care (<33% vs. >42%, p<0.001). Linkage to care was lower in students (adjusted odds‐ratio [aOR]=0.47; 95% confidence interval [CI] 0.24–0.92) than in employed adults, in adults who completed secondary school (aOR=0.68; CI 0.49–0.96) or at least some secondary school (aOR=0.59; CI 0.41–0.84) versus ≤ primary school, in those who lived at 1 to 2 km (aOR=0.58; CI 0.44–0.78) or 2–5 km from the nearest TasP clinic (aOR=0.57; CI 0.41–0.77) versus <1 km, and in those who were referred to clinic after ≥2 contacts (aOR=0.75; CI 0.58–0.97) versus those referred at the first contact. Linkage to care was higher in adults who reported knowing an HIV‐positive family member (aOR=1.45; CI 1.12–1.86) versus not, and in those who said that they would take ART as soon as possible if they were diagnosed HIV positive (aOR=2.16; CI 1.13–4.10) versus not. Conclusions Fewer than 40% of HIV‐positive adults not in care at referral were linked to HIV care within three months of HBHCT in the TasP trial. Achieving universal test and treat coverage will require innovative interventions to support linkage to HIV care.

Introduction The aim of this study was to determine whether counselling provided subsequent to HIV testing and referral for care increases linkage to care among HIV‐positive persons identified through home‐based HIV counselling and testing (HBHCT) in Masaka, Uganda. Methods The study was an open‐label cluster‐randomized trial. 28 rural communities were randomly allocated (1:1) to intervention (HBHCT, referral and counselling at one and two months) or control (HBHCT and referral only). HIV‐positive care‐naïve adults (≥18 years) were enrolled. To conceal participants’ HIV status, one HIV‐negative person was recruited for every three HIV‐positive participants. Primary outcomes were linkage to care (clinic‐verified registration for care) status at six months, and time to linkage. Primary analyses were intention‐to‐treat using random effects logistic regression or Cox regression with shared frailty, as appropriate. Results Three hundred and two(intervention, n = 149; control, n = 153) HIV‐positive participants were enrolled. Except for travel time to the nearest HIV clinic, baseline participant characteristics were generally balanced between trial arms. Retention was similar across trial arms (92% overall). One hundred and twenty‐seven (42.1%) participants linked to care: 76 (51.0%) in the intervention arm versus 51 (33.3%) in the control arm [odds ratio = 2.18, 95% confidence interval (CI) = 1.26–3.78; p = 0.008)]. There was evidence of interaction between trial arm and follow‐up time (p = 0.009). The probability of linkage to care, did not differ between arms in the first two months of follow‐up, but was subsequently higher in the intervention arm versus the control arm [hazard ratio = 4.87, 95% CI = 1.79–13.27, p = 0.002]. Conclusions Counselling substantially increases linkage to care among HIV‐positive adults identified through HBHCT and may enhance efforts to increase antiretroviral therapy coverage in sub‐Saharan Africa.

Background By testing children and adolescents of HIV positive caretakers, index-linked HIV testing, a targeted HIV testing strategy, has the ability to identify high risk children and adolescents earlier and more efficiently, compared to blanket testing. We evaluated the incremental cost of integrating index-linked HIV testing via three modalities into HIV services in Zimbabwe. Methods A mixture of bottom-up and top-down costing was employed to estimate the provider cost per test and per HIV diagnosis for 2–18 year olds, through standard of care testing, and the incremental cost of index-linked HIV testing via three modalities: facility-based testing, home-based testing by a healthcare worker, and testing at home by the caregiver using an oral mucosal transudate test. In addition to interviews, direct observation and study process data, facility registries were abstracted to extract outcome data and resource use. Costs were converted to 2019 constant US$. Results The average cost per standard of care test in urban facilities was US$5.91 and US$7.15 at the rural facility. Incremental cost of an index-linked HIV test was driven by the uptake and number of participants tested. The lowest cost approach in the urban setting was home-based testing (US$6.69) and facility-based testing at the rural clinic (US$5.36). Testing by caregivers was almost always the most expensive option (rural US$62.49, urban US$17.49). Conclusions This is the first costing analysis of index-linked HIV testing strategies. Unit costs varied across sites and with uptake. When scaling up, alternative testing solutions that increase efficiency such as index-linked HIV testing of the entire household, as opposed to solely targeting children/adolescents, need to be explored.

We developed an innovative home-based HIV self-testing (HIVST) service that included mailing of a free HIVST kit, and providing online real-time instructions and pre-test/post-test counseling (HIVST-OIC). The present parallel-group and non-blinded randomized controlled trial was conducted to evaluate the efficacy of promoting HIVST-OIC in increasing HIV testing rate among 430 men who have sex with men (MSM), with access to online live-chat applications in Hong Kong. At month 6, as compared to the control group, the intervention group reported significantly higher prevalence of HIV testing of any type (89.8 vs. 50.7%; relative risk (RR): 1.77; p < 0.001). Among those who have taken up any HIV testing in the last six months, significant between-group difference was found in multiple male sex partnerships (34.2 vs. 47.7%, RR: 0.72; p = 0.021). HIVST-OIC has a strong potential in increasing prevalence of HIV testing and reducing sexual risk behaviors. Implementation research is warranted.

The COVID-19 pandemic created disruptions in HIV testing service utilization among men who have sex with men (MSM). The present study was to evaluate the effectiveness of an online health promotion program implemented by a community-based organization (CBO) in increasing the uptake of any type of HIV testing and home-based HIV self-testing (HIVST) over a six-month follow-up period. Participants of an observational prospective cohort study conducted during the same period served as the comparison group. This study was conducted between September 2020 and December 2021. Participants were Chinese-speaking adult MSM who were HIV-negative/unknown sero-status recruited through multiple sources in Hong Kong, China. Participants in the intervention group were exposed to the following health promotion components: (1) viewing an online video promoting HIVST, (2) visiting the project webpage, and (3) having access to a chargeable HIVST service implemented by the CBO. Among 400 and 412 participants in the intervention group and the comparison group, 349 (87.3%) and 298 (72.3%) completed follow-up evaluation at Month 6. Multiple imputation was used to replace missing values. At Month 6, participants in the intervention group reported significantly higher uptake of any type of HIV testing (57.0% versus 49.0%, adjusted odds ratios [AOR]: 1.43, p = .03) and HIVST (25.8% versus 14.8%, AOR: 2.04, p = .001), as compared to those in the comparison group. Process evaluation of the health promotion components for the intervention group was positive. Promoting HIVST is a potentially useful strategy to increase HIV testing service utilization among Chinese MSM during the pandemic.

Background To realize the full benefits of treatment as prevention in many hyperendemic African contexts, there is an urgent need to increase uptake of HIV testing and HIV treatment among men to reduce the rate of HIV transmission to (particularly young) women. This trial aims to evaluate the effect of two interventions - micro-incentives and a tablet-based male-targeted HIV decision support application - on increasing home-based HIV testing and linkage to HIV care among men with the ultimate aim of reducing HIV-related mortality in men and HIV incidence in young women. Methods/design This is a cluster randomized trial of 45 communities (clusters) in a rural area in the uMkhanyakude district of KwaZulu Natal, South Africa (2018–2021). The study is built upon the Africa Health Research Institute (AHRI)‘s HIV testing platform, which offers annual home-based rapid HIV testing to individuals aged 15 years and above. In a 2 × 2 factorial design, individuals aged ≥15 years living in the 45 clusters are randomly assigned to one of four arms: i) a financial micro-incentive (food voucher) ( n  = 8); ii) male-targeted HIV specific decision support (EPIC-HIV) ( n  = 8); iii) both the micro incentives and male-targeted decision support ( n  = 8); and iv) standard of care ( n  = 21). The EPIC-HIV application is developed and delivered via a tablet to encourage HIV testing and linkage to care among men. A mixed method approach is adopted to supplement the randomized control trial and meet the study aims. Discussion The findings of this trial will provide evidence on the feasibility and causal impact of two interventions - micro-incentives and a male-targeted HIV specific decision support - on uptake of home-based HIV testing, linkage to care, as well as population health outcomes including population viral load, HIV related mortality in men, and HIV incidence in young women (15-30 years of age). Trial registration This trial was registered on 28 November 2018 on, identifier https://clinicaltrials.gov/ .