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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.

Background HIV self-testing (HIVST) can be performed using directly assisted and unassisted approaches in facilities or communities to reach different populations. The aim of this study was to compare the practicability and effectiveness of the two delivery approaches for HIVST, unassisted HIVST (UH) and directly assisted HIVST (DAH), in the field setting of Kisangani, the Democratic Republic of the Congo (DRC). Methods A randomized (1:1), non-blinded, non-inferiority trial using a blood-based and facility-based HIVST method was carried out in four facilities in Kisangani, the DRC, targeting populations at high risk for HIV infection. The primary outcome was the difference in the practicability of the HIV self-test between the two arms. Practicability was defined as successfully performing the test and correctly interpreting the result. Requests for assistance, positivity rate, linkage to care, and willingness to buy an HIV self-test kit constituted the secondary outcomes for HIVST effectiveness. The adjusted risk ratios (aRRs) were calculated using Poisson regression. Results The rate of successfully performing the test was same (93.2%) in the UH and DAH arms. The rate of correctly interpreting the results was 86.9% in the UH arm versus 93.2% in the DAH arm, for a difference of − 6.3%. After the follow-up 72 h later, participants in the UH arm had a significantly lower chance of correctly interpreting the test results than those in the DAH arm (aRR: 0.60; P  = 0.019). Although the positivity rate was 3.4% among the participants in the DAH arm and 1.7% among those in the UH arm, no significant differences were found between the two arms in the positivity rate, requests for assistance, and linkage to care. Willingness to buy an HIV self-test was higher in the UH arm than in the DAH arm (92.3% versus 74.1%; aRR: 4.20; P  < 0.001). Conclusion The results of this study indicate that UH is as practicable and effective as DAH among individuals at high risk for HIV infection in Kisangani, the DRC. However, additional support tools need to be assessed to improve the interpretation of the self-test results when using the UH approach. Trial registration PACTR201904546865585. Registered 03 April 2019 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=6032

Globally, men are less likely to access HIV services, and addressing HIV service challenges among men is crucial to the global HIV/AIDS response. HIV self-testing (HIVST) has been shown to be a potentially effective strategy in improving HIV testing coverage among men. This study assessed and identified factors influencing willingness to receive HIVST kits from sexual partners among men in Tanzania. Data are from the baseline survey of the Self-Testing Education and Promotion (STEP) project, a five-year study comprising male participants aged 18 or older who self-reported as HIV-negative. Logistic regression models were used to assess factors associated with men’s willingness to receive HIVST kits from their sexual partners. There were 505 heterosexual male participants enrolled in the study with an average age of 29 years, of whom 69% reported being willing to receive HIVST kits from their sexual partner. Logistic regression models demonstrated that willingness to receive HIVST kits from sexual partners was significantly associated with number of sexual partners within 12 months (aOR = 1.2, 95% CI [1.1–1.3]), awareness of HIVST (aOR = 5.6, 95% CI [3.2–9.5]), previous discussion of HIVST with sexual partners aOR = 14.0, 95% CI [8.0–24.6]), and previous testing for HIV with sexual partners not (aOR = 2.5, 95% CI [1.3–4.7]). These findings suggest additional promotional strategies to improve men’s awareness of HIVST and support open conversations about HIVST and HIV testing with sexual partners could improve men’s willingness to receive HIVST kits when distributed through their sexual partners.

Background: HIV self-testing (HIVST) can be performed using directly assisted and unassisted approaches in facilities or communities to reach different populations. The aim of this study was to compare the practicability andeffectiveness of the two delivery approaches for HIVST, unassisted HIVST (UH) and directly assisted HIVST (DAH), in the field setting of Kisangani, the Democratic Republic of the Congo (DRC). Methods: A randomized (1:1), non-blinded, non-inferiority trial using a blood-based and facility-based HIVST method was carried out in four facilities in Kisangani, the DRC, targeting populations at high risk for HIV infection. The primary outcome was the difference in the practicability of the HIV self-test between the two arms. Practicability was defined as successfully performing the test and correctly interpreting the result. Requests for assistance, positivity rate, linkage to care, and willingness to buy an HIV self-test kit constituted the secondary outcomes for HIVST effectiveness. The adjusted risk ratios (aRRs) were calculated using Poisson regression. Results: The rate of successfully performing the test was same (93.2%) in the UH and DAH arms. The rate of correctly interpreting the results was 86.9% in the UH arm versus 93.2% in the DAH arm, for a difference of − 6.3%. After the follow-up 72 h later, participants in the UH arm had a significantly lower chance of correctly interpreting the test results than those in the DAH arm (aRR: 0.60; P = 0.019). Although the positivity rate was 3.4% among the participants in the DAH arm and 1.7% among those in the UH arm, no significant differences were found between the two arms in the positivity rate, requests for assistance, and linkage to care. Willingness to buy an HIV self-test was higher in the UH arm than in the DAH arm (92.3% versus 74.1%; aRR: 4.20; P < 0.001).Conclusion: The results of this study indicate that UH is as practicable and effective as DAH among individuals at high risk for HIV infection in Kisangani, the DRC. However, additional support tools need to be assessed to improve the interpretation of the self-test results when using the UH approach.

HIV self-testing (HIVST) is a potential strategy to overcome disparities in access to and uptake of HIV testing, particularly among key populations (KP). A literature review was conducted on the acceptability, values and preferences among KP. Data was analyzed by country income World Bank classification, type of specimen collection, level of support offered and other qualitative aspects. Most studies identified were from high-income countries and among men who have sex with men (MSM) who found HIVST to be acceptable. In general, MSM were interested in HIVST because of its convenient and private nature. However, they had concerns about the lack of counseling, possible user error and accuracy. Data on the values and preferences of other KP groups regarding HIVST is limited. This should be a research priority, as HIVST is likely to become more widely available, including in resource-limited settings.

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.

Introduction Social network strategies, in which social networks are utilized to influence individuals or communities, are increasingly being used to deliver human immunodeficiency virus (HIV) interventions to key populations. We summarized and critically assessed existing research on the effectiveness of social network strategies in promoting HIV self‐testing (HIVST). Methods Using search terms related to social network interventions and HIVST, we searched five databases for trials published between 1st January 2010 and 30th June 2023. Outcomes included uptake of HIV testing, HIV prevalence and linkage to antiretroviral therapy (ART) or HIV care. We used network meta‐analysis to assess the uptake of HIV testing through social network strategies compared with control methods. A pairwise meta‐analysis of studies with a comparison arm that reported outcomes was performed to assess relative risks (RR) and their corresponding 95% confidence intervals (CI). Results Among the 4496 manuscripts identified, 39 studies fulfilled the inclusion criteria, including one quasi‐experimental study, 22 randomized controlled trials and 16 observational studies. Networks HIVST testing was organized by peers (distributed to known peers, 15 studies), partners (distributed to their sexual partners, 16 studies) and peer educators (distributed to unknown peers, 8 studies). Among social networks, simulating the possibilities of ranking position, peer distribution had the highest uptake of HIV testing (84% probability), followed by partner distribution (80% probability) and peer educator distribution (74% probability). Pairwise meta‐analysis showed that peer distribution (RR 2.29, 95% CI 1.54−3.39, 5 studies) and partner distribution (RR 1.76, 95% CI 1.50−2.07, 10 studies) also increased the probability of detecting HIV reactivity during testing within the key population when compared to the control. Discussion All of the three social network distribution strategies enhanced the uptake of HIV testing compared to standard facility‐based testing. Linkage to ART or HIV care remained comparable to facility‐based testing across the three HIVST distribution strategies. Conclusions Network‐based HIVST distribution is considered effective in augmenting HIV testing rates and reaching marginalized populations compared to facility‐based testing. These strategies can be integrated with the existing HIV care services, to fill the testing gap among key populations globally. PROSPERO Number CRD42022361782

IntroductionUrban refugee youth remain underserved by current HIV prevention strategies, including HIV self-testing (HIVST). Examining HIVST feasibility with refugees can inform tailored HIV testing strategies. We examined if HIVST and mobile health (mHealth) delivery approaches could increase HIV testing uptake and HIV status knowledge among refugee youth in Kampala, Uganda.MethodsWe conducted a three-arm pragmatic controlled trial across five informal settlements grouped into three sites in Kampala from 2020 to 2021 with peer-recruited refugee youth aged 16–24 years. The intervention was HIVST and HIVST + mHealth (HIVST with bidirectional SMS), compared with standard of care (SOC). Primary outcomes were self-reported HIV testing uptake and correct status knowledge verified by point-of-care testing. Some secondary outcomes included: depression, HIV-related stigma, and adolescent sexual and reproductive health (SRH) stigma at three time points (baseline [T0], 8 months [T1] and 12 months [T2]). We used generalized estimating equation regression models to estimate crude and adjusted odds ratios comparing arms over time, adjusting for age, gender and baseline imbalances. We assessed study pragmatism across PRECIS-2 dimensions.ResultsWe enrolled 450 participants (50.7% cisgender men, 48.7% cisgender women, 0.7% transgender women; mean age: 20.0, standard deviation: 2.4) across three sites. Self-reported HIV testing uptake increased significantly from T0 to T1 in intervention arms: HIVST arm: (27.6% [n = 43] at T0 vs. 91.2% [n = 135] at T1; HIVST + mHealth: 30.9% [n = 47] at T0 vs. 94.2% [n = 113] at T1]) compared with SOC (35.5% [n = 50] at T0 vs. 24.8% [ = 27] at T1) and remained significantly higher than SOC at T2 (p<0.001). HIV status knowledge in intervention arms (HIVST arm: 100% [n = 121], HIVST + mHealth arm: 97.9% [n = 95]) was significantly higher than SOC (61.5% [n = 59]) at T2. There were modest changes in secondary outcomes in intervention arms, including decreased depression alongside increased HIV-related stigma and adolescent SRH stigma. The trial employed both pragmatic (eligibility criteria, setting, organization, outcome, analysis) and explanatory approaches (recruitment path, flexibility of delivery flexibility, adherence flexibility, follow-up).ConclusionsOffering HIVST is a promising approach to increase HIV testing uptake among urban refugee youth in Kampala. We share lessons learned to inform future youth-focused HIVST trials in urban humanitarian settings.

HIV self-testing has gained momentum following the approval of self-testing methods and novel technological advancements. Digital HIV self-testing involves completing an oral or blood-based HIV self-test with support from a digital innovation. We conducted a systematic review on the existing data analyzing digital HIV self-testing accuracy while updating research on digital HIV self-test acceptability, preference, feasibility, and impact. We searched Embase and PubMed for records on HIV self-testing with digital support. Included studies significantly incorporated a form of digital innovation throughout the HIV self-test process and reported quantitative data. For accuracy measures, the search spanned January 1, 2013, to October 15, 2024; for patient-centered and impact outcomes, we updated existing literature (June 16, 2021, to October 15, 2024) reported in a previous systematic review. Studies' quality was assessed using the QUADAS 2 Tool, Newcastle-Ottawa Scale, and Cochrane Risk of Bias Tool 2. Fifty-five studies (samples ranging 120-21,035, median 1267 participants) were summarized from 19 middle- to high-income countries. Seven studies reported on the accuracy of HIV self-testing with innovations from >5000 participants. Diagnostic performance metrics, including point estimates of specificity, sensitivity, positive predictive value, and negative predictive value were measured (n=3), and ranged from: 96.8% to 99.9%, 92.9% to 100.0%, 76.5% to 99.2%, and 99.2% to 100.0%, respectively. The percentage of invalid test results for oral and blood-based self-tests ranged from 0.2% to 12.7% (n=4). Fifty-one studies reported data on metrics beyond accuracy, including acceptability, preference, feasibility, and impact outcomes from >30,000 participants. Majority (38/51, 74.5%) were observational studies, while 25.5% (13/51) reported data from randomized controlled trials. Acceptability and preference outcomes varied from 64.5% to 99.0% (14/51) and 4.6% to 99.3% (8/51), respectively. Feasibility outcomes included test uptake (30.9% to 98.2%; 28/51), response rate (26.0% to 94.8%; 7/51), and visits to web-based providers (43.0% to 70.7%; n=4). Impact outcomes assessed new infections (0.0% to 25.8%; 31/51), first-time testers (2.0% to 53.0%; 26/51), result return proportions (22.1% to 100.0%; 24/51), linkage to care as both connections to confirmatory testing and counseling (53.0% to 100.0%; 16/51), and referrals for treatment initiation (44.4% to 98.1%; 8/51). The quality of studies varied, though they generally demonstrated low risk of bias. Digital innovations improved the accuracy of HIV self-test results, and were well-accepted and preferred by participants. Operationally, they were found to be feasible and reported impacting the HIV self-testing process. These findings are in favor of the use of digital HIV self-test innovations as a promising support tool and suggest that digital HIV self-tests' service delivery models hold promise in not only facilitating HIV testing but also impacting operational outcomes that are crucial to reaching Joint United Nations Program on HIV/AIDS targets in middle- to high-income countries. PROSPERO CRD42020205025; https://www.crd.york.ac.uk/prospero/CRD42020205025.

Introduction Past research shows that HIV self‐testing (HIVST) can increase testing and facilitate more HIV diagnoses relative to clinic testing. However, in the United States, the use of HIVSTs is limited due to concerns that those who use HIVST could be less likely to be linked to care. Methods From January 2019 to April 2022, we recruited 811 men who have sex with men (MSM) in the United States who tested infrequently using an online marketing campaign and randomized them 1:1:1 to receive one of the following every 3 months for a year: (1) text message reminders to get tested at a local clinic (control); (2) mailed HIVST kits with access to a free helpline (standard HIVST); and (3) mailed HIVST kits with counselling provided within 24 hours of opening a kit (eTest). Quarterly follow‐up surveys assessed HIV testing, sexually transmitted infection (STI) testing, pre‐exposure prophylaxis (PrEP) use and sexual risk behaviour. Findings Eight participants were diagnosed with HIV, and all but one were through HIVST. Participants in either HIVST condition, standard or eTest, had significantly higher odds of any testing (OR = 7.9, 95% CI = 4.9−12.9 and OR = 6.6, 95% CI = 4.2−10.5) and repeat testing (>1 test; OR = 8.5, 95% CI = 5.7−12.6; OR = 8.9, 95% CI = 6.1−13.4) over 12 months relative to the control group. Rates of STI testing and PrEP uptake did not differ across study condition, but those in the eTest condition reported 27% fewer sexual risk events across the study period relative to other groups. Conclusions HIVST vastly increased testing, encouraged more regular testing among MSM, and identified nearly all new cases, suggesting that HIVST could diagnose HIV acquisition earlier. Providing timely follow‐up counselling after HIVST did not increase rates of STI testing or PrEP use, but some evidence suggested that counselling may have reduced sexual risk behaviour. To encourage more optimal testing, programmes should incorporate HIVST and ship kits directly to recipients at regular intervals.