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.

Performance evaluation of a self-administered point-of-care test for anal HPV screening in PrEP users: data from a community-based PrEP service.

OBJECTIVES: In this study, we compared the performance of a self-administered point-of-care test (POCT) for anal human papillomavirus (HPV) screening with laboratory gold-standard test in pre-exposure prophylaxis (PrEP) users and evaluated its feasibility. METHODS: We enrolled PrEP users from a local community-based PrEP service. Each participant self-collected an anal swab to test anal HPV with a PCR POCT capable of detecting 14 high-risk HPV genotypes. Anonymous questionnaires on self-sampling feasibility were completed. Participants were then referred to local clinics to undergo standard viral genotyping. Concordance between POCT and gold-standard test was measured with absolute agreement and Cohen's kappa. Receiver operating characteristic (ROC) curves were used to calculate POCT sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). RESULTS: 179 subjects got a valid POCT result, most of them men (98.3%) and men who have sex with men (90.4%). 68.2% tested positive for at least one high-risk HPV genotype on POCT. 150 feasibility questionnaires were collected: 92.7% of compilers found the self-swab easy to perform. For 178 subjects, a gold-standard test valid result was also available: 77% tested positive for at least one high-risk HPV genotype. The median time elapsed between the two tests was 9.8 months, due to COVID-19-related service interruptions. Agreement between POCT and gold-standard test was 79.3% (Cohen's kappa=0.49). POCT showed a sensitivity of 81.0%, a specificity of 73.8%, a PPV of 91.0% and an NPV of 54.4%. CONCLUSIONS: POCT showed a moderate agreement with gold-standard test and a discrete sensitivity and specificity, suggesting that it could be a useful and feasible additional tool for HPV screening, especially in low-resource and community-based settings.

The economic costs and cost-effectiveness of HIV self-testing among truck drivers in Kenya.

HIV status awareness is critical for ending the HIV epidemic but remains low in high-HIV-risk and hard-to-reach sub-populations. Targeted, efficient interventions are needed to improve HIV test-uptake. We examined the incremental cost-effectiveness of offering the choice of self-administered oral HIV-testing (HIVST-Choice) compared with provider-administered testing only [standard-of-care (SOC)] among long-distance truck drivers. Effectiveness data came from a randomized-controlled trial conducted at two roadside wellness clinics in Kenya (HIVST-Choice arm, n = 150; SOC arm, n = 155). Economic cost data came from the literature, reflected a societal perspective and were reported in 2020 international dollars (I$), a hypothetical currency with equivalent purchasing power as the US dollar. Generalized Poisson and linear gamma regression models were used to estimate effectiveness and incremental costs, respectively; incremental effectiveness was reported as the number of long-distance truck drivers needing to receive HIVST-Choice for an additional HIV test-uptake. We calculated the incremental cost-effectiveness ratio (ICER) of HIVST-Choice compared with SOC and estimated 95% confidence intervals (CIs) using non-parametric bootstrapping. Uncertainty was assessed using deterministic sensitivity analysis and the cost-effectiveness acceptability curve. HIV test-uptake was 23% more likely for HIVST-Choice, with six individuals needing to be offered HIVST-Choice for an additional HIV test-uptake. The mean per-patient cost was nearly 4-fold higher in HIVST-Choice (I$39.28) versus SOC (I$10.80), with an ICER of I$174.51, 95% CI [165.72, 194.59] for each additional test-uptake. HIV self-test kit and cell phone service costs were the main drivers of the ICER, although findings were robust even at highest possible costs. The probability of cost-effectiveness approached 1 at a willingness-to-pay of I$200 for each additional HIV test-uptake. HIVST-Choice improves HIV-test-uptake among truck drivers at low willingness-to-pay thresholds, suggesting that HIV self-testing is an efficient use of resources. Policies supporting HIV self-testing in similar high risk, hard-to-reach sub-populations may expedite achievement of international targets.

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

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

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

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

On the impact of mass screening for SARS-CoV-2 through self-testing in Greece.

Background: Screening programs that pre-emptively and routinely test population groups for disease at a massive scale were first implemented during the COVID-19 pandemic in a handful of countries. One of these countries was Greece, which implemented a mass self-testing program during 2021. In contrast to most other non-pharmaceutical interventions (NPIs), mass self-testing programs are particularly attractive for their relatively small financial and social burden, and it is therefore important to understand their effectiveness to inform policy makers and public health officials responding to future pandemics. This study aimed to estimate the number of deaths and hospitalizations averted by the program implemented in Greece and evaluate the impact of several operational decisions. Methods: Granular data from the mass self-testing program deployed by the Greek government between April and December 2021 were obtained. The data were used to fit a novel compartmental model that was developed to describe the dynamics of the COVID-19 pandemic in Greece in the presence of self-testing. The fitted model provided estimates on the effectiveness of the program in averting deaths and hospitalizations. Sensitivity analyses were used to evaluate the impact of operational decisions, including the scale of the program, targeting of sub-populations, and sensitivity (i.e., true positive rate) of tests. Results: Conservative estimates show that the program reduced the reproduction number by 4%, hospitalizations by 25%, and deaths by 20%, translating into approximately 20,000 averted hospitalizations and 2,000 averted deaths in Greece between April and December 2021. Conclusion: Mass self-testing programs are efficient NPIs with minimal social and financial burden; therefore, they are invaluable tools to be considered in pandemic preparedness and response.

The impact of HIV self-testing on risk behaviors among men who have sex with men: a mixed-methods study.

Background: Men who have sex with men (MSM) have a high prevalence of HIV and a low rate of HIV testing in China. HIV self-testing (HIVST) presents a viable strategy for expanding HIV testing among MSM. However, the impact of HIVST on risk behaviors among MSM remains controversial. Our study sought to ascertain this impact. Methods: From April 2021 to January 2022, a mixed-methods study was conducted in Qingdao City, employing both quantitative and qualitative methodologies. The quantitative component entailed a cohort study among MSM who had used HIVST. Generalized estimating equations fitting Poisson regressions were used to analyze the changes in risk behaviors of MSM in short time after HIVST (ST-HIVST) and longer time after HIVST (LT-HIVST) compared to before HIVST. Subsequently, we conducted in-depth interviews with 18 MSM who completed the follow-up to delve deeper into the impact of HIVST on MSM. Results: A total of 410 MSM were recruited in the cohort, of whom 83 were lost to follow-up. Compared to before HIVST, there were no significant changes in risk behaviors in ST-HIVST (p > 0.05), while the proportion of recreational drugs abuse (20.7% vs. 33.3%), commercial sex (14.6% vs. 22.9%), and unprotected anal sex (95.9% vs. 98.5%) increased significantly in LT-HIVST (p < 0.05). Specific changes varied across demographic characteristics. According to qualitative interviews, MSM might have decreased risk perception and increased risk behaviors after HIVST. Conclusion: The use of HIVST may promote MSM to engage in risk behaviors. In the future, customized HIVST promotion programs need to be developed to expand HIV testing among MSM and simultaneously control their risk behaviors.

Targeted HIV Self-Testing Identifies Persons with Undiagnosed HIV and Active Engagement Links them to Care: The GetaKit Study.

Current international HIV testing guidelines recommend that HIV negative persons from HIV priority groups complete repeat screening every 3-6 months; local guidelines in our jurisdiction recommend that such retesting should occur every 3 months. Such an approach allows for timely HIV diagnosis and linkage to care - and aligns with the UNAIDS 95-95-95 targets to have 95% of undiagnosed persons be aware of their HIV status. To meet these aims, new approaches to HIV testing have been developed, including our HIV self-testing initiative, GetaKit.ca, which uses an online screening algorithm to determine eligibility and has built in pathways for re-test reminders, linkage HIV prevention care, and rapid follow-up for positive test results. To understand self-testing frequency in relation to our local recommendations for resting every 3 months, we evaluated data from participants who ordered repeat HIV self-tests through GetaKit.ca. Descriptive analyses were performed on participant characteristics and chi-square tests were performed on aggregated participant risk data. During the study period, 5235 HIV self-tests were distributed to 3627 participants, of whom, 26% ordered more than once and 27% belonged to an HIV priority population. Participants who retested were more likely to have been white, male, and part of an HIV priority population; they were also more likely to have completed prior STI or HIV testing or had a prior STI diagnosis, compared to those who did not. We identified 16 new HIV diagnoses, 2 of which were among repeat testers. Our results suggest that HIV self-testing can be useful to help meet UNAIDS targets to identify undiagnosed infections; however, such efforts are less likely to be successful without adequate linkage to follow-up services, including HIV treatment and prevention care.

Effect of differentiated direct-to-pharmacy PrEP refill visits supported with client HIV self-testing on clinic visit time and early PrEP continuation.

INTRODUCTION: Delivery of oral pre-exposure prophylaxis (PrEP) is being scaled up in Africa, but clinic-level barriers including lengthy clinic visits may threaten client continuation on PrEP. METHODS: Between January 2020 and January 2022, we conducted a quasi-experimental evaluation of differentiated direct-to-pharmacy PrEP refill visits at four public health HIV clinics in Kenya. Two clinics implemented the intervention package, which included direct-to-pharmacy for PrEP refill, client HIV self-testing (HIVST), client navigator, and pharmacist-led rapid risk assessment and dispensing. Two other clinics with comparable size and client volume served as contemporaneous controls with the usual clinic flow. PrEP continuation was evaluated by visit attendance and pharmacy refill records, and time and motion studies were conducted to determine time spent in the clinics. Dried blood spots were collected to test for tenofovir-diphosphate (TFV-DP) at random visits. We used logistic regression to assess the intervention effect on PrEP continuation and the Wilcoxon rank sum test to assess the effect on clinic time. RESULTS: Overall, 746 clients were enrolled, 366 at control clinics (76 during pre-implementation and 290 during implementation phase), and 380 at direct-to-pharmacy clinics (116 during pre-implementation and 264 during implementation phase). Prior to implementation, the intervention and control clinics were comparable on client characteristics (female: 51% vs. 47%; median age: 33 vs. 33 years) and PrEP continuation (35% vs. 37% at 1 month, and 37% vs. 39% at 3 months). The intervention reduced total time spent at the clinic by 35% (median of 51 minutes at control vs. 33 minutes at intervention clinics; p<0.001), while time spent on HIV testing (20 vs. 20 minutes; p = 0.50) and pharmacy (8 vs. 8 minutes; p = 0.8) was unchanged. PrEP continuation was higher at intervention versus the control clinics: 45% versus 33% at month 1, 34% versus 25% at month 3 and 23% versus 16% at month 6. TFV-DP was detected in 85% (61/72) of samples, similar by the study group (83% vs. 85%). CONCLUSIONS: A client-centred PrEP delivery approach with direct-to-pharmacy PrEP refill visits plus client HIVST significantly reduced clinic visit time by more than one-third and improved PrEP continuation in public health HIV clinics in Kenya.

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

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

Measuring the performance of computer vision artificial intelligence to interpret images of HIV self-testing results.

Introduction: HIV self-testing (HIVST) is highly sensitive and specific, addresses known barriers to HIV testing (such as stigma), and is recommended by the World Health Organization as a testing option for the delivery of HIV pre-exposure prophylaxis (PrEP). Nevertheless, HIVST remains underutilized as a diagnostic tool in community-based, differentiated HIV service delivery models, possibly due to concerns about result misinterpretation, which could lead to inadvertent onward transmission of HIV, delays in antiretroviral therapy (ART) initiation, and incorrect initiation on PrEP. Ensuring that HIVST results are accurately interpreted for correct clinical decisions will be critical to maximizing HIVST's potential. Early evidence from a few small pilot studies suggests that artificial intelligence (AI) computer vision and machine learning could potentially assist with this task. As part of a broader study that task-shifted HIV testing to a new setting and cadre of healthcare provider (pharmaceutical technologists at private pharmacies) in Kenya, we sought to understand how well AI technology performed at interpreting HIVST results. Methods: At 20 private pharmacies in Kisumu, Kenya, we offered free blood-based HIVST to clients ≥18 years purchasing products indicative of sexual activity (e.g., condoms). Trained pharmacy providers assisted clients with HIVST (as needed), photographed the completed HIVST, and uploaded the photo to a web-based platform. In real time, each self-test was interpreted independently by the (1) client and (2) pharmacy provider, with the HIVST images subsequently interpreted by (3) an AI algorithm (trained on lab-captured images of HIVST results) and (4) an expert panel of three HIVST readers. Using the expert panel's determination as the ground truth, we calculated the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for HIVST result interpretation for the AI algorithm as well as for pharmacy clients and providers, for comparison. Results: From March to June 2022, we screened 1,691 pharmacy clients and enrolled 1,500 in the study. All clients completed HIVST. Among 854 clients whose HIVST images were of sufficient quality to be interpretable by the AI algorithm, 63% (540/854) were female, median age was 26 years (interquartile range: 22-31), and 39% (335/855) reported casual sexual partners. The expert panel identified 94.9% (808/854) of HIVST images as HIV-negative, 5.1% (44/854) as HIV-positive, and 0.2% (2/854) as indeterminant. The AI algorithm demonstrated perfect sensitivity (100%), perfect NPV (100%), and 98.8% specificity, and 81.5% PPV (81.5%) due to seven false-positive results. By comparison, pharmacy clients and providers demonstrated lower sensitivity (93.2% and 97.7% respectively) and NPV (99.6% and 99.9% respectively) but perfect specificity (100%) and perfect PPV (100%). Conclusions: AI computer vision technology shows promise as a tool for providing additional quality assurance of HIV testing, particularly for catching Type II error (false-negative test interpretations) committed by human end-users. We discuss possible use cases for this technology to support differentiated HIV service delivery and identify areas for future research that is needed to assess the potential impacts-both positive and negative-of deploying this technology in real-world HIV service delivery settings.

"They call me the 'Great Queen'": implementing the Malkia Klabu program to improve access to HIV self-testing and contraception for adolescent girls and young women in Tanzania.

BACKGROUND: Adolescent girls and young woman (AGYW) comprise a significant proportion of new HIV infections and unintended pregnancies in sub-Saharan Africa yet face many barriers to accessing family planning and reproductive health (FPRH) information and services. Developed via human-centered design, the Malkia Klabu ("Queen Club") program aimed to facilitate access to HIV self-testing (HIVST) and FPRH information and products at privately-owned drug shops. We sought to understand barriers and facilitators to program implementation in a 4-month pilot in Tanzania. METHODS: Forty semi-structured interviews were conducted with participants in a cluster randomized trial of the Malkia Klabu program from November 2019 through March 2020, including 11 with AGYW, 26 with drug shopkeepers, and three with counselors at health facilities to whom AGYW were referred. Interviews were audio-recorded, transcribed, coded, and analyzed to identify key themes. The Consolidated Framework for Implementation Research (CFIR) was used to assess barriers and facilitators to program implementation at multiple levels. CFIR considers the outer setting (e.g., culture and systemic conditions), the inner setting where the intervention is implemented (e.g., incentives, relationships, and available resources), the individuals involved, the innovation as it relates to stakeholder needs, and the implementation process. RESULTS: The Malkia Klabu program reshaped and directed the role of drug shopkeepers as providers of information and resources rather than FPRH gatekeepers. Key implementation facilitators included the program's adaptability to a wide range of needs and stages of readiness among AGYW, ability to capitalize on AGYW social networks for driving membership, responsiveness to AGYW's need for privacy, and positive contributions to the income and community standing of drug shopkeepers. Components such as HIVST were highly acceptable to both AGYW and shopkeepers, and the introduction of the loyalty program and HIVST kits in shops opened doors to the provision of FPRH products and information, which was further facilitated by program tools such as videos, product displays, and symbol cards. Although some shopkeepers maintained beliefs that certain contraceptive methods were inappropriate for AGYW, most appeared to provide the products as part of the program. CONCLUSIONS: The Malkia Klabu intervention's success was due in part to its ability to address key motivations of both AGYW and drug shopkeepers, such as maintaining privacy and increasing access to FPRH products for AGYW and increasing business for shops. Better understanding these implementation barriers and facilitators can inform the program's future adaptation and scale-up. TRIAL REGISTRATION: clinicaltrials.gov #NCT04045912.

Adolescent girls and young women (AGYW) in sub-Saharan Africa have limited access to family planning and reproductive health products and information even though they are at greater risk of pregnancy and HIV infection. The Malkia Klabu intervention was designed with AGYW and shopkeepers from private drug shops to facilitate access to products and information through a loyalty program that included free products, prizes for purchases, educational videos, and a non-verbal system of requesting products through symbols. Qualitive interviews with AGYW, drug shop staff, and health system counselors suggested that the program helped provide greater privacy and confidence to AGYW while bringing new business to drug shops. These findings can help as the study team charts a pathway for scaling up the intervention.

Organisation of testing services, structural barriers and facilitators of routine HIV self-testing during sexually transmitted infection consultations: a qualitative study of patients and providers in Abidjan, Côte d'Ivoire.

BACKGROUND: Consultations for sexually transmitted infection (STI) provide an opportunity to offer HIV testing to both patients and their partners. This study describes the organisation of HIV self-testing (HIVST) distribution during STI consultations in Abidjan (Côte d'Ivoire) and analyse the perceived barriers and facilitators associated with the use and redistribution of HIVST kits by STI patients. MATERIALS AND METHODS: A qualitative study was conducted between March and August 2021 to investigate three services providing HIVST: an antenatal care clinic (ANC), a general health centre that also provided STI consultations, and a dedicated STI clinic. Data were collected through observations of medical consultations with STI patients (N = 98) and interviews with both health professionals involved in HIVST distribution (N = 18) and STI patients who received HIVST kits for their partners (N = 20). RESULTS: In the ANC clinic, HIV testing was routinely offered during the first prenatal visit. HIVST was commonly offered to women who had been diagnosed with an STI for their partner's use (27/29 observations). In the general health centre, two parallel pathways coexisted: before the consultation, a risk assessment tool was used to offer HIV testing to eligible patients and, after the consultation, patients who had been diagnosed with an STI were referred to a care assistant for HIVST. Due to this HIV testing patient flow, few offers of HIV testing and HIVST were made in this setting (3/16). At the dedicated STI clinic, an HIVST video was played in the waiting room. According to the health professionals interviewed, this video helped reduce the time required to offer HIVST after the consultation. Task-shifting was implemented there: patients were referred to a nurse for HIV testing, and HIVST was commonly offered to STI patients for their partners' use (28/53). When an HIVST was offered, it was generally accepted (54/58). Both health professionals and patients perceived HIVST positively despite experiencing a few difficulties with respect to offering HIVST to partners and structural barriers associated with the organisation of services. CONCLUSION: The organisation of patient flow and task-shifting influenced HIV testing and offers of HIVST kits. Proposing HIVST is more systematic when HIV testing is routinely offered to all patients. Successful integration requires improving the organisation of services, including task-shifting.

Cofactors of Partner HIV Self-testing and Oral PrEP Acceptance Among Pregnant Women at High Risk of HIV in Kenya.

BACKGROUND: Oral pre-exposure prophylaxis (PrEP) and male partner HIV self-testing (HIVST) is being scaled up within antenatal clinics. Few data are available on how co-distribution influences acceptance of both interventions. METHODS: We used data from the PrEP Implementation of Mothers in Antenatal Care (NCT03070600) trial in Kenya. Women included in this analysis were determined to be at high risk of HIV and offered oral PrEP and partner HIVST. Characteristics were compared between women who chose: (1) PrEP and HIVST, (2) HIVST-alone, (3) PrEP-alone, or (4) declined both (reference), excluding women who had partners known to be living with HIV. RESULTS: Among 911 women, median age was 24 years, 87.3% were married, 43.9% perceived themselves to be at high risk of HIV and 13.0% had history of intimate partner violence (IPV). Overall, 68.9% accepted HIVST and 18.4% accepted PrEP, with 54.7% accepting HIVST-alone, 4.2% PrEP-alone, and 14.3% both HIVST and PrEP. Of women accepting HIVST, partner HIV testing increased from 20% to 82% and awareness of partner HIV status increased from 4.7% to 82.0% between pregnancy and 9 months postpartum (P < 0.001). Compared with women who accepted neither, choosing: (1) HIVST-alone was associated with being married, higher level of education, and residing with partner; (2) PrEP-alone was associated with lower social support, IPV, not residing with partner, longer time living with partner, and suspicion of other partners; and (3) PrEP and HIVST was associated with being married, IPV, and suspicion that partner had other partners. CONCLUSIONS: Understanding factors associated with accepting HIVST and PrEP can inform HIV prevention programs for pregnant women. CLINICAL TRIAL NUMBER: NCT03070600.

Costs and scale-up costs of community-based Oral HIV Self-Testing for female sex workers and men who have sex with men in Jakarta and Bali, Indonesia.

BACKGROUND: The proportion of individuals who know their HIV status in Indonesia (66% in 2021) still remains far below the first 95% of UNAIDS 2030 target and were much lower in certain Key Populations (KPs) particularly Female Sex Workers (FSW) and Male having Sex with Male (MSM). Indonesia has implemented Oral HIV Self-testing (oral HIVST) through Community-based screening (HIV CBS) in addition to other testing modalities aimed at hard-to-reach KPs, but the implementation cost is still not analysed. This study provides the cost and scale up cost estimation of HIV CBS in Jakarta and Bali, Indonesia. METHODS: We estimated the societal cost of HIV CBS that was implemented through NGOs. The HIV CBS's total and unit cost were estimated from HIV CBS outcome, health care system cost and client costs. Cost data were presented by input, KPs and areas. Health care system cost inputs were categorized into capital and recurrent cost both in start-up and implementation phases. Client costs were categorized as direct medical, direct non-medical cost and indirect costs. Sensitivity and scenario analyses for scale up were performed. RESULTS: In total, 5350 and 1401 oral HIVST test kits were distributed for HIV CBS in Jakarta and Bali, respectively. Average total client cost for HIV CBS Self testing process ranged from US$1.9 to US$12.2 for 1 day and US$2.02 to US$33.61 for 2 days process. Average total client cost for HIV CBS confirmation test ranged from US$2.83 to US$18.01. From Societal Perspective, the cost per HIVST kit distributed were US$98.59 and US$40.37 for FSW and MSM in Jakarta andUS$35.26 and US$43.31 for FSW and MSM in Bali. CONCLUSIONS: CBS using oral HIVST approach varied widely along with characteristics of HIV CBS volume and cost. HIV CBS was most costly among FSW in Jakarta, attributed to the low HIV CBS volume, high personnel salary cost and client cost. Future approaches to minimize cost and/or maximize testing coverage could include unpaid community led distribution to reach end-users, integrating HIVST into routine clinical services via direct or secondary distribution and using social media network.

Determinants and acceptability of HIV self-testing among vulnerable groups in sub-Saharan Africa: A scoping review protocol.

INTRODUCTION: HIV self-testing (HIVST) is where individuals collect their specimens and perform the HIV test privately. HIVST has improved testing uptake and coverage, especially among vulnerable groups of sub-Saharan Africa (SSA). Vulnerable groups include key populations such as men who have sex with men, sex workers, people who inject drugs, lesbian, gay, bisexual and transgender persons and young women. However, little is known about the determinants and acceptability of HIVST among these groups in SSA. Therefore, this scoping review aims to explore the determinants and acceptability of HIVST among vulnerable groups in SSA. METHODS: A scoping review will be conducted using the Arksey and O'Malley framework and further refined by Levac framework. The review will follow a six-step approach: (1) identifying the research question, (2) identifying relevant studies, (3) study selection eligibility, (4) charting the data, (5) collating, summarising and reporting the results and (6) consultation. A comprehensive search strategy will be developed, and the following electronic databases will be searched: MEDLINE, Embase, Global Health and the Cochrane Library. Grey literature will also be searched, including conference abstracts and reports. Eligibility criteria will include studies conducted in SSA, published between 2010 and 2023, focusing on vulnerable groups and exploring the determinants and acceptability of HIVST. Two independent reviewers will screen identified studies' titles, abstracts and full texts. Any disagreements will be resolved through discussion or consultation with a third reviewer. Data extraction will be conducted using a standardised form. ETHICS AND DISSEMINATION: This review, not requiring ethical approval, aims to inform policy and intervention design to boost HIV testing adoption within vulnerable communities. We plan to disseminate our findings via a peer-reviewed journal, policy briefs, conference presentations and stakeholder engagement.

Village health team-delivered oral HIV self-testing increases linkage-to-care and antiretroviral-therapy initiation among men in Uganda.

Targeted strategies are central to increasing HIV-status awareness and progress on the care cascade among men. We implemented Village-Health-Team (VHT)-delivered HIV self-testing (HIVST) among men in a peri-urban Ugandan district and assessed linkage to confirmatory-testing, antiretroviral-therapy (ART) initiation and HIV-status disclosure following HIVST. We conducted a prospective cohort study from November 2018 to June 2019 and enrolled 1628 men from 30-villages of Mpigi district. VHTs offered each participant one HIVST-kit and a linkage-to-care information leaflet. At baseline, we collected data on demographics, testing history and risk behavior. At one-month, we measured linkage to confirmatory-testing and HIV-status disclosure, and at three months ART-initiation if tested HIV-positive. We used Poisson regression generalized estimating equations to evaluate predictors of confirmatory-testing. We found that 19.8% had never tested for HIV and 43% had not tested in the last 12-months. After receiving HIVST-kits, 98.5% self-reported HIVST-uptake in 10-days, 78.8% obtained facility-based confirmation in 30-days of HIVST with 3.9% tested HIV-positive. Of the positives, 78.8% were newly diagnosed, 88% initiated ART and 57% disclosed their HIV-status to significant others. Confirmatory testing was associated with having a higher level of education and knowing a partner's HIV-status. VHT-delivered HIVST may be effective for boosting testing, ART-initiation and HIV-status disclosure among men.

Facility HIV Self-Testing in Outpatient Departments: An Assessment of Characteristics and Concerns of Outpatients Who Opt Out of Testing in Malawi.

BACKGROUND: Facility HIV self-testing (HIVST) in outpatient departments can dramatically increase testing among adult outpatients. However, it is still unclear why populations opt out of facility HIVST and reasons for opt outing. Using data from a parent facility HIVST trial, we sought to understand individual characteristics associated with opting out of facility HIVST and reported reasons for not testing. METHODS: Exit surveys were conducted with outpatients aged ≥15 years at 5 facilities in Central and Southern Malawi randomized to the facility HIVST arm of the parent trial. Outpatients were eligible for our substudy if they were offered HIVST and eligible for HIV testing (ie, never previously tested HIV positive and tested ≥12 months ago or never tested). Summary statistics and multivariate regression models were used. RESULTS: Seven hundred seventy-one outpatients were included in the substudy. Two hundred sixty-three (34%) opted out of HIVST. Urban residency (adjusted risk ratios [aRR] 3.48; 95% CI: 1.56 to 7.76) and self-reported poor health (aRR 1.86; 95% CI: 1.27 to 2.72) were associated with an increased risk of opting out. Male participants had a 69% higher risk of opting out (aRR 1.69; 95% CI: 1.14 to 2.51), with risk being 38% lower among working male participants. Primary reasons for not testing were feeling unprepared to test (49·4%) and perceived low risk of HIV infection (30·4%)-only 2.6% believed that HIVST instructions were unclear, and 1.7% were concerned about privacy. CONCLUSION: Working, risky sexual behavior, rural residence, and good self-rated health were positively associated with opting out of HIVST among outpatients. Strategies to address internalized barriers, such as preparedness to test and perceived need to test, should be incorporated into facility HIVST interventions.

Efectos de un curso universitario de extensión sobre habilidades sociales de adolescentes / Efeitos de um curso universitário de extensão sobre habilidades sociais de adolescentes / Effects of a university extension course on adolescent's social skills

As habilidades sociais têm importante papel na vida escolar e profissional. Este estudo, de natureza descritiva e correlacional, analisa os efeitos de um Curso de extensão intitulado "Imersão na Universidade: você protagonista do seu futuro", sobre as habilidades sociais de estudantes do Ensino Médio da rede pública. Para tanto, aplicou-se o Inventário de Habilidades Sociais em Adolescentes (IHSA-DelPrette) no momento inicial e três meses após o término do curso, considerando dois indicadores: (1) frequência e (2) dificuldade com que reagiam às diferentes demandas de interação social. Verificou-se diferença estatisticamente significante entre os escores pré e pós intervenção (p = 0,014), evidenciando aumento da frequência das habilidades. Para a dificuldade não foi observada diferença significante, embora tenha ocorrido uma diminuição de 13,45%. A universidade pode ser um espaço não apenas para capacitação analítica e instrumental, mas para o desenvolvimento interpessoal tanto da comunidade interna quanto externa.

Las habilidades sociales poseen importante papel en la vida escolar y profesional. En este estudio, de naturaleza descriptiva y correlacional, se analiza los efectos de un Curso de extensión intitulado "Inmersión en la Universidad: usted es protagonista de su futuro", sobre las habilidades sociales de estudiantes de la enseñanza secundaria de la red pública. Para tanto, se aplicó el Inventario de Habilidades Sociales en Adolescentes (IHSA-DelPrette) en el momento inicial y tres meses tras el término del curso, considerando dos indicadores: (1) frecuencia y (2) dificultad con que reaccionaran a las diferentes demandas de interacción social. Se verificó diferencia estadísticamente significante entre los escores pre y tras intervención (p = 0,014), evidenciando aumento de la frecuencia de las habilidades. Para la dificultad no se observó diferencia significante, aunque haya sucedido una disminución del 13,45%. La universidad puede ser un espacio no solo para capacitación analítica e instrumental, pero también para el desarrollo interpersonal de la comunidad interna y externa.

Social skills play an important role in school and professional life. This descriptive and correlational study analyzes the effects of an extension course entitled "Immersion in the University: you are the protagonist of your future", about the social skills of High School students in public schools. To this end, the Inventory of Social Skills in Adolescents (IHSA-DelPrette) was applied at the beginning and three months after the end of the course, considering two indicators: (1) assiduity and (2) difficulties they had when handling the different demands of social interaction. There was a statistically significant difference between the pre and post intervention scores (p = 0.014), showing an increase in the frequency of skills. For difficulty, no significant difference was observed, although there was a decrease of 13.45%. The university can be a space not only for analytical and instrumental training, but for the interpersonal development of both the internal and external community.

"Black Women Don't Always Put Our Healthcare First": Facilitators and Barriers to Cervical Cancer Screening and Perceptions of Human Papillomavirus Self-Testing Among Church-Affiliated African American Women.

Background: African American women are at greater risk for cervical cancer incidence and mortality than White women. Up to 90% of cervical cancers are caused by human papillomavirus (HPVs) infections. The National Institutes of Health (NIH) co-developed HPV self-test kits to increase access to screening, which may be critical for underserved populations. Purpose/Research Design: This mixed methods study used the Theory of Planned Behavior to examine attitudes, barriers, facilitators, and intentions related to receipt of cervical cancer screening and perceptions of HPV self-testing among church-affiliated African American women. Study Sample/Data Collection: Participants (N = 35) aged 25-53 participated in focus groups and completed a survey. Results: Seventy-four percent of participants reported receipt of cervical cancer screening in the past 3 years. Healthcare providers and the church were supportive referents of screening. Past trauma and prioritizing children's healthcare needs were screening barriers. Concerns about HPV self-testing included proper test administration and result accuracy. Conclusions: Strategies to mitigate these concerns (e.g., delivering HPV self-test kits to the health department) are discussed.