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HIV self-testing (HIVST) may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs) in Zambia. Trained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator-FSW groups were randomized to 1 of 3 arms: (1) delivery (direct distribution of an oral HIVST from the peer educator), (2) coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy), or (3) standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320); 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99-1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86-1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04-1.22, P = 0.005). Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98-1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92-1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94-1.18, P = 0.40). At 1 month, the majority of HIV tests were self-tests (88.4%). HIV self-test use was higher in the delivery arm compared to the coupon arm (RR = 1.14, 95% CI 1.05-1.23, P = 0.001) at 1 month, but there was no difference at 4 months. Among participants reporting a positive HIV test at 1 (N = 144) and 4 months (N = 235), linkage to care was non-significantly lower in the 2 HIVST arms compared to the standard-of-care arm. There were 4 instances of intimate partner violence related to study participation, 3 of which were related to HIV self-test use. Limitations include the self-reported nature of study outcomes and overall high uptake of HIV testing. In this study among FSWs in Zambia, we found that HIVST was acceptable and accessible. However, HIVST may not substantially increase HIV cascade progression in contexts where overall testing and linkage are already high. ClinicalTrials.gov NCT02827240.

Novel intervention strategies have been developed to expand access and reach of HIV testing services, including assisted partner notification systems, community-based testing, and more recently HIV self-testing (HIVST) [2]. Additionally, using HIVST as a catalyst for engagement in HIV prevention and STI diagnosis interventions might result in the greatest benefits and smallest risks. Because oral fluid self-tests are significantly less sensitive than other tests during early HIV infection, some mathematical models caution that replacement of blood-based facility HIV testing with oral-fluid self-testing may increase HIV prevalence among MSM [6]. HIVST to increase self-efficacy and support mental health outcomes Evidence suggests that access to HIVST can have mental health benefits. While this should remain an important goal of HIVST programs, we should also capitalize on the unique characteristics of this testing technology (e.g., privacy, mobility) and utilize HIVST in ways that facilitate linkage to HIV prevention interventions, support health systems, and improve mental health outcomes.

Tuberculosis transmission and progression are largely driven by social factors such as poor living conditions and poor nutrition. Increased standards of living and social approaches helped to decrease the burden of tuberculosis before the introduction of chemotherapy in the 1940s. Since then, management of tuberculosis has been largely biomedical. More funding for tuberculosis since 2000, coinciding with the Millennium Development Goals, has yielded progress in tuberculosis mortality but smaller reductions in incidence, which continues to pose a risk to sustainable development, especially in poor and susceptible populations. These at-risk populations need accelerated progress to end tuberculosis as resolved by the World Health Assembly in 2015. Effectively addressing the worldwide tuberculosis burden will need not only enhancement of biomedical approaches but also rebuilding of the social approaches of the past. To combine a biosocial approach, underpinned by social, economic, and environmental actions, with new treatments, new diagnostics, and universal health coverage, will need multisectoral coordination and action involving the health and other governmental sectors, as well as participation of the civil society, and especially the poor and susceptible populations. A biosocial approach to stopping tuberculosis will not only target morbidity and mortality from disease but would also contribute substantially to poverty alleviation and sustainable development that promises to meet the needs of the present, especially the poor, and provide them and subsequent generations an opportunity for a better future.

Background Cost remains an important barrier to HIV pre-exposure prophlyaxis (PrEP) delivery in Africa. Simplified delivery models that reduce costs without compromising PrEP outcomes are needed. The JiPime-JiPrEP trial tested a model of six-month PrEP dispensing supported with interim HIV self-testing (HIVST) and found non-inferior HIV testing, PrEP refilling, and adherence compared to three-month PrEP dispensing and quarterly clinic visits, the standard-of-care (SOC). We estimated the cost of this novel differentiated PrEP delivery model compared to SOC in Kenya. Methods Using activity-based micro-costing (payer perspective) and time-and-motion observations, we estimated the cost of PrEP delivery (per client-month) in the intervention and SOC between May 2018 to December 2019. Data from budgets and expense reports, published documents, and interviews informed our estimates. We calculated costs over a one-year horizon for: 1) the trial scenario (i.e., costs within the trial), and 2) the Ministy of Health (MOH) scenario (i.e., hypothetical costs at public clinics). Estimates were in 2019 US dollars and excluded research-related costs. Results The mean personnel time attributable to PrEP delivery was 76 minutes per visit and 152 minutes projected over a year in the intervention and 54 minutes per visit and 282 minutes per year in the SOC. In the trial scenario, PrEP delivery cost $17.73 per client-month in the intervention (n=2039 PrEP-months) and $25.50 in the SOC (n=913 PrEP-months). The projected cost of PrEP delivery in the MOH scenario was $11.94 in the intervention and $14.76 in the SOC, with the addition of HIVST kits in the intervention more than offset by personnel savings. In this scenario, personnel (intervention: 55%; SOC: 44%) and medication (intervention: 16%; SOC: 32%) were the primary cost drivers. Including serum creatine testing twice a year in the MOH scenario resulted in a slight increase in the cost of PrEP delivery in the intervention ($12.88 per client-month) versus SOC ($16.17 per client-month). Conclusions Six-month PrEP with interim HIVST demonstrated lower costs than three-month dispensing, with decreased personnel time. Scale-up of PrEP delivery requires efficient use of limited resources; the savings in this model of PrEP delivery could be redirected towards currently unmet medical needs. Clinial trial number NCT03593629|| https://www.clinicaltrials.gov/ with the Clinical Trial Registry (Registration date: 2018-07-20).

Introduction New longer‐acting antiretroviral (ARV) drugs—that is single doses with antiviral activity for at least a month—are being utilized for HIV treatment and pre‐exposure prophylaxis (PrEP) but have not been explored for post‐exposure prophylaxis (PEP). A “one‐and‐done” simplification of PEP has the potential to serve the HIV prevention needs of individuals not being met with traditional services and expand overall biomedical HIV prevention coverage. We discuss challenges with the assessment of PEP effectiveness in human trials and potential study designs that could generate evidence needed to inform the use of new, single‐administered, long‐acting ARVs for PEP. Discussion Challenges with determining the effectiveness of new long‐acting PEP agents in human trials include the low likelihood of observing an HIV acquisition and the short period for outcome assessment (likely 1 month) following PEP administration. Additional challenges include recruiting individuals in the brief window in which they could benefit (<72 hours of a potential HIV exposure) and ethics of conducting informed consent during a period of high stress/vulnerability. Consequently, design approaches where the efficacy goal is to establish that the HIV incidence rate following PEP administration (of the standard or a novel agent) approaches zero should be considered. HIV RNA testing conducted within 5 days of a potential exposure could define prevention per exposure. Novel recruitment venues—such as community‐based retail or online pharmacies—could be used to reach individuals after a potential exposure. Potential study designs include one‐ or two‐arm individual‐level product assignment aimed at demonstration of short‐course efficacy or longer‐term effectiveness compared to a background rate; cluster‐randomized controlled trials of recruitment venues; and novel individual‐level approaches that either do not or do utilize randomization in combination with choice, enabling assessment of preferences and effectiveness. Conclusions Over the past decade, multiple new HIV PrEP products—but no new PEP products—have been developed to meet the diverse needs of individuals seeking HIV prevention services. Challenges exist with generating PEP effectiveness evidence, but they are not insurmountable. Effectiveness research on new PEP products could advance the number of HIV prevention options available.

Background HIV pre- and post-exposure prophylaxis (PrEP/PEP) provision via online pharmacies could expand reach of HIV prevention in Eastern and Southern Africa, but designing sustainable delivery models will require assessing the amount potential users are willing to pay for online PrEP/PEP provision. Methods We administered willingness to pay (WTP) questionnaires to both potential online PrEP users and current online PrEP/PEP users in Nairobi, Kenya using a stated preference approach to measure the amount participants were willing to pay for PrEP/PEP service delivery components. Participants ≥ 18 years were recruited via banner ads on an online pharmacy website on pages displaying sexual health products. We used multivariable gamma regression models to assess characteristics associated with differences in mean WTP for a 30-day PrEP or 28-day PEP course (including HIV self-testing, remote clinical consultation, drugs, and delivery fees). Results From May 2022 and December 2023, 1,512 participants completed WTP questionnaires: 772 potential online PrEP users and 740 current online PrEP/PEP users. Most participants (98.3%, 1486/1,512) were willing to pay some amount for online PrEP services. For a one-month PrEP supply, potential online PrEP users were willing to pay 1388 KSH ($11.77 USD) and current online PrEP/PEP users were willing to pay 1271.2 KSH ($10.77 USD) on average. Most current online PrEP/PEP users (81.4%, 602/740) were also willing to pay for online PEP services; for a 28-day PEP supply, they were willing to pay 812.9 KSH ($6.89 USD) on average. Among potential online PrEP users, male sex, current enrollment in school, high income, and a history of online pharmacy purchases were associated with higher WTP for PrEP. Among current online PrEP/PEP users, higher income and prior online pharmacy purchases were associated with higher WTP for PrEP, and older age (> 24) and prior online pharmacy purchases were associated with higher WTP for PEP. Conclusion Most potential and current online PrEP/PEP users in Nairobi were willing to pay for online pharmacy-based PrEP/PEP and demonstrated similar WTP. Providing PrEP/PEP through online pharmacies may sustainably expand coverage of these HIV prevention services.

Background Private pharmacies are a primary access point for health services in many African countries. Leveraging private-sector pharmacies to deliver HIV prevention services, including pre- and post-exposure prophylaxis (PrEP/PEP), may expand the reach of these services. Understanding delivery costs is necessary to inform scale-up. Methods We used data from two pilot studies conducted in Kisumu County, Kenya. In the first pilot, pharmacy providers at 12 pharmacies delivered free PrEP/PEP to eligible clients (≥ 18 years) using a prescribing checklist with remote clinician oversight; PrEP/PEP drugs were donated from government stock. Using microcosting, we estimated the economic and financial costs from the provider’s perspective for: (1) subsidized delivery (donated commodities excluded), and (2) non-subsidized delivery (donated commodities included). We also assessed client willingness to pay for PrEP services at pharmacies using PrEP client survey data. In the second pilot, pharmacy providers at 20 pharmacies delivered HIV testing services. We assessed providers’ anticipated willingness to deliver PrEP services using provider survey data. Result From February to July 2022, pharmacies in the first pilot recorded 1,564 PrEP/PEP visits, and initiated 691 clients on PrEP. Among clients eligible to continue PrEP at the pharmacy, 69% (479/691) refilled at least once. We collected 694 surveys from PrEP clients. From March to June 2022, 40 providers in the second pilot completed surveys. The estimated economic (financial) costs per client-month on PrEP were $3.66 ($2.17) USD for subsidized and $13.23 ($11.74) USD for non-subsidized delivery, and for PEP were $3.66 ($2.15) USD for subsidized and $10.75 ($9.24) USD for non-subsidized delivery. Most PrEP clients (83%, 575/691) expressed willingness to pay for pharmacy-delivered PrEP services; the median amount they were willing to pay per visit was $3.30 USD (IQR $1.60-$4.10 USD), which exceeded the median maximum amount providers said they would charge per visit ($2.40 USD, IQR $1.60-$4.10 USD). Conclusions When subsidized with drugs from government stock, pharmacies are a low-cost platform for delivering PrEP and PEP services in Kenya. Client out-of-pocket payments could help sustain pharmacy PrEP/PEP delivery at scale, enabling broader coverage of HIV prevention services.

Background In Africa, dispensing oral HIV pre-exposure prophylaxis (PrEP) within already strained public health facilities has led to prolonged waiting periods and suboptimal experiences for clients. We sought to explore the acceptability of dispensing PrEP semiannually with interim HIV self-testing (HIVST) versus quarterly PrEP dispensing with clinic-based HIV testing to optimize clinic-delivered PrEP services. Methods We conducted a qualitative study within a non-inferiority individual-level randomized controlled trial testing the effect of six-monthly PrEP dispensing with HIVST compared to the standard-of-care three-monthly PrEP dispensing on PrEP clinical outcomes in Kenya (ClinicalTrials.gov: NCT03593629). Eligible participants were ≥ 18 years, refilling PrEP for the first time, and either in an HIV serodifferent relationship (men and women) or singly enrolled (women only). A subset of participants in the intervention group completed serial in-depth interviews (IDIs) at enrollment, six months, and 12 months. We utilized stratified purposive sampling to ensure representation across participant groups. We analyzed our qualitative data thematically using a combination of inductive and deductive approaches, the latter guided by the Theoretical Framework of Acceptability (TFA). Results Between May 2018 and June 2021, we conducted 120 serial IDIs with 55 participants; 64% (35/55) were in a serodifferent relationship, 64% (35/55) were women, and the median age was 32 years (IQR 27–40). Overall, participants found this novel PrEP delivery model highly acceptable; it was well-liked, private (TFA construct: affective attitude), and less burdensome (TFA construct: burden) compared to standard PrEP delivery. Additionally, participants were confident in their ability to participate in the intervention (TFA construct: self-efficacy). Some participants, however, highlighted model disadvantages, including fewer opportunities for in-person counseling and potentially less accurate HIV testing (TFA construct: opportunity costs). Ultimately, most participants reported that the intervention allowed them to achieve their HIV prevention goals (TFA construct: perceived effectiveness) and that their confidence in at-home HIVST and PrEP continuation increased following each semiannual clinic visit. Conclusions Semiannual PrEP clinic visits supported with six-monthly drug dispensing and interim HIVST was acceptable among PrEP users who experienced the intervention in Kenya. More comprehensive pre-intervention counseling and training on HIVST may help alleviate the client concerns presented, which were often resolved over time with intervention experience.

Introduction In Kenya, pre-exposure prophylaxis (PrEP) for HIV prevention is almost exclusively delivered at HIV clinics. Developing novel PrEP delivery models is important for increasing the reach of PrEP. Delivery of PrEP through pharmacies is one approach utilized in the US to improve accessibility. Retail pharmacies are commonly used as a first-line access point for medical care in Kenya, but have not been utilized for PrEP delivery. We conducted a collaborative consultative meeting of stakeholders to develop a care pathway for pharmacy-based PrEP delivery in Kenya. Methods In January 2020, we held a one-day meeting in Nairobi with 36 stakeholders from PrEP regulatory, professional, healthcare service delivery, civil society, and research organizations. Attendees reviewed a theory of change model, results from formative qualitative research with pharmacy providers and clients, and anticipated core components of pharmacy-based PrEP delivery: counseling, HIV testing, prescribing, and dispensing. Stakeholders participated in small and large group discussions to identify potential challenges and solutions. We synthesized the key findings from these discussions. Results Stakeholders were enthusiastic about a model for pharmacy-based PrEP delivery. Potential challenges identified included insufficient pharmacy provider knowledge and skills, regulatory hurdles to providing affordable HIV testing at pharmacies, and undefined pathways for PrEP procurement. Potential solutions identified included having pharmacy providers complete the Kenya Ministry of Health-approved PrEP training, use of a PrEP prescribing checklist with remote clinician oversight and provider-assisted HIV self-testing, and having the government provide PrEP and HIV self-testing kits to pharmacies during a pilot test. A care pathway was developed over the course of the meeting. Conclusions PrEP delivery stakeholders in Kenya were strongly supportive of developing and testing a model for pharmacy-based PrEP delivery to increase PrEP access. We collaboratively developed a care pathway for pilot testing that has the potential to expand PrEP delivery options in Kenya and other similar settings.

Introduction The delivery of daily, oral HIV pre‐exposure prophylaxis (PrEP) at private pharmacies may overcome barriers to PrEP delivery at public healthcare facilities, including HIV‐associated stigma, long wait times and overcrowding. Methods At five private, community‐based pharmacies in Kenya, a care pathway for PrEP delivery (ClinicalTrials.gov: NCT04558554) was piloted—the first of its kind in Africa. Pharmacy providers screened clients interested in PrEP for HIV risk, then used a prescribing checklist to identify clients without medical conditions that might contraindicate PrEP safety, counsel them on PrEP use and safety, conduct provider‐assisted HIV self‐testing and dispense PrEP. For complex clinical cases, a remote clinician was available for consultation. Clients who did not meet the checklist criteria were referred to public facilities for free services delivered by clinicians. Pharmacy providers dispensed a 1‐month PrEP supply at initiation and a 3‐month supply thereafter at a client fee of 300 KES (∼$3 USD) per visit. Results From November 2020 to October 2021, pharmacy providers screened 575 clients, identified 476 who met the prescribing checklist criteria and initiated 287 (60%) on PrEP. Among pharmacy PrEP clients, the median age was 26 years (IQR 22–33) and 57% (163/287) were male. The prevalence of behaviours associated with HIV risk among clients was high; 84% (240/287) reported sexual partners with unknown HIV status and 53% (151/287) reported multiple sexual partners (past 6 months). PrEP continuation among clients was 53% (153/287) at 1 month, 36% (103/287) at 4 months and 21% (51/242) at 7 months. During the pilot observation period, 21% (61/287) of clients stopped and restarted PrEP and overall pill coverage was 40% (IQR 10%–70%). Nearly, all pharmacy PrEP clients (≥96%) agreed or strongly agreed with statements regarding the acceptability and appropriateness of pharmacy‐delivered PrEP services. Conclusions Findings from this pilot suggest that populations at HIV risk frequently visit private pharmacies and PrEP initiation and continuation at pharmacies is similar to or exceeds that at public healthcare facilities. Private pharmacy‐based PrEP delivery, conducted entirely by private‐sector pharmacy staff, is a promising new delivery model that has the potential to expand PrEP reach in Kenya and similar settings.