Getting HIV Pre-exposure Prophylaxis (PrEP) into Private Pharmacies: Global Delivery Models and Research Directions.

PURPOSE OF REVIEW: To provide an overview of the current state of HIV pre-exposure prophylaxis (PrEP) delivery via private sector pharmacies globally, to discuss the context-specific factors that have influenced the design and implementation of different pharmacy-based PrEP delivery models in three example settings, and to identify future research directions. RECENT FINDINGS: Multiple high- and low-income countries are implementing or pilot testing PrEP delivery via private pharmacies using a variety of delivery models, tailored to the context. Current evidence indicates that pharmacy-based PrEP services are in demand and generally acceptable to clients and pharmacy providers. Additionally, the evidence suggests that with proper training and oversight, pharmacy providers are capable of safely initiating and managing clients on PrEP. The delivery of PrEP services at private pharmacies also achieves similar levels of PrEP initiation and continuation as traditional health clinics, but additionally reach individuals underserved by such clinics (e.g., young men; minorities), making pharmacies well-positioned to increase overall PrEP coverage. Implementation of pharmacy-based PrEP services will look different in each context and depend not only on the state of the private pharmacy sector, but also on the extent to which key needs related to governance, financing, and regulation are addressed. Private pharmacies are a promising delivery channel for PrEP in diverse settings. Countries with robust private pharmacy sectors and populations at HIV risk should focus on aligning key areas related to governance, financing, and regulation that have proven critical to pharmacy-based PrEP delivery while pursuing an ambitious research agenda to generate information for decision-making. Additionally, the nascency of pharmacy-based PrEP delivery in both high- and low-and-middle-income settings presents a prime opportunity for shared learning and innovation.

Low selection of HIV PrEP refills at private pharmacies among clients who initiated PrEP at public clinics: findings from a mixed-methods study in Kenya.

BACKGROUND: In Africa, the delivery of HIV pre-exposure prophylaxis (PrEP) at public healthcare clinics is challenged by understaffing, overcrowding, and HIV-associated stigma, often resulting in low PrEP uptake and continuation among clients. Giving clients the option to refill PrEP at nearby private pharmacies, which are often more convenient and have shorter wait times, may address these challenges and improve PrEP continuation. METHODS: This mixed methods study used an explanatory sequential design. At two public clinics in Kiambu County, Kenya, clients ≥ 18 years initiating PrEP were given the option to refill PrEP at the clinic where they initiated for free or at one of three nearby private pharmacies for 300 Kenyan Shillings (~ $3 US Dollars). The providers at these pharmacies (pharmacists and pharmaceutical technologists) were trained in PrEP service delivery using a prescribing checklist and provider-assisted HIV self-testing, both with remote clinician oversight. Clients were followed up to seven months, with scheduled refill visits at one, four, and seven months. The primary outcomes were selection of pharmacy-based PrEP refills and PrEP continuation. Following pilot completion, 15 in-depth interviews (IDIs) with clients who refilled PrEP were completed. We used descriptive statistics and thematic analysis to assess study outcomes. RESULTS: From November 2020 to November 2021, 125 PrEP clients were screened and 106 enrolled. The majority (59%, 63/106) of clients were women and the median age was 31 years (IQR 26-38 years). Over 292 client-months of follow-up, 41 clients (39%) refilled PrEP; only three (3%) at a participating pharmacy. All clients who completed IDIs refilled PrEP at clinics. The reasons why clients did not refill PrEP at pharmacies included: a preference for clinic-delivered PrEP services (i.e., pre-existing relationships, access to other services), concerns about pharmacy-delivered PrEP services (i.e., mistrust, lower quality care, costs), and lack of knowledge of this refill location. CONCLUSIONS: These findings suggest that clients who initiate PrEP at public clinics in Kenya may have already overcome barriers to clinic-delivered PrEP services and prefer PrEP access there. To reach new populations that could benefit from PrEP, a stand-alone model of pharmacy-delivered PrEP services may be needed. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04558554 [registered: June 5, 2020].

Acceptability of six-monthly PrEP dispensing supported with interim HIV self-testing to simplify PrEP delivery in Kenya: findings from qualitative research.

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.

Acceptability Assessment in HIV Prevention and Treatment Intervention and Service Delivery Research: A Systematic Review and Qualitative Analysis.

We reviewed the literature on the assessment of acceptability of HIV prevention and treatment interventions and service delivery strategies. Following PRISMA guidelines, we screened 601 studies published from 2015 to 2020 and included 217 in our review. Of 384 excluded studies, 21% were excluded because they relied on retention as the sole acceptability indicator. Of 217 included studies, only 16% were rated at our highest tier of methodological rigor. Operational definitions of acceptability varied widely and failed to comprehensively represent the suggested constructs in current acceptability frameworks. Overall, 25 studies used formal quantitative assessments (including four adapted measures used in prior studies) and six incorporated frameworks of acceptability. Findings suggest acceptability assessment in recent HIV intervention and service delivery research lacks harmonization and rigor. We offer guidelines for best practices and future research, which are timely and critical in this era of informed choice and novel options for HIV prevention and treatment.

Examining the Use of HIV Self-Testing to Support PrEP Delivery: a Systematic Literature Review.

PURPOSE OF REVIEW: HIV self-testing (HIVST) has the potential to expand access to and uptake of HIV pre-exposure prophylaxis (PrEP) delivery. We conducted a systematic literature review to understand the evidence on HIVST use for PrEP delivery. RECENT FINDINGS: After screening 1055 records, we included eight: three randomized trials and five values and preferences studies. None measured PrEP initiation. Most studies occurred in Sub-Saharan Africa (7/8) and included different populations. One trial found that HIVST use between quarterly clinic visits as part of an adherence package with biofeedback slightly increased adherence; the other two trials found that HIVST use between or in lieu of quarterly clinic visits had no significant or non-inferior effects on adherence. HIVST to support PrEP delivery was acceptable, feasible, and preferred. HIVST use for PrEP continuation largely resulted in similar outcomes to standard-of-care delivery and was perceived acceptable and feasible. Further research is needed to optimize HIVST use within PrEP programming.

Using routine programmatic data to measure HIV incidence among pregnant women in Botswana.

INTRODUCTION: Pregnant women in sub-Saharan Africa have high risk of HIV acquisition, yet approaches for measuring maternal HIV incidence using routine surveillance systems are undefined. We used programmatic data from routine antenatal care (ANC) HIV testing in Botswana to measure real-world HIV incidence during pregnancy. METHODS: From January 2018 to September 2019, the Botswana Ministry of Health and Wellness implemented an HIV testing program at 139 ANC clinics. The program captured information on testers' age, testing date and result, and antiretroviral treatment (ART) initiation. In our analysis, we excluded individuals who previously tested HIV-positive prior to their first ANC visit. We defined incident HIV infection as testing HIV-positive at an ANC visit after a prior HIV-negative result within ANC. RESULTS: Overall, 29,570 pregnant women (median age 26 years, IQR 22-31) tested for HIV at ANC clinics: 3% (836) tested HIV-positive at their first recorded ANC visit and 97% tested HIV-negative (28,734). Of those who tested HIV-negative, 28% (7940/28,734) had a repeat HIV test recorded at ANC. The median time to HIV re-testing was 92 days (IQR 70-112). In total, 17 previously undiagnosed HIV infections were detected (HIV incidence 8 per 1000 person-years, 95% CI 0.5-1.3). ART initiation among women newly diagnosed with HIV at ANC (853) was 88% (671/762). CONCLUSIONS: In Botswana, real-world HIV incidence among pregnant women at ANC remains above levels of HIV epidemic control (≤ 1 per 1000 person-years). This study shows how HIV programmatic data can answer timely population-level epidemiological questions and inform ongoing implementation of HIV prevention and treatment programs.

Understanding how social support influences peer-delivered HIV prevention interventions among Ugandan female sex workers: a case study from HIV self-testing.

BACKGROUND: Female sex workers (FSWs) have tightly connected peer networks and remain at high risk of HIV acquisition. Peer delivery of HIV prevention interventions, such as HIV self-testing (HIVST), is a recommended implementation strategy for increasing intervention uptake and continuation among FSWs. We analyzed qualitative data from a peer-delivered HIVST intervention among FSWs in urban Uganda to understand the ways social support within this peer network can motivate or discourage the uptake of peer-delivered HIVST. METHODS: Between February and April 2017, we conducted in-depth interviews (IDIs) with FSWs (n = 30) and focus group discussions (FGDs) with FSW peer educators (PEs, n = 5) finishing participation in a four-month randomized implementation trial testing models of peer-delivered HIVST in Kampala. FSW participants were ≥ 18 years old, self-reported exchanging sex for money or goods (past month) and had not recently tested for HIV (past 3 months). FSW PEs either directly distributed HIVST kits to participants or provided coupons exchangeable for HIVST kits from specified healthcare facilities. In the IDIs and FGDs, we asked participants to share their experiences receiving or delivering peer-delivered HIVST, respectively. Using a hybrid deductive and inductive coding approach, we arranged findings along the dimensions of an established social support theory: informational, instrumental, and emotional support. RESULTS: The median age of participants was 30 years (IQR: 27-33) and PEs was 33 years (IQR: 29-37). We found that social support within FSW peer networks both motivated and discouraged uptake of peer-delivered HIVST. For example, sharing positive HIVST experiences (informational support), directly delivering HIVST kits (instrumental support), and encouraging linkage to care (emotional support) motivated HIVST uptake among FSWs. Conversely, the spread of misinformation (informational support), limited HIVST kit availability fostering mistrust of PEs (instrumental support), and fear of social exclusion following HIV status disclosure (emotional support) discouraged HIVST uptake among FSWs. CONCLUSIONS: In Uganda, social support (e.g., informational, instrumental, and emotional support) among FSW peers can work in ways that both motivate and discourage peer-delivered intervention uptake. Future FSW peer-delivered HIV prevention interventions should be designed around the dimensions of social support within FSW peer networks to maximize initial and repeat intervention delivery and uptake.

Frequent Detection of Undiagnosed HIV Within Emergency Departments in Botswana.

ABSTRACT: Among 130,161 HIV testing records from unique individuals at 149 programmatic sites in Botswana, frequency of detecting undiagnosed HIV infection within emergency departments (EDs) was 4.7% (455/9695), 2-fold higher than other clinic-based HIV counseling and testing. Men and noncitizens less frequently initiated same-day antiretroviral therapy after testing HIV positive within emergency departments.

Acceptability and Feasibility of Pharmacy-Based Delivery of Pre-Exposure Prophylaxis in Kenya: A Qualitative Study of Client and Provider Perspectives.

As countries scale up pre-exposure prophylaxis (PrEP) for HIV prevention, diverse PrEP delivery models are needed to expand access to populations at HIV risk that are unwilling or unable to access clinic-based PrEP care. To identify factors that may influence implementation of retail pharmacy-based PrEP delivery in Kenya, we conducted in-depth interviews with 40 pharmacy clients, 16 pharmacy providers, 16 PrEP clients, and 10 PrEP providers from two provinces. Most participants expressed strong support for expanding PrEP to retail pharmacies, though conditioned their acceptance on assurances that care would be private, respectful, safe, and affordable. Participant-reported determinants of feasibility centered primarily on ensuring that the intervention is compatible with retail pharmacy operations (e.g., staffing levels, documentation requirements). Future research is needed to develop and test tailored packages of implementation strategies that are most effective at integrating PrEP delivery into routine pharmacy practice in Kenya and other high HIV prevalence settings.

RESUMEN: Ya que varios países están ampliando sus programas de profilaxis previa a la exposición al VIH (PrEP, por sus siglas en inglés), se necesitan modelos diversos para ampliar el acceso a poblaciones que no están dispuestos a acceder, o que no pueden acceder, a los servicios de PrEP que se ofrecen en las instalaciones de salud. Para identificar los factores que pueden influir en la prestación de servicios de PrEP a través de farmacias privadas, realizamos entrevistas en profundidad con 40 clientes de farmacia, 16 proveedores de servicios de farmacia, 16 usuarios de PrEP, y 10 proveedores de PrEP. La mayoría de los participantes manifestó su firme apoyo a la propuesta de expandir la provisión de PrEP a las farmacias privadas, aunque condicionó su aceptación a la garantía de que la atención sea privada, respetuosa, segura, y asequible. Según los participantes, los factores determinantes de la viabilidad de ofrecer PrEP en las farmacias privadas se centran en asegurar de que la intervención sea compatible con las operaciones de las farmacias privadas (p. ej., el número de personal, los requisitos de documentación). Se necesitan investigaciones adicionales para desarrollar y evaluar diferentes paquetes de estrategias de implementación para descubrir cuáles son los más eficaces para integrar los servicios de PrEP en la prestación rutinaria de servicios de farmacia tanto en Kenia como en otros lugares de alta prevalencia del VIH.

Unintended uses, meanings, and consequences: HIV self-testing among female sex workers in urban Uganda.

ABSTRACTFemale sex workers (FSWs) are at increased risk of HIV and face significant barriers to clinic-based HIV testing, including provider stigma and privacy constraints. HIV self-testing (HIVST) has been proven to significantly increase HIV testing among FSWs. Less is known, however, about how FSWs make meaning of oral-fluid HIV self-tests, and the unintended ways they use and understand this novel technology. From October 2016 to March 2017, we conducted 61 in-depth interviews with FSWs (n = 31) in Kampala, Uganda. Eligible participants were: female, ≥18 years, exchanged sex for money or goods, and had not recently tested for HIV. We used inductive coding to identify emerging themes and re-arranged these into an adapted framework. Unintended desirable ways FSWs described self-testing included as a means to test others, to bolster their reputation as a health-conscious sex worker, and to avoid bearing witness to suffering at health facilities. Unintended undesirable meanings ascribed to self-testing included misunderstandings about how HIV is transmitted (via saliva versus blood) and whether self-tests also test for other infections. HIVST can increase FSWs' knowledge of their own HIV status and that of their sexual partners, but messaging and intervention design must address misunderstandings and misuses of self-testing.Trial registration: ClinicalTrials.gov identifier: NCT02846402.

"But I Gathered My Courage": HIV Self-Testing as a Pathway of Empowerment Among Ugandan Female Sex Workers.

HIV self-testing (HIVST) increases HIV testing in diverse populations, but little is known about the experiences of individuals who self-test. We used a five-step framework approach to analyze 62 qualitative interviews with 33 female sex workers (FSWs) participating in an HIVST trial in urban Uganda. Notions of empowerment emerged from the data, and findings were interpreted based on Kabeer's empowerment framework of resources, agency, and achievements. We found that access to HIVST bolstered empowerment because it increased participant's time and money (resources), control of testing circumstances and status disclosure (agency), and sense of competency (achievements). In addition, we found that knowledge of HIV status empowered participants to better control HIV-related behaviors (agency) and recognize a new sense of self (achievements). This suggests that the availability of HIVST can facilitate feelings of empowerment, meriting a higher awareness for benefits outside of linkage to HIV treatment and prevention services.

No Evidence of Sexual Risk Compensation Following PrEP Initiation Among Heterosexual HIV Serodiscordant Couples in Kenya and Uganda.

Recent studies among men who have sex with men suggest that sexual behaviors associated with risk of sexually transmitted infections increase following initiation of pre-exposure prophylaxis (PrEP) for HIV prevention. We used longitudinal data from HIV-uninfected participants (n = 1013) enrolled in an open-label study of PrEP delivered to Ugandan and Kenyan heterosexual HIV serodiscordant couples to understand the association between PrEP initiation and HIV risk-related sexual behaviors among these couples. In the month following PrEP initiation, the mean number of monthly sex acts within couples decreased from 7.9 to 6.9 (mean difference: - 1.1; 95% CI - 1.5, - 0.7) and the proportion of couples having condomless sex decreased from 65% to 32% (percentage point change: - 33%; 95% CI - 37%, - 30%); these behaviors then remained relatively constant over 2 years. We found no evidence of sexual risk compensation following PrEP initiation within African serodiscordant couples. However, roughly a third of couples continued to engage in condomless sex during follow up, emphasizing the importance of continued PrEP use to sustain HIV protection.

Design of a care pathway for pharmacy-based PrEP delivery in Kenya: results from a collaborative stakeholder consultation.

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.

The influence of interviewers on survey responses among female sex workers in Zambia.

BACKGROUND: Interviewers can substantially affect self-reported data. This may be due to random variation in interviewers' ability to put respondents at ease or in how they frame questions. It may also be due to systematic differences such as social distance between interviewer and respondent (e.g., by age, gender, ethnicity) or different perceptions of what interviewers consider socially desirable responses. Exploration of such variation is limited, especially in stigmatized populations. METHODS: We analyzed data from a randomized controlled trial of HIV self-testing amongst 965 female sex workers (FSWs) in Zambian towns. In the trial, 16 interviewers were randomly assigned to respondents. We used hierarchical regression models to examine how interviewers may both affect responses on more and less sensitive topics, and confound associations between key risk factors and HIV self-test use. RESULTS: Model variance (ICC) at the interviewer level was over 15% for most topics. ICC was lower for socio-demographic and cognitively simple questions, and highest for sexual behaviour, substance use, violence and psychosocial wellbeing questions. Respondents reported significantly lower socioeconomic status and more sex-work related violence to female interviewers. Not accounting for interviewer identity in regressions predicting HIV self-test behaviour led to coefficients moving from non-significant to significant. CONCLUSIONS: We found substantial interviewer-level effects for prevalence and associational outcomes among Zambian FSWs, particularly for sensitive questions. Our findings highlight the importance of careful training and response monitoring to minimize inter-interviewer variation, of considering social distance when selecting interviewers and of evaluating whether interviewers are driving key findings in self-reported data. TRIAL REGISTRATION: clinicaltrials.gov NCT02827240 . Registered 11 July 2016.

The Effect of HIV Self-Testing Delivery Models on Female Sex Workers' Sexual Behaviors: A Randomized Controlled Trial in Urban Uganda.

HIV self-testing increases recent and frequent HIV testing among female sex workers (FSWs) in urban Uganda. Using results from a randomized controlled trial, we aim to establish the effect of HIV self-testing delivery models on FSWs' sexual behaviors in this setting. Clusters of one peer educator and eight participants were 1:1:1 randomized to: (1) direct provision of an HIV self-test, (2) provision of a coupon for facility collection of an HIV self-test, or (3) referral to standard-of-care HIV testing services. Sexual behaviors were self-reported at 1 and 4 months. From October to November 2016, 960 participants were enrolled and randomized. At 4 months, there were no statistically significant differences in participants' sexual behaviors, including inconsistent condom use, across study arms. We do not find any changes in sexual risk-taking among FSWs in response to the delivery of HIV self-tests. Routine policies for HIV self-testing are likely a behaviorally safe component of comprehensive HIV prevention strategies.

Structural, interpersonal, psychosocial, and behavioral risk factors for HIV acquisition among female bar workers in Dar es Salaam, Tanzania.

In sub-Saharan Africa, female bar workers (FBWs) often serve as informal sex workers. Little is known about the prevalence of HIV and HIV-related risk factors among FBWs in Dar es Salaam (DSM), Tanzania. Using an adapted Structural HIV Determinants Framework, we identified structural, interpersonal, psychosocial, and behavioral risk factors for HIV acquisition. We compared the prevalence of HIV and HIV-related risk factors among a random sample of 66 FBWs from DSM to an age-standardized, representative sample of female DSM-residents from the 2016 Demographic and Health and 2011-2012 AIDS Indicator Surveys. Compared to other women in DSM, FBWs had elevated prevalence of all four groups of risk factors. Key risk factors included gender and economic inequalities (structural); sexual violence and challenges negotiating condom use (interpersonal); depression, post-traumatic stress disorder, and low social support (psychosocial); and history of unprotected sex, multiple sex partners, and high alcohol consumption (behavioral). HIV prevalence did not differ between FBWs (7.1%, 95% CI 3.7-13.3%) and survey respondents (7.7%, 95% CI: 5.3-11.1%), perhaps due to FBWs' higher - though sub-optimal - engagement with HIV prevention strategies. Elevated exposure to HIV-related risk factors but low HIV prevalence suggests economic, psychosocial, and biomedical interventions may prevent HIV among FBWs in DSM.

Acceptability of HIV self-testing to support pre-exposure prophylaxis among female sex workers in Uganda and Zambia: results from two randomized controlled trials.

BACKGROUND: HIV pre-exposure prophylaxis (PrEP) is highly effective for prevention of HIV acquisition, but requires HIV testing at regular intervals. Female sex workers (FSWs) are a priority population for HIV prevention interventions in many settings, but face barriers to accessing healthcare. Here, we assessed the acceptability of HIV self-testing for regular HIV testing during PrEP implementation among FSWs participating in a randomized controlled trial of HIV self-testing delivery models. METHODS: We used data from two HIV self-testing randomized controlled trials with identical protocols in Zambia and in Uganda. From September-October 2016, participants were randomized in groups to: (1) direct delivery of an HIV self-test, (2) delivery of a coupon, exchangeable for an HIV self-test at nearby health clinics, or (3) standard HIV testing services. Participants completed assessments at baseline and 4 weeks. Participants reporting their last HIV test was negative were asked about their interest in various PrEP modalities and their HIV testing preferences. We used mixed effects logistic regression models to measure differences in outcomes across randomization arms at four weeks. RESULTS: At 4 weeks, 633 participants in Zambia and 749 participants in Uganda reported testing negative at their last HIV test. The majority of participants in both studies were "very interested" in daily oral PrEP (91% Zambia; 66% Uganda) and preferred HIV self-testing to standard testing services while on PrEP (87% Zambia; 82% Uganda). Participants in the HIV self-testing intervention arms more often reported preference for HIV self-testing compared to standard testing services to support PrEP in both Zambia (P = 0.002) and Uganda (P < 0.001). CONCLUSION: PrEP implementation programs for FSW could consider inclusion of HIV self-testing to reduce the clinic-based HIV testing burden. TRIAL REGISTRATION: ClinicalTrials.gov NCT02827240 and NCT02846402 .

HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial.

BACKGROUND: 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. METHODS AND FINDINGS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02827240.

Stopping tuberculosis: a biosocial model for sustainable development.

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.

Global, regional, and national incidence and mortality for HIV, tuberculosis, and malaria during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013.

BACKGROUND: The Millennium Declaration in 2000 brought special global attention to HIV, tuberculosis, and malaria through the formulation of Millennium Development Goal (MDG) 6. The Global Burden of Disease 2013 study provides a consistent and comprehensive approach to disease estimation for between 1990 and 2013, and an opportunity to assess whether accelerated progress has occured since the Millennium Declaration. METHODS: To estimate incidence and mortality for HIV, we used the UNAIDS Spectrum model appropriately modified based on a systematic review of available studies of mortality with and without antiretroviral therapy (ART). For concentrated epidemics, we calibrated Spectrum models to fit vital registration data corrected for misclassification of HIV deaths. In generalised epidemics, we minimised a loss function to select epidemic curves most consistent with prevalence data and demographic data for all-cause mortality. We analysed counterfactual scenarios for HIV to assess years of life saved through prevention of mother-to-child transmission (PMTCT) and ART. For tuberculosis, we analysed vital registration and verbal autopsy data to estimate mortality using cause of death ensemble modelling. We analysed data for corrected case-notifications, expert opinions on the case-detection rate, prevalence surveys, and estimated cause-specific mortality using Bayesian meta-regression to generate consistent trends in all parameters. We analysed malaria mortality and incidence using an updated cause of death database, a systematic analysis of verbal autopsy validation studies for malaria, and recent studies (2010-13) of incidence, drug resistance, and coverage of insecticide-treated bednets. FINDINGS: Globally in 2013, there were 1·8 million new HIV infections (95% uncertainty interval 1·7 million to 2·1 million), 29·2 million prevalent HIV cases (28·1 to 31·7), and 1·3 million HIV deaths (1·3 to 1·5). At the peak of the epidemic in 2005, HIV caused 1·7 million deaths (1·6 million to 1·9 million). Concentrated epidemics in Latin America and eastern Europe are substantially smaller than previously estimated. Through interventions including PMTCT and ART, 19·1 million life-years (16·6 million to 21·5 million) have been saved, 70·3% (65·4 to 76·1) in developing countries. From 2000 to 2011, the ratio of development assistance for health for HIV to years of life saved through intervention was US$4498 in developing countries. Including in HIV-positive individuals, all-form tuberculosis incidence was 7·5 million (7·4 million to 7·7 million), prevalence was 11·9 million (11·6 million to 12·2 million), and number of deaths was 1·4 million (1·3 million to 1·5 million) in 2013. In the same year and in only individuals who were HIV-negative, all-form tuberculosis incidence was 7·1 million (6·9 million to 7·3 million), prevalence was 11·2 million (10·8 million to 11·6 million), and number of deaths was 1·3 million (1·2 million to 1·4 million). Annualised rates of change (ARC) for incidence, prevalence, and death became negative after 2000. Tuberculosis in HIV-negative individuals disproportionately occurs in men and boys (versus women and girls); 64·0% of cases (63·6 to 64·3) and 64·7% of deaths (60·8 to 70·3). Globally, malaria cases and deaths grew rapidly from 1990 reaching a peak of 232 million cases (143 million to 387 million) in 2003 and 1·2 million deaths (1·1 million to 1·4 million) in 2004. Since 2004, child deaths from malaria in sub-Saharan Africa have decreased by 31·5% (15·7 to 44·1). Outside of Africa, malaria mortality has been steadily decreasing since 1990. INTERPRETATION: Our estimates of the number of people living with HIV are 18·7% smaller than UNAIDS's estimates in 2012. The number of people living with malaria is larger than estimated by WHO. The number of people living with HIV, tuberculosis, or malaria have all decreased since 2000. At the global level, upward trends for malaria and HIV deaths have been reversed and declines in tuberculosis deaths have accelerated. 101 countries (74 of which are developing) still have increasing HIV incidence. Substantial progress since the Millennium Declaration is an encouraging sign of the effect of global action. FUNDING: Bill & Melinda Gates Foundation.