Pre-exposure Prophylaxis Continuation Research Articles

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

BackgroundIn 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.MethodsThis 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.ResultsFrom 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.ConclusionsThese 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 registrationClinicalTrials.gov: NCT04558554 [registered: June 5, 2020].

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

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. 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. 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%). 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.

Estimating the costs and perceived benefits of oral pre-exposure prophylaxis (PrEP) delivery in ten counties of Kenya: a costing and a contingent valuation study.

Kenya included oral PrEP in the national guidelines as part of combination HIV prevention, and subsequently began providing PrEP to individuals who are at elevated risk of HIV infection in 2017. However, as scale-up continued, there was a recognized gap in knowledge on the cost of delivering oral PrEP. This gap limited the ability of the Government of Kenya to budget for its PrEP scale-up and to evaluate PrEP relative to other HIV prevention strategies. The following study calculated the actual costs of oral PrEP scale-up as it was being delivered in ten counties in Kenya. This costing also allowed for a comparison of various models of service delivery in different geographic regions from the perspective of service providers in Kenya. In addition, the analysis was also conducted to understand factors that indicate why some individuals place a greater value on PrEP than others, using a contingent valuation technique. Data collection was completed between November 2017 and September 2018. Costing data was collected from 44 Kenyan health facilities, consisting of 23 public facilities, 5 private facilities and 16 drop-in centers (DICEs) through a cross-sectional survey in ten counties. Financial and programmatic data were collected from financial and asset records and through interviewer administered questionnaires. The costs associated with PrEP provision were calculated using an ingredients-based costing approach which involved identification and costing of all the economic inputs (both direct and indirect) used in PrEP service delivery. In addition, a contingent valuation study was conducted at the same 44 facilities to understand factors that reveal why some individuals place a greater value on PrEP than others. Interviews were conducted with 2,258 individuals (1,940 current PrEP clients and 318 non-PrEP clients). A contingent valuation method using a "payment card approach" was used to determine the maximum willingness to pay (WTP) of respondents regarding obtaining access to oral PrEP services. The weighted cost of providing PrEP was $253 per person year, ranging from $217 at health centers to $283 at dispensaries. Drop-in centers (DICEs), which served about two-thirds of the client volume at surveyed facilities, had a unit cost of $276. The unit cost was highest for facilities targeting MSM ($355), while it was lowest for those targeting FSW ($248). The unit cost for facilities targeting AGYW was $323 per person year. The largest percentage of costs were attributable to personnel (58.5%), followed by the cost of drugs, which represented 25% of all costs. The median WTP for PrEP was $2 per month (mean was $4.07 per month). This covers only one-third of the monthly cost of the medication (approximately $6 per month) and less than 10% of the full cost of delivering PrEP ($21 per month). A sizable proportion of current clients (27%) were unwilling to pay anything for PrEP. Certain populations put a higher value on PrEP services, including: FSW and MSM, Muslims, individuals with higher education, persons between the ages of 20 and 35, and households with a higher income and expenditures. This is the most recent and comprehensive study on the cost of PrEP delivery in Kenya. These results will be used in determining resource requirements and for resource mobilization to facilitate sustainable PrEP scale-up in Kenya and beyond. This contingent valuation study does have important implications for Kenya's PrEP program. First, it indicates that some populations are more motivated to adopt oral PrEP, as indicated by their higher WTP for the service. MSM and FSW, for example, placed a higher value on PrEP than AGYW. Higher educated individuals, in turn, put a much higher value on PrEP than those with less education (which may also reflect the higher "ability to pay" among those with more education). This suggests that any attempt to increase demand or improve PrEP continuation should consider these differences in client populations. Cost recovery from existing PrEP clients would have potentially negative consequences for uptake and continuation.

Peer PrEP referral + HIV self-test delivery for PrEP initiation among young Kenyan women: study protocol for a hybrid cluster-randomized controlled trial

BackgroundOral HIV pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but uptake remains low in Africa, especially among young women who are a priority population for HIV prevention services. HIV self-testing (HIVST) has been proven to increase HIV testing in diverse populations but has been underutilized to support linkage to HIV prevention services. Most young women who initiate PrEP in Africa do so through informal peer referral. We wanted to test a model of formalized peer referral enhanced with HIVST delivery among young Kenyan women.MethodsThe Peer PrEP Trial is a two-arm hybrid effectiveness-implementation cluster-randomized controlled trial being conducted in central Kenya. Eligible participants (i.e., peer providers, n = 80) are women (≥ 16–24 years) refilling or initiating PrEP at public healthcare clinics who can identify at least four peers who could benefit from PrEP and not enrolled in another HIV study. Peer providers will be 1:1 randomized to (1) formal peer PrEP referral + HIVST delivery, where they will be encouraged to refer four peers (i.e., peer clients, ≥ 16–24 years) using educational materials and HIVST kits (two per peer client), or (2) informal peer PrEP referral, where they are encouraged to refer four peer clients using informal word-of-mouth referral. In both arms, peer providers will deliver a standard PrEP referral card with information on nearby public clinics delivering PrEP services. Peer providers will complete surveys at baseline and 3 months; peer clients will complete surveys at 3 months. Our primary outcome is PrEP initiation among peer clients, as reported by peer providers at 3 months. Secondary outcomes include PrEP continuation (any refilling), HIV testing (past 3 months), sexual behaviors (past month), and PrEP adherence (past month) among peer clients, as reported by both peer providers and clients at 3 months. Implementation outcomes will include participants’ perceived acceptability, appropriateness, and feasibility of the intervention as well assessments of the intervention’s fidelity and cost.DiscussionEvidence from this trial will help us understand how HIVST could support health systems by facilitating linkage to PrEP services among young women who could benefit in Kenya and similar settings.Trial registrationClinicalTrials.gov NCT04982250. Registered on July 29, 2021.

PrEP Use and HIV Incidence Among Youth At-Risk for HIV Infection in Los Angeles and New Orleans: Findings From ATN 149.

Expanding HIV pre-exposure prophylaxis (PrEP) use is key to goals for lowering new HIV infections in the U.S. by 90% between 2022 and 2030. Unfortunately, youth aged 16-24 have the lowest PrEP use of any age group and the highest HIV incidence rates. To examine the relationship between HIV seroconversion and PrEP uptake, adherence, and continuity, we used survival analysis and multivariable logistic regression on data of 895 youth at-risk for HIV infection enrolled in Adolescent Trials Network for HIV Medicine protocol 149 in Los Angeles and New Orleans, assessed at 4-month intervals over 24 months. The sample was diverse in race/ethnicity (40% Black, 28% Latine, 20% White). Most participants (79%) were cis-gender gay/bisexual male but also included 7% transgender female and 14% trans masculine and nonbinary youth. Self-reported weekly PrEP adherence was high (98%). Twenty-seven participants acquired HIV during the study. HIV incidence among PrEP users (3.12 per 100 person year [PY]) was higher than those who never used PrEP (2.53/100 PY). The seroconversion incidence was highest among PrEP users with discontinuous use (3.36/100 PY). If oral PrEP users were adherent using 2-monthly long-acting injectables, our estimate suggests 2.06 infections per 100 PY could be averted. Discontinuous use of PrEP may increase risk of HIV acquisition among youth at higher risk for HIV infection and indications for PrEP. Thus, to realize the promise of PrEP in reducing new HIV infections, reducing clinical burdens for PrEP continuation are warranted.

Stakeholder perspectives on interventions to improve HIV pre-exposure prophylaxis uptake and continuation in Lesotho: A participant-ranked preferences study.

Low uptake and high discontinuation remain major obstacles to realizing the potential of Pre-Exposure Prophylaxis (PrEP) in changing the trajectory of the HIV epidemic. We conducted a card sorting and ranking exercise with 155 local stakeholders to determine their views on the most important barriers and most promising interventions to achieving high PrEP coverage. Stakeholders were a purposive sample of PrEP policymakers and implementing partners (n = 7), healthcare providers (n = 51), and end-users (n = 97). End-users included adults who were currently using PrEP (n = 55), formerly using PrEP (n = 36), and those who were offered PrEP but declined (n = 6). Participants sorted pre-selected interventions and barriers to PrEP coverage into three piles-most, somewhat, and least important. Participants then ranked interventions and barriers in the "most important" piles in ascending order of significance. Ranked preferences were analyzed as voting data to identify the smallest set of candidates for which each candidate in the set would win in a two-candidate election against any candidate outside the set. Participants viewed a lack of PrEP awareness as the most important barrier to PrEP uptake for women, and a fear of HIV testing for men. Community-based HIV testing was ranked as the most promising intervention to improve PrEP uptake for both men and women. Perceived or experienced stigma was seen as an important barrier for PrEP continuation for both men and women, with an additional important barrier for men being daily activities that compete with the time needed to take a daily pill. Adherence counseling and multi-month PrEP prescriptions were seen as the most promising interventions to improve PrEP continuation. Our findings suggest community-based activities that generate PrEP demand (community-based HIV testing and mass media campaigns), reinforced with facility-based follow-up (counseling and multi-month prescription) could be promising interventions for PrEP programs that are aimed at the general adult population.

Evaluating the use of oral pre-exposure prophylaxis among pregnant and postpartum adolescent girls and young women in Cape Town, South Africa.

Adolescent girls and young women (AGYW) in South Africa are at a higher risk of acquiring HIV. Despite the increasing availability of daily oral pre-exposure prophylaxis (PrEP) for HIV prevention, knowledge on PrEP use during pregnancy and postpartum periods at antenatal care (ANC) facilities remains inadequate. Data from HIV-uninfected pregnant women in Cape Town, South Africa, were used in this study. These women aged 16-24 years were enrolled in the PrEP in pregnancy and postpartum (PrEP-PP) cohort study during their first ANC visit. Using the PrEP cascade framework, the outcomes of the study were PrEP initiation (prescribed tenofovir disoproxil fumarate and emtricitabine at baseline), continuation (returned for prescription), and persistence [quantifiable tenofovir diphosphate (TFV-DP) in dried blood samples]. The two primary exposures of this study were risk perception for HIV and baseline HIV risk score (0-5), which comprised condomless sex, more than one sexual partner, partner living with HIV or with unknown serostatus, laboratory-confirmed sexually transmitted infections (STIs), and hazardous alcohol use before pregnancy (Alcohol Use Disorders Identification Test for Consumption score ≥ 3). Logistic regression was used to examine the association between HIV risk and PrEP, adjusting for a priori confounders. A total of 486 pregnant women were included in the study, of which 16% were "adolescents" (aged 16-18 years) and 84% were "young women" (aged 19-24 years). The adolescents initiated ANC later than the young women [median = 28 weeks (20-34) vs. 23 weeks (16-34), p = 0.04]. Approximately 41% of the AGYW were diagnosed with sexually transmitted infection at baseline. Overall, 83% of the AGYW initiated PrEP use during their first ANC. The percentage of PrEP continuation was 63% at 1 month, 54% at 3 months, and 39% at 6 months. Approximately 27% consistently continued PrEP use through 6 months, while 6% stopped and restarted on PrEP use at 6 months. With a higher risk score of HIV (≥2 vs. ≤1), the AGYW showed higher odds of PrEP continuation [adjusted odds ratio: 1.85 (95% CI: 1.12-3.03)] through 6 months, adjusting for potential confounders. Undergoing the postpartum period (vs. pregnant) and having lower sexual risk factors were found to be the barriers to PrEP continuation. TFV-DP concentration levels were detected among 49% of the AGYW, and 6% of these women had daily adherence to PrEP at 3 months. AGYW were found to have high oral PrEP initiation, but just over one-third of these women continued PrEP use through 6 months. Pregnant AGYW who had a higher risk of acquiring HIV (due to condomless sex, frequent sex, and STIs) were more likely to continue on PrEP use through the postpartum period. Pregnant and postpartum AGYW require counseling and other types of support, such as community delivery and peer support to improve their effective PrEP use through the postpartum period. ClinicalTrials.gov, NCT03826199.

Effect of 6-Month HIV Preexposure Prophylaxis Dispensing With Interim Self-testing on Preexposure Prophylaxis Continuation at 12 Months

Daily oral HIV preexposure prophylaxis (PrEP) delivery requires quarterly clinic visits for HIV testing and drug refilling that are costly to health systems and clients. To evaluate whether 6-month PrEP dispensing supported with interim HIV self-testing (HIVST) results in noninferior PrEP continuation outcomes at 12 months compared with standard quarterly clinic visits. This randomized noninferiority trial was conducted from May 2018 to May 2021 with 12 months of follow-up among PrEP clients aged 18 years or older who were returning for their first refill at a research clinic in Kiambu County, Kenya. Participants were randomized 2:1 to (1) 6-month PrEP dispensing with semiannual clinic visits and interim HIVST at 3 months or (2) standard-of-care (SOC) PrEP delivery with 3-month dispensing, quarterly clinic visits, and clinic-based HIV testing. Prespecified 12-month outcomes included recent HIV testing (any in past 6 months), PrEP refilling, and PrEP adherence (detectable tenofovir-diphosphate concentrations in dried blood spots). Binomial regression models were used to estimate risk differences (RDs), and a 1-sided 95% CI lower bound (LB) of -10% or greater was interpreted as noninferior. A total of 495 participants were enrolled, with 329 enrolled in the intervention group and 166 enrolled in the SOC group; 330 (66.7%) were women, 295 (59.6%) were in serodifferent relationships, and the median (IQR) age was 33 (27-40) years. At 12 months, 241 individuals in the intervention group (73.3%) and 120 in the SOC group (72.3%) returned to clinic. In the intervention group, recent HIV testing was noninferior (230 individuals [69.9%]) compared with the SOC group (116 [69.9%]; RD, -0.33%, 95% CI LB, -7.44%). PrEP refilling in the intervention group (196 [59.6%]) was inconclusive compared with the SOC group (104 [62.7%]; RD, -3.25%; 95% CI LB, -10.84%), and PrEP adherence was noninferior in the intervention group (151 [45.9%]) compared with the SOC group (70 [42.2%]; RD, 4.96%; 95% CI LB, -2.46%). No HIV seroconversions were observed over the follow-up period. In this analysis of secondary trial end points at 1 year, semiannual PrEP dispensing with interim HIVST resulted in noninferior recent HIV testing and PrEP adherence compared with SOC quarterly PrEP dispensing. This novel model has the potential to optimize PrEP delivery. ClinicalTrials.gov Identifier: NCT03593629.

Stand-alone model for delivery of oral HIV pre-exposure prophylaxis in Kenya: a single-arm, prospective pilot evaluation.

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. 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. 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. 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.

Understanding Retention in the HIV Pre-Exposure Prophylaxis Cascade Among Cisgender Women.

HIV remains a significant public health concern in the United States, with 34,800 new cases diagnosed in 2019; of those, 18% were among women. Oral pre-exposure prophylaxis (PrEP) with daily tenofovir disoproxil fumarate/emtricitabine is effective and safe, reducing HIV transmission by up to 92% in women. Though studies demonstrate low rates of PrEP adherence among cisgender women prescribed oral PrEP, little is known about the factors that shape PrEP continuation among them. This study focuses on understanding the experiences of cisgender women who have initiated PrEP to gain insight into the factors that shape PrEP continuation. We conducted semi-structured interviews with (N = 20) women who had been prescribed oral PrEP. Interviews were guided by the social-ecological framework to identify multilevel factors affecting PrEP continuation; we specifically examined the experience of engagement and retention in the PrEP cascade. We recruited women who had been prescribed oral PrEP by a government-sponsored sexual health center or a hospital-based family planning clinic in Washington, DC. Factors facilitating PrEP continuation included a positive emotional experience associated with PrEP use, high perceived risk of HIV acquisition, and high-quality communication with health care providers. The most common reason for PrEP discontinuation was low perceived HIV risk (n = 11). Other factors influencing discontinuation were side effects, a negative emotional experience while using PrEP, and negative interactions with the health care system. This study underscores the importance of specific multi-level factors, including the provision of high-quality communication designed to resonate with women and shared decision making between women and their health care providers.

Psychosocial determinants of pre-exposure prophylaxis use among pregnant adolescent girls and young women in Cape Town, South Africa: A qualitative study.

In South Africa, at least 7.5million people (age ≥15years) are living with Human Immunodeficiency Virus (HIV). In 2020, 220,000 new infections occurred, approximately one-third of which were among cisgender adolescent girls and women (age ≥15years). The perspectives of pregnant adolescent girls and young women (AGYW) as key, targeted end-users of pre-exposure prophylaxis (PrEP) in this setting are not well known. We purposively recruited participants enrolled in an ongoing cohort study at an urban antenatal clinic in Cape Town, South Africa for in-depth interviews between July-September 2020. We restricted our analysis to pregnant AGYW (age: 16-25years) who initiated daily oral PrEP (Tenofovir/Emtricitabine) antenatally and self-reported either high PrEP persistence (≥25days in the past 30days and no missed PrEP collection), or low PrEP persistence and/or discontinuation (missing >5days in the last 30days or missed PrEP collection). The findings were organized thematically, per the adapted Health Behavior Model (2000), using Nvivo-v.1.5. We interviewed 18 AGYW (mean age = 22years), at a mean of 14weeks postpartum. Higher self-esteem and high-quality study provider-client relationships, including empathic psychosocial support, facilitated PrEP continuation. Reported barriers included unstable social structure characteristics (i.e., financial hardship) and individual factors (i.e., unintended pregnancy, parental rejection, and inadequate peer- and [non-cohabiting] partner support). Participants self-perceived a need for PrEP, feeling susceptible to non-consensual, forced sex, or considering partners' (presumed) sexual risk-taking. Limited community awareness regarding PrEP availability and/or perceived complexity in navigating health system access to PrEP, impede continuation. PrEP-focused healthcare access pathways for pregnant and postpartum AGYW need to be simplified. Further research is needed on health system determinants (i.e., structural barriers, provider-client interactions, and related outcomes) of oral PrEP utilization. In 2022, South Africa announced regulatory approval of long-acting PrEP options (i.e., the dapivirine ring for non-pregnant women and injectable cabotegravir, respectively); these may mitigate implementation barriers reported in this study. However, the safety and efficacy of long-acting PrEP (e.g., injectables, implants) among pregnant or breastfeeding women, specifically, remains to be confirmed in this setting.

Uptake and continuation of HIV pre-exposure prophylaxis among women of reproductive age in two health facilities in Kisumu County, Kenya.

In 2020, Kenya had 19,000 new HIV infections among women aged 15+ years. Studies have shown sub-optimal oral pre-exposure prophylaxis (PrEP) use among sub-populations of women. We assessed the uptake and continuation of oral PrEP among women 15-49 years in two health facilities in Kisumu County, Kenya. A retrospective cohort of 262 women aged 15-49 years, initiated into oral PrEP between 12 November 2019 and 31 March 2021, was identified from two health facilities in the urban setting of Kisumu County, Kenya. Data on baseline characteristics and oral PrEP continuation at months 1, 3 and 6 were abstracted from patient records and summarized using descriptive statistics. Missing data in the predictor variables were imputed within the joint modelling multiple imputation framework. Using logistic regression, we evaluated factors associated with the discontinuation of oral PrEP at month 1. Of the 66,054 women screened, 320 (0.5%) were eligible and 262 (82%) were initiated on oral PrEP. Uptake was higher among women 25-29 years as compared to those 15-24 years (77% vs. 33%). Oral PrEP continuation declined significantly with increasing duration of follow-up; 37% at month 1, 21% at month 3 and 12% at month 6 (p<0.05). In the adjusted analysis, women 15-24 years had lower adjusted odds of continuing at month 1 than women ≥25 years (adjusted odds ratio [aOR]: 0.41, 95% CI: 0.21-0.82). There was no association between being sero-discordant and continuation of oral PrEP at month 1 (aOR; 1.21, 95% CI 0.59-2.50). Women from the sub-county hospital were more likely to continue at month 1 of follow-up compared to women enrolled in the county referral hospital (aOR 5.11; 95% CI 2.24-11.70). The low eligibility for oral PrEP observed among women 15-49 years in an urban setting with high HIV prevalence calls for a review of the screening process to validate the sensitivity of the screening tool and its proper application. The low uptake and continuation among adolescent girls and young women underscores the need to identify and address specific patient- and facility-level barriers affecting different sub-populations at risk for HIV acquisition.

Barriers to and strategies for early implementation of pharmacy-delivered HIV PrEP services in Kenya: An analysis of routine data.

For individuals who face challenges accessing clinic-based HIV pre-exposure prophylaxis (PrEP), differentiated service delivery models are needed to expand access and reach. During a pilot study testing a novel pharmacy-delivered oral PrEP model in Kenya, we used routine programmatic data to identify early implementation barriers and actions that providers and study staff took in response to the barriers. We trained pharmacy providers at five private pharmacies in Kisumu and Kiambu Counties to initiate and continue clients at risk of HIV acquisition on PrEP for a fee of 300 KES per visit (∼$3 USD) using a prescribing checklist with remote clinician oversight. Research assistants stationed at the pharmacies completed weekly observation reports of pharmacy-delivered PrEP services using a structured template. We analyzed reports from the first 6 month of implementation using content analysis and identified multi-level early implementation barriers and actions taken to address these. We then organized the identified barriers and actions according to the Consolidated Framework for Implementation Research (CFIR). From November 2020 to May 2021, research assistants completed 74 observation reports (∼18/pharmacy). During this period, pharmacy providers screened 496 potential PrEP clients, identified 425 as eligible for pharmacy-delivered PrEP services, and initiated 230 (54%) on PrEP; 125 of 197 (63%) clients eligible for PrEP continuation refilled PrEP. We identified the following early implementation barriers to pharmacy-delivered PrEP services (by CFIR domain): high costs to clients (intervention characteristics), client discomfort discussing sexual behaviors and HIV testing with providers (outer setting), provider frustrations that PrEP delivery was time-consuming and disruptive to their workflow (inner setting), and provider hesitancy to deliver PrEP due to concerns about encouraging sexual promiscuity (characteristics of individuals). To help address these, pharmacy providers implemented a self-screening option for behavioral HIV risk assessment for prospective PrEP clients, allowed flexible appointment scheduling, and conducted pharmacy PrEP trainings for newly hired staff. Our study provides insight into early barriers to implementing pharmacy-delivered PrEP services in Kenya and potential actions to mitigate these barriers. It also demonstrates how routine programmatic data can be used to understand the early implementation process.

Barriers to uptake of PrEP across the continuum among transgender women: A global scoping review.

Although preexposure prophylaxis (PrEP) has demonstrated high efficacy for HIV prevention, rates of PrEP uptake remain low among the transgender population, especially in transgender women (TGW). We conducted this scoping review to assess and characterize barriers to PrEP use along the PrEP care continuum among TGW. We conducted this scoping review by searching studies in Embase, PubMed, Scopus, and Web of Science. Eligibility criteria included: reporting a PrEP related quantitative result among TGW; peer-reviewed and published in English between 2010-2021. Globally, high willingness (80%) to use PrEP was found, yet uptake and adherence (35.4%) were low. TGW experiencing hardship, including poverty, incarceration, and substance use, were associated with higher odds of PrEP awareness but lower odds of PrEP use. Structural and social barriers such as stigma, medical mistrust, and perceived racism can be important barriers for PrEP continuation. High social cohesion and hormone replacement therapy were associated with greater odds of awareness. In addition, our study confirmed prior research showing that PrEP does not lower feminizing hormone levels in TGW. Significant demographic factors among TGW that are associated with PrEP engagement. It is imperative to focus on TGW as a population with independent needs, requiring specific PrEP care guidelines and tailored resource allocation, that fully considers individual-, provider-, and community/structural-level barriers and facilitators. The present review also indicates that combining PrEP care with GAHT or broader gender-affirmation care may facilitate PrEP use.

Factors influencing the retention of clients in oral pre-exposure prophylaxis (PrEP) care at 3 months after initiation in the Omusati region of Namibia

BackgroundThe United Nations has set a target of ending the HIV/AIDS epidemic as a public health threat by 2030. The WHO recommended the use of oral pre-exposure prophylaxis (PrEP) for HIV prevention for all people at substantial risk of HIV infection in 2016. In Namibia since the adoption of PrEP in 2016, many clients have been initiated on PrEP. ObjectivesThe objectives of this study were to measure clients’ rate of PrEP retention at three months and determine factors that influence it in the Omusati region of Namibia. MethodsAn analytical cross-sectional design was used for this study. Three hundred and forty-five participants were selected for this study using a simple random sampling method. The data were collected from the Electronic Patient Monitoring System (EPMS). Chi-square tests and logistic regression were used for data analysis. ResultsThe retention rate in PrEP care at three months was 60 %. The Chi-square tests showed significant associations between age, sex, sexually transmitted infection (STI) symptoms, marital status, HIV status and viral load of partner, number of sexual partners, and retention in PrEP care at three months (p < 0.05). Logistic regression analysis revealed that females and those with STI symptoms were more likely to be retained in PrEP care, Adjusted Odds Ratio (AOR) = 2.21, 95 % CI (1.36–3.57), and AOR = 4.25, 95 % CI (1.23–14.63), respectively. Participants with HIV-negative/unknown status partners and with multiple/concurrent sexual partners were less likely to continue with PrEP, Crude Odds Ratio (COR) = 0.56, 95 % CI (0.36–0.86), COR = 0.39, 95 % CI (0.16–0.96), respectively. ConclusionThe findings of this study accentuate the need for increased provision of information on the importance of the continuation of PrEP.

Measuring Oral Pre-exposure Prophylaxis (PrEP) Continuation Through Electronic Health Records During Program Scale-Up Among the General Population in Zambia.

HIV pre-exposure prophylaxis (PrEP) is being scaled-up in Zambia, but PrEP continuation data are limited by paper-based registers and aggregate reports. Utilization of Zambia's electronic health record (EHR) system, SmartCare, may address this gap. We analyzed individuals aged ≥ 15years who initiated PrEP between October 2020 and September 2021 in four provinces in Zambia in SmartCare versus aggregate reports. We measured PrEP continuation using Kaplan-Meier survival analysis and Cox proportional hazards models. SmartCare captured 29% (16,791/58,010) of new PrEP clients; 49% of clients continued at one month, and 89% discontinued PrEP by February 2022. Women were less likely than men to discontinue PrEP (adjusted hazard ratio [aHR]: 0.89, 95% CI 0.86-0.92, z = - 6.99, p < 0.001), and PrEP clients aged ≥ 50years were less likely to discontinue PrEP compared to clients 15-19years (aHR: 0.53, 95% CI 0.48-0.58, z = - 13.04, p < 0.001). Zambia's EHR is a valuable resource for measuring individual-level PrEP continuation over time and can be used to inform HIV prevention programs.

Interventions to increase the uptake and continuation of pre-exposure prophylaxis (PrEP) by adolescent girls and young women at high risk of HIV in low-income and middle-income countries: a scoping review

IntroductionEffective strategies to increase pre-exposure prophylaxis (PrEP) uptake and continuation among adolescent girls and young women (AGYW) who engage in sex work or transactional sex are sparsely reported. We aimed...

Caring for the whole person: transgender-competent HIV pre-exposure prophylaxis as part of integrated primary healthcare services in Vietnam.

IntroductionAlthough HIV prevalence among transgender women who have sex with men in Vietnam is high (16–18%), uptake of pre‐exposure prophylaxis (PrEP) is low compared to other populations. When PrEP was initiated in 2017, gender‐affirming healthcare was largely unavailable. Lack of access to competent, stigma‐free healthcare is a well‐documented barrier to transgender women's uptake of PrEP and primary healthcare (PHC). We aimed to demonstrate the utility of a PrEP quality improvement intervention in pinpointing and addressing barriers to PrEP use among transgender women in Vietnam.MethodsWe applied a real‐world participatory continuous quality improvement (CQI) and Plan‐Do‐Study‐Act (PDSA) methodology to ascertain barriers to PrEP uptake among transgender women and determine priority actions for quality improvement. A CQI team representing transgender women leaders, key population (KP)‐clinic staff, public‐sector HIV managers and project staff applied PDSA to test solutions to identified barriers that addressed the primary quality improvement outcome of the monthly change in PrEP uptake among transgender women and secondary outcomes, including month‐3 PrEP continuation, the impact of offering PHC on PrEP uptake and unmet PrEP need. We utilized routine programmatic data and a descriptive cross‐sectional study enrolling 124 transgender women to measure these outcomes from October 2018 to September 2021.ResultsFive key barriers to PrEP uptake among transgender women were identified and corresponding solutions were put in place: (1) offering gender‐affirming care training to KP‐clinics and community‐based organizations; (2) integrating gender‐affirming services into 10 KP‐clinics; (3) offering PHC through five one‐stop shop (OSS) clinics; (4) implementing a campaign addressing concerns related to hormone use and PrEP interactions; and (5) developing national HIV and transgender healthcare guidelines. New PrEP enrolment and month‐3 PrEP continuation increased significantly among transgender women. Of 235 transgender women who initially sought healthcare other than PrEP at OSS clinics, 26.4% subsequently enrolled in PrEP. About one‐third of transgender women reported unmet PrEP need, while two‐thirds indicated an interest in long‐acting cabotegravir.ConclusionsOffering gender‐competent, integrated PHC can increase PrEP enrolment and continuation, and can be an entry‐point for PrEP among those seeking care within PHC clinics. More work is needed to expand access to transgender women‐led and ‐competent healthcare in Vietnam.

Providers' Attitudes and Experiences with Pre-Exposure Prophylaxis Implementation in a Population-Based Study in Kenya and Uganda.

Pre-exposure prophylaxis (PrEP) implementation is underway across sub-Saharan Africa. However, little is known about health care providers' experiences with PrEP provision in generalized epidemic settings, particularly outside of selected risk groups. In this study (NCT01864603), universal access to PrEP was offered to adolescents and adults at elevated risk during population-level HIV testing in rural Kenya and Uganda. Providers received training on PrEP prescribing and support from local senior clinicians. We conducted in-depth interviews with providers (n = 19) in four communities in Kenya and Uganda to explore the attitudes and experiences with implementation. Transcripts were coded and analyzed using interpretivist methods. Providers had heterogenous attitudes toward PrEP in its early implementation: some expressed enthusiasm, while others feared being blamed for "failures" (HIV seroconversions) if participants were nonadherent, or that offering PrEP would increase "immorality." Providers supported PrEP usage among HIV-serodifferent couples, whose mutual support for daily pill-taking facilitated harmony and protection from HIV. Providers reported challenges with counseling on "seasons of risk," and safely stopping and restarting PrEP. They felt uptake was hampered for women by difficulties negotiating with partners, and for youth by parental consent requirements. They believed PrEP continuation was hindered by transportation costs, stigma, pill burden, and side effects, and was facilitated by counseling, proactive management of side effects, and home/community-based provision. Providers are critical "implementation actors" in interventions to promote adoption of new technologies such as PrEP. Dedicated training and ongoing support for providers may facilitate successful scale-up.

Stepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trial

BackgroundHIV incidence among pregnant and postpartum women remains high in South Africa. Pre-exposure prophylaxis (PrEP) use remains suboptimal in this population, particularly during the postpartum period when women’s engagement with routine clinic visits outside PrEP decreases. Key barriers to sustained PrEP use include the need for ongoing contact with the health facility and suboptimal counseling around effective PrEP use.MethodsStepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP), is a two-stepped unblinded, individually randomized controlled trial (RCT) that aims to optimize peripartum and postpartum PrEP use by providing a stepped package of evidence-based interventions. We will enroll 650 pregnant women (> 25 weeks pregnant) who access PrEP at a busy antenatal clinic in Cape Town at the time of recruitment and follow them for 15 months. We will enroll and individually randomize pregnant women > 16 years who are not living with HIV who are either on PrEP or interested in starting PrEP during pregnancy. In step 1, we will evaluate the impact of enhanced adherence counselling and biofeedback (using urine tenofovir tests for biofeedback) and rapid PrEP collection (to reduce time required) on PrEP use in early peripartum compared to standard of care (SOC) (n = 325 per arm). The primary outcome is PrEP persistence per urine tenofovir levels and dried blood spots of tenofovir diphosphate (TFV-DP) after 6-months. The second step will enroll and individually randomize participants from Step 1 who discontinue taking PrEP or have poor persistence in Step 1 but want to continue PrEP. Step 2 will test the impact of enhanced counseling and biofeedback plus rapid PrEP collection compared to community PrEP delivery with HIV self-testing on PrEP use (n = up to 325 postpartum women). The primary outcome is PrEP continuation and persistence 6-months following second randomization (~ 9-months postpartum). Finally, we will estimate the cost effectiveness of SCOPE-PP vs. SOC per primary outcomes and disability-adjusted life-years (DALYs) averted in both Step 1 and 2 using micro-costing with trial- and model-based economic evaluation.DiscussionThis study will provide novel insights into optimal strategies for delivering PrEP to peripartum and postpartum women in this high-incidence setting.Trial registrationNCT05322629: Date of registration: April 12, 2022.