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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. Summary 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.

Common mental disorders (CMDs) are prevalent among adolescent girls and young women (AGYW) in high HIV-burden settings. However, mental health is underprioritized within HIV interventions targeting AGYW. We conducted a qualitative study to explore AGYW and healthcare providers' perceptions of mental health service delivery within HIV clinics. Between 16th February and 14th June 2021, we conducted in-depth interviews with AGYW receiving HIV services and healthcare providers from eight clinics in Central Kenya. Eligible AGYW were aged 16-25 years and reported mild-to-moderate CMD symptoms, determined by the Self-Reporting Questionnaire 20-item (SRQ-20) mental health screening tool. Eligible providers currently provided HIV or mental health services. Interviews explored AGYW's experiences with CMDs and factors influencing mental health service delivery by providers within HIV clinics. We analyzed data deductively and inductively using thematic analysis and organized findings using the socio-ecological model. Median age among AGYW (n = 20) was 21 years (IQR:18-24), and SRQ-20 screening score was 9 (IQR: 8-11). Providers (n = 10) comprised seven females; and included six HIV and four mental healthcare providers. AGYW described experiences of CMDs due to multi-level risk factors, including HIV stigma, financial problems, and relationship challenges. AGYW reported a high demand for mental health services but described a systemic lack of access. Convenience and positive experiences with providers facilitated AGYW's access to services. Conversely, HIV care providers felt less confident in delivering mental health services due to inadequate mental health training compared to mental healthcare providers. Providers also reported inadequate training, poor referral systems, and unclear guidelines that hindered service delivery. AGYW and providers endorsed mental health service integration within HIV clinics to potentially reduce referral burden for AGYW and improve service quality. Our findings highlight gaps in mental health service delivery among AGYW receiving HIV services. Integrated service delivery within HIV clinics could improve AGYW's access to mental health services.

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).

Adolescent girls and young women (AGYW) are at high risk of sexually transmitted infections (STIs). It is unknown whether beginning to have sexual intercourse results in changes to immune mediators in the cervicovaginal tract that contribute to this risk. We collected cervicovaginal lavages from Kenyan AGYW in the months before and after first penile-vaginal sexual intercourse and measured the concentrations of 20 immune mediators. We compared concentrations pre- and post-first sex using mixed effect models. We additionally performed a systematic review to identify similar studies and combined them with our results by meta-analysis of individual participant data. We included 180 samples from 95 AGYW, with 44% providing only pre-first sex samples, 35% matched pre and post, and 21% only post. We consistently detected 19/20 immune mediators, all of which increased post-first sex (p<0.05 for 13/19; Holm-Bonferroni-adjusted p<0.05 for IL-1β, IL-2, and CXCL8). Effects remained similar after excluding samples with STIs and high Nugent scores. Concentrations increased cumulatively over time after date of first sex, with an estimated doubling time of about 5 months.Our systematic review identified two eligible studies, one of 93 Belgian participants, and the other of 18 American participants. Nine immune mediators were measured in at least two-thirds of studies. Meta-analysis confirmed higher levels post-first sex for 8/9 immune mediators (p<0.05 for six mediators, most prominently IL-1α, IL-1β, and CXCL8). Cervicovaginal immune mediator concentrations were higher in women who reported that they started sexual activity. Results were consistent across three studies conducted on three different continents. This research was funded by R01 HD091996-01 (ACR), by P01 AI 030731-25 (Project 1) (AW), R01 AI116292 (FH), R03 AI154366 (FH) and by the Center for AIDS Research (CFAR) of the University of Washington/Fred Hutchinson Cancer Research Center AI027757.

Background Increased risk of HIV acquisition during pregnancy and lactation among women is evident, necessitating their inclusion in the evaluation of new HIV prevention interventions. Pregnant and postpartum women specifically face challenges with oral PrEP associated with stigma, and the burden of using other tablets. Long-acting products may address challenges related to oral PrEP, however, there is limited data on product-specific preferences and acceptability among pregnant and lactating women. Methods We conducted a mixed-method study to assess the preferences and acceptability of long-acting PrEP modalities either under development or already established among pregnant and lactating women. We conducted quantitative surveys ( n  = 434) and in-depth interviews ( n  = 80) in central and western Kenya. We used descriptive statistics and categorical variables to summarize frequencies and proportions. Inductive and deductive content analytic approaches were used for in-depth interviews. Results The median age of respondents was 25 years (IQR 19.3–31.0). Majority were married (263/434, 61%), had completed high school (222/434, 51%), with no condoms use in the prior 3 months (348/434, 80%). The most preferred PrEP formulations were injectable (251/434, 57%) and implantable (175/434, 40%) options. Participants who preferred injectable PrEP had 8.56 times higher odds of considering ease of use as a reason. (aOR = 8.56, 95% CI [3.81–20.48]) and 3.71 odds of choosing perceived discreteness (aOR = 3.71, 95% CI (1.57–9.97)) as their preference reasons. Participants who preferred Implant for HIV prevention had 2.31 odds of considering it due to perceived effectiveness in preventing HIV as a preference reason (aOR = 2.31, 95% CI (1.21—4.66)) and 2.53-fold of considering discreteness as a preference reason (aOR = 2.53, 95% CI (1.46—4.59)). From the in-depth interviews, women reported prospective acceptability due to the perceived convenience of LA products, perceived effectiveness, reduced cost, improved privacy, and reduced stigma. Women had concerns regarding the safety and efficacy of the products during pregnancy and lactation. Conclusion Acceptability of LA products underscores the importance of considering the unique needs of pregnant and breastfeeding women in the development of future prevention interventions . Aligning preferences and needs would enhance the uptake and adherence outcomes of HIV prevention products.

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.

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, 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].

Background African women face high rates of depression, particularly during pregnancy or postpartum or after a recent HIV diagnosis. The Patient Health Questionnaire-9 (PHQ-9) depression screening tool has been quantitatively validated and extensively used to identify depression and link individuals to care. However, qualitative work is necessary to identify important opportunities to improve PHQ-9 question comprehension and performance among Kenyan women. Methods We administered the Kiswahili or English PHQ-9 (based on preference) to 29 pregnant and postpartum women in Thika, Kenya. Following administration, we conducted cognitive interviews with a purposive sample of 20 women. We used analytic memos and data matrices to identify themes around scale acceptability, comprehension, and decision and response processes. Results Most participants preferred to answer the PHQ-9 in Kiswahili ( N  = 15; 52%). Among the 20 interview participants, 12 (60%) had scores ≥5, indicating depressive symptoms. Overall, participants found the scale acceptable as an interviewer-administered tool. Participants reported few problems related to comprehension but had difficulty answering items not relevant to their lives (e.g., “watching television”) and double-barreled items (e.g., “poor appetite or overeating”). They were hesitant to endorse items related to “duties as a wife and mother” and suicidal ideation. Most participants had difficulty distinguishing between response options of “several days” and “more than half the days”. Conclusions We detected several problems related to PHQ-9 comprehension, decision processes, and response processes. We provide recommended changes to instructions and item wording to improve PHQ-9 validity among Kenyan women.