Discontinuation of HIV oral pre-exposure prophylaxis: findings from programmatic surveillance within two general population HIV programs in Nigeria.

BACKGROUND: As oral PrEP scales up in Nigeria, information about uptake, use pattern and client preference in a real-world, implementation setting is invaluable to guide refining service provision and incorporation of oral PrEP and other prevention measures into routine health services. To add to this body of knowledge, our study examines factors associated with discontinuation of PrEP among HIV negative individuals across two large scale programs in Nigeria. METHODS: Using program implementation data from two large-scale HIV projects in Akwa Ibom and Cross River states in Nigeria between January 2020 and July 2021, we used logistic regression to explore factors associated with early discontinuation (i.e., stopping PrEP within one month of starting) among HIV-negative individuals who initiated PrEP in the programs. RESULTS: Of a total of 26,325 clients; 22,034 (84%) discontinued PrEP within the first month. The odds of PrEP discontinuation were higher among clients who enrolled in community-based distribution sites (aOR 2.72; 95% C.I: 2.50-2.96) compared to those who enrolled in program-supported facilities and never married (aOR 1.76; 95% C.I: 1.61-1.92) compared to married clients. Clients who initiated PrEP because of high-risk sexual behaviour (aOR 1.15, 95% C.I 1.03-1.30) or inconsistent use or non-use of condoms (aOR 1.96, 95% C.I 1.60-2.41) had greater odds of discontinuing PrEPthan those who initiated PrEP because they were in a serodifferent relationship. CONCLUSION: The behavioural and demographic factors associated with early discontinuation of PrEP suggest that risk stratification of pre-initiation and follow up counselling may be helpful in raising continuation rates. On the service delivery side, strategies to strengthen follow-up services provided by community-based distribution sites need to be introduced. Overall, the low continuation rate calls for a review of programmatic approaches in provision of PrEP services in Nigeria.

Development and use of a porcine model with clinically relevant chronic infected wounds.

Chronic ischemic wounds affect millions of people causing significant pain and disability. They can be considered to be stalled in the inflammatory stage and cannot heal without additional measures. A valid animal model is necessary to evaluate the efficacy of topical wound healing therapies and wearable technologies. A porcine model, although higher in cost, maintenance, and space requirements, is superior to the commonly used rodent or rabbit model for wound healing. Previous studies have shown that pig wounds have greater similarity to human wounds in responses to a variety of treatments, including wound dressings and antibiotics. The current study created a porcine model of large chronic wounds to assess a wearable electroceutical technology, with monitoring of healing variables and infection. Electroceutical therapy is the only adjunctive treatment recommended for chronic wound therapy. A porcine model of large chronic wounds of clinically realistic size was created and utilized to evaluate a wearable electroceutical biotechnology. Multivariate non-invasive assessment was used to monitor wound progression over multiple timepoints. Outcomes suggest that a wearable electrostimulation bandage, has the potential to offer therapeutic benefit in human wounds. The tested wearable device provides the same proven effectiveness of traditional electroceutical therapy while mitigating commonly cited barriers, including substantial time requirements, and availability and complexity of currently available equipment, preventing its implementation in routine wound care. The model is also appropriate for evaluation of other wearables or topical therapeutics.

Introducing the Dapivirine Vaginal Ring in Sub-Saharan Africa: What Can We Learn from Oral PrEP?

PURPOSE OF REVIEW: Clinical trials have found that the dapivirine vaginal ring (DVR) is safe to use and effective at reducing women's risk of acquiring HIV infection. As countries prepare for the introduction of this novel long-acting, woman-controlled prevention method, an examination of key learnings from oral pre-exposure prophylaxis (PrEP) delivery will help programs leverage successful innovations and approaches to support DVR scale-up and expand the method mix for HIV prevention. RECENT FINDINGS: Intensive efforts over the past 5 years have yielded lessons on how to facilitate access to oral PrEP; expand service delivery for PrEP; address the knowledge, attitudes, and skills providers need to support PrEP initiation and effective use; develop messaging that builds community and partner support and combats stigma; and understand the cyclical nature of PrEP use. Evidence from oral PrEP introduction and scale-up can help inform and expedite DVR introduction.

Impact of Male Partner Involvement on Women's Adherence to the Dapivirine Vaginal Ring During a Phase III HIV Prevention Trial.

Although vaginal microbicides for HIV prevention are designed to be female-initiated, male partner influence has been identified as one of the most significant factors impacting women's willingness and ability to use them. As a result, research teams have sought to increase male partner involvement by encouraging disclosure of product use to male partners, promoting male partner engagement in the study through attendance at the study clinic, and helping women to garner male partner support for product use. This paper aims to assess the impact of these three elements of male partner involvement on women's adherence to the dapivirine vaginal ring during MTN-020/ASPIRE, a phase III randomized placebo-controlled clinical trial involving 2629 women in Malawi, South Africa, Uganda, and Zimbabwe. During the study, 64-80% of participants reported disclosure of ring use at each quarterly visit, and 13% reported that their partners had attended the study clinic at some point during the study. At study exit, 66% reported that their partner was supportive, 18% unsupportive, and 17% were unsure. After adjusting for age, site and time in study, women were more likely to have low ring adherence if they had an unsupportive male partner (aRR 1.29, 95% CI 1.03-1.62). Neither disclosure nor clinic attendance directly predicted ring adherence, but disclosure increased the probability of having a supportive partner (aRRR 24.17, 95% CI 16.38-35.66) or an unsupportive partner (aRRR 4.10, 95% CI 2.70-6.24), relative to an unknown level of partner support. Women were also more likely to have a supportive partner if their partner had attended the clinic (aRRR 3.77, 95% CI 1.36-10.42). This study suggests that although the vaginal ring is relatively discreet, lack of support from male partners remains a relevant barrier to use. Though both disclosure and clinic attendance may increase partner support, disclosure may also increase partner opposition. Interventions to reduce male partner opposition are needed to maximize the potential impact of the ring and other PrEP products for HIV prevention.

Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women.

BACKGROUND: Antiretroviral medications that are used as prophylaxis can prevent acquisition of human immunodeficiency virus type 1 (HIV-1) infection. However, in clinical trials among African women, the incidence of HIV-1 infection was not reduced, probably because of low adherence. Longer-acting methods of drug delivery, such as vaginal rings, may simplify use of antiretroviral medications and provide HIV-1 protection. METHODS: We conducted a phase 3, randomized, double-blind, placebo-controlled trial of a monthly vaginal ring containing dapivirine, a non-nucleoside HIV-1 reverse-transcriptase inhibitor, involving women between the ages of 18 and 45 years in Malawi, South Africa, Uganda, and Zimbabwe. RESULTS: Among the 2629 women who were enrolled, 168 HIV-1 infections occurred: 71 in the dapivirine group and 97 in the placebo group (incidence, 3.3 and 4.5 per 100 person-years, respectively). The incidence of HIV-1 infection in the dapivirine group was lower by 27% (95% confidence interval [CI], 1 to 46; P=0.046) than that in the placebo group. In an analysis that excluded data from two sites that had reduced rates of retention and adherence, the incidence of HIV-1 infection in the dapivirine group was lower by 37% (95% CI, 12 to 56; P=0.007) than that in the placebo group. In a post hoc analysis, higher rates of HIV-1 protection were observed among women over the age of 21 years (56%; 95% CI, 31 to 71; P<0.001) but not among those 21 years of age or younger (-27%; 95% CI, -133 to 31; P=0.45), a difference that was correlated with reduced adherence. The rates of adverse medical events and antiretroviral resistance among women who acquired HIV-1 infection were similar in the two groups. CONCLUSIONS: A monthly vaginal ring containing dapivirine reduced the risk of HIV-1 infection among African women, with increased efficacy in subgroups with evidence of increased adherence. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01617096 .).

Evaluating Two Sampling Methods for Mycoplasma Bovis Diagnosis in American Bison (Bison Bison).

Mycoplasma bovis is a bacterial pathogen endemic to cattle. In the early 2000s, M. bovis emerged as a cause of respiratory disease in American bison (Bison bison), causing significant morbidity and mortality. Bison herds that experience an outbreak of M. bovis are at higher risk for subsequent outbreaks, suggesting that chronic, subclinical infections can be established. Antemortem testing is therefore crucial to disease management; however, the precise sampling method to maximize detection of M. bovis in bison is unknown. We evaluated two sample types-superficial nasal swabs and deep nasopharyngeal swabs-collected from apparently healthy or symptomatic bison from January 2021 through December 2022. We used real-time PCR to detect M. bovis in 76/938 bison (8.1%) from 11 herds. For bison testing positive on at least one swab type, M. bovis was detected in 63/76 (82.8%) deep nasopharyngeal swabs and 29/73 (38.1%) superficial nasal swabs. Agreement between swabs for positive bison was 21% (n=16, kappa coefficient 0.319). We conclude that deep nasopharyngeal swabbing is more sensitive than superficial nasal swabbing for detection of M. bovis in bison and that low agreement between methods may be related to stage of infection. We further tested pooled samples by PCR and found that pooling of up to five samples can be effective to increase throughput and minimize costs. Management of wild bison relies on the ability to relocate animals to maintain gene flow and healthy populations. Sensitive and specific diagnostic tests are needed to inform decisions and minimize risk of transmission, especially from subclinical carriers. This study provides valuable insight that will inform best practices for M. bovis testing, thereby supporting the conservation of bison as healthy wildlife, which in turn promotes ecological restoration, safeguards cultural practices of Tribal Nations, and upholds the bison as a unique American icon.

Caregiver and Juvenile Justice Personnel Perspectives on challenges and importance of caregiver engagement and the potential utility of a peer navigator program in the Juvenile Justice System.

BACKGROUND: For youth involved in the juvenile justice (JJ) system, caregiver involvement and engagement in the system is crucial for youth development and outcomes of JJ cases; however, there are challenges to establishing positive/productive partnerships between caregivers and JJ representatives. The current project examines perspectives of caregivers and JJ personnel regarding facilitators and barriers to establishing JJ-caregiver partnerships, as well as their perceptions of the use of a caregiver navigator program to support caregivers of system-involved youth. Results are used to inform development of a caregiver navigator program to support caregivers and help them navigate the JJ system. RESULTS: Semi-structured interviews were conducted with caregivers of youth involved in JJ (n = 15, 53% White, 93% female), JJ personnel (n = 7, 100% White, 50% female), and JJ family advisory board members (n = 5, 100% Black, 100% female). Caregivers reported varying experiences across intake/arrest, court, and probation processes. Positive experiences were characterized by effective communication and feeling supported by JJ. Negative experiences related to feeling blamed and punished for their child's system involvement and feeling unsupported. JJ interviews corroborated caregiver sentiments and also illustrated facilitators and barriers to JJ-caregiver partnerships. Both JJ personnel and caregivers endorsed potential benefits of a peer-based caregiver navigator program to provide social, informational, and emotional support. CONCLUSION: Continued work is needed to improve JJ-caregiver partnerships and use of a peer-based navigator program has the potential to address barriers to caregiver engagement in the JJ system.

Implementation and resource needs for long-acting PrEP in low- and middle-income countries: a scoping review.

INTRODUCTION: Several low- and middle-income countries (LMICs) are preparing to introduce long-acting pre-exposure prophylaxis (LAP). Amid multiple pre-exposure prophylaxis (PrEP) options and constrained funding, decision-makers could benefit from systematic implementation planning and aligned costs. We reviewed national costed implementation plans (CIPs) to describe relevant implementation inputs and activities (domains) for informing the costed rollout of LAP. We assessed how primary costing evidence aligned with those domains. METHODS: We conducted a rapid review of CIPs for oral PrEP and family planning (FP) to develop a consensus of implementation domains, and a scoping review across nine electronic databases for publications on PrEP costing in LMICs between January 2010 and June 2022. We extracted cost data and assessed alignment with the implementation domains and the Global Health Costing Consortium principles. RESULTS: We identified 15 implementation domains from four national PrEP plans and FP-CIP template; only six were in all sources. We included 66 full-text manuscripts, 10 reported LAP, 13 (20%) were primary cost studies-representing seven countries, and none of the 13 included LAP. The 13 primary cost studies included PrEP commodities (n = 12), human resources (n = 11), indirect costs (n = 11), other commodities (n = 10), demand creation (n = 9) and counselling (n = 9). Few studies costed integration into non-HIV services (n = 5), above site costs (n = 3), supply chains and logistics (n = 3) or policy and planning (n = 2), and none included the costs of target setting, health information system adaptations or implementation research. Cost units and outcomes were variable (e.g. average per person-year). DISCUSSION: LAP planning will require updating HIV prevention policies, technical assistance for logistical and clinical support, expanding beyond HIV platforms, setting PrEP achievement targets overall and disaggregated by method, extensive supply chain and logistics planning and support, as well as updating health information systems to monitor multiple PrEP methods with different visit schedules. The 15 implementation domains were variable in reviewed studies. PrEP primary cost and budget data are necessary for new product introduction and should match implementation plans with financing. CONCLUSIONS: As PrEP services expand to include LAP, decision-makers need a framework, tools and a process to support countries in planning the systematic rollout and costing for LAP.

Patient satisfaction with integrated HIV and antenatal care services in rural Kenya.

A cluster randomized controlled trial was initiated in Kenya to determine if full integration (FI) of HIV care, including HAART, into antenatal care (ANC) clinics improves health outcomes among HIV-infected women and exposed infants, compared to a non-integrated (NI) model. This article examines ANC clients' satisfaction with and preferences regarding HIV-integrated services. In this cross-sectional study, pregnant women attending five FI clinics (n=185) and four NI clinics (n=141) completed an interviewer-administered questionnaire following an ANC visit. By self-report, 55 women (17%) were HIV(+), 230 (71%) were HIV(-), and 40 (12%) did not know their HIV status. Among HIV-infected women, 79% attending FI clinics were very satisfied with their clinic visit compared to 54% of women attending NI clinics (P=0.044); no such difference was found among HIV-uninfected women. In multivariate analysis, overall satisfaction was also independently associated with satisfaction with administrative staff, satisfaction with health care providers, positive evaluation of wait time, and having encountered a receptionist. Full integration of HIV care into antenatal clinics can significantly increase overall satisfaction with care for HIV-infected women, with no significant decrease in satisfaction for HIV-uninfected women served in the same clinics.

Fertility intentions and interest in integrated family planning services among women living with HIV in Nyanza Province, Kenya: a qualitative study.

Despite increasing efforts to address the reproductive health needs of people living with HIV, a high unmet need for contraception exists among HIV+ women in sub-Saharan Africa. This study explores the fertility intentions and family planning (FP) preferences of Kenyan women accessing HIV treatment. We conducted 30 semistructured interviews and qualitatively analyzed the data with a grounded theory approach. Fears of premature death, financial hardship, and perinatal HIV transmission emerged as reasons for participants' desire to delay/cease childbearing. Participants strongly identified FP needs, yet two-thirds were using male condoms alone or no modern method of contraception. Women preferred the HIV clinic as the site of FP access for reasons of convenience, provider expertise, and a sense of belonging, though some had privacy concerns. Our findings support the acceptability of integrated FP and HIV services. Efforts to empower women living with HIV to prevent unintended pregnancies must expand access to contraceptive methods, provide confidential services, and take into account women's varied reproductive intentions.

Biomarkers for recurrent pressure injury risk in persons with spinal cord injury.

Objective: To investigate potential linkages between pressure injury (PrI) recurrence following spinal cord injury (SCI) and muscle-based and circulatory biomarkers, specifically fatty metabolites and inflammatory cytokines. Design: Observational study. Setting: Tertiary Care Center. Participants: 30 individuals with complete or incomplete SCI. Study participants either had never developed a PrI (Group I) or had a history of recurrent PrI (Group II). Interventions: Not applicable. Outcome Measures: Gluteal muscle histology, immunohistochemistry, muscle-based and circulatory fatty metabolites and inflammatory cytokines. Results: Gluteal intramuscular adipose tissue (IMAT) was greater than 15% in most Group II (83%) individuals. Muscle tissue histology confirmed intramuscular structural differences. Fatty acid binding protein 4 (FABP4) and fatty acid binding protein 3 (FABP3) were reliably detected in muscle and blood and significantly correlated with IMAT (P < 0.001). FABP4 was significantly higher in Group II muscle and blood (P < 0.05). FABP3 was significantly higher in Group I muscle (P < 0.05). Circulatory FABP3 levels were lower for Group I. Inflammatory biomarkers were more reliably detected in blood. Colony-Stimulating Factor-1 was slightly higher in Group II muscle. Circulatory interleukin-13 was significantly higher (P < 0.01) in Group I. Vascular endothelial growth factor (VEGF-A) was significantly increased (P < 0.05) in Group I muscle and blood. Conclusion: Identifying individuals with SCI at highest risk for recurrent PrI may impact patient management. IMAT content evaluation illustrates that muscle quality is a key biomarker. Low circulatory inflammatory biomarker expression potentially limits clinical significance for between group differences. Circulatory levels of FABP4 hold great potential as a recurrent PrI risk biomarker.

Reaching at-risk women for PrEP delivery: What can we learn from clinical trials in sub-Saharan Africa?

INTRODUCTION: ARV-based pre-exposure prophylaxis (PrEP) has the potential to avert many new HIV infections, yet little is known about how to reach women at high risk for HIV infection and motivate them to initiate PrEP. Clinical trials have succeeded in recruiting at-risk participants, evidenced by control arm HIV incidence ≥3% (defined by the World Health Organization as "substantial risk"). We examined experiences from HIV prevention trials to document recruitment strategies and identify practical, potentially effective strategies for reaching women in real-world PrEP delivery. METHODS: We conducted semi-structured qualitative phone interviews with 31 staff from five countries who had worked on one or more of seven ARV-based HIV prevention clinical trials. Questions explored recruitment strategies used to reach women at risk of HIV and to successfully communicate about PrEP (inclusive of oral and vaginal formulations). We structurally coded data in NVivo and analyzed codes to derive themes. We conducted results interpretation webinars with research and programmatic stakeholders to validate findings and develop recommendations. RESULTS: Clinical trial researchers employed a range of recruitment strategies to recruit at-risk women. They recommended engaging the local community and potential PrEP users via community events, meetings with gatekeepers, and use of community advisory boards; and they encouraged interpersonal communication like presentations in waiting rooms and door-to-door recruitment to address personal concerns and prevent misinformation. Participants also stressed the importance of addressing the challenges that already exist within the health system to create a more enabling environment and delivering positive messages through a variety of communication channels to normalize PrEP. CONCLUSIONS: Findings from this study provide important insights into potentially effective ways for countries currently rolling out oral PrEP to reach at-risk women with information about PrEP and promote uptake.

PrEP Communications Accelerator: a digital demand creation tool for sub-Saharan Africa.

Background Strategic communications are critical for successful market introduction of oral pre-exposure prophylaxis (PrEP). This paper focuses on the OPTIONS Consortium's approach to developing the PrEP Communications Accelerator, a digital tool that provides communication strategies and tools for generating demand for PrEP across sub-Saharan Africa. METHODS: The PrEP Communications Accelerator was developed through needs assessment, communications landscape and gap analysis, market research and content development and testing. Stakeholder consultations across multiple African countries and audiences were conducted to validate and refine findings at each step. RESULTS: The PrEP Communications Accelerator provides customised communications plans that vary by target audience (adolescent girls and young women, female sex workers, serodiscordant couples, men who have sex with men, people who inject drugs and the general population) and by setting (clinic, community, subnational or national level). Users of the interactive tool receive custom-built demand creation strategy guidance, including suggested media channels and communication tactics based on available evidence about the population and setting. DISCUSSION: The PrEP Communications Accelerator is a digital demand creation tool intended to equip those who work in resource- and time-constrained environments with the evidence-based guidance needed to jump-start local demand creation efforts. The tool provides guidance on strategic PrEP communications for target audiences most at risk of HIV infection, as well as a broad profile of the general population to cultivate support for PrEP as a new public health product.

Impact of Partner-Related Social Harms on Women's Adherence to the Dapivirine Vaginal Ring During a Phase III Trial.

BACKGROUND: Long-acting female-initiated methods such as the dapivirine ring may give women greater agency in HIV-1 prevention. However, social harms, defined as nonmedical adverse consequences of study participation or dapivirine ring use, may reduce product adherence and consequently HIV-1 protection. METHODS: We assessed whether experiencing social harms from male partners was associated with lower adherence to the dapivirine ring in the MTN-020/ASPIRE trial. Reports of social harms were solicited quarterly. Low adherence was defined by plasma dapivirine levels ≤95 pg/mL or residual dapivirine levels in returned rings >23.5 mg. RESULTS: Among 2629 women enrolled in ASPIRE, 85 (3.2%) reported 87 social harms during a median follow-up of 1.6 years. Women were significantly more likely to have low adherence, measured by plasma dapivirine levels, at visits with a social harm in the past month than at visits where no social harm was reported (adjusted risk ratio 2.53, 95% confidence interval: 1.37 to 4.66, P = 0.003). There was no association for social harms reported ≥1 month prior, suggesting an acute, short-term effect. Women were significantly more likely to not return a ring at visits with a social harm reported (adjusted risk ratio 24.70, 95% confidence interval: 18.57 to 32.85, P < 0.001). In rings that were returned, social harms were not associated with residual dapivirine levels. CONCLUSIONS: Although social harms were uncommon (<5% of women with >1 year of use), participants reporting social harms by male partners had lower adherence to the dapivirine ring. Strategies to mitigate nonadherence to product use related to social harms should be evaluated in future studies of female-controlled HIV-1 prevention options.

Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial.

BACKGROUND: Placebo-controlled HIV-1 prevention trials of pre-exposure prophylaxis (PrEP) have not generally used concurrent measurement of adherence because of the potential risk of unblinding. However, several pre-exposure prophylaxis trials for HIV-1 prevention among women failed to show effectiveness because of low product adherence. Evaluation of product adherence objectively during a study provides the opportunity for strengthening adherence activities at sites having low adherence. METHODS: During MTN-020/ASPIRE, a phase III, placebo-controlled trial of the dapivirine intravaginal ring, we implemented an adherence monitoring system. Monitoring began in quarter 1 (Q1) 2013 and continued through the conclusion of the trial. Blood plasma was collected quarterly and tested for dapivirine concentrations while maintaining blinding among study team members involved in participant management. Dapivirine concentrations >95 pg/mL, reflecting >8 hours of continuous use, were assessed as signaling product use. Study leadership monitored results on a monthly basis and provided feedback to site investigators. Experiences were shared across sites to motivate staff and counsel participants to strive toward higher adherence levels. RESULTS: An upward trend in adherence was observed (P < 0.0001); the proportion of samples from subjects in the active arm with dapivirine >95 pg/mL increased from 63% in Q1 2013 to 84% by Q1 2015. CONCLUSIONS: Ongoing drug level testing as a marker of adherence in MTN-020/ASPIRE demonstrates the feasibility of real-time adherence monitoring while maintaining study blinding at the level of participants, sites, and study leadership. This approach is novel for large-scale effectiveness studies for HIV-1 prevention.

Characteristics of Women Enrolled into a Randomized Clinical Trial of Dapivirine Vaginal Ring for HIV-1 Prevention.

INTRODUCTION: Women in sub-Saharan Africa are a priority population for evaluation of new biomedical HIV-1 prevention strategies. Antiretroviral pre-exposure prophylaxis is a promising prevention approach; however, clinical trials among young women using daily or coitally-dependent products have found low adherence. Antiretroviral-containing vaginal microbicide rings, which release medication over a month or longer, may reduce these adherence challenges. METHODS: ASPIRE (A Study to Prevent Infection with a Ring for Extended Use) is a phase III, randomized, double-blind, placebo-controlled trial testing the safety and effectiveness of a vaginal ring containing the non-nucleoside reverse transcriptase inhibitor dapivirine for prevention of HIV-1 infection. We describe the baseline characteristics of African women enrolled in the ASPIRE trial. RESULTS: Between August 2012 and June 2014, 5516 women were screened and 2629 HIV-1 seronegative women between 18-45 years of age were enrolled from 15 research sites in Malawi, South Africa, Uganda, and Zimbabwe. The median age was 26 years (IQR 22-31) and the majority (59%) were unmarried. Nearly 100% of participants reported having a primary sex partner in the prior three months but 43% did not know the HIV-1 status of their primary partner; 17% reported additional concurrent partners. Nearly two-thirds (64%) reported having disclosed to primary partners about planned vaginal ring use in the trial. Sexually transmitted infections were prevalent: 12% had Chlamydia trachomatis, 7% Trichomonas vaginalis, 4% Neisseria gonorrhoeae, and 1% syphilis. CONCLUSIONS: African HIV-1 seronegative women at risk of HIV -1 infection were successfully enrolled into a phase III trial of dapivirine vaginal ring for HIV-1 prevention.

Delivered volumes of enteral nutrition exceed prescribed volumes.

BACKGROUND: Enteral nutrition (EN) provisions are typically calculated based on a 24-hour infusion period. However, feedings are often interrupted for daily activities, procedures, or gastrointestinal intolerance. The study's objective was to determine the delivered EN quantities provided to stable hospitalized patients, using cellular time and measured volumes to verify our EN calculation adjustment. METHODS: A supply of consecutively numbered ready-to-hang (RTH) EN product was delivered to the bedside of 26 inpatients with established EN tolerance at goal rates on various types of nursing units. The dietitian weighed the volume remaining in the infusing product and recorded the measurement time. On the following days, the dietitian continued to weigh the infusing RTH product and the empty RTH bottles saved by nursing. The primary outcome was the difference between the prescribed and delivered EN provisions, which was calculated with a paired t test. RESULTS: Patients received significantly more calories in the delivered enteral feeding (mean [SD], 1678 [385] kcal) than prescribed calories in the EN order (1489 [246 kcal]; t = 3.736, P = .001), adjusting for observed time. No significant differences were found between nursing units, product, and rate. CONCLUSION: EN delivered may actually exceed ordered amounts by 5%­21% (mean, 12%) with feeding pump inaccuracy as the primary contributing factor. This differs from what others have found. Our findings support using a volume-based ordering system vs a rate-based ordering system for more accurate EN delivery.

Women's experiences with oral and vaginal pre-exposure prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa.

BACKGROUND: In VOICE, a multisite HIV pre-exposure prophylaxis (PrEP) trial, plasma drug levels pointed to widespread product nonuse, despite high adherence estimated by self-reports and clinic product counts. Using a socio-ecological framework (SEF), we explored socio-cultural and contextual factors that influenced participants' experience of daily vaginal gel and oral tablet regimens in VOICE. METHODS: In Johannesburg, a qualitative ancillary study was concurrently conducted among randomly selected VOICE participants assigned to in-depth interviews (n = 41), serial ethnographic interviews (n = 21), or focus group discussions (n = 40). Audiotaped interviews were transcribed, translated, and coded thematically for analysis. RESULTS: Of the 102 participants, the mean age was 27 years, and 96% had a primary sex partner with whom 43% cohabitated. Few women reported lasting nonuse, which they typically attributed to missed visits, lack of product replenishments, and family-related travel or work. Women acknowledged occasionally skipping or mistiming doses because they forgot, were busy, felt lazy or bored, feared or experienced side effects. However, nearly all knew or heard of other study participants who did not use products daily. Three overarching themes emerged from further analyses: ambivalence toward research, preserving a healthy status, and managing social relationships. These themes highlighted the profound and complex meanings associated with participating in a blinded HIV PrEP trial and taking antiretroviral-based products. The unknown efficacy of products, their connection with HIV infection, challenges with daily regimen given social risks, lack of support-from partners and significant others-and the relationship tradeoffs entailed by using the products appear to discourage adequate product use. CONCLUSIONS: Personal acknowledgment of product nonuse was challenging. This qualitative inquiry highlighted key influences at all SEF levels that shaped women's perceptions of trial participation and experiences with investigational products. Whether these impacted women's behaviors and may have contributed to ineffective trial results warrants further investigation.

Providers' Perspectives on Provision of Family Planning to HIV-Positive Individuals in HIV Care in Nyanza Province, Kenya.

Objective. To inform an intervention integrating family planning into HIV care, family planning (FP) knowledge, attitudes and practices, and perspectives on integrating FP into HIV care were assessed among healthcare providers in Nyanza Province, Kenya. Methods. Thirty-one mixed-method, structured interviews were conducted among a purposive sample of healthcare workers (HCWs) from 13 government HIV care facilities in Nyanza Province. Structured questions and case scenarios assessed contraceptive knowledge, training, and FP provision experience. Open-ended questions explored perspectives on integration. Data were analyzed descriptively and qualitatively. Results. Of the 31 HCWs interviewed, 45% reported previous FP training. Few providers thought long-acting methods were safe for HIV-positive women (19% viewed depot medroxyprogesterone acetate as safe and 36% viewed implants and intrauterine contraceptives as safe); fewer felt comfortable recommending them to HIV-positive women. Overall, providers supported HIV and family planning integration, yet several potential barriers were identified including misunderstandings about contraceptive safety, gendered power differentials relating to fertility decisions, staff shortages, lack of FP training, and contraceptive shortages. Conclusions. These findings suggest the importance of considering issues such as patient flow, provider burden, commodity supply, gender and cultural issues affecting FP use, and provider training in FP/HIV when designing integrated FP/HIV services in high HIV prevalence areas.