Dataset Information

Point-of-Care Test for Assessing Tenofovir Adherence: Feasibility and Recommendations from Women in an Oral PrEP Program in Kenya and Their Healthcare Providers.

ABSTRACT: Oral pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention modality when taken as recommended. Women in sub-Saharan Africa may have adherence challenges that remain undisclosed to providers. Real-time measures that identify non-adherence can allow for immediate exploration of adherence challenges, counseling and interventions. We conducted a formative qualitative study in Kenya to explore oral PrEP experiences and reactions to a point-of-care urine test (UT) identifying recent (past 4 days) non-adherence to tenofovir-based PrEP among female PrEP users (25 in-depth interviews; 4 focus groups) and health care provider (10 key informant interviews). Findings indicate that use of the UT would be highly feasible in the context of regular PrEP care, largely acceptable to clients and providers, and could improve adherence. Clients emphasized the need for transparent client-centered strategies in delivering results. This formative study informs the development of tools to implement this point-of-care UT in future interventional studies and clinical settings.

SUBMITTER: Thuo N

PROVIDER: S-EPMC9271229 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Point-of-Care Test for Assessing Tenofovir Adherence: Feasibility and Recommendations from Women in an Oral PrEP Program in Kenya and Their Healthcare Providers.

Thuo Nicholas N Polay Madison M Leddy Anna M AM Ngure Kenneth K Chatterhee Purba P Gandhi Monica M Amico K Rivet KR

AIDS and behavior 20210424 11

Oral pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention modality when taken as recommended. Women in sub-Saharan Africa may have adherence challenges that remain undisclosed to providers. Real-time measures that identify non-adherence can allow for immediate exploration of adherence challenges, counseling and interventions. We conducted a formative qualitative study in Kenya to explore oral PrEP experiences and reactions to a point-of-care urine test (UT) identifying recent (pa ...[more]

PMID: 33893877

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Project description:BackgroundA novel point-of-care ultrasound (PoCUS) training program was developed to train rural healthcare providers in Kenya on the Focused Assessment with Sonography for Trauma (FAST), thoracic ultrasound, basic echocardiography, and focused obstetric ultrasonography. The program includes a multimedia manual, pre-course testing, 1-day hands-on training, post-testing, 3-month post-course evaluation, and scheduled refresher training. This study evaluates the impact of the course on PoCUS knowledge and skills. Competency results were compared based on number of previous training/refresher sessions and time elapsed since prior training.MethodsTrainees were evaluated using a computer-based, 30 question, multiple-choice test, a standardized observed structured clinical exam (OSCE), and a survey on their ultrasound use over the previous 3 months.ResultsThirty-three trainees were evaluated at 21 different facilities. All trainees completed the written exam, and 32 completed the OSCE. Nine trainees out of 33 (27.3%) passed the written test. Trainees with two or more prior training sessions had statistically significant increases in their written test scores, while those with only one prior training session maintained their test scores. Time elapsed since last training was not associated with statistically significant differences in mean written test scores. Mean image quality scores (95% confidence interval) were 2.65 (2.37-2.93) for FAST, 2.41 (2.03-2.78) for thoracic, 2.22 (1.89-2.55) for cardiac, and 2.95 (2.67-3.24) for obstetric exams. There was a trend towards increased mean image quality scores with increases in the number of prior training sessions, and a trend towards decreased image quality with increased time elapsed since previous training. Forty percent of trainees reported performing more than 20 scans in the previous 3 months, while 22% reported less than 10 scans in the previous 3 months. Second and third trimester focused obstetric ultrasound was the most frequently performed scan type. Frequency of scanning was positively correlated with written test scores and image quality scores.ConclusionThis novel training program has the potential to improve PoCUS knowledge and skills amongst rural healthcare providers in Kenya. There is an ongoing need to increase refresher/re-training opportunities and to enhance frequency of scanning in order to improve PoCUS competency.

Project description:BackgroundAdherence challenges with oral tenofovir-based pre-exposure prophylaxis (PrEP) are common. We developed a point-of-care assay to objectively assess tenofovir in urine and conducted a pilot trial examining the impact of counselling informed by use of this urine assay on long-term PrEP adherence.MethodsThis randomised trial enrolled women not in serodiscordant partnerships 3 months after PrEP initiation at the Kenya Medical Research Institute to compare standard-of-care adherence counselling versus counselling informed by the urine assay (urine-test counselling group) every 3 months for 12 months. In the standard of care group, urine samples were stored and tested at study end without participant feedback. Here we report the adherence primary outcome of hair concentrations of tenofovir at 12 months as a long-term metric (undetectable levels defined long-term non-adherence), as well as urine concentrations of tenofovir at each visit as a short-term adherence metric and acceptability of the assay assessed by quantitative surveys. Data were analysed by randomisation group. This completed trial was registered with ClinicalTrials.gov (NCT03935464).FindingsFrom March 17, 2021 to Jan 18, 2022 we enrolled 49 women in the urine-test counselling group and 51 in the standard of care group; retention was 86 (86%) of 100. Nine (21%) of 42 in the urine-test counselling group had hair samples at 12 months with tenofovir concentrations below the limit of quantification compared with 15 (37%) of 41 in the standard of care group. The relative odds of long-term non-adherence in the standard of care group compared with urine-test counselling were 3·53 (95% CI 1·03-12·03; p=0·044). Pre-intervention, urine tenofovir was detectable in 65% in the urine-test counselling group and 71% in the standard of care group (p=0·68). At 12 months, 31 (72%) of 43 in the intervention group had detectable urine tenofovir compared with 19 (45%) of 42 in the standard of care group (p=0·0015). 40 (93%) of 43 participants liked the test very much and only one disliked the test. One participant in the standard of care group was withdrawn at the 6-month visit due to HIV seroconversion.InterpretationA low-cost urine tenofovir assay to inform PrEP counselling resulted in improvement in both short-term and long-term metrics of adherence. This urine tenofovir assay could help to improve long-term PrEP adherence.FundingNational Institute of Allergy and Infectious Diseases and National Institutes of Health.

Project description:IntroductionHIV incidence remains high among African adolescent girls and young women (AGYW), who would benefit from pre-exposure prophylaxis (PrEP). Strategies to increase PrEP adherence and persistence need to be evaluated in African AGY, including incentives conditional on high adherence.MethodsThe 3Ps for Prevention Study was a 12-month prospective cohort of 200 women ages 16 to 25 initiating PrEP in South Africa from 2017 to 2018. Participants received retrospective feedback about drug levels at Months 1, 2 and 3; half was randomized to receive a 200 Rand shopping voucher ($13 US) at Months 2, 3 and 4, conditioned on high intracellular tenofovir diphosphate (TFV-DP) levels in dried blood spots (≥500 fmol/punch at Month 1, ≥700 fmol/punch at Months 2 and 3). The primary analysis was intention-to-treat, comparing the proportion with high PrEP adherence (≥700 fmol/punch) at Month 3 by randomized group, based on 100% efficacy among men who have sex with men.ResultsMedian age of the 200 women was 19 years (interquartile range [IQR] 17, 21); 86% had a primary sexual partner. At Month 3, the mean TFV-DP level was 822 fmol/punch (SD 522) in the incentive group and 689 fmol/punch (SD 546) in the control group (p = 0.11). Forty-five (56%) of 85 women in the incentive group and 35 (41%) of 85 women in the control group had TFV-DP levels ≥700 fmol/punch (RR 1.35; 95% CI 0.98, 1.86; p = 0.067), which declined to 8% and 5% in the incentive and control groups at Month 12 (no significant difference by arm). 44% refilled PrEP without gaps, 14% had a gap of ≥3 weeks in coverage subsequently restarted PrEP and 54% accepted at the final dispensing visit at Month 9. No new HIV infections were observed after PrEP initiation.ConclusionsAmong South African AGYW initiating PrEP, drug levels indicated high PrEP adherence in almost half of women at Month 3, with a non-statistically significant higher proportion with high adherence among those in the incentive group. Over half persisted with the 12-month PrEP programme although high adherence declined after Month 3. Strategies to support PrEP adherence and persistence and longer-acting PrEP formulations are needed.

Project description:BackgroundUltrasound is a crucial and effective diagnostic tool in medicine. Recent advancements in technology have led to increased use of point-of-care ultrasound (POCUS). Access to ultrasound equipment and training programs in low-and middle-income countries (LMICs) is limited. Despite the World Health Organization (WHO) recommendations for universal antenatal ultrasounds, POCUS for reproductive health applications has not been widely used in LMICs. We describe here the feasibility of implementation of a training of obstetrics point-of-care ultrasound (OB POCUS) for high-risk conditions in rural public healthcare facilities in Kenya with partnership from Butterfly Network, Global Ultrasound Institute, and Kenyatta University.MethodsAs part of the initiation of a large-scale implementation study of OB POCUS, clinician trainees were recruited from rural Kenyan hospitals for participation in a series of five-day POCUS workshops held between September and December 2022. Trainers provided brief didactic lessons followed by hands-on training with live models and at regional clinical sites for 5 OB POCUS applications. Instructor-observed assessment of students' scanning and image interpretation occurred over the training period. Assessment of knowledge and confidence was performed via an online pre-test and post-test as well as Objective Structured Clinical Examination (OSCE) was administered at course completion.ResultsFive hundred and fourteen mid-level Health Care Providers (HCPs) in Kenya were trained over a three-month period through in-person didactic sessions, bedside instruction, and clinical practice over a 5-day period with a trainer: trainee ratio of approximately 1:5. Out of the 514 trained HCPs, 468 were from 8 rural counties with poor maternal and neonatal outcomes, while the remaining 46 were from nearby facilities. OB POCUS topics covered included: malpresentation, multiple gestation, fetal cardiac activity, abnormalities of the placenta and amniotic fluid volume. There was marked improvement in the post training test scores compared to the pretest scores.ConclusionOur implementation description serves as a guide for successful rapid dissemination of OB POCUS training for mid-level providers. Our experience demonstrates the feasibility of a short intensive POCUS training to rapidly establish specific POCUS skills in efforts to rapidly scale POCUS access and services. There is a widespread need for expanding access to ultrasound in pregnancy through accessible OB POCUS training programs. An implementation study is currently underway to assess the patient and systems-level impact of the training.

Project description:IntroductionMale clients (MCs) are integral to sex work-driven HIV transmission dynamics as sexual partners of female sex worker (FSW). MCs contribute disproportionately to incident HIV globally and in sub-Saharan Africa, with 27% of new infections attributed to MCs of FSW and other partners of key populations. Gaps in coverage of HIV testing and prevention services for men, including MCs, are well-documented, yet research and innovative interventions to improve MC uptake of effective prevention services, including pre-exposure prophylaxis (PrEP), are scarce.Methods and analysisMPrEP+ is a cohort study designed to assess the feasibility and acceptability of a PrEP-focused HIV prevention strategy providing daily oral tenofovir/emtricitabine (TDF/FTC) in combination with three adherence self-management interventions: (1) use of a validated point-of-care urine drug-level assay with real-time feedback and tailored self-management counselling; (2) frequent HIV self-testing; and (3) weekly one-way text messaging. This package of interventions is being delivered to 120 MCs enrolled in the study in Kisumu, Kenya over a 6-month period. The primary outcome is PrEP adherence at 6 months as measured by PrEP drug levels. Bivariate and multivariable regression models will be used to identify predictors of PrEP adherence. We will also explore associations of sociodemographic characteristics and PrEP beliefs with PrEP adherence.Ethics and disseminationThe study was approved by the Columbia University Irving Medical Center Institutional Review Board and the Maseno University Ethical Review Committee. Study enrolment was initiated in November 2021 with participant follow-up planned through August 2022. Study results will be submitted for publication in peer-reviewed journals. Summaries and infographics of study findings will be developed and distributed to MC, FSW and stakeholders working in HIV prevention and support for people who sell and buy sex, including Kenya's Ministry of Health.Trial registration numberNCT04898699; Registered on 24 May 2021.

Dataset Information

Point-of-Care Test for Assessing Tenofovir Adherence: Feasibility and Recommendations from Women in an Oral PrEP Program in Kenya and Their Healthcare Providers.

Publications

Point-of-Care Test for Assessing Tenofovir Adherence: Feasibility and Recommendations from Women in an Oral PrEP Program in Kenya and Their Healthcare Providers.

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