Publications by authors named "Baeten J"
Leachables in drug products and from medical devices can adversely affect patient health and thus must be identified and quantified. Accurate and protective quantitation in target analysis for leachables (and extractables as potential leachables) is accomplished via compound-specific calibration curves. Quantification in non-targeted analysis (NTA) is complicated by the variable relative response factors (RRFs) among and between individual leachables and the circumstance that the leachables are not known until the NTA is completed.
View Article and Find Full Text PDFBackground: Adherence to daily oral pre-exposure prophylaxis (PrEP) is low among African young women, and layered support strategies are needed to improve PrEP adherence in this population. We aimed to evaluate potentially scalable adherence-support strategies for young women aged 18-25 years who initiated PrEP in Johannesburg, South Africa.
Methods: We conducted a sequential multiple-assignment randomised trial at Ward 21 of the Wits Reproductive Health and HIV Institute clinical research site, affiliated with University of the Witwatersrand, Johannesburg, South Africa.
Background: Twice-yearly subcutaneous lenacapavir has been shown to be efficacious for prevention of HIV infection in cisgender women. The efficacy of lenacapavir for preexposure prophylaxis (PrEP) in cisgender men, transgender women, transgender men, and gender-nonbinary persons is unclear.
Methods: In this phase 3, double-blind, randomized, active-controlled trial, we randomly assigned participants in a 2:1 ratio to receive subcutaneous lenacapavir every 26 weeks or daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF).
Article Synopsis
- - Women-initiated HIV-1 prevention methods, like vaginal microbicides, have shown limited effectiveness in clinical trials, with hypotheses suggesting that efficacy dilution is a key issue.
- - A microsimulation model analyzed the MTN-020/ASPIRE trial of a dapivirine vaginal ring, identifying factors causing efficacy dilution, such as risk variability, product non-adherence, and differences in sexual behavior between study groups.
- - The study found that heterogeneity in risk was the primary contributor to efficacy dilution (42%), highlighting the need for better trial designs in future research to address this bias.
Background: Complex antiretroviral therapy (ART) regimens, such as those requiring multiple tablets, several doses per day, or both, can negatively affect quality of life and treatment adherence among people with human immunodeficiency virus (HIV).
Methods: ARTISTRY-1 is a phase 2/3, operationally seamless, randomized, open-label, multicenter, active-controlled study (GS-US-621-6289; NCT05502341). Phase 2 of the study enrolled adults with plasma HIV-1 RNA <50 copies/mL receiving a complex ART regimen for ≥6 months.
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.
Article Synopsis
- Product adherence significantly impacts the accurate evaluation of HIV-1 prevention methods like the dapivirine vaginal ring, with varying levels of adherence leading to biased efficacy estimates.* -
- In the MTN-020/ASPIRE trial, per-protocol analyses indicated a 30.8% efficacy, while those with the highest adherence showed an efficacy of 53.6% when analyzing drug release from the ring.* -
- Advanced statistical methods, such as principal stratification and marginal structural models, enhance our understanding of HIV-1 prevention effectiveness in clinical trials by adjusting for adherence levels.*
Article Synopsis
- The study investigated the accuracy of HIV point-of-care testing among African women using various contraceptive methods, focusing on the occurrence of true and false positive results.
- Out of 48,234 visits by 7,730 women, true positive results were found in only 0.9% of cases, while false positives occurred in 0.2%, necessitating additional confirmatory testing.
- The findings emphasize the need for confirmatory tests, as not all HIV infections presented typical laboratory results, particularly in populations with low HIV prevalence and repeat testing.
Purpose Of Review: This review summarizes differentiated service delivery (DSD) models for HIV treatment and prevention that have been adapted for maintaining continuity of services during the COVID-19 pandemic and proposes strategies for sustaining their benefits now and during future disruptions.
Recent Findings: The COVID-19 pandemic resulted in an overburdened and disrupted health system, forcing countries to adopt and/or scale up DSD models for HIV services. While initially implemented as emergency measures, these models evolved and were refined over time to fit recipient needs ensuring continued HIV treatment and prevention services with minimal health system impact.
Background: There are gaps in uptake of, adherence to, and persistence in the use of preexposure prophylaxis for human immunodeficiency virus (HIV) prevention among cisgender women.
Methods: We conducted a phase 3, double-blind, randomized, controlled trial involving adolescent girls and young women in South Africa and Uganda. Participants were assigned in a 2:2:1 ratio to receive subcutaneous lenacapavir every 26 weeks, daily oral emtricitabine-tenofovir alafenamide (F/TAF), or daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF; active control); all participants also received the alternate subcutaneous or oral placebo.
Background: Data characterising the long-term use and safety of emtricitabine plus tenofovir disoproxil fumarate as daily oral pre-exposure prophylaxis (PrEP) are scarce and there are uncertainties regarding the value of routine HIV-1 RNA testing during oral PrEP follow-up.
Methods: The DISCOVER trial was a randomised, controlled, phase 3 trial in which cisgender men and transgender women aged 18 years and older with a high likelihood of acquiring HIV were recruited from 94 clinics in Europe and North America and randomly assigned to receive either emtricitabine plus tenofovir disoproxil fumarate (200/25 mg) tablets daily, with matched placebo tablets, or emtricitabine plus tenofovir alafenamide (200/300 mg) tablets daily, with matched placebo tablets, for at least 96 weeks. After completion of the trial, participants were offered enrolment in this 48-week open-label extension study of emtricitabine plus tenofovir alafenamide.
Introduction: Pharmacy-delivered HIV prevention services might create more options for pregnant women to use HIV prevention tools earlier and more consistently during pregnancy. We quantified preferences for attributes of potential HIV prevention services among women of childbearing age in Western Kenya.
Methods: From June to November 2023, we administered a face-to-face discrete choice experiment survey to women aged 15-44 in Kenya's Homa Bay, Kisumu and Siaya counties.
Article Synopsis
- The Healthy Families-PrEP intervention was designed to promote HIV prevention during the period around conception and pregnancy among women in KwaZulu-Natal, South Africa, enrolling HIV-uninfected women in relationships with partners of unknown HIV status.
- Out of 330 enrolled women, 60% initiated PrEP, with adherence rates varying over time; factors like lower income, alcohol use, and higher HIV stigma negatively impacted adherence.
- Despite some success in PrEP uptake, there were 11 instances of HIV-seroconversions in participants, none of whom had detectable levels of the drug, highlighting the need for improved strategies to reduce HIV risk in this demographic.
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.
Background: Contraceptive use has complex effects on sexual behaviour and mood, including those related to reduced concerns about unintended pregnancy, direct hormonal effects and effects on endogenous sex hormones. We set out to obtain robust evidence on the relative effects of three contraceptive methods on sex behaviours, which is important for guiding contraceptive choice and future contraceptive developments.
Methods: This is a secondary analysis of data from the Evidence for Contraceptive Options and HIV Outcomes (ECHO) randomized trial in which 7,829 HIV-uninfected women from 12 sites in Eswatini, Kenya, South Africa and Zambia seeking contraception were randomly assigned to intramuscular depot-medroxyprogesterone acetate (DMPA-IM), the copper intrauterine device (Cu-IUD) or the levonorgestrel (LNG) implant.
Article Synopsis
- - The study measured tenofovir (TFV) concentrations in hair as a way to track adherence to HIV preexposure prophylaxis during pregnancy and after childbirth.
- - Researchers collected hair samples from 102 women and compared them with dried blood spots (DBSs) to evaluate the effectiveness of this method.
- - Results showed that having an HIV-positive partner increased hair TFV levels significantly, and there was a strong correlation between hair TFV concentrations and DBS TFV-diphosphate levels, suggesting hair analysis is a reliable adherence indicator.
Article Synopsis
- Adolescent girls and young women in Africa are highly interested in using pre-exposure prophylaxis (PrEP) for HIV prevention but face challenges in maintaining consistent usage; understanding their preferences for PrEP delivery methods is crucial to improving access.
- The POWER implementation study in Cape Town examined how AGYW (ages 16-25) accessed PrEP from various platforms, including mobile clinics, government facilities, courier services, and community-based youth clubs, collecting data through in-depth interviews.
- Findings revealed four behavioral profiles among PrEP-users: "Social PrEP-users" seek peer support, "Convenient PrEP-users" prefer accessible and quick services, and "Independent PrEP-users" value control over delivery times, indicating diverse needs
Background: Oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (F/TDF) has high efficacy against HIV-1 acquisition. Seventy-two prospective studies of daily oral F/TDF PrEP were conducted to evaluate HIV-1 incidence, drug resistance, adherence, and bone and renal safety in diverse settings.
Methods: HIV-1 incidence was calculated from incident HIV-1 diagnoses after PrEP initiation and within 60 days of discontinuation.
Real-time electronic adherence monitoring involves "smart" pill boxes that record and monitor openings as a proxy for pill taking and may be useful in understanding and supporting PrEP use; however, acceptability and/or feasibility for PrEP users is uncertain. We sought to understand the experiences of using a real-time electronic adherence monitor for PrEP delivery among young women in Kisumu and Thika, Kenya. We used the Wisepill device to monitor PrEP use among 18-24-year-old women for two years.
View Article and Find Full Text PDFIntroduction: 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.
Methods: 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.
Importance: Emtricitabine and tenofovir disoproxil fumarate (F/TDF) for HIV preexposure prophylaxis (PrEP) is highly effective in cisgender men who have sex with men (MSM) when adherence is high (>4 doses/week). Real-world effectiveness and adherence with F/TDF for PrEP in cisgender women is less well characterized.
Objective: To characterize the effectiveness of F/TDF for PrEP and its relationship with adherence in cisgender women.
Background: Oral pre-exposure prophylaxis (PrEP) and male partner HIV self-testing (HIVST) is being scaled up within antenatal clinics. Few data are available on how co-distribution influences acceptance of both interventions.
Methods: We used data from the PrEP Implementation of Mothers in Antenatal Care (NCT03070600) trial in Kenya.
Introduction: Young women in sub-Saharan Africa are a priority population for HIV prevention, yet challenges with adherence and persistence to HIV pre-exposure prophylaxis (PrEP) are common. This study involved the development and pilot testing of My Way-a novel delivery system for PrEP and co-packaged sexual health services.
Methods: My Way was developed in Kisumu, Kenya through a user-centred design process (2020).
Article Synopsis
- The study explores a long-acting HIV treatment combining broadly neutralising antibodies (bNAbs) with lenacapavir, aiming for improved patient adherence and viral suppression.
- Conducted at 11 treatment centers in the USA, the phase 1b trial included adults who had maintained viral suppression with oral antiretroviral therapy and were tested for their reaction to the bNAbs.
- Out of 21 participants, no serious adverse events were noted, while some mild reactions occurred, indicating the treatment's potential safety and feasibility for long-term use.
Background: Doxycycline postexposure prophylaxis (PEP) has been shown to prevent sexually transmitted infections (STIs) among cisgender men and transgender women, but data from trials involving cisgender women are lacking.
Methods: We conducted a randomized, open-label trial comparing doxycycline PEP (doxycycline hyclate, 200 mg taken within 72 hours after condomless sex) with standard care among Kenyan women 18 to 30 years of age who were receiving preexposure prophylaxis against human immunodeficiency virus (HIV). The primary end point was any incident infection with , , or .