1,441 results on '"Haberer, Jessica E"'
Search Results
2. Integrated PrEP and STI Services for Transgender Women in Uganda: Qualitative Findings from a Randomized Trial
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Mujugira, Andrew, Nakyanzi, Agnes, Bagaya, Monica, Mugisha, Jackson, Kamusiime, Brenda, Nalumansi, Alisaati, Kasiita, Vicent, Ssebuliba, Timothy, Nampewo, Olivia, Nsubuga, Rogers, Muwonge, Timothy R., Bukenya, Musa, Gandhi, Monica, Wyatt, Monique A., Ware, Norma C., and Haberer, Jessica E.
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- 2024
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3. Factors Affecting the Implementation of Electronic Antiretroviral Therapy Adherence Monitoring and Associated Interventions for Routine HIV Care in Uganda: Qualitative Study
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Haberer, Jessica E, Garrison, Lindsey, Tumuhairwe, John Bosco, Baijuka, Robert, Tindimwebwa, Edna, Tinkamanyire, James, Burns, Bridget F, and Asiimwe, Stephen
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Computer applications to medicine. Medical informatics ,R858-859.7 ,Public aspects of medicine ,RA1-1270 - Abstract
BackgroundHigh, sustained adherence to HIV antiretroviral therapy (ART) is critical for achieving viral suppression, which in turn leads to important individual health benefits and reduced secondary viral transmission. Electronic adherence monitors record a date-and-time stamp with each opening as a proxy for pill-taking behavior. These monitors can be combined with interventions (eg, data-informed adherence counseling, SMS-based adherence support, and/or alarms) and have been shown to improve adherence in multiple settings. Their use, however, has largely been limited to the research context. ObjectiveThe goal of the research was to use the Consolidated Framework for Implementation Research (CFIR) to understand factors relevant for implementing a low-cost electronic adherence monitor and associated interventions for routine HIV clinical care in Uganda. MethodsWe conducted in-depth qualitative interviews with health care administrators, clinicians, and ART clients about likes and dislikes of the features and functions of electronic adherence monitors and associated interventions, their potential to influence HIV care, suggestions on how to measure their value, and recommendations for their use in routine care. We used an inductive, content analysis approach to understand participant perspectives, identifying aspects of CFIR most relevant to technology implementation in this setting. ResultsWe interviewed 34 health care administrators/clinicians and 15 ART clients. Participants largely saw the monitors and associated interventions as favorable and beneficial for supporting adherence and improving clinical outcomes through efficient, differentiated care. Relevant outside factors included structural determinants of health, international norms around supporting adherence, and limited funding that necessitates careful assessment of costs and benefits. Within the clinic, the adherence data were felt likely to improve the quality of counseling and thereby morale, as well as increase the efficiency of care delivery. Existing infrastructure and care expenditures and the need for proper training were other noted considerations. At the individual level, the desire for good health and a welcomed pressure to adhere favored uptake of the monitors, although some participants were concerned with clients not using the monitors as planned and the influence of poverty, stigma, and need for privacy. Finally, participants felt that decisions around the implementation process would have to come from the Ministry of Health and other funders and would be influenced by sustainability of the technology and the target population for its use. Coordination across the health care system would be important for implementation. ConclusionsLow-cost electronic adherence monitoring combined with data-informed counseling, SMS-based support, and/or alarms have potential for use in routine HIV care in Uganda. Key metrics of successful implementation will include their impact on efficiency of care delivery and clinical outcomes with careful attention paid to factors such as stigma and cost. Further theory-driven implementation science efforts will be needed to move promising technology from research into clinical care. Trial RegistrationClinicalTrials.gov NCT03825952; https://clinicaltrials.gov/ct2/show/NCT03825952
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- 2020
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4. Implementing mHealth Interventions in a Resource-Constrained Setting: Case Study From Uganda
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Meyer, Amanda J, Armstrong-Hough, Mari, Babirye, Diana, Mark, David, Turimumahoro, Patricia, Ayakaka, Irene, Haberer, Jessica E, Katamba, Achilles, and Davis, J Lucian
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Information technology ,T58.5-58.64 ,Public aspects of medicine ,RA1-1270 - Abstract
BackgroundMobile health (mHealth) interventions are becoming more common in low-income countries. Existing research often overlooks implementation challenges associated with the design and technology requirements of mHealth interventions. ObjectiveWe aimed to characterize the challenges that we encountered in the implementation of a complex mHealth intervention in Uganda. MethodsWe customized a commercial mobile survey app to facilitate a two-arm household-randomized, controlled trial of home-based tuberculosis (TB) contact investigation. We incorporated digital fingerprinting for patient identification in both study arms and automated SMS messages in the intervention arm only. A local research team systematically documented challenges to implementation in biweekly site visit reports, project management reports, and minutes from biweekly conference calls. We then classified these challenges using the Consolidated Framework for Implementation Research (CFIR). ResultsWe identified challenges in three principal CFIR domains: (1) intervention characteristics, (2) inner setting, and (3) characteristics of implementers. The adaptability of the app to the local setting was limited by software and hardware requirements. The complexity and logistics of implementing the intervention further hindered its adaptability. Study staff reported that community health workers (CHWs) were enthusiastic regarding the use of technology to enhance TB contact investigation during training and the initial phase of implementation. After experiencing technological failures, their trust in the technology declined along with their use of it. Finally, complex data structures impeded the development and execution of a data management plan that would allow for articulation of goals and provide timely feedback to study staff, CHWs, and participants. ConclusionsmHealth technologies have the potential to make delivery of public health interventions more direct and efficient, but we found that a lack of adaptability, excessive complexity, loss of trust among end users, and a lack of effective feedback systems can undermine implementation, especially in low-resource settings where digital services have not yet proliferated. Implementers should anticipate and strive to avoid these barriers by investing in and adapting to local human and material resources, prioritizing feedback from end users, and optimizing data management and quality assurance procedures. Trial RegistrationPan-African Clinical Trials Registration PACTR201509000877140; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=877
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- 2020
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5. Explaining Differences in the Acceptability of 99DOTS, a Cell Phone–Based Strategy for Monitoring Adherence to Tuberculosis Medications: Qualitative Study of Patients and Health Care Providers
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Thomas, Beena E, Kumar, J Vignesh, Onongaya, Chidiebere, Bhatt, Spurthi N, Galivanche, Amith, Periyasamy, Murugesan, Chiranjeevi, M, Khandewale, Amit Subhash, Ramachandran, Geetha, Shah, Daksha, Haberer, Jessica E, Mayer, Kenneth H, and Subbaraman, Ramnath
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Information technology ,T58.5-58.64 ,Public aspects of medicine ,RA1-1270 - Abstract
Background99DOTS is a cell phone–based strategy for monitoring tuberculosis (TB) medication adherence that has been rolled out to more than 150,000 patients in India’s public health sector. A considerable proportion of patients stop using 99DOTS during therapy. ObjectiveThis study aims to understand reasons for variability in the acceptance and use of 99DOTS by TB patients and health care providers (HCPs). MethodsWe conducted qualitative interviews with individuals taking TB therapy in the government program in Chennai and Vellore (HIV-coinfected patients) and Mumbai (HIV-uninfected patients) across intensive and continuation treatment phases. We conducted interviews with HCPs who provide TB care, all of whom were involved in implementing 99DOTS. Interviews were transcribed, coded using a deductive approach, and analyzed with Dedoose 8.0.35 software (SocioCultural Research Consultants, LLC). The findings of the study were interpreted using the unified theory of acceptance and use of technology, which highlights 4 constructs associated with technology acceptance: performance expectancy, effort expectancy, social influences, and facilitating conditions. ResultsWe conducted 62 interviews with patients with TB, of whom 30 (48%) were HIV coinfected, and 31 interviews with HCPs. Acceptance of 99DOTS by patients was variable. Greater patient acceptance was related to perceptions of improved patient-HCP relationships from increased phone communication, TB pill-taking habit formation due to SMS text messaging reminders, and reduced need to visit health facilities (performance expectancy); improved family involvement in TB care (social influences); and from 99DOTS leading HCPs to engage positively in patients’ care through increased outreach (facilitating conditions). Lower patient acceptance was related to perceptions of reduced face-to-face contact with HCPs (performance expectancy); problems with cell phone access, literacy, cellular signal, or technology fatigue (effort expectancy); high TB- and HIV-related stigma within the family (social influences); and poor counseling in 99DOTS by HCPs or perceptions that HCPs were not acting upon adherence data (facilitating conditions). Acceptance of 99DOTS by HCPs was generally high and related to perceptions that the 99DOTS adherence dashboard and patient-related SMS text messaging alerts improve quality of care, the efficiency of care, and the patient-HCP relationship (performance expectancy); that the dashboard is easy to use (effort expectancy); and that 99DOTS leads to better coordination among HCPs (social influences). However, HCPs described suboptimal facilitating conditions, including inadequate training of HCPs in 99DOTS, unequal changes in workload, and shortages of 99DOTS medication envelopes. ConclusionsIn India’s government TB program, 99DOTS had high acceptance by HCPs but variable acceptance by patients. Although some factors contributing to suboptimal patient acceptance are modifiable, other factors such as TB- and HIV-related stigma and poor cell phone accessibility, cellular signal, and literacy are more difficult to address. Screening for these barriers may facilitate targeting of 99DOTS to patients more likely to use this technology.
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- 2020
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6. Combining Real-Time Ratings With Qualitative Interviews to Develop a Smoking Cessation Text Messaging Program for Primary Care Patients
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Kruse, Gina, Park, Elyse R, Shahid, Naysha N, Abroms, Lorien, Haberer, Jessica E, and Rigotti, Nancy A
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Information technology ,T58.5-58.64 ,Public aspects of medicine ,RA1-1270 - Abstract
BackgroundText messaging (short message service, SMS) interventions show promise as a way to help cigarette smokers quit. Few studies have examined the effectiveness of text messaging (SMS) programs targeting smokers associated with primary care or hospital settings. ObjectiveThis study aimed to develop a text messaging (SMS) program targeting primary care smokers. MethodsAdult smokers in primary care were recruited from February 2017 to April 2017. We sent patients 10 to 11 draft text messages (SMS) over 2 days and asked them to rate each message in real time. Patients were interviewed daily by telephone to discuss ratings, message preferences, and previous experiences with nicotine replacement therapy (NRT). Content analysis of interviews was directed by a step-wise text messaging (SMS) intervention development process and the Information-Motivation-Behavioral Skills model of medication adherence. ResultsWe sent 149 text messages (SMS) to 15 patients. They replied with ratings for 93% (139/149) of the messages: 134 (96%, 134/139) were rated as clear or useful and 5 (4%, 5/139) as unclear or not useful. Patients’ preferences included the addition of graphics, electronic cigarette (e-cigarette) content, and use of first names. Regarding NRT, patients identified informational gaps around safety and effectiveness, preferred positively framed motivational messages, and needed behavioral skills to dose and dispose of NRT. ConclusionsPatients recommended text message (SMS) personalization, inclusion of e-cigarette information and graphics, and identified barriers to NRT use.
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- 2019
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7. Text Messages Sent to Household Tuberculosis Contacts in Kampala, Uganda: Process Evaluation
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Meyer, Amanda J, Babirye, Diana, Armstrong-Hough, Mari, Mark, David, Ayakaka, Irene, Katamba, Achilles, Haberer, Jessica E, and Davis, J Lucian
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Information technology ,T58.5-58.64 ,Public aspects of medicine ,RA1-1270 - Abstract
BackgroundPrevious studies have reported the inconsistent effectiveness of text messaging (short message service, SMS) for improving health outcomes, but few have examined to what degree the quality, or “fidelity,” of implementation may explain study results. ObjectiveThe aim of this study was to determine the fidelity of a one-time text messaging (SMS) intervention to promote the uptake of tuberculosis evaluation services among household contacts of index patients with tuberculosis. MethodsFrom February to June 2017, we nested a process evaluation of text message (SMS) delivery within the intervention arm of a randomized controlled trial of tuberculosis contact investigation in Kampala, Uganda. Because mobile service providers in Uganda do not provide delivery confirmations, we asked household tuberculosis contacts to confirm the receipt of a one-time tuberculosis-related text message (SMS) by sending a text message (SMS) reply through a toll-free “short code.” Two weeks later, a research officer followed up by telephone to confirm the receipt of the one-time text message (SMS) and administer a survey. We considered participants lost to follow-up after 3 unsuccessful call attempts on 3 separate days over a 1-week period. ResultsOf 206 consecutive household contacts, 119 had a text message (SMS) initiated from the server. While 33% (39/119) were children aged 5-14 years, including 20% (24/119) girls and 13% (15/119) boys, 18 % (21/119) were adolescents or young adults, including 12% (14/119) young women and 6% (7/119) young men. 50% (59/119) were adults, including 26% (31/119) women and 24% (28/119) men. Of 107 (90%) participants for whom we could ascertain text message (SMS) receipt status, 67% (72/107) confirmed text message (SMS) receipt, including 22% (24/107) by reply text message (SMS) and 45% (48/107) during the follow-up telephone survey. No significant clinical or demographic differences were observed between those who did and did not report receiving the text message (SMS). Furthermore, 52% (56/107) reported ever reading the SMS. The cumulative likelihood of a text message (SMS) reaching its target and being read and retained by a participant was 19%. ConclusionsThe fidelity of a one-time text message (SMS) intervention to increase the uptake of household tuberculosis contact investigation and linkage to care was extremely low, a fact only discoverable through detailed process evaluation. This study suggests the need for systematic process monitoring and reporting of implementation fidelity in both research studies and programmatic interventions using mobile communications to improve health.
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- 2018
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8. Acceptability and Feasibility of Real-Time Antiretroviral Therapy Adherence Interventions in Rural Uganda: Mixed-Method Pilot Randomized Controlled Trial
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Musiimenta, Angella, Atukunda, Esther C, Tumuhimbise, Wilson, Pisarski, Emily E, Tam, Melanie, Wyatt, Monique A, Ware, Norma C, and Haberer, Jessica E
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Information technology ,T58.5-58.64 ,Public aspects of medicine ,RA1-1270 - Abstract
BackgroundWireless electronic adherence monitors can detect antiretroviral therapy (ART) adherence lapses and trigger interventions in real time, thus potentially avoiding unnecessary HIV viremia. Evidence about the acceptability and feasibility of these monitors and associated interventions, however, is limited. ObjectiveThe aim of this study was to assess the acceptability and feasibility of real-time adherence monitoring linked to text messaging (short message service, SMS) reminders and notifications to support adherence among individuals living with HIV who are taking ART in rural southwestern Uganda. MethodsIndividuals living with HIV who were initiating ART were enrolled in a pilot randomized controlled trial and followed up for 9 months. Participants received a real-time adherence monitor and were randomized to one of the following study arms: (1) scheduled SMS, (2) SMS triggered by missed or delayed doses, or (3) no SMS. SMS notifications were also sent to 45 patient-identified social supporters for sustained adherence lapses in the scheduled SMS and triggered SMS arms. Study participants and social supporters participated in qualitative semistructured in-depth interviews on acceptability and feasibility of this technology. An inductive, content analytic approach, framed by the unified theory of acceptance and use of technology model, was used to analyze qualitative data. Quantitative feasibility data, including device functionality and SMS tracking data, were recorded based upon device metrics collected electronically and summarized descriptively. ResultsA total of 63 participants participated in the study. Participants reported that real-time monitoring intervention linked to SMS reminders and notifications are generally acceptable; the predominant feedback was perceived utility—the intervention was beneficial in motivating and reminding patients to take medication, as well as enabling provision of social support. ConclusionsReal-time adherence monitoring integrated with SMS reminders and social support notifications is a generally acceptable (based primarily on perceived utility) and feasible intervention in a resource-limited country. Future efforts should focus on optimized device design, user training to overcome the challenges we encountered, cost effectiveness studies, as well as studying the monitoring aspect of the device without accompanying interventions. Trial RegistrationClinicalTrials.gov NCT01957865; https://clinicaltrials.gov/ct2/show/NCT01957865 (Archived by WebCite at http://www.webcitation.org/6zFiDlXDa)
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- 2018
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9. Effects of Maternal HIV Infection and Alcohol Use in Pregnancy on Birth Outcomes in Uganda
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Adong, Julian, Musinguzi, Nicholas, Ngonzi, Joseph, Haberer, Jessica E., Bassett, Ingrid V., Siedner, Mark J., Roberts, Drucilla J., Hahn, Judith A., and Bebell, Lisa M.
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- 2024
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10. Performance of Multiple Adherence Measures for pre-exposure Prophylaxis (PrEP) Among Young Women in Kenya
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Musinguzi, Nicholas, Ngure, Kenneth, Bukusi, Elizabeth A., Mugo, Nelly R., Baeten, Jared M., Anderson, Peter L., and Haberer, Jessica E.
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- 2023
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11. Know Your Audience: Predictors of Success for a Patient-Centered Texting App to Augment Linkage to HIV Care in Rural Uganda
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Siedner, Mark J, Santorino, Data, Haberer, Jessica E, and Bangsberg, David R
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Computer applications to medicine. Medical informatics ,R858-859.7 ,Public aspects of medicine ,RA1-1270 - Abstract
BackgroundDespite investments in infrastructure and evidence for high acceptability, few mHealth interventions have been implemented in sub-Saharan Africa. ObjectiveWe sought to (1) identify predictors of uptake of an mHealth application for a low-literacy population of people living with HIV (PLWH) in rural Uganda and (2) evaluate the efficacy of various short message service (SMS) text message formats to optimize the balance between confidentiality and accessibility. MethodsThe trial evaluated the efficacy of a SMS text messaging app to notify PLWH of their laboratory results and request return to care for those with abnormal test results. Participants with a normal laboratory result received a single SMS text message indicating results were normal. Participants with an abnormal test result were randomized to 1 of 3 message formats designed to evaluate trade-offs between clarity and privacy: (1) an SMS text message that stated results were abnormal and requested return to clinic (“direct”), (2) the same message protected by a 4-digit PIN code (“PIN”), and (3) the message “ABCDEFG” explained at enrollment to indicate abnormal results (“coded”). Outcomes of interest were (1) self-reported receipt of the SMS text message, (2) accurate identification of the message, and (3) return to care within 7 days (for abnormal results) or on the date of the scheduled appointment (for normal results). We fit regression models for each outcome with the following explanatory variables: sociodemographic characteristics, CD4 count result, ability to read a complete sentence, ability to access a test message on enrollment, and format of SMS text message. ResultsSeventy-two percent (234/385) of participants successfully receiving a message, 87.6% (219/250) correctly identified the message format, and 60.8% (234/385) returned to clinic at the requested time. Among participants with abnormal tests results (138/385, 35.8%), the strongest predictors of reported message receipt were the ability to read a complete sentence and a demonstrated ability to access a test message on enrollment. Participants with an abnormal result who could read a complete sentence were also more likely to accurately identify the message format (AOR 4.54, 95% CI 1.42-14.47, P=.01) and return to clinic appropriately (AOR 3.81, 95% CI 1.61-9.03, P=.002). Those who were sent a PIN-protected message were less likely to identify the message (AOR 0.11, 95% CI 0.03-0.44, P=.002) or return within 7 days (AOR 0.26, 95% CI 0.10-0.66, P=.005). Gender, age, and socioeconomic characteristics did not predict any outcomes and there were no differences in outcomes between those receiving direct or coded messages. ConclusionsConfirmed literacy at the time of enrollment was a robust predictor of SMS text message receipt, identification, and appropriate response for PLWH in rural Uganda. PIN-protected messages reduced odds of clinic return, but coded messages were as effective as direct messages and might augment privacy. Trial RegistrationClinicaltrials.gov NCT 01579214; https://clinicaltrials.gov/ct2/show/NCT01579214 (Archived by WebCite at http://www.webcitation.org/6Ww8R4sKq).
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- 2015
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12. Factors Associated With Changes in Alcohol Use During Pregnancy and the Postpartum Transition Among People With HIV in South Africa and Uganda
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Stanton, Amelia M, Hornstein, Benjamin D, Musinguzi, Nicholas, Dolotina, Brett, Orrell, Catherine, Amanyire, Gideon, Asiimwe, Stephen, Cross, Anna, Psaros, Christina, Bangsberg, David, Hahn, Judith A, Haberer, Jessica E, Matthews, Lynn T, and Team, For the META Study
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Biomedical and Clinical Sciences ,Public Health ,Health Sciences ,Prevention ,Alcoholism ,Alcohol Use and Health ,HIV/AIDS ,Behavioral and Social Science ,Mental Health ,Clinical Research ,Substance Misuse ,Pediatric ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Cardiovascular ,Good Health and Well Being ,Female ,Pregnancy ,Humans ,HIV Infections ,South Africa ,Uganda ,Postpartum Period ,Alcohol Drinking ,HIV ,sub-Saharan Africa ,alcohol use ,pregnancy ,META Study Team - Abstract
Identifying factors associated with alcohol use changes during pregnancy is important for developing interventions for people with HIV (PWH). Pregnant PWH (n = 202) initiating antiretroviral therapy in Uganda and South Africa completed two assessments, 6 months apart (T1, T2). Categories were derived based on AUDIT-C scores: "no use" (AUDIT-C = 0 at T1 and T2), "new use" (AUDIT-C = 0 at T1, >0 at T2), "quit" (AUDIT-C > 0 at T1, =0 at T2), and "continued use" (AUDIT-C > 0, T1 and T2). Factors associated with these categories were assessed. Most participants had "no use" (68%), followed by "continued use" (12%), "quit" (11%), and "new use" (9%). Cohabitating with a partner was associated with lower relative risk of "continued use." Borderline significant associations between food insecurity and higher risk of "new use" and between stigma and reduced likelihood of "quitting" also emerged. Alcohol use interventions that address partnership, food security, and stigma could benefit pregnant and postpartum PWH.
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- 2023
13. Model-based predictions of protective HIV pre-exposure prophylaxis adherence levels in cisgender women
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Zhang, Lanxin, Iannuzzi, Sara, Chaturvedula, Ayyappa, Irungu, Elizabeth, Haberer, Jessica E., Hendrix, Craig W., and von Kleist, Max
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- 2023
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14. Oral preexposure prophylaxis uptake, adherence, and persistence during periconception periods among women in South Africa
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Matthews, Lynn T., Jaggernath, Manjeetha, Kriel, Yolandie, Smith, Patricia M., Haberer, Jessica E., Baeten, Jared M., Hendrix, Craig W., Ware, Norma C., Moodley, Pravi, Pillay, Melendhran, Bennett, Kara, Bassler, John, Psaros, Christina, Hurwitz, Kathleen E., Bangsberg, David R., and Smit, Jennifer A.
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- 2024
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15. A user-centred implementation strategy for tuberculosis contact investigation in Uganda: protocol for a stepped-wedge, cluster-randomised trial
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Katamba, Achilles, Gupta, Amanda J, Turimumahoro, Patricia, Ochom, Emmanuel, Ggita, Joseph M, Nakasendwa, Suzan, Nanziri, Leah, Musinguzi, Johnson, Hennein, Rachel, Sekadde, Moorine, Hanrahan, Colleen, Byaruhanga, Raymond, Yoeli, Erez, Turyahabwe, Stavia, Cattamanchi, Adithya, Dowdy, David W, Haberer, Jessica E, Armstrong-Hough, Mari, Kiwanuka, Noah, and Davis, J. Lucian
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- 2023
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16. mHealth to improve implementation of TB contact investigation: a case study from Uganda
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Gupta, Amanda J., Turimumahoro, Patricia, Ochom, Emmanuel, Ggita, Joseph M., Babirye, Diana, Ayakaka, Irene, Mark, David, Okello, Daniel Ayen, Cattamanchi, Adithya, Dowdy, David W., Haberer, Jessica E., Armstrong-Hough, Mari, Katamba, Achilles, and Davis, J. Lucian
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- 2023
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17. Protocol for an evaluation of adherence monitoring and support interventions among people initiating antiretroviral therapy in Cape Town, South Africa—a multiphase optimization strategy (MOST) approach using a fractional factorial design
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Jennings, Lauren, West, Rebecca L., Halim, Nafisa, Kaiser, Jeanette L., Gwadz, Marya, MacLeod, William B., Gifford, Allen L., Haberer, Jessica E., Orrell, Catherine, and Sabin, Lora L.
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- 2023
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18. Dual trajectories of antiretroviral therapy adherence and polypharmacy in women with HIV in the United States
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Elbur, Abubaker Ibrahim, Ghebremichael, Musie, Konkle-Parker, Deborah, Jones, Deborah L, Collins, Shelby, Adimora, Adaora A., Schneider, Michael F., Cohen, Mardge H., Tamraz, Bani, Plankey, Michael, Wilson, Tracey, Adedimeji, Adebola, Haberer, Jessica E., and Jacobson, Denise L.
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- 2023
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19. Barriers to engagement in the care cascade for tuberculosis disease in India: A systematic review of quantitative studies
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Jhaveri, Tulip A., Jhaveri, Disha, Galivanche, Amith, Lubeck-Schricker, Maya, Voehler, Dominic, Chung, Mei, Thekkur, Pruthu, Chadha, Vineet, Nathavitharana, Ruvandhi, Kumar, Ajay M. V., Shewade, Hemant Deepak, Powers, Katherine, Mayer, Kenneth H., Haberer, Jessica E., Bain, Paul, Pai, Madhukar, Satyanarayana, Srinath, and Subbaraman, Ramnath
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India -- Health aspects ,Medical research ,Medicine, Experimental ,Tuberculosis -- Care and treatment -- Social aspects -- Diagnosis ,Biological sciences - Abstract
Background India accounts for about one-quarter of people contracting tuberculosis (TB) disease annually and nearly one-third of TB deaths globally. Many Indians do not navigate all care cascade stages to receive TB treatment and achieve recurrence-free survival. Guided by a population/exposure/comparison/outcomes (PECO) framework, we report findings of a systematic review to identify factors contributing to unfavorable outcomes across each care cascade gap for TB disease in India. Methods and findings We defined care cascade gaps as comprising people with confirmed or presumptive TB who did not: start the TB diagnostic workup (Gap 1), complete the workup (Gap 2), start treatment (Gap 3), achieve treatment success (Gap 4), or achieve TB recurrence-free survival (Gap 5). Three systematic searches of PubMed, Embase, and Web of Science from January 1, 2000 to August 14, 2023 were conducted. We identified articles evaluating factors associated with unfavorable outcomes for each gap (reported as adjusted odds, relative risk, or hazard ratios) and, among people experiencing unfavorable outcomes, reasons for these outcomes (reported as proportions), with specific quality or risk of bias criteria for each gap. Findings were organized into person-, family-, and society-, or health system-related factors, using a social-ecological framework. Factors associated with unfavorable outcomes across multiple cascade stages included: male sex, older age, poverty-related factors, lower symptom severity or duration, undernutrition, alcohol use, smoking, and distrust of (or dissatisfaction with) health services. People previously treated for TB were more likely to seek care and engage in the diagnostic workup (Gaps 1 and 2) but more likely to suffer pretreatment loss to follow-up (Gap 3) and unfavorable treatment outcomes (Gap 4), especially those who were lost to follow-up during their prior treatment. For individual care cascade gaps, multiple studies highlighted lack of TB knowledge and structural barriers (e.g., transportation challenges) as contributing to lack of care-seeking for TB symptoms (Gap 1, 14 studies); lack of access to diagnostics (e.g., X-ray), non-identification of eligible people for testing, and failure of providers to communicate concern for TB as contributing to non-completion of the diagnostic workup (Gap 2, 17 studies); stigma, poor recording of patient contact information by providers, and early death from diagnostic delays as contributing to pretreatment loss to follow-up (Gap 3, 15 studies); and lack of TB knowledge, stigma, depression, and medication adverse effects as contributing to unfavorable treatment outcomes (Gap 4, 86 studies). Medication nonadherence contributed to unfavorable treatment outcomes (Gap 4) and TB recurrence (Gap 5, 14 studies). Limitations include lack of meta-analyses due to the heterogeneity of findings and limited generalizability to some Indian regions, given the country's diverse population. Conclusions This systematic review illuminates common patterns of risk that shape outcomes for Indians with TB, while highlighting knowledge gaps-particularly regarding TB care for children or in the private sector-to guide future research. Findings may inform targeting of support services to people with TB who have higher risk of poor outcomes and inform multicomponent interventions to close gaps in the care cascade., Author(s): Tulip A. Jhaveri 1,2, Disha Jhaveri 3,4, Amith Galivanche 3, Maya Lubeck-Schricker 3, Dominic Voehler 3, Mei Chung 3,5, Pruthu Thekkur 6,7, Vineet Chadha 8, Ruvandhi Nathavitharana 9, Ajay [...]
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- 2024
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20. Urine tenofovir testing for real‐time PrEP adherence feedback: a qualitative study involving transgender women in Uganda
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Mujugira, Andrew, Karungi, Beyonce, Mugisha, Jackson, Nakyanzi, Agnes, Nampewo, Olivia, Naddunga, Faith, Kamusiime, Brenda, Nsubuga, Rogers, Nyanzi, Kikulwe R., Muwonge, Timothy R., Wyatt, Monique A., Ware, Norma C., Gandhi, Monica, and Haberer, Jessica E.
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HIV (Viruses) -- Analysis -- Health aspects ,Urine -- Analysis ,HIV testing -- Analysis -- Health aspects ,Sexually transmitted diseases -- Analysis -- Health aspects ,Transgender people -- Analysis -- Health aspects ,Disease transmission -- Analysis -- Health aspects ,Nurses -- Analysis -- Health aspects ,Health - Abstract
: Introduction: Adherence counselling with point‐of‐care (POC) drug‐level feedback using a novel tenofovir assay may support pre‐exposure prophylaxis (PrEP) adherence; however, perceptions of urine testing and its impact on adherence are not well studied. We qualitatively examined how POC tenofovir testing was experienced by transgender women (TGW) in Uganda. Methods: Within a cluster randomized trial of peer‐delivered HIV self‐testing, self‐sampling for sexually transmitted infections and PrEP among HIV‐negative TGW showing overall low PrEP prevention‐effective adherence (NCT04328025), we conducted a nested qualitative sub‐study of the urine POC assay among a random sample of 30 TGW (August 2021−February 2022). TGW interviews explored: (1) experiences with POC urine tenofovir testing and (2) perceptions of PrEP adherence counselling with drug‐level feedback. We used an inductive content analytic approach for analysis. Results: Median age was 21 years (interquartile range 20–24), and 70% engaged in sex work. Four content categories describe how TGW experienced POC urine tenofovir testing: (1) Urine tenofovir testing was initially met with scepticism: Testing urine to detect PrEP initially induced anxiety, with some perceptions of being intrusive and unwarranted. With counselling, however, participants found POC testing acceptable and beneficial. (2) Alignment of urine test results and adherence behaviours: Drug‐level feedback aligned with what TGW knew about their adherence. Concurrence between pill taking and tenofovir detection in urine reinforced confidence in test accuracy. (3) Interpretation of urine tenofovir results: TGW familiar with the interpretation of oral‐fluid HIV self‐tests knew that two lines on the test device signified positivity (presence of HIV). However, two lines on the urine test strip indicated a positive result for non‐adherence (absence of tenofovir), causing confusion. Research nurses explained the difference in test interpretation to participants’ satisfaction. (4) White coat dosing: Some TGW deliberately chose not to attend scheduled clinic appointments to avoid detecting their PrEP non‐adherence during urine testing. They restarted PrEP before returning to clinic, a behaviour called “white coat dosing.” Conclusions: Incorporating POC urine testing into routine PrEP adherence counselling was acceptable and potentially beneficial for TGW but required attention to context. Additional research is needed to identify effective strategies for optimizing adherence monitoring and counselling for this population., INTRODUCTION Transgender women (TGW), who are biologically assigned male at birth but identify as female, face a significant burden of HIV in East and Southern Africa. The reported prevalence of [...]
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- 2024
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21. Social networks and HIV treatment adherence among people with HIV initiating treatment in rural Uganda and peri-urban South Africa
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Haberer, Jessica E., Orrell, Catherine, Ware, Norma, Bwana, Mwebesa Bosco, Asiimwe, Stephen, Amaniyre, Gideon, Tumwesigye, Elioda, Bangsberg, David R., Comfort, Alison B., Moody, James, Musinguzi, Nicholas, and Tsai, Alexander C.
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- 2024
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22. A Digital Platform to Support HIV Case Management for Youth and Young Adults: Mixed Methods Feasibility Study
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Fee, Connie, Fuller, Julia, Guss, Carly E, Woods, Elizabeth R, Cooper, Ellen R, Bhaumik, Urmi, Graham, Dionne, Burchett, Sandra K, Dumont, Olivia, Martey, Emily B, Narvaez, Maria, Haberer, Jessica E, Swendeman, Dallas, Mulvaney, Shelagh A, Kumar, Vikram S, Jackson, Jonathan L, and Ho, Y Xian
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Biomedical and Clinical Sciences ,Public Health ,Health Sciences ,Clinical Research ,Women's Health ,Behavioral and Social Science ,Pediatric ,HIV/AIDS ,Health Services ,Pediatric AIDS ,Infectious Diseases ,Sexually Transmitted Infections ,7.1 Individual care needs ,Infection ,Good Health and Well Being ,HIV ,case management ,youth ,young adult ,mobile health ,mHealth ,digital health ,mobile phone ,Biomedical and clinical sciences ,Health sciences - Abstract
BackgroundAdvances in medical treatments in recent years have contributed to an overall decline in HIV-related opportunistic infections and deaths in youth; however, mortality and morbidity rates in perinatally and nonperinatally infected adolescents and young adults (AYA) living with HIV remain relatively high today.ObjectiveThe goal of this project was to assess the use, utility, and cost-effectiveness of PlusCare, a digital app for HIV case management in AYA living with HIV. The app supports routine case management tasks, such as scheduling follow-up visits, sharing documents for review and signature, laboratory test results, and between-visit communications (eg, encouraging messages).MethodsWe conducted a single-group mixed methods pre-post study with HIV case management programs in 2 large urban hospitals in the Boston metro area. Case management staff (case managers [CMs], N=20) and AYA living with HIV participants (N=45) took part in the study with access to PlusCare for up to 15 and 12 months, respectively.ResultsThe CMs and AYA living with HIV reported mean System Usability Scale scores of 51 (SD 7.9) and 63 (SD 10.6), respectively. Although marginally significant, total charges billed at 1 of the 2 sites compared with the 12 months before app use (including emergency, inpatient, and outpatient charges) decreased by 41% (P=.046). We also observed slight increases in AYA living with HIV self-reported self-efficacy in chronic disease management and quality of life (Health-Related Quality of Life-4) from baseline to the 12-month follow-up (P=.02 and P=.03, respectively) and increased self-efficacy from the 6- to 12-month follow-up (P=.02). There was no significant change in HIV viral suppression, appointment adherence, or medication adherence in this small-sample pilot study.ConclusionsAlthough perceived usability was low, qualitative feedback from CMs and use patterns suggested that direct messaging and timely, remote, and secure sharing of laboratory results and documents (including electronic signatures) between CMs and AYA living with HIV can be particularly useful and have potential value in supporting care coordination and promoting patient self-efficacy and quality of life.Trial registrationClinicalTrials.gov NCT03758066; https://clinicaltrials.gov/ct2/show/NCT03758066.
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- 2022
23. Roll-out of HIV pre-exposure prophylaxis: a gateway to mental health promotion
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Ikeda, Daniel J, Kidia, Khameer, Agins, Bruce D, Haberer, Jessica E, and Tsai, Alexander C
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Health Services and Systems ,Public Health ,Health Sciences ,Prevention ,Mental Health ,Behavioral and Social Science ,Infectious Diseases ,HIV/AIDS ,Infection ,Mental health ,Good Health and Well Being ,Anti-HIV Agents ,HIV Infections ,Health Promotion ,Humans ,Pre-Exposure Prophylaxis ,Risk Factors ,HIV ,mental health & psychiatry ,Health services and systems ,Public health - Abstract
HIV remains a pressing global health problem, with 1.5 million new infections reported globally in 2020. HIV pre-exposure prophylaxis (PrEP) can lower the likelihood of HIV acquisition among populations at elevated risk, yet its global roll-out has been discouragingly slow. Psychosocial factors, such as co-occurring mental illness and substance use, are highly prevalent among populations likely to benefit from PrEP, and have been shown to undermine persistence and adherence. In this analysis, we review the high burden of mental health problems among PrEP candidates and contend that inattention to mental health stands to undermine efforts to implement PrEP on a global scale. We conclude that integration of mental health screening and treatment within PrEP scale-up efforts represents an important strategy for maximising PrEP effectiveness while addressing the high burden of mental illness among at-risk populations. As implementers seek to integrate mental health services within PrEP services, efforts to keep access to PrEP as low-threshold as possible should be maintained. Moreover, programmes should seek to implement mental health interventions that are sensitive to local resource constraints and seek to reduce intersecting stigmas associated with HIV and mental illness.
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- 2021
24. Internalized stigma, depressive symptoms, and the modifying role of antiretroviral therapy: A cohort study in rural Uganda
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Bebell, Lisa M, Kembabazi, Annet, Musinguzi, Nicholas, Martin, Jeffrey N, Hunt, Peter W, Boum, Yap, O’Laughlin, Kelli N, Muzoora, Conrad, Haberer, Jessica E, Bwana, Mwebesa Bosco, Bangsberg, David R, Siedner, Mark J, and Tsai, Alexander C
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Social and Personality Psychology ,Psychology ,Brain Disorders ,Prevention ,HIV/AIDS ,Behavioral and Social Science ,Clinical Research ,Mental Health ,Depression ,Good Health and Well Being ,Antiretroviral therapy ,Discrimination ,HIV ,Mental health ,Prejudice ,Stigma ,Sub-saharan africa ,Uganda ,Social and personality psychology - Abstract
Depression affects over 40% of people with HIV (PHIV) in low- and middle-income countries, and over half of PHIV report HIV-related internalized stigma. However, few longitudinal studies of PHIV have examined the relationship between HIV-related stigma and depression. Data were analyzed from the 2007-15 Uganda AIDS Rural Treatment Outcomes (UARTO) Study, a cohort of 454 antiretroviral therapy (ART)-naïve PHIV (68% women) starting ART. Our primary outcome was depression symptom severity over the first two years of ART, measured using a locally adapted version of the Hopkins Symptom Checklist; our primary exposure was the 6-item Internalized AIDS-Related Stigma Scale. Both scores were measured at enrollment and at quarterly follow-up visits. We fit linear generalized estimating equations (GEE) regression models to estimate the association between stigma and depression symptom severity, adjusting for potential confounders. We included a stigma×time product term to assess the modifying effect of ART on the association between internalized stigma and depression symptom severity. UARTO participants had a median age of 32 years and median enrollment CD4 count of 217 cells/mm3. Both depression symptom severity and internalized stigma declined on ART, particularly during the first treatment year. In multivariable regression models, depression symptom severity was positively associated with internalized stigma (b=0.03; 95% confidence interval [CI], 0.02 to 0.04) and negatively associated with ART duration >6 months (b =- 0.16; 95% CI,- 0.19 to -0.13). The estimated product term coefficient was negative and statistically significant (P = 0.004), suggesting that the association between internalized stigma and depression symptom severity weakened over time on ART. Thus, in this large cohort of PHIV initiating ART in rural Uganda, depression symptom severity was associated with internalized stigma but the association declined with time on ART. These findings underscore the potential value of ART as a stigma reduction intervention for PHIV, particularly during early treatment.
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- 2021
25. Systematic Review of mHealth Interventions for Adolescent and Young Adult HIV Prevention and the Adolescent HIV Continuum of Care in Low to Middle Income Countries
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Goldstein, Madeleine, Archary, Moherndran, Adong, Julian, Haberer, Jessica E., Kuhns, Lisa M., Kurth, Ann, Ronen, Keshet, Lightfoot, Marguerita, Inwani, Irene, John-Stewart, Grace, Garofalo, Robert, and Zanoni, Brian C.
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- 2023
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26. Individual health behaviours to combat the COVID‐19 pandemic: lessons from HIV socio‐behavioural science
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Haberer, Jessica E, van der Straten, Ariane, Safren, Steven A, Johnson, Mallory O, Amico, K Rivet, del Rio, Carlos, Andrasik, Michele, Wilson, Ira B, and Simoni, Jane M
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Biomedical and Clinical Sciences ,Clinical Sciences ,Infectious Diseases ,Immunization ,Prevention ,Vaccine Related ,Infection ,Good Health and Well Being ,Behavioral Sciences ,COVID-19 ,COVID-19 Vaccines ,HIV Infections ,Health Behavior ,Humans ,Pandemics ,Public Health ,SARS-CoV-2 ,HIV ,social science ,behavioural science ,public health ,vaccine ,Public Health and Health Services ,Other Medical and Health Sciences ,Clinical sciences ,Epidemiology ,Public health - Abstract
IntroductionCOVID-19 parallels HIV in many ways. Socio-behavioural science has been critical in elucidating the context and factors surrounding individual levels of engagement with known effective prevention and treatment tools for HIV, thus offering important lessons for ongoing efforts to combat the COVID-19 pandemic.DiscussionNon-adherence to effective disease mitigation strategies (e.g. condoms for HIV and masks for COVID-19) can be attributed in part to prioritizing comfort, convenience and individual autonomy over public health. Importantly, misinformation can fuel denialism and conspiracies that discredit scientific knowledge and motivate nonadherence. These preferences and the extent to which individuals can act on their preferences may be constrained by the structures and culture in which they live. Both HIV and COVID-19 have been politicized and influenced by evolving recommendations from scientists, clinicians, policymakers and politically motivated organizations. While vaccines are vital for ending both pandemics, their impact will depend on availability and uptake. Four decades of experience with the HIV epidemic have shown that information alone is insufficient to overcome these challenges; interventions must address the underlying, often complex factors that influence human behaviour. This article builds from socio-behavioural science theory and describes practical and successful approaches to enable and support adherence to prevention and treatment strategies, including vaccine adoption. Key methods include reframing tools to enhance motivation, promoting centralized sources of trusted information, strategic development and messaging with and within key populations (e.g. through social media) and appealing to self-empowerment, altruism and informed decision making. Orchestrated evidence-based activism is needed to overcome manipulative politicization, while consistent transparent messaging around scientific discoveries and clinical recommendations are critical for public acceptance and support. Ultimately, the effectiveness of COVID-19 vaccines will depend on our ability to engender trust in the communities most affected.ConclusionsMany lessons learned from socio-behavioural science in the HIV pandemic are applicable to the COVID-19 pandemic. Individual behaviour must be understood within its interpersonal and societal context to address the current barriers to adherence to disease-mitigating strategies and promote an effective response to the COVID-19 pandemic, which is likely to be endured for the foreseeable future.
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- 2021
27. Treated HIV Infection and Progression of Carotid Atherosclerosis in Rural Uganda: A Prospective Observational Cohort Study
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Siedner, Mark J, Bibangambah, Prossy, Kim, June‐Ho, Lankowski, Alexander, Chang, Jonathan L, Yang, Isabelle T, Kwon, Douglas S, North, Crystal M, Triant, Virginia A, Longenecker, Christopher, Ghoshhajra, Brian, Peck, Robert N, Sentongo, Ruth N, Gilbert, Rebecca, Kakuhikire, Bernard, Boum, Yap, Haberer, Jessica E, Martin, Jeffrey N, Tracy, Russell, Hunt, Peter W, Bangsberg, David R, Tsai, Alexander C, Hemphill, Linda C, and Okello, Samson
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Biomedical and Clinical Sciences ,Clinical Sciences ,Sexually Transmitted Infections ,Prevention ,Cardiovascular ,Infectious Diseases ,Clinical Research ,Women's Health ,HIV/AIDS ,Heart Disease ,Atherosclerosis ,2.2 Factors relating to the physical environment ,Aetiology ,Infection ,Good Health and Well Being ,Anti-HIV Agents ,Carotid Artery Diseases ,Carotid Intima-Media Thickness ,Case-Control Studies ,Disease Progression ,Female ,HIV Infections ,Humans ,Longitudinal Studies ,Male ,Middle Aged ,Prospective Studies ,Risk Assessment ,Risk Factors ,Time Factors ,Uganda ,Urban Health ,antiretroviral therapy ,atherosclerosis ,cardiovascular disease risk ,carotid intima media thickness ,HIV infection ,Cardiorespiratory Medicine and Haematology ,Cardiovascular medicine and haematology - Abstract
Background Although ≈70% of the world's population of people living with HIV reside in sub-Saharan Africa, there are minimal prospective data on the contributions of HIV infection to atherosclerosis in the region. Methods and Results We conducted a prospective observational cohort study of people living with HIV on antiretroviral therapy >40 years of age in rural Uganda, along with population-based comparators not infected with HIV. We collected data on cardiovascular disease risk factors and carotid ultrasound measurements annually. We fitted linear mixed effects models, adjusted for cardiovascular disease risk factors, to estimate the association between HIV serostatus and progression of carotid intima media thickness (cIMT). We enrolled 155 people living with HIV and 154 individuals not infected with HIV and collected cIMT images at 1045 visits during a median of 4 annual visits per participant (interquartile range 3-4, range 1-5). Age (median 50.9 years) and sex (49% female) were similar by HIV serostatus. At enrollment, there was no difference in mean cIMT by HIV serostatus (0.665 versus 0.680 mm, P=0.15). In multivariable models, increasing age, blood pressure, and non-high-density lipoprotein cholesterol were associated with greater cIMT (P
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- 2021
28. Changes in Immune Activation During Pregnancy and the Postpartum Period in Treated HIV Infection
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Schnittman, Samuel R, Byakwaga, Helen, Boum, Yap, Kabakyenga, Jerome, Matthews, Lynn T, Burdo, Tricia H, Huang, Yong, Tracy, Russell P, Haberer, Jessica E, Kembabazi, Annet, Kaida, Angela, Moisi, Daniela, Lederman, Michael M, Bangsberg, David R, Martin, Jeffrey N, and Hunt, Peter W
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Medical Microbiology ,Reproductive Medicine ,Biomedical and Clinical Sciences ,Sexually Transmitted Infections ,HIV/AIDS ,Emerging Infectious Diseases ,Maternal Morbidity and Mortality ,Clinical Research ,Infectious Diseases ,Rare Diseases ,Tuberculosis ,Pregnancy ,Maternal Health ,Women's Health ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Reproductive health and childbirth ,Infection ,Good Health and Well Being ,HIV ,indoleamine 2 ,3-dioxygenase-1 ,inflammation ,kynurenine/tryptophan ratio ,pregnancy ,indoleamine 2 ,3-dioxygenase-1 ,kynurenine ,tryptophan ratio ,Clinical sciences ,Medical microbiology - Abstract
BackgroundPregnant women with HIV (PWWH) have high postpartum morbidity and mortality from infections like tuberculosis. Immunologic changes during pregnancy and postpartum periods may contribute to these risks, particularly the immunoregulatory kynurenine pathway of tryptophan catabolism, which contributes to both HIV and tuberculosis pathogenesis and increases in the early postpartum period.MethodsWomen with HIV initiating antiretroviral therapy (ART) in the Uganda AIDS Rural Treatment Outcomes (UARTO) cohort who were pregnant at enrollment or became pregnant during observation were studied (n = 54). Plasma kynurenine/tryptophan (KT) ratio, soluble CD14 (sCD14), sCD163, sCD27, interferon-inducible protein 10 (IP-10), D-dimer, interleukin-6, and intestinal fatty-acid binding protein levels were assessed through the first year of ART and at 3-month intervals throughout pregnancy and 1 year postpartum. Biomarker changes were assessed with linear mixed models adjusted for ART duration. Hemoglobin concentration changes were used to estimate pregnancy-related changes in plasma volume.ResultsThe median pre-ART CD4 count was 134. D-dimer increased through the third trimester before returning to baseline postpartum, while most other biomarkers declined significantly during pregnancy, beyond what would be expected from pregnancy-associated plasma volume expansion. IP-10 and sCD14 remained suppressed for at least 12 months postpartum. KT ratio was the only biomarker that increased above prepregnancy baseline postpartum (mean + 30%; P
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- 2021
29. Pre-treatment integrase inhibitor resistance is uncommon in antiretroviral therapy-naive individuals with HIV-1 subtype A1 and D infections in Uganda
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McCluskey, Suzanne M, Kamelian, Kimia, Musinguzi, Nicholas, Kigozi, Simone, Boum, Yap, Bwana, Mwebesa B, Muzoora, Conrad, Brumme, Zabrina L, Carrington, Mary, Carlson, Jonathan, Foley, Brian, Hunt, Peter W, Martin, Jeffrey N, Bangsberg, David R, Harrigan, P Richard, Siedner, Mark J, Haberer, Jessica E, and Lee, Guinevere Q
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Medical Microbiology ,Biomedical and Clinical Sciences ,Clinical Sciences ,Immunology ,HIV/AIDS ,Genetics ,Pediatric AIDS ,Clinical Research ,Sexually Transmitted Infections ,Pediatric ,Clinical Trials and Supportive Activities ,Infectious Diseases ,Development of treatments and therapeutic interventions ,Evaluation of treatments and therapeutic interventions ,5.1 Pharmaceuticals ,6.1 Pharmaceuticals ,Infection ,Good Health and Well Being ,Africa South of the Sahara ,Drug Resistance ,Viral ,HIV Infections ,HIV Integrase ,HIV Integrase Inhibitors ,HIV-1 ,Humans ,Mutation ,Retrospective Studies ,Uganda ,dolutegravir ,HIV integrase ,integrase strand transfer inhibitors ,mutation ,sub-Saharan Africa ,Biological Sciences ,Medical and Health Sciences ,Psychology and Cognitive Sciences ,Virology ,Biomedical and clinical sciences ,Health sciences - Abstract
ObjectiveDolutegravir (DTG) is now a preferred component of first-line antiretroviral therapy (ART). However, prevalence data on natural resistance to integrase inhibitors [integrase strand transfer inhibitors (INSTIs)] in circulating non-subtype B HIV-1 in sub-Saharan Africa is scarce. Our objective is to report prevalence of pre-treatment integrase polymorphisms associated with resistance to INSTIs in an ART-naive cohort with diverse HIV-1 subtypes.DesignWe retrospectively examined HIV-1 integrase sequences from Uganda.MethodsPlasma samples were derived from the Uganda AIDS Rural Treatment Outcomes (UARTO) cohort, reflecting enrollment from 2002 to 2010, prior to initiation of ART. HIV-1 integrase was amplified using nested-PCR and Sanger-sequenced (HXB2 4230-5093). Stanford HIVdb v8.8 was used to infer clinically significant INSTI-associated mutations. Human leukocyte antigen (HLA) typing was performed for all study participants.ResultsPlasma samples from 511 ART-naive individuals (subtype: 48% A1, 39% D) yielded HIV-1 integrase genotyping results. Six out of 511 participants (1.2%) had any major INSTI-associated mutations. Of these, two had E138T (subtype A1), three had E138E/K (subtype D), and one had T66T/I (subtype D). No participants had mutations traditionally associated with high levels of INSTI resistance. HLA genotypes A∗02:01/05/14, B∗44:15, and C∗04:07 predicted the presence of L74I, a mutation recently observed in association with long-acting INSTI cabotegravir virologic failure.ConclusionWe detected no HIV-1 polymorphisms associated with high levels of DTG resistance in Uganda in the pre-DTG era. Our results support widespread implementation of DTG but careful monitoring of patients on INSTI with virologic failure is warranted to determine if unique mutations predict failure for non-B subtypes of HIV-1.
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- 2021
30. Factors associated with phosphatidylethanol (PEth) sensitivity for detecting unhealthy alcohol use: An individual patient data meta-analysis.
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Hahn, Judith A, Murnane, Pamela M, Vittinghoff, Eric, Muyindike, Winnie R, Emenyonu, Nneka I, Fatch, Robin, Chamie, Gabriel, Haberer, Jessica E, Francis, Joel M, Kapiga, Saidi, Jacobson, Karen, Myers, Bronwyn, Couture, Marie Claude, DiClemente, Ralph J, Brown, Jennifer L, So-Armah, Kaku, Sulkowski, Mark, Marcus, Gregory M, Woolf-King, Sarah, Cook, Robert L, Richards, Veronica L, Molina, Patricia, Ferguson, Tekeda, Welsh, David, Piano, Mariann R, Phillips, Shane A, Stewart, Scott, Afshar, Majid, Page, Kimberly, McGinnis, Kathleen, Fiellin, David A, Justice, Amy C, Bryant, Kendall, and Saitz, Richard
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alcohol ,individual participant data meta-analysis ,phosphatidylethanol ,sensitivity ,individual participant data meta‐ ,analysis ,Substance Abuse ,Liver Disease ,Alcoholism ,Alcohol Use and Health ,Clinical Research ,Digestive Diseases ,Oral and gastrointestinal ,Clinical Sciences ,Neurosciences ,Psychology - Abstract
BackgroundObjective measurement of alcohol consumption is important for clinical care and research. Adjusting for self-reported alcohol use, we conducted an individual participant data (IPD) meta-analysis to examine factors associated with the sensitivity of phosphatidylethanol (PEth), an alcohol metabolite, among persons self-reporting unhealthy alcohol consumption.MethodsWe identified 21 eligible studies and obtained 4073 observations from 3085 participants with Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) positive scores (≥3 for women and ≥4 for men) and PEth measurements. We conducted 1-step IPD meta-analysis using mixed effects models with random intercepts for study site. We examined the associations between demographic (sex, race/ethnicity, and age) and biologic (body mass index-BMI, hemoglobin, HIV status, liver fibrosis, and venous versus finger-prick blood collection) variables with PEth sensitivity (PEth≥8 ng/ml), adjusting for the level of self-reported alcohol use using the AUDIT-C score.ResultsOne third (31%) of participants were women, 32% were African, 28% African American, 28% White, and 12% other race/ethnicity. PEth sensitivity (i.e., ≥8 ng/ml) was 81.8%. After adjusting for AUDIT-C, we found no associations of sex, age, race/ethnicity, or method of blood collection with PEth sensitivity. In models that additionally included biologic variables, those with higher hemoglobin and indeterminate and advanced liver fibrosis had significantly higher odds of PEth sensitivity; those with higher BMI and those living with HIV had significantly lower odds of PEth sensitivity. African Americans and Africans had higher odds of PEth sensitivity than whites in models that included biologic variables.ConclusionsAmong people reporting unhealthy alcohol use, several biological factors (hemoglobin, BMI, liver fibrosis, and HIV status) were associated with PEth sensitivity. Race/ethnicity was associated with PEth sensitivity in some models but age, sex, and method of blood collection were not. Clinicians should be aware of these factors, and researchers should consider adjusting analyses for these characteristics where possible.
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- 2021
31. My Way: development and preliminary evaluation of a novel delivery system for PrEP and other sexual health needs of young women in Western Kenya
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Haberer, Jessica E., Oware, Kevin, Juma, Lawrence, Nyerere, Bernard, Momanyi, Vincent, Odoyo, Josephine, Garrison, Lindsey, Bhagat, Julita, Musinguzi, Nicholas, Baeten, Jared M., Siegler, Aaron, and Bukusi, Elizabeth A.
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Antiviral agents -- Distribution ,Women's health services -- Management ,HIV infection -- Prevention ,Company business management ,Company distribution practices ,Health - Abstract
: 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). The intervention involves peer‐delivery and support for HIV testing and PrEP use, self‐collected vaginal swabs for sexually transmitted infection (STI) testing, pregnancy testing, oral contraceptive pills, self‐injectable medroxyprogesterone and/or condoms. My Way was assessed among 16‐ to 24‐year‐old sexually active women in a randomized controlled trial versus standard of care (SoC; 2021–2022). Use of PrEP and other sexual health services were tracked at 1, 3 and 6 months for feasibility. Acceptability was determined by questionnaire. The effect of the intervention on tenofovir diphosphate (TFV‐DP) levels was assessed by chi‐square test (primary outcome); other predictors were explored with regression analysis. Results: Among 150 women, the median age was 22 years and the median number of sexual partners was 2. Moderate/severe depression was common (60%). In the intervention arm, peers made 88% (198/225) of possible kit deliveries (177 with PrEP) and 49 STIs were diagnosed. In the SoC arm, 24% (55/225) of expected clinic visits occurred (53 with PrEP); no STI testing was performed. TVF‐DP was detected in 16 participants at 6 months: 16% (12/75) in the intervention arm versus 5% (4/75) in the SoC arm (p = 0.03). Persistence among those with ongoing HIV prevention needs (i.e. prevention‐effective persistence) was 18% (12/67) versus 7% (4/56; p = 0.08). No women acquired HIV. The intervention was significantly associated with detectable TFV‐DP (OR 3.5, 1.1‐11.4; p = 0.04); moderate/severe depression trended towards an association with TFV‐DP (OR 0.2, 0.03–1.6; p = 0.13). Conclusions: My Way is a promising delivery system for PrEP and other sexual health services among young women in Western Kenya. We found high feasibility and acceptability. PrEP use was modest, but higher with My Way compared to SoC. Long‐acting PrEP formulations may overcome important barriers to PrEP use and should be explored in combination with the My Way delivery model., INTRODUCTION Young women in sub‐Saharan Africa (sSA) are a priority population for HIV prevention, accounting for 63% of all new cases in 2021 [1]. Approximately six of seven new HIV [...]
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32. 'I felt special!': a qualitative study of peer‐delivered HIV self‐tests, STI self‐sampling kits and PrEP for transgender women in Uganda
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Mujugira, Andrew, Karungi, Beyonce, Mugisha, Jackson, Nakyanzi, Agnes, Bagaya, Monica, Kamusiime, Brenda, Nalumansi, Alisaati, Nalukwago, Grace Kakoola, Kasiita, Vicent, Twesigye, Chris Collins, Nampewo, Olivia, Nsubuga, Rogers, Nyanzi, Kikulwe Robert, Muwonge, Timothy, Wyatt, Monique A., Ware, Norma C., and Haberer, Jessica E.
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Sexually transmitted diseases -- Prevention ,Transgender people -- Health aspects ,Health behavior -- Evaluation ,HIV infection -- Prevention ,Health - Abstract
: Introduction: Peer delivery is a client‐centred approach that could maximize the coverage and impact of HIV services for transgender women (TGW). We conducted qualitative interviews to examine how peer‐delivered HIV self‐testing (HIVST), sexually transmitted infection self‐sampling (STISS) and oral pre‐exposure prophylaxis (PrEP) influenced prevention choices among TGW and their intimate partners in Uganda. Methods: Within a cluster randomized trial of peer‐delivered HIVST, STISS and PrEP among HIV‐negative TGW (NCT04328025), we conducted 55 qualitative interviews with 30 TGW, 15 intimate partners and 10 TGW peers (August 2021–February 2022). TGW interviews explored: (1) HIV self‐test and PrEP experiences; (2) HIVST with intimate partners; and (3) descriptions of self‐sampling for STI testing. Partner interviews covered: (1) experiences with HIVST; (2) disclosure of HIV status to intimate partner; and (3) descriptions of sexual behaviours after testing. Peer interview topics included: (1) intervention delivery experiences; and (2) recommendations for peer‐delivered HIV prevention services to TGW, including psychological support and coping strategies. Qualitative data were analysed using an inductive content analytic approach. Results: Peer‐delivered combination prevention was valued by this group of TGW and their partners. (1) Peer services extended beyond delivering HIV/STI kits and PrEP refills to caring for individual health and wellbeing by providing stigma coping strategies. Peer psychosocial support empowered research participants to become “HIVST ambassadors,” teach non‐study TGW about self‐testing and PrEP, and encourage linkage to care. (2) HIVST with intimate partners and mutual disclosure of HIV status strengthened partnered relationships. PrEP use after both partners tested HIV negative implied infidelity. (3) Self‐sampling enabled TGW to take control of their STI testing and avoid the embarrassment of exposing their bodies. Privacy and confidentiality motivated the uptake of STI testing and treatment. Conclusions: In this sample of TGW from Uganda, peer delivery of HIVST, STISS and PrEP refills benefitted individual prevention efforts and extended to a new linkage of TGW not engaged in care. Integrating peer services into differentiated PrEP delivery could increase HIV/STI test coverage and PrEP use in this vulnerable population., INTRODUCTION Globally, transgender women (TGW; people who are assigned male sex at birth but identify as female) are 14 times as likely to be living with HIV as other women [...]
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- 2023
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33. Multi-level Factors Driving Pre-exposure Prophylaxis Non-initiation Among Young Women at High Risk for HIV in Kenya
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Katz, Ingrid T., Ngure, Kenneth, Kamolloh, Kevin, Ogello, Vallery, Okombo, Moses, Thuo, Nicholas B., Owino, Esther, Garrison, Lindsey E., Lee, Yeonsoo S., Nardell, Maria F., Anyacheblu, Chiemelie, Bukusi, Elizabeth, Mugo, Nelly, Baeten, Jared M., and Haberer, Jessica E.
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- 2023
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34. “Yes, I’m reminded, but it doesn’t mean I’m taking them”: Experiences with Short Message Service Reminder Use in Real-time Monitoring of HIV PrEP among Young Women in Kenya
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Ogello, Vallery, Ngure, Kenneth, Thuo, Nicholas, Burns, Bridget, Rono, Bernard, Oware, Kevin, Kiptiness, Catherine, Mugo, Nelly, Bukusi, Elizabeth, Garrison, Lindsey, Baeten, Jared M., and Haberer, Jessica E.
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- 2023
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35. Trajectories of Oral PrEP Adherence Among Young Kenyan Women: Implications for Promoting Effective PrEP Use
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Musinguzi, Nicholas, Pyra, Maria, Bukusi, Elizabeth A., Mugo, Nelly R., Baeten, Jared M., and Haberer, Jessica E.
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- 2023
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36. The future of HIV pre-exposure prophylaxis adherence: reducing barriers and increasing opportunities
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Haberer, Jessica E, Mujugira, Andrew, and Mayer, Kenneth H
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- 2023
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37. Approaches to Objectively Measure Antiretroviral Medication Adherence and Drive Adherence Interventions
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Spinelli, Matthew A, Haberer, Jessica E, Chai, Peter R, Castillo-Mancilla, Jose, Anderson, Peter L, and Gandhi, Monica
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Medical Microbiology ,Biomedical and Clinical Sciences ,Clinical Research ,Infectious Diseases ,Sexually Transmitted Infections ,Behavioral and Social Science ,Prevention ,HIV/AIDS ,Infection ,Good Health and Well Being ,Adenine ,Adult ,Anti-HIV Agents ,Emtricitabine ,Female ,HIV Infections ,Hair ,Humans ,Leukocytes ,Mononuclear ,Male ,Medication Adherence ,Monitoring ,Ambulatory ,Organophosphates ,Pre-Exposure Prophylaxis ,Tenofovir ,Viral Load ,Adherence metrics ,PrEP ,ART ,Pharmacologic metrics ,Electronic adherence monitors ,Ingestible sensors ,Immunology ,Virology ,Clinical sciences - Abstract
Purpose of reviewTraditional methods to assess antiretroviral adherence, such as self-report, pill counts, and pharmacy refill data, may be inaccurate in determining actual pill-taking to both antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP). HIV viral loads serve as surrogates of adherence on ART, but loss of virologic control may occur well after decreases in adherence and viral loads are not relevant to PrEP.Recent findingsPharmacologic measures of adherence, electronic adherence monitors, and ingestible electronic pills all serve as more objective metrics of adherence, surpassing self-report in predicting outcomes. Pharmacologic metrics can identify either recent adherence or cumulative adherence. Recent dosing measures include antiretroviral levels in plasma or urine, as well as emtricitabine-triphosphate in dried blood spots (DBS) for those on tenofovir-emtricitabine-based therapy. A urine tenofovir test has recently been developed into a point-of-care test for bedside adherence monitoring. Cumulative adherence metrics assess adherence over weeks to months and include measurement of tenofovir-diphosphate in peripheral blood mononuclear cells or DBS, as well as ART levels in hair. Electronic adherence monitors and ingestible electronic pills can track pill bottle openings or medication ingestion, respectively. New and objective approaches in adherence monitoring can be used to detect nonadherence prior to loss of prevention efficacy or virologic control with PrEP or ART, respectively.
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- 2020
38. Defining gaps in pre-exposure prophylaxis delivery for pregnant and post-partum women in high-burden settings using an implementation science framework
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Pintye, Jillian, Davey, Dvora L Joseph, Wagner, Anjuli D, John-Stewart, Grace, Baggaley, Rachel, Bekker, Linda-Gail, Celum, Connie, Chi, Benjamin H, Coates, Thomas J, Groves, Allison K, Haberer, Jessica E, Heffron, Renee, Kinuthia, John, Matthews, Lynn T, McIntyre, James A, Moodley, Dhayendre, Mofenson, Lynne M, Mugo, Nelly, Mujugira, Andrew, Myer, Landon, Shoptaw, Steven, Stranix-Chibanda, Lynda, Baeten, Jared M, and Group, for the PrEP in Pregnancy Working
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Reproductive Medicine ,Biomedical and Clinical Sciences ,Public Health ,Health Sciences ,Behavioral and Social Science ,Infectious Diseases ,Prevention ,Pediatric AIDS ,Clinical Research ,Pediatric ,HIV/AIDS ,Infection ,Reproductive health and childbirth ,Good Health and Well Being ,Anti-HIV Agents ,Female ,HIV Infections ,Health Plan Implementation ,Humans ,Infectious Disease Transmission ,Vertical ,Male ,Postnatal Care ,Pre-Exposure Prophylaxis ,Pregnancy ,PrEP in Pregnancy Working Group ,Medical and Health Sciences ,Biomedical and clinical sciences ,Health sciences - Abstract
Pregnancy is a high-risk period for HIV acquisition in African women, and pregnant women who become acutely infected with HIV account for up to a third of vertical HIV transmission cases in African settings. To protect women and eliminate vertical transmission, WHO recommends offering oral pre-exposure prophylaxis (PrEP) based on tenofovir to HIV-negative pregnant and post-partum women with a substantial risk of HIV acquisition. PrEP implementation for pregnant and post-partum women lags behind implementation for other high-risk populations. Unique considerations for PrEP implementation arise during pregnancy and post partum, including the integration of provider training with clinical delivery and monitoring of PrEP exposure and outcomes within existing maternal health systems, yet scarce implementation data are available to generate evidence in this context.
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- 2020
39. Super learner analysis of real‐time electronically monitored adherence to antiretroviral therapy under constrained optimization and comparison to non‐differentiated care approaches for persons living with HIV in rural Uganda
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Benitez, Alejandra E, Musinguzi, Nicholas, Bangsberg, David R, Bwana, Mwebesa B, Muzoora, Conrad, Hunt, Peter W, Martin, Jeffrey N, Haberer, Jessica E, and Petersen, Maya L
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Medical Microbiology ,Biomedical and Clinical Sciences ,Clinical Sciences ,Sexually Transmitted Infections ,Prevention ,Clinical Research ,Machine Learning and Artificial Intelligence ,HIV/AIDS ,Bioengineering ,Infectious Diseases ,Infection ,Good Health and Well Being ,Adult ,Anti-HIV Agents ,CD4 Lymphocyte Count ,Cohort Studies ,Drug Monitoring ,Female ,HIV Infections ,HIV-1 ,Humans ,Longitudinal Studies ,Machine Learning ,Male ,Medication Adherence ,Uganda ,Viral Load ,Viremia ,adherence ,machine learning ,real-time adherence monitoring ,viral load monitoring ,virologic failure ,viraemia ,Public Health and Health Services ,Other Medical and Health Sciences ,Clinical sciences ,Epidemiology ,Public health - Abstract
IntroductionReal-time electronic adherence monitoring (EAM) systems could inform on-going risk assessment for HIV viraemia and be used to personalize viral load testing schedules. We evaluated the potential of real-time EAM (transferred via cellular signal) and standard EAM (downloaded via USB cable) in rural Uganda to inform individually differentiated viral load testing strategies by applying machine learning approaches.MethodsWe evaluated an observational cohort of persons living with HIV and treated with antiretroviral therapy (ART) who were monitored longitudinally with standard EAM from 2005 to 2011 and real-time EAM from 2011 to 2015. Super learner, an ensemble machine learning method, was used to develop a tool for targeting viral load testing to detect viraemia (>1000 copies/ml) based on clinical (CD4 count, ART regimen), viral load and demographic data, together with EAM-based adherence. Using sample-splitting (cross-validation), we evaluated area under the receiver operating characteristic curve (cvAUC), potential for EAM data to selectively defer viral load tests while minimizing delays in viraemia detection, and performance compared to WHO-recommended testing schedules.ResultsIn total, 443 persons (1801 person-years) and 485 persons (930 person-years) contributed to standard and real-time EAM analyses respectively. In the 2011 to 2015 dataset, addition of real-time EAM (cvAUC: 0.88; 95% CI: 0.83, 0.93) significantly improved prediction compared to clinical/demographic data alone (cvAUC: 0.78; 95% CI: 0.72, 0.86; p = 0.03). In the 2005 to 2011 dataset, addition of standard EAM (cvAUC: 0.77; 95% CI: 0.72, 0.81) did not significantly improve prediction compared to clinical/demographic data alone (cvAUC: 0.70; 95% CI: 0.64, 0.76; p = 0.08). A hypothetical testing strategy using real-time EAM to guide deferral of viral load tests would have reduced the number of tests by 32% while detecting 87% of viraemia cases without delay. By comparison, the WHO-recommended testing schedule would have reduced the number of tests by 69%, but resulted in delayed detection of viraemia a mean of 74 days for 84% of individuals with viraemia. Similar rules derived from standard EAM also resulted in potential testing frequency reductions.ConclusionsOur machine learning approach demonstrates potential for combining EAM data with other clinical measures to develop a selective testing rule that reduces number of viral load tests ordered, while still identifying those at highest risk for viraemia.
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- 2020
40. Knowledge of HIV Status Is Associated With a Decrease in the Severity of Depressive Symptoms Among Female Sex Workers in Uganda and Zambia
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Ortblad, Katrina F, Musoke, Daniel Kibuuka, Chanda, Michael M, Ngabirano, Thomson, Velloza, Jennifer, Haberer, Jessica E, McConnell, Margaret, Oldenburg, Catherine E, and Bärnighausen, Till
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Pediatric ,Behavioral and Social Science ,Prevention ,Mental Health ,Pediatric AIDS ,Clinical Research ,Depression ,Infectious Diseases ,HIV/AIDS ,Mental health ,Infection ,Good Health and Well Being ,Adult ,Female ,HIV Infections ,Humans ,Longitudinal Studies ,Randomized Controlled Trials as Topic ,Severity of Illness Index ,Sex Work ,Uganda ,Zambia ,HIV status knowledge ,HIV testing ,depressive symptoms ,female sex workers ,Clinical Sciences ,Public Health and Health Services ,Virology - Abstract
BackgroundKnowledge of HIV-positive status may result in depressive symptoms, which may be a concern to scaling novel HIV testing interventions that move testing outside the health system and away from counselor support.SettingUganda and Zambia.MethodsWe used longitudinal data from 2 female sex worker (FSW) cohorts in Uganda (n = 960) and Zambia (n = 965). Over 4 months, participants had ample opportunity to HIV testing using standard-of-care services or self-tests. At baseline and 4 months, we measured participants' perceived knowledge of HIV status, severity of depressive symptoms (continuous PHQ-9 scale, 0-27 points), and prevalence of likely depression (PHQ-9 scores ≥10). We estimated associations using individual fixed-effects estimation.ResultsCompared with unknown HIV status, knowledge of HIV-negative status was significantly associated with a decrease in depressive symptoms of 1.06 points in Uganda (95% CI -1.79 to -0.34) and 1.68 points in Zambia (95% CI -2.70 to -0.62). Knowledge of HIV-positive status was significantly associated with a decrease in depressive symptoms of 1.01 points in Uganda (95% CI -1.82 to -0.20) and 1.98 points in Zambia (95% CI -3.09 to -0.88). The prevalence of likely depression was not associated with knowledge of HIV status in Uganda but was associated with a 14.1% decrease with knowledge of HIV-negative status (95% CI -22.1% to -6.0%) and a 14.3% decrease with knowledge of HIV-positive status (95% CI -23.9% to -4.5%) in Zambia.ConclusionsKnowledge of HIV status, be it positive or negative, was significantly associated with a decrease in depressive symptoms in 2 FSW populations. The expansion of HIV testing programs may have mental health benefits for FSWs.
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- 2020
41. Emerging evidence from a systematic review of safety of pre-exposure prophylaxis for pregnant and postpartum women: where are we now and where are we heading?
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Joseph Davey, Dvora L, Pintye, Jillian, Baeten, Jared M, Aldrovandi, Grace, Baggaley, Rachel, Bekker, Linda-Gail, Celum, Connie, Chi, Benjamin H, Coates, Thomas J, Haberer, Jessica E, Heffron, Renee, Kinuthia, John, Matthews, Lynn T, McIntyre, James, Moodley, Dhayendre, Mofenson, Lynne M, Mugo, Nelly, Myer, Landon, Mujugira, Andrew, Shoptaw, Steven, Stranix-Chibanda, Lynda, John-Stewart, Grace, and PrEP in Pregnancy Working Group
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PrEP in Pregnancy Working Group ,Humans ,HIV-1 ,Pregnancy Complications ,Infectious ,HIV Infections ,Anti-HIV Agents ,Postnatal Care ,Breast Feeding ,Pregnancy ,Adult ,Female ,Young Adult ,Pre-Exposure Prophylaxis ,Tenofovir ,HIV ,PMTCT ,PrEP ,breastfeeding ,preexposure prophylaxis ,pregnancy ,prevention of mother to child transmission ,Pregnancy Complications ,Infectious ,Clinical Sciences ,Public Health and Health Services ,Other Medical and Health Sciences - Abstract
IntroductionHIV incidence is high during pregnancy and breastfeeding with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are not pregnant. The World Health Organization recommends offering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV infection. However, maternal PrEP national guidelines differ and most countries with high maternal HIV incidence are not offering PrEP. We conducted a systematic review of recent research on PrEP safety in pregnancy to inform national policy and rollout.MethodsWe used a standard Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) approach to conduct a systematic review by searching for completed, ongoing, or planned PrEP in pregnancy projects or studies from clinicaltrials.gov, PubMed and NIH RePORTER from 2014 to March 2019. We performed a systematic review of studies that assess tenofovir disoproxil fumarate (TDF)-based oral PrEP safety in pregnant and breastfeeding HIV-uninfected women.Results and discussionWe identified 14 completed (n = 5) and ongoing/planned (n = 9) studies that evaluate maternal and/or infant outcomes following PrEP exposure during pregnancy or breastfeeding. None of the completed studies found differences in pregnancy or perinatal outcomes associated with PrEP exposure. Nine ongoing studies, to be completed by 2022, will provide data on >6200 additional PrEP-exposed pregnancies and assess perinatal, infant growth and bone health outcomes, expanding by sixfold the data on PrEP safety in pregnancy. Research gaps include limited data on (1) accurately measured PrEP exposure within maternal and infant populations including drug levels needed for maternal protection; (2) uncommon perinatal outcomes (e.g. congenital anomalies); (3) infant outcomes such as bone growth beyond one year following PrEP exposure; (4) outcomes in HIV-uninfected women who use PrEP during pregnancy and/or lactation.ConclusionsExpanding delivery of PrEP is an essential strategy to reduce HIV incidence in pregnancy and breastfeeding women. Early safety studies of PrEP among pregnant women without HIV infection are reassuring and ongoing/planned studies will contribute extensive new data to bolster the safety profile of PrEP use in pregnancy. However, addressing research gaps is essential to expanding PrEP delivery for women in the context of pregnancy.
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- 2020
42. Emerging evidence from a systematic review of safety of pre‐exposure prophylaxis for pregnant and postpartum women: where are we now and where are we heading?
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Davey, Dvora L Joseph, Pintye, Jillian, Baeten, Jared M, Aldrovandi, Grace, Baggaley, Rachel, Bekker, Linda‐Gail, Celum, Connie, H, Benjamin, Coates, Thomas J, Haberer, Jessica E, Heffron, Renee, Kinuthia, John, Matthews, Lynn T, McIntyre, James, Moodley, Dhayendre, Mofenson, Lynne M, Mugo, Nelly, Myer, Landon, Mujugira, Andrew, Shoptaw, Steven, Stranix‐Chibanda, Lynda, John‐Stewart, Grace, and Group, for the PrEP in Pregnancy Working
- Subjects
Biomedical and Clinical Sciences ,Midwifery ,Public Health ,Health Sciences ,Reproductive Medicine ,Breastfeeding ,Lactation and Breast Milk ,HIV/AIDS ,Sexually Transmitted Infections ,Prevention ,Pregnancy ,Maternal Health ,Infectious Diseases ,Maternal Morbidity and Mortality ,Pediatric ,Women's Health ,Perinatal Period - Conditions Originating in Perinatal Period ,Reproductive health and childbirth ,Infection ,Good Health and Well Being ,Adult ,Anti-HIV Agents ,Breast Feeding ,Female ,HIV Infections ,HIV-1 ,Humans ,Postnatal Care ,Pre-Exposure Prophylaxis ,Pregnancy Complications ,Infectious ,Tenofovir ,Young Adult ,preexposure prophylaxis ,PrEP ,pregnancy ,breastfeeding ,PMTCT ,prevention of mother to child transmission ,HIV ,PrEP in Pregnancy Working Group ,Clinical Sciences ,Public Health and Health Services ,Other Medical and Health Sciences ,Clinical sciences ,Epidemiology ,Public health - Abstract
IntroductionHIV incidence is high during pregnancy and breastfeeding with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are not pregnant. The World Health Organization recommends offering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV infection. However, maternal PrEP national guidelines differ and most countries with high maternal HIV incidence are not offering PrEP. We conducted a systematic review of recent research on PrEP safety in pregnancy to inform national policy and rollout.MethodsWe used a standard Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) approach to conduct a systematic review by searching for completed, ongoing, or planned PrEP in pregnancy projects or studies from clinicaltrials.gov, PubMed and NIH RePORTER from 2014 to March 2019. We performed a systematic review of studies that assess tenofovir disoproxil fumarate (TDF)-based oral PrEP safety in pregnant and breastfeeding HIV-uninfected women.Results and discussionWe identified 14 completed (n = 5) and ongoing/planned (n = 9) studies that evaluate maternal and/or infant outcomes following PrEP exposure during pregnancy or breastfeeding. None of the completed studies found differences in pregnancy or perinatal outcomes associated with PrEP exposure. Nine ongoing studies, to be completed by 2022, will provide data on >6200 additional PrEP-exposed pregnancies and assess perinatal, infant growth and bone health outcomes, expanding by sixfold the data on PrEP safety in pregnancy. Research gaps include limited data on (1) accurately measured PrEP exposure within maternal and infant populations including drug levels needed for maternal protection; (2) uncommon perinatal outcomes (e.g. congenital anomalies); (3) infant outcomes such as bone growth beyond one year following PrEP exposure; (4) outcomes in HIV-uninfected women who use PrEP during pregnancy and/or lactation.ConclusionsExpanding delivery of PrEP is an essential strategy to reduce HIV incidence in pregnancy and breastfeeding women. Early safety studies of PrEP among pregnant women without HIV infection are reassuring and ongoing/planned studies will contribute extensive new data to bolster the safety profile of PrEP use in pregnancy. However, addressing research gaps is essential to expanding PrEP delivery for women in the context of pregnancy.
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- 2020
43. High Rates of Biomarker-Confirmed Alcohol Use Among Pregnant Women Living With HIV in South Africa and Uganda
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Raggio, Greer A, Psaros, Christina, Fatch, Robin, Goodman, Georgia, Matthews, Lynn T, Magidson, Jessica F, Amanyire, Gideon, Cross, Anna, Asiimwe, Stephen, Hahn, Judith A, and Haberer, Jessica E
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Reproductive Medicine ,Biomedical and Clinical Sciences ,Public Health ,Health Sciences ,HIV/AIDS ,Mental Health ,Prevention ,Health Services ,Clinical Research ,Substance Misuse ,Brain Disorders ,Alcoholism ,Alcohol Use and Health ,Behavioral and Social Science ,Infection ,Reproductive health and childbirth ,Stroke ,Mental health ,Good Health and Well Being ,Adult ,Alcohol Drinking ,Biomarkers ,Cross-Sectional Studies ,Depression ,Female ,Glycerophospholipids ,HIV Infections ,Humans ,Pregnancy ,Pregnant Women ,Prevalence ,Self Report ,Social Stigma ,South Africa ,Uganda ,Young Adult ,alcohol ,HIV ,pregnancy ,phosphatidylethanol ,women living with HIV ,Clinical Sciences ,Public Health and Health Services ,Virology ,Clinical sciences ,Epidemiology ,Public health - Abstract
BACKGROUND:Alcohol use is common among people living with HIV and particularly harmful during pregnancy. However, objective data on alcohol use in pregnant women living with HIV (WLWH) are lacking. In areas with high levels of alcohol use generally, such as South Africa and Uganda, these data are needed to inform interventions. METHODS:Pregnant and nonpregnant, antiretroviral therapy-naive WLWH were recruited from outpatient clinics in South Africa and Uganda. Women provided self-report data on previous three-month alcohol use and potential mental health correlates of alcohol use (depression and stigma). Blood samples were used to measure phosphatidylethanol (PEth), an objective biomarker of recent alcohol intake. We analyzed any alcohol use (ie, any self-reported use or PEth-positive [≥8 ng/mL]) and under-reporting of alcohol use (ie, no self-reported use with concurrent PEth-positive). RESULTS:Among pregnant WLWH (n = 163, median age was 26 [interquartile range: 23-29], median gestational age was 20 weeks [interquartile range: 16-26]), 40% were using alcohol and 16% under-reported alcohol use. Neither any alcohol use nor under-reporting of alcohol use differed significantly between pregnant and nonpregnant women or by country (P > 0.05). Greater depression (but not greater stigma) was significantly associated with any alcohol use (adjusted odds ratio = 1.41, 95% confidence interval: [1.01 to 1.99]; P = 0.045). CONCLUSIONS:Alcohol use was prevalent and under-reported among pregnant WLWH in South Africa and Uganda, similar to nonpregnant participants, and associated with depression. General health care and antenatal clinic settings present opportunities to provide integrated alcohol-based counseling and depression treatment.
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- 2019
44. Antiretroviral Therapy Adherence Interruptions Are Associated With Systemic Inflammation Among Ugandans Who Achieved Viral Suppression.
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Musinguzi, Nicholas, Castillo-Mancilla, Jose, Morrow, Mary, Byakwaga, Helen, Mawhinney, Samantha, Burdo, Tricia H, Boum, Yap, Muzoora, Conrad, Bwana, Bosco M, Siedner, Mark J, Martin, Jeffrey N, Hunt, Peter W, Bangsberg, David R, and Haberer, Jessica E
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Medical Microbiology ,Biomedical and Clinical Sciences ,Immunology ,Sexually Transmitted Infections ,Infectious Diseases ,HIV/AIDS ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Infection ,Adult ,Anti-HIV Agents ,Female ,HIV Infections ,Humans ,Inflammation ,Male ,Medication Adherence ,Time Factors ,adherence ,treatment interruption ,inflammation ,antiretroviral therapy ,Uganda ,Clinical Sciences ,Public Health and Health Services ,Virology ,Clinical sciences ,Epidemiology ,Public health - Abstract
BackgroundResidual systemic inflammation, which is associated with non-AIDS clinical outcomes, may persist despite viral suppression. We assessed the effect of antiretroviral therapy (ART) adherence interruptions on systemic inflammation among Ugandans living with HIV who were virally suppressed.SettingWe evaluated adults initiating first-line ART at a regional referral hospital clinic in Mbarara, Uganda.MethodsPlasma concentrations of interleukin-6 (IL-6), D-dimer, soluble sCD14, sCD163, the kynurenine/tryptophan (K/T) ratio, and CD8 T-cell activation (HLA-DR/CD38 coexpression) were measured at baseline and 6 months after ART initiation among participants who achieved viral suppression (
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- 2019
45. Individual and structural-level Correlates of Pre-exposure Prophylaxis (PrEP) lifetime and current use in a nationwide sample of young sexual and gender minorities
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Fitch, Calvin, Haberer, Jessica E., Serrano, Pedro A., Muñoz, Alejandro, French, Audrey L., and Hosek, Sybil G.
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- 2022
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46. Development of a transition readiness score for adolescents living with perinatally-acquired HIV and transitioning to adult care
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Zanoni, Brian C., Musinguzi, Nicholas, Archary, Moherndran, Sibaya, Thobekile, and Haberer, Jessica E.
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- 2022
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47. PrEP initiation, persistence, and adherence during pregnancy through the postpartum period: a prospective analysis in Kenya
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Pintye, Jillian, Kinuthia, John, Abuna, Felix, Anderson, Peter L., Dettinger, Julia C., Gomez, Laurén, Haberer, Jessica E., Marwa, Mary, Mwongeli, Nancy, Omondi, Pascal., Ochieng, Ben, Stern, Joshua, Watoyi, Salphine, Baeten, Jared M., and John-Stewart, Grace
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- 2023
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48. Sexually Transmitted Infection Point-of-Care Testing in Resource-Limited Settings: A Narrative Review Guided by an Implementation Framework
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Chitneni, Pooja, Owembabazi, Moran, Muyindike, Winnie, Asiimwe, Stephen, Masete, Godfrey, Mbalibulha, Yona, Nakku-Joloba, Edith, Manabe, Yukari C., Haberer, Jessica E., Matthews, Lynn T., and Van Der Pol, Barbara
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- 2023
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49. HIV pre-exposure prophylaxis initiation, persistence, and adherence during pregnancy through the postpartum period
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Pintye, Jillian, Kinuthia, John, Abuna, Felix, Anderson, Peter L., Dettinger, Julia C., Gomez, Laurén, Haberer, Jessica E., Marwa, Mary M., Ngumbau, Nancy, Omondi, Pascal, Odhiambo, Ben, Stern, Joshua, Watoyi, Salphine, Baeten, Jared M., and John-Stewart, Grace
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- 2023
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50. WhatsApp-based sexual and reproductive health education for adolescents with perinatally acquired HIV: lessons learned from an mHealth pilot intervention in South Africa
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Bergam, Scarlett, primary, Sibaya, Thobekile, additional, Gethers, Casiel T., additional, Ndlela, Nompumelelo, additional, Kuzwayo, Mpume, additional, Marconi, Vincent C., additional, Haberer, Jessica E., additional, Archary, Moherndran, additional, and Zanoni, Brian C., additional
- Published
- 2024
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