Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania.

BACKGROUND: Economic incentives can improve clinical outcomes among in-care people living with HIV (PLHIV), but evidence is limited for their effectiveness among out-of-care PLHIV or those at risk of disengagement. We propose a type 1 hybrid effectiveness-implementation study to advance global knowledge about the use of economic incentives to strengthen the continuity of HIV care and accelerate global goals for HIV epidemic control. METHODS: The Rudi Kundini, Pamoja Kundini study will evaluate two implementation models of an economic incentive strategy for supporting two groups of PLHIV in Tanzania. Phase 1 of the study consists of a two-arm, cluster randomized trial across 32 health facilities to assess the effectiveness of a home visit plus one-time economic incentive on the proportion of out-of-care PLHIV with viral load suppression (< 1000 copies/ml) 6 months after enrollment (n = 640). Phase 2 is an individual 1:1 randomized controlled trial designed to determine the effectiveness of a short-term counseling and economic incentive program offered to in-care PLHIV who are predicted through machine learning to be at risk of disengaging from care on the outcome of viral load suppression at 12 months (n = 692). The program includes up to three incentives conditional upon visit attendance coupled with adapted counselling sessions for this population of PLHIV. Consistent with a hybrid effectiveness-implementation study design, phase 3 is a mixed methods evaluation to explore barriers and facilitators to strategy implementation in phases 1 and 2. Results will be used to guide optimization and scale-up of the incentive strategies, if effective, to the larger population of Tanzanian PLHIV who struggle with continuity of HIV care. DISCUSSION: Innovative strategies that recognize the dynamic process of lifelong retention in HIV care are urgently needed. Strategies such as conditional economic incentives are a simple and effective method for improving many health outcomes, including those on the HIV continuum. If coupled with other supportive services such as home visits (phase 1) or with tailored counselling (phase 2), economic incentives have the potential to strengthen engagement among the subpopulation of PLHIV who struggle with retention in care and could help to close the gap towards reaching global "95-95-95" goals for ending the AIDS epidemic. TRIAL REGISTRATION: Phase 1: ClinicalTrials.gov, NCT05248100 , registered 2/21/2022. Phase 2: ClinicalTrials.gov, NCT05373095 , registered 5/13/2022.

Opportunities to Increase Access to HIV Prevention: Evaluating the Implementation of Pharmacist-Initiated Pre-exposure Prophylaxis in California.

Background: Pharmacies are a promising setting through which to expand access to human immunodeficiency virus (HIV) prevention, including pre-exposure and post-exposure prophylaxis (PrEP and PEP, respectively). We aimed to evaluate and inform the implementation of California's Senate Bill 159 (2019), allowing pharmacists to independently prescribe PrEP and PEP. Methods: From October through December 2022, we conducted a cross-sectional study of 919 California pharmacists and pharmacy students, primarily recruited via the email listservs of professional organizations. Participants completed an online survey assessing the implementation of pharmacist-initiated PrEP/PEP, including knowledge, attitudes, practices, perceived barriers, and implementation preferences elicited through a discrete choice experiment. Results: Among 919 participants (84% practicing pharmacists, 43% in community pharmacies), 11% and 13% reported that pharmacists at their pharmacy initiate PrEP and PEP, respectively. Most believed that pharmacist-initiated PrEP/PEP is important (96%) and were willing to provide PrEP (81%); fewer (27%) had PrEP/PEP training. Common implementation barriers were lack of staff/time and payment for pharmacist services. Participants preferred PrEP implementation models with in-pharmacy rapid oral HIV testing and pharmacists specifically hired to provide PrEP services. Conclusions: Despite pharmacists' supportive attitudes, Senate Bill 159 implementation in California pharmacies remains limited, in part due to policy-level and organizational-level barriers. Ensuring PrEP/PEP-related payment for services and sufficient workforce capacity is key to leveraging pharmacists' role in HIV prevention.

Effects of the COVID-19 pandemic on sales of sexual and reproductive health products: an ecological study of pharmacies in Kenya.

OBJECTIVES: To examine how sales of sexual and reproductive health (SRH) products varied among pharmacies in Kenya using administrative data, leveraging natural variation in the COVID-19 pandemic and accompanying policy restrictions between 2019 and 2021. DESIGN AND SETTING: Ecological study of pharmacies in Kenya. PARTICIPANTS: 761 pharmacies using the Maisha Meds product inventory management system (capturing 572 916 products sold). OUTCOMES: Sales quantity, price and revenue of SRH products sold per pharmacy per week. RESULTS: COVID-19 deaths were associated with a -2.97% (95% CI -3.82%, -2.11%) decrease in sales quantity, a 1.09% (95% CI 0.44%, 1.72%) increase in sales price and a -1.89% (-1.00%, -2.79%) decrease in revenues per pharmacy per week. Results were similar when considering new COVID-19 cases (per 1000) and the Average Policy Stringency Index. Results differed substantially between individual SRH products-a large decrease in sales quantity in pregnancy tests, injectables and emergency contraception, a modest decrease in condoms and no change in oral contraception. Sales price increases were similarly varied; four of the five most sold products were revenue neutral. CONCLUSIONS: We found a robust negative association between SRH sales at pharmacies in Kenya and COVID-19 reported cases, deaths and policy restriction. Although our data cannot definitively point to reduced access, existing evidence from Kenya regarding unchanged fertility intentions, increases in unintended pregnancies and reported reasons for non-use of contraceptives during COVID-19 suggests a prominent role of reduced access. While policymakers may have a role in sustaining access, their role may be limited by broader macroeconomic problems, such as global supply chain disruptions and inflation, during supply shocks.

Monitoring SARS-CoV-2 incidence and seroconversion among university students and employees: a longitudinal cohort study in California, June-August 2020.

OBJECTIVES: To identify incident SARS-CoV-2 infections and inform effective mitigation strategies in university settings, we piloted an integrated symptom and exposure monitoring and testing system among a cohort of university students and employees. DESIGN: Prospective cohort study. SETTING: A public university in California from June to August 2020. PARTICIPANTS: 2180 university students and 738 university employees. PRIMARY OUTCOME MEASURES: At baseline and endline, we tested participants for active SARS-CoV-2 infection via quantitative PCR (qPCR) test and collected blood samples for antibody testing. Participants received notifications to complete additional qPCR tests throughout the study if they reported symptoms or exposures in daily surveys or were selected for surveillance testing. Viral whole genome sequencing was performed on positive qPCR samples, and phylogenetic trees were constructed with these genomes and external genomes. RESULTS: Over the study period, 57 students (2.6%) and 3 employees (0.4%) were diagnosed with SARS-CoV-2 infection via qPCR test. Phylogenetic analyses revealed that a super-spreader event among undergraduates in congregate housing accounted for at least 48% of cases among study participants but did not spread beyond campus. Test positivity was higher among participants who self-reported symptoms (incidence rate ratio (IRR) 12.7; 95% CI 7.4 to 21.8) or had household exposures (IRR 10.3; 95% CI 4.8 to 22.0) that triggered notifications to test. Most (91%) participants with newly identified antibodies at endline had been diagnosed with incident infection via qPCR test during the study. CONCLUSIONS: Our findings suggest that integrated monitoring systems can successfully identify and link at-risk students to SARS-CoV-2 testing. As the study took place before the evolution of highly transmissible variants and widespread availability of vaccines and rapid antigen tests, further research is necessary to adapt and evaluate similar systems in the present context.

Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania.

Background: Economic incentives can improve clinical outcomes among in-care people living with HIV (PLHIV), but evidence is limited for their effectiveness among out-of-care PLHIV or those at-risk of disengagement. We propose a type 1 hybrid effectiveness-implementation study to advance global knowledge about the use of economic incentives to strengthen the continuity of HIV care and accelerate global goals for HIV epidemic control. Methods: The Rudi Kundini, Pamoja Kundini study will evaluate two implementation models of an economic incentive strategy for supporting two groups of PLHIV in Tanzania. Phase 1 of the study consists of a two-arm, cluster randomized trial across 32 health facilities to assess the effectiveness of a home visit plus one-time economic incentive on the proportion of out-of-care PLHIV with viral load suppression (<1000 copies/ml) 6 months after enrollment (n = 640). Phase 2 is an individual 1:1 randomized controlled trial designed to determine the effectiveness of a short-term counseling and economic incentive program offered to in-care PLHIV who are predicted through machine learning to be at-risk of disengaging from care on the outcome of viral load suppression at 12 months (n = 692). The program includes up to three incentives conditional upon visit attendance coupled with adapted counselling sessions for this population of PLHIV. Consistent with a hybrid effectiveness-implementation study design, phase 3 is a mixed methods evaluation to explore barriers and facilitators to strategy implementation in phases 1 and 2. Results will be used to guide optimization and scale-up of the incentive strategies, if effective, to the larger population of Tanzanian PLHIV who struggle with continuity of HIV care. Discussion: Innovative strategies that recognize the dynamic process of lifelong retention in HIV care are urgently needed. Strategies such as conditional economic incentives are a simple and effective method for improving many health outcomes, including those on the HIV continuum. If coupled with other supportive services such as home visits (phase 1) or with tailored counselling (phase 2), economic incentives have the potential to strengthen engagement among the subpopulation of PLHIV who struggle with retention in care and could help to close the gap towards reaching global '95-95-95' goals for ending the AIDS epidemic.Phase 1: Clinicaltrials.gov, NCT05248100, registered 2/21/2022 https://clinicaltrials.gov/ct2/show/NCT05248100Phase 2: Clinicaltrials.gov, NCT05373095, registered 5/13/2022 https://clinicaltrials.gov/ct2/show/NCT05373095.

Feasibility and effectiveness of daily temperature screening to detect COVID-19 in a prospective cohort at a large public university.

BACKGROUND: Many persons with active SARS-CoV-2 infection experience mild or no symptoms, presenting barriers to COVID-19 prevention. Regular temperature screening is nonetheless used in some settings, including university campuses, to reduce transmission potential. We evaluated the potential impact of this strategy using a prospective university-affiliated cohort. METHODS: Between June and August 2020, 2912 participants were enrolled and tested for SARS-CoV-2 by PCR at least once (median: 3, range: 1-9). Participants reported temperature and symptoms daily via electronic survey using a previously owned or study-provided thermometer. We assessed feasibility and acceptability of daily temperature monitoring, calculated sensitivity and specificity of various fever-based strategies for restricting campus access to reduce transmission, and estimated the association between measured temperature and SARS-CoV-2 test positivity using a longitudinal binomial mixed model. RESULTS: Most participants (70.2%) did not initially have a thermometer for taking their temperature daily. Across 5481 total person months, the average daily completion rate of temperature values was 61.6% (median: 67.6%, IQR: 41.8-86.2%). Sensitivity for SARS-CoV-2 ranged from 0% (95% CI 0-9.7%) to 40.5% (95% CI 25.6-56.7%) across all strategies for self-report of possible COVID-19 symptoms on day of specimen collection, with corresponding specificity of 99.9% (95% CI 99.8-100%) to 95.3% (95% CI 94.7-95.9%). An increase of 0.1 °F in individual mean body temperature on the same day as specimen collection was associated with 1.11 increased odds of SARS-CoV-2 positivity (95% CI 1.06-1.17). CONCLUSIONS: Our study is the first, to our knowledge, that examines the feasibility, acceptability, and effectiveness of daily temperature screening in a prospective cohort during an infectious disease outbreak, and the only study to assess these strategies in a university population. Daily temperature monitoring was feasible and acceptable; however, the majority of potentially infectious individuals were not detected by temperature monitoring, suggesting that temperature screening is insufficient as a primary means of detection to reduce transmission of SARS-CoV-2.

A randomized trial of cash incentives for sexual behavior change among female sex workers in Dar es Salaam.

RATIONALE: Female sex workers (FSW) across the world are at high risk for HIV infection and much work is needed to scale up HIV prevention programs among this group. Conditional cash transfer (CCT) programs have been used successfully in recent years to encourage behavior change. We report the results of a CCT intervention among FSW in Tanzania. METHODS: We conducted a randomized controlled trial (N = 100) of a CCT intervention among FSW in Dar-es-Salaam, Tanzania in 2013. A respondent-driven sampling approach recruited women and randomized them into two groups based on the value of the cash incentive ($20 vs. $40 per visit). All women received testing for 2 curable sexually transmitted infections (STIs), trichomonas and syphilis, free treatment for those STIs and counseling. Women attended study visits at 0, 2 and 4 months and were tested for STIs and received counseling at each visit. Women testing negative for both STIs at the 2- and 4-month visits received a cash reward. RESULTS: Eighty-four women were retained in the study through all three visits. Participants reported significant reductions in the number of clients per week, and increases in the proportion of clients that they used condoms with over the course of the study. STI results showed decreases in prevalence from baseline to final study visit for syphilis and trichomonas. CONCLUSION: While this study was not powered to determine if the incentive resulted in statistically significant increases in condom use or decreases in STI prevalence, the results show the acceptability of the intervention, the feasibility of the recruitment methods, and the ability to retain FSW participants across multiple study visits. A follow-up randomized study with a larger number of participants is planned to test the efficacy of the intervention among high-risk populations of women engaging in transactional sex.

Female sex workers use power over their day-to-day lives to meet the condition of a conditional cash transfer intervention to incentivize safe sex.

Female Sex Workers are a core population in the HIV epidemic, and interventions such as conditional cash transfers (CCTs), effective in other health domains, are a promising new approach to reduce the spread of HIV. Here we investigate how a population of Tanzanian female sex workers, though constrained in many ways, experience and use their power in the context of a CCT intervention that incentivizes safe sex. We analyzed 20 qualitative in-depth interviews with female sex workers enrolled in a randomized-controlled CCT program, the RESPECT II pilot, and found that while such women have limited choices, they do have substantial power over their work logistics that they leveraged to meet the conditions of the CCT and receive the cash award. It was through these decisions over work logistics, such as reducing the number of workdays and clients, that the CCT intervention had its greatest impact on modifying female sex workers' behavior.

Patient-delivered partner therapy for chlamydial infections: attitudes and practices of California physicians and nurse practitioners.

OBJECTIVE: The objective of this study was to examine California clinicians' use of and attitudes toward patient-delivered partner therapy (PDPT) to treat sexual partners of patients infected with chlamydia. STUDY DESIGN: In 2002, a stratified random sample of primary care physicians and nurse practitioners completed a mailed, self-administered survey. Weighted frequencies were calculated to assess partner management practices, including PDPT, and attitudes toward PDPT. Multivariate models were constructed to determine independent predictors of PDPT use. RESULTS: Of 708 physicians and 895 nurse practitioners, approximately half (47% and 48%, respectively) reported that they use PDPT usually or always. Over 90% agreed that PDPT protects patients from reinfection and provides better care for patients with chlamydia. However, providers reported concerns that PDPT may result in incomplete care for the partner, may be dangerous without knowing the partner's medical or allergy history, is an activity the practice may not get paid for, and may get them sued. Obstetrics/gynecology and family practice physicians were more likely than internal medicine physicians to report routine use of PDPT. Concerns about adverse outcomes of PDPT were associated with less PDPT use. CONCLUSIONS: Although the proportion of California healthcare providers routinely using PDPT is comparatively high, further study is warranted to examine the circumstances under which this partner management strategy is used.