Supporting young women's health through girl-friendly drug vendors in Lake Zone, Tanzania: protocol for the AmbassADDOrs for Health cluster-randomised controlled trial.

INTRODUCTION: Adverse sexual and reproductive health (SRH) outcomes, such as unplanned pregnancies and HIV infection, disproportionately affect adolescent girls and young women (AGYW; aged 15-24 years) in east Africa. Increasing uptake of preventive SRH services via innovative, youth-centred interventions is imperative to addressing disparities in SRH outcomes. METHODS AND ANALYSIS: From 2018 to 2019, we used human-centred design to co-develop a theoretically driven HIV and pregnancy prevention intervention for AGYW at private drug shops called Accredited Drug Dispensing Outlets (ADDOs) in Tanzania. The result, Malkia Klabu (Queen Club), was a customer loyalty programme designed to strengthen ADDOs' role as SRH providers while encouraging uptake of critical SRH prevention products among AGYW. Malkia Klabu members had access to free contraceptives and oral HIV self-test (HIVST) kits and earned punches on a loyalty card for other shop purchases; punches were redeemable for small prizes. Our pilot among 40 shops showed that intervention ADDOs had higher AGYW patronage and distributed more HIVST kits and contraceptives to AGYW relative to business-as-usual (ie, client purchasing) comparison shops. We will conduct a cluster-randomised controlled trial (c-RCT) among 120-140 ADDOs in 40 health catchment areas in Shinyanga and Mwanza Regions (Lake Zone), Tanzania. ADDO shop recruitment includes a 1-month run-in with a tablet-based electronic inventory management system for tracking shop transactions, followed by enrolment, randomisation and a 24-month trial period. Our c-RCT evaluating the human-centred design-derived intervention will assess population impact on the primary outcomes of HIV diagnoses and antenatal care registrations, measured with routine health facility data. We will also assess secondary outcomes focusing on mechanisms of action, evaluate programme exposure and AGYW behaviour change in interviews with AGYW, and assess shop-level implementation strategies and fidelity. ETHICS AND DISSEMINATION: Ethical approval was granted from both the University of California, San Francisco and the Tanzanian National Institute for Medical Research. Study progress and final outcomes will be posted annually to the National Clinical Trials website; study dissemination will occur at conferences, peer-reviewed manuscripts and local convenings of stakeholders. TRIAL REGISTRATION NUMBER: NCT05357144.

Outcomes of an Emergency Department Program to Identify and Link Patients at Increased Risk for Acquiring HIV Infection to Outpatient HIV Prevention Services: The HIV PreventED Program.

BACKGROUND: Emergency departments (EDs) provide care to patients at increased risk for acquiring HIV, and for many of them, the ED serves as their sole point of entry into the healthcare system. We implemented the HIV PreventED Program to increase access to HIV prevention services for ED patients. SETTING: ED in Oakland, CA with an annual census of 57,000 visits. METHODS: This cross-sectional study evaluated the first 9 months of the HIV PreventED Program. In this program, a navigator surveyed adult ED patients who tested HIV negative to determine their risk for acquiring HIV infection, incorporating HIV prevention counseling into their assessments. Patients at higher risk for acquiring HIV were referred to outpatient prevention services, if interested. The primary outcome measure was the number and proportion of ED patients at higher risk for acquiring HIV who followed up for outpatient prevention services. RESULTS: In this study, 1233 patients who tested HIV negative were assessed by the navigator and received ED-based HIV prevention counseling. Of these, 193 (15.7%) were identified at higher risk and offered an outpatient referral for prevention services, of which 104 accepted (53.9%), 23 (11.9%) attended the referral, and 13 (6.7%) were prescribed preexposure prophylaxis (PrEP). The median time to linkage was 28 days (interquartile range 15-41 days). CONCLUSION: A navigator focused on providing ED-based HIV prevention counseling and linkage to outpatient services is feasible. Strategies to more efficiently identify ED patients at higher risk for HIV acquisition, such as automated identification of risk data from the electronic health record, and policies to improve follow-up and the receipt of PrEP, such as same-day PrEP initiation, should be prospectively evaluated.

Willingness of Pharmacists to Prescribe Medication Abortion in California.

Importance: Nearly half of US states have restricted abortion access. Policy makers are exploring pathways to increase access to abortion and reproductive health care more broadly. Since 2016, California pharmacists could prescribe hormonal birth control, providing an opportunity to learn about the implementation of pharmacist-provided reproductive health care. Objective: To explore the feasibility of broadening pharmacist scope of practice to include prescribing medication abortion. Design, Setting, and Participants: A cross-sectional online survey was conducted from October 11 to December 20, 2022, among a convenience sample of California licensed community pharmacists to examine their attitudes toward, knowledge of, and confidence in prescribing hormonal birth control and reports of pharmacy-level practices. Main Outcomes and Measures: Descriptive analyses and log-binomial regression models were used to compare medication abortion and contraceptive provision attitudes by pharmacist and pharmacy characteristics. Results: Among the 316 pharmacists included in the analysis who worked at community pharmacies across California (mean [SD] age, 40.9 [12.0] years; 169 of 285 [59.3%] cisgender women; and 159 of 272 [58.5%] non-Hispanic Asian individuals), most (193 of 280 [68.9%]) indicated willingness to prescribe medication abortion to pharmacy clients if allowed by law. However, less than half were confident in their knowledge of medication abortion (139 of 288 [48.3%]) or their ability to prescribe it (115 of 285 [40.4%]). Pharmacists who indicated that providing access to hormonal birth control as a prescribing provider was important (263 of 289 [91.0%]) and were confident in their ability to prescribe it (207 of 290 [71.4%]) were 3.96 (95% CI, 1.80-8.73) times and 2.44 (95% CI, 1.56-3.82) times more likely to be willing to prescribe medication abortion and to express confidence in doing so, respectively. Although most pharmacists held favorable attitudes toward hormonal birth control, less than half (144 of 308 [46.8%]) worked in a pharmacy that provided prescriptions for hormonal birth control, and 149 who did not reported barriers such as lack of knowledge or training (65 [43.6%]), insufficient staff or time to add new services (58 [38.9%]), and lack of coverage for services (50 [33.6%]). Conclusions and Relevance: The findings of this cross-sectional survey study of California pharmacists suggest that most pharmacists were willing to prescribe medication abortion. However, future efforts to expand pharmacists' scope of practice should include training to increase knowledge and confidence in prescribing medication abortion. Pharmacy-level barriers to hormonal birth control prescription, such as insurance coverage for pharmacist effort, should also be addressed, as they may serve as barriers to medication abortion access.

Age-disparate relationships at first sex and reproductive autonomy, empowerment, and sexual violence among adolescent girls and young women in Rwanda.

Background: Age-disparate relationships (ADR) place adolescent girls and young women (AGYW) at higher risk of unprotected sex and HIV infection; few studies have investigated ADR at first sex in sub-Saharan Africa. This study investigates ADR at first sex and its association with reproductive autonomy, reproductive empowerment, contraception coercion, and consent at first sex among female Rwandan youth. Methods: Cross-sectional data from a randomized trial (n = 5768) of in-school youth ages 12-19 at enrollment were analyzed with focus on those who reported sexual activity (n = 1319). General estimating equation linear models and Poisson models were used to estimate linear coefficients and prevalence ratios (PR), with 95% confidence intervals (CIs) estimated using robust standard errors. Results: Females reported a significantly higher average partner age gap than males by 2.43 years (2.90 years vs. 0.46 years, 95% CI: 2.01, 2.86). Overall, 23.4% (n = 102) of sexually active AGYW engaged in an ADR at first sex. The prevalence of non-consensual first sex was 60% higher among AGYW reporting ADR at first sex compared to AGYW reporting similar-aged partners (adjusted PR = 1.59, 95% CI: 1.25, 2.02). No association was found between ADR at first sex and reproductive autonomy, reproductive empowerment, or contraception coercion. Conclusions: Our results suggest a high prevalence of sexual violence among AGYW engaging in first sex with an age-disparate partner. However, we did not find evidence that ADR at first sex affects reproductive autonomy or empowerment within the first few years of sexual initiation. Further research is needed to explore the impact of ADR at first sex and longer-term trajectories of sexual behavior, empowerment and autonomy.

CyberRwanda's Pathway to Impact: Results From a Cluster-Randomized Trial of Adolescent Family Planning Knowledge, Beliefs, Self-Efficacy, and Behavior.

PURPOSE: CyberRwanda is a digital health intervention designed to increase knowledge of family planning and reproductive health (FP/RH) and access to youth-friendly services in Rwanda. METHODS: Sixty schools in eight districts were randomized 1:1:1 to one of two CyberRwanda implementation models-self-service (tablet-only) or facilitated (tablet, activity booklet, peer facilitators)-or to control. Students aged 12-19 years were randomly selected to participate. Baseline and 12-month midline surveys assessed intermediate (secondary) outcomes of FP/RH and HIV knowledge, attitudes/beliefs, self-efficacy, and behavior. Prevalence differences (PDs) were estimated using generalized linear mixed models. RESULTS: There were 5,767 midline participants (51% female, mean/median age: 16 years, 29.9% sexually active). Those in CyberRwanda schools had higher knowledge of emergency contraception (57.3% vs. 47.5%, PD: 0.09, 95% confidence interval [CI]: 0.05-0.13); greater confidence in providing consent (73.3% vs. 68.1%, PD: 0.05, 95% CI: 0.01-0.08), negotiating partner's contraceptive use (88.3% vs. 85.0%, PD: 0.03, 95% CI: 0.01-0.06), and accessing/using contraceptive services (95.6% vs. 91.8%, PD: 0.03, 95% CI: 0.02-0.05); and more favorable views on FP/RH services (54.5% vs. 48.5%, PD: 0.06, 95% CI: 0.02-0.11) and condoms (76.9% vs. 71.3%, PD: 0.06, 95% CI: 0.03-0.08) compared to control. No significant differences in HIV/fertility knowledge, confidence in accessing HIV testing, or condom use were observed. DISCUSSION: CyberRwanda increased FP/RH knowledge, supportive attitudes/beliefs, self-efficacy, and behavior at 12 months. The 24-month endline analysis will reveal whether CyberRwanda's benefits on intermediate outcomes result in changes to the primary outcomes, including contraception use and childbearing.

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.

Food Insecurity and Engagement in Transactional Sex Among Female Secondary Students in Rwanda.

The relationship between food insecurity and transactional sex is well recognized, but less is known about this relationship among adolescents. We analyzed cross-sectional baseline data from 3,130 female secondary students aged 12-19 enrolled in a three-arm, cluster randomized controlled trial to examine the association between food insecurity and transactional sex. The explanatory variable was food security and the outcome was ever engaging in transactional sex. Over one quarter (28.7%) reported any food insecurity and 1.9% of all participants (9.6% of sexually active participants) reported ever engaging in transactional sex. In adjusted models, ever experiencing any food insecurity was associated with a higher prevalence of ever transactional sex (PR: 1.60; 95% CI: 1.02, 2.49) compared to little to no food insecurity. These results provide insight into potential predictors of higher-risk sexual behavior in Rwanda; they also provide policy-makers with populations with whom to intervene on upstream determinants of transactional sex, notably poverty and food insecurity.

Adaptive Strategies for Retention in Care among Persons Living with HIV.

BACKGROUND: Optimizing retention in human immunodeficiency virus (HIV) treatment may require sequential behavioral interventions based on patients' response. METHODS: In a sequential multiple assignment randomized trial in Kenya, we randomly assigned adults initiating HIV treatment to standard of care (SOC), Short Message Service (SMS) messages, or conditional cash transfers (CCT). Those with retention lapse (missed a clinic visit by ≥14 days) were randomly assigned again to standard-of-care outreach (SOC-Outreach), SMS+CCT, or peer navigation. Those randomly assigned to SMS or CCT who did not lapse after 1 year were randomly assigned again to either stop or continue the initial intervention. Primary outcomes were retention in care without an initial lapse, return to the clinic among those who lapsed, and time in care; secondary outcomes included adjudicated viral suppression. Average treatment effect (ATE) was calculated using targeted maximum likelihood estimation with adjustment for baseline characteristics at randomization and certain time-varying characteristics at rerandomization. RESULTS: Among 1809 participants, 79.7% of those randomly assigned to CCT (n=523/656), 71.7% to SMS (n=393/548), and 70.7% to SOC (n=428/605) were retained in care in the first year (ATE: 9.9%; 95% confidence interval [CI]: 5.4%, 14.4% and ATE: 4.2%; 95% CI: -0.7%, 9.2% for CCT and SMS compared with SOC, respectively). Among 312 participants with an initial lapse who were randomly assigned again, 69.1% who were randomly assigned to a navigator (n=76/110) returned, 69.5% randomly assigned to CCT+SMS (n=73/105) returned, and 55.7% randomly assigned to SOC-Outreach (n=54/97) returned (ATE: 14.1%; 95% CI: 0.6%, 27.6% and ATE: 11.4%; 95% CI: -2.2%, 24.9% for navigator and CCT+SMS compared with SOC-Outreach, respectively). Among participants without lapse on SMS, continuing SMS did not affect retention (n=122/180; 67.8% retained) versus stopping (n=151/209; 72.2% retained; ATE: -4.4%; 95% CI: -16.6%, 7.9%). Among participants without lapse on CCT, those continuing CCT had higher retention (n=192/230; 83.5% retained) than those stopping (n=173/287; 60.3% retained; ATE: 28.6%; 95% CI: 19.9%, 37.3%). Among 15 sequenced strategies, initial CCT, escalated to navigator if lapse occurred and continued if no lapse occurred, increased time in care (ATE: 7.2%, 95% CI: 3.7%, 10.7%) and viral suppression (ATE: 8.2%, 95% CI: 2.2%, 14.2%), the most compared with SOC throughout. Initial SMS escalated to navigator if lapse occurred, and otherwise continued, showed similar effect sizes compared with SOC throughout. CONCLUSIONS: Active interventions to prevent retention lapses followed by navigation for those who lapse and maintenance of initial intervention for those without lapse resulted in best overall retention and viral suppression among the strategies studied. Among those who remained in care, discontinuation of CCT, but not SMS, compromised retention and suppression. (Funded by National Institutes of Health grants R01 MH104123, K24 AI134413, and R01 AI074345; ClinicalTrials.gov number, NCT02338739.).

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.

Increased prevalence of depression and anxiety among adults initiating antiretroviral therapy during the COVID-19 pandemic in Shinyanga region, Tanzania.

BACKGROUND: Concerns about the interconnected relationship between HIV and mental health were heightened during the COVID-19 pandemic. This study assessed whether there were temporal changes in the mental health status of people living with HIV presenting for care in Shinyanga region, Tanzania. Specifically, we compared the prevalence of depression and anxiety before and during COVID-19, with the goal of describing the changing needs, if any, to person-centered HIV services. METHODS: We analyzed baseline data from two randomized controlled trials of adults initiating ART in Shinyanga region, Tanzania between April-December 2018 (pre-COVID-19 period, n = 530) and May 2021-March 2022 (COVID-19 period, n = 542), respectively. We compared three mental health indicators that were similarly measured in both surveys: loss of interest in things, hopelessness about the future, and uncontrolled worrying. We also examined depression and anxiety which were measured using the Hopkins Symptom Checklist-25 in the pre-COVID-19 period and the Patient Health Questionnaire-4 in the COVID-19 period, respectively, and classified as binary indicators per each scale's threshold. We estimated prevalence differences (PD) in adverse mental health status before and during the COVID-19 pandemic, using stabilized inverse probability of treatment weighting to adjust for underlying differences in the two study populations. RESULTS: We found significant temporal increases in the prevalence of feeling 'a lot' and 'extreme' loss of interest in things ['a lot' PD: 38, CI 34,41; 'extreme' PD: 9, CI 8,12)], hopelessness about the future [' a lot' PD: 46, CI 43,49; 'extreme' PD: 4, CI 3,6], and uncontrolled worrying [' a lot' PD: 34, CI 31,37; 'extreme' PD: 2, CI 0,4] during the COVID-19 pandemic. We also found substantially higher prevalence of depression [PD: 38, CI 34,42] and anxiety [PD: 41, CI 37,45]. CONCLUSIONS: After applying a quasi-experimental weighting approach, the prevalence of depression and anxiety symptoms among those starting ART during COVID-19 was much higher than before the pandemic. Although depression and anxiety were measured using different, validated scales, the concurrent increases in similarly measured mental health indicators lends confidence to these findings and warrants further research to assess the possible influence of COVID-19 on mental health among adults living with HIV. Trial Registration NCT03351556, registered November 24, 2017; NCT04201353, registered December 17, 2019.

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.

Measuring sexual behavior among in-school youth in Rwanda: a cross-sectional analysis of self-reported timing of first sex and correlates of early sexual debut.

PURPOSE: Understanding the timing of sexual debut is critical for informing sexual and reproductive health interventions. We investigated sexual behavior and early sexual debut among Rwandan youth. METHODS: We conducted a cross-sectional analysis of data from a cluster-randomized trial with 6079 students ages 12-19 years in Rwanda. We examined predictors of early sexual debut (<15 years) using logistic regression to estimate odds ratios and factors associated with the timing of first sex using Cox models to estimate hazard ratios. Interpretations of sex were also explored. RESULTS: Participants were 15 years and 51.5% female on average; 1723 (28.3%) reported sexual activity. Among the 1320 participants who provided an age of sexual debut, 51.4% reported sex at ≤12 years and 75.7% at<15 years. Males had a higher odds of early sexual debut (adjusted odds ratio: 2.40; 95% CI: 1.99, 2.90) and a higher hazard of sex occuring at an earlier age than females (adjusted hazard ratio: 1.91; 95% CI: 1.67, 2.20). One-third of participants considered "sexual intercourse" to include kissing, touching, or masturbation. CONCLUSIONS: Sex at ≤12 years was frequently reported, indicating that interventions facilitating access to youth-friendly sexual and reproductive health services are necessary before age 12. Validation studies are needed to evaluate how interpretations of sexual intercourse influence the assessment of sexual activity. CLINICAL TRIAL: NCT04198272.

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.

Digital self-care for improved access to family planning and reproductive health services among adolescents in Rwanda: preliminary findings from a pilot study of CyberRwanda.

Adolescents experience significant barriers, including stigma and discrimination, to accessing voluntary family planning and reproductive health (FP/RH) services in Rwanda. Self-care interventions have been shown to reduce social barriers to FP/RH care, but little is known about the effectiveness of digital self-care for adolescents, particularly in low-resource settings. This paper presents findings from a pilot study of CyberRwanda, a digital self-care intervention providing comprehensive sexuality education and confidential online ordering of contraceptives for school-aged youth in Rwanda through a rights-based approach. A mixed-methods pilot study was conducted from November 2019 to February 2020 to assess feasibility, acceptability, and engagement and to inform a future impact evaluation. Surveys were administered to a random sample of 158 students aged 12-19 years in three secondary schools. In-depth interviews were conducted with students, parents, teachers, pharmacists, district-level administrators, and youth centre staff. Descriptive statistics were calculated and qualitative data were analyzed using a thematic coding approach. One hundred and fifty-eight surveys and 28 interviews were conducted. Results revealed high demand for CyberRwanda in schools. Students were interested in engaging with the program and found the FP/RH content relevant to their needs. However, few purchased contraceptive products through the online ordering system. There are preliminary indications that CyberRwanda may improve access to FP/RH information. An extended implementation period and further research are needed to measure the long-term impacts of the program and evaluate whether this digital self-care intervention can increase uptake of contraceptive methods and reduce adolescent pregnancy among school-aged youth.

Risky business: A mixed methods study of decision-making regarding COVID-19 risk at a public university in the United States.

Introduction: Until vaccines became available in late 2020, our ability to prevent the spread of COVID-19 within countries depended largely on voluntary adherence to mitigation measures. However, individual decision-making regarding acceptable COVID-19 risk is complex. To better understand decision-making regarding COVID-19 risk, we conducted a qualitative substudy within a larger Berkeley COVID-19 Safe Campus Initiative (BCSCI) during the summer of 2020, and completed a mixed-methods analysis of factors influencing decision-making. Materials and methods: We interviewed 20 participants who tested positive for SARS-CoV-2 and 10 who remained negative, and analyzed quantitative survey data from 3,324 BCSCI participants. The BCSCI study enrolled university-affiliated people living in the local area during summer of 2020, collected data on behaviors and attitudes toward COVID-19, and conducted SARS-CoV-2 testing at baseline and endline. Results: At baseline, 1362 students (57.5%) and 285 non-students (35.1%) said it had been somewhat or very difficult to comply with COVID-19-related mandates. Most-cited reasons were the need to go out for food/essentials, difficulty of being away from family/friends, and loneliness. Eight interviewees explicitly noted they made decisions partially because of others who may be at high risk. We did not find significant differences between the behaviors of students and non-students. Discussion: Despite prevailing attitudes about irresponsibility of college students during the COVID-19 pandemic, students in our study demonstrated a commitment to making rational choices about risk behavior, not unlike non-students around them. Decision-making was driven by perceived susceptibility to severe disease, need for social interaction, and concern about risk to others. A harm reduction public health approach may be beneficial.

Anticipated and Experienced Stigma After Testing Positive for SARS-CoV-2: A Qualitative Study.

INTRODUCTION: Stigma has inhibited public health practitioners' influence during the COVID-19 pandemic. We explore the experienced and anticipated stigma of people affiliated with a large university in the United States, using the Health Stigma and Discrimination Framework. METHODS: We conducted a qualitative secondary substudy of 20 people who tested SARS-CoV-2 positive and 10 who tested negative in the summer of 2020, selected from a study of 3,324 university students and employees. FINDINGS: No participants reported anticipated stigmatization prior to testing positive. However, eight of 20 participants recounted stigma marking (being marked by COVID-19 diagnosis or membership in a "high-risk" group) or manifestations of stigma after testing positive, including feelings of guilt or shame, and concerns about being judged as selfish or irresponsible. Three described being denied services or social interactions as a result of having had COVID-19, long after their infectiousness ended. Participants noted that clear public health messaging must be paired with detailed scientific information, rather than leaving people to resort to non-experts to understand the science. DISCUSSION: Public health messaging designed to mitigate spread of SARS-CoV-2 and protect the community may perpetuate stigma and exacerbate inequities. As a result, people may avoid testing or treatment, mistrust public health messaging, or even use risk-increasing behavior as coping mechanisms. IMPLICATIONS FOR PRACTICE: Intentional use of language that promotes equity and deters discrimination must be high priority for any COVID-19-related public health messaging. Partnership with community leaders to co-create programs and disseminate messaging is a critical strategy for reducing stigma, especially for historically mistreated groups.

Machine learning with routine electronic medical record data to identify people at high risk of disengagement from HIV care in Tanzania.

Machine learning methods for health care delivery optimization have the potential to improve retention in HIV care, a critical target of global efforts to end the epidemic. However, these methods have not been widely applied to medical record data in low- and middle-income countries. We used an ensemble decision tree approach to predict risk of disengagement from HIV care (missing an appointment by ≥28 days) in Tanzania. Our approach used routine electronic medical records (EMR) from the time of antiretroviral therapy (ART) initiation through 24 months of follow-up for 178 adults (63% female). We compared prediction accuracy when using EMR-based predictors alone and in combination with sociodemographic survey data collected by a research study. Models that included only EMR-based indicators and incorporated changes across past clinical visits achieved a mean accuracy of 75.2% for predicting risk of disengagement in the next 6 months, with a mean sensitivity of 54.7% for targeting the 30% highest-risk individuals. Additionally including survey-based predictors only modestly improved model performance. The most important variables for prediction were time-varying EMR indicators including changes in treatment status, body weight, and WHO clinical stage. Machine learning methods applied to existing EMR data in resource-constrained settings can predict individuals' future risk of disengagement from HIV care, potentially enabling better targeting and efficiency of interventions to promote retention in care.

Patient preferences for HIV service delivery models; a Discrete Choice Experiment in Kisumu, Kenya.

Novel "differentiated service delivery" models for HIV treatment that reduce clinic visit frequency, minimize waiting time, and deliver treatment in the community promise retention improvement for HIV treatment in Sub-Saharan Africa. Quantitative assessments of differentiated service delivery (DSD) feature most preferred by patient populations do not widely exist but could inform selection and prioritization of different DSD models. We used a discrete choice experiment (DCE) to elicit patient preferences of HIV treatment services and how they differ across DSD models. We surveyed 18+year-olds, enrolled in HIV care for ≥6 months between February-March, 2019 at four facilities in Kisumu County, Kenya. DCE offered patients a series of comparisons between three treatment models, each varying across seven attributes: ART refill location, quantity of dispensed ART at each refill, medication pick-up hours, type of adherence support, clinical visit frequency, staff attitude, and professional cadre of person providing ART refills. We used hierarchical Bayesian model to estimate attribute importance and relative desirability of care characteristics, latent class analysis (LCA) for groups of preferences and mixed logit model for willingness to trade analysis. Of 242 patients, 128 (53.8%) were females and 150 (62.8%) lived in rural areas. Patients placed greatest importance on ART refill location [19.5% (95% CI 18.4, 10.6) and adherence support [19.5% (95% CI 18.17, 20.3)], followed by staff attitude [16.1% (95% CI 15.1, 17.2)]. In the mixed logit, patients preferred nice attitude of staff (coefficient = 1.60), refill ART health center (Coeff = 1.58) and individual adherence support (Coeff = 1.54), 3 or 6 months for ART refill (Coeff = 0.95 and 0.80, respectively) and pharmacists (instead of lay health workers) providing ART refill (Coeff = 0.64). No differences were observed by gender or urbanicity. LCA revealed two distinct groups (59.5% vs. 40.5%). Participants preferred 3 to 6-month refill interval or clinic visit spacing, which DSD offers stable patients. While DSD has encouraged community ART group options, our results suggest strong preferences for ART refills from health-centers or pharmacists over lay-caregivers or community members. These preferences held across gender&urban/rural subpopulations.

Preparing a financial incentive program to improve retention in HIV care and viral suppression for scale: using an implementation science framework to evaluate an mHealth system in Tanzania.

BACKGROUND: Viral suppression is key to ending the HIV epidemic, yet only 58% of people living with HIV (PLHIV) in sub-Saharan Africa are suppressed. Cash transfers are an effective strategy to improve retention in care, but little is known about optimization of implementation; for example, designing effective programs that integrate into existing clinic workflows. We studied implementation of an mHealth system to deliver cash transfers to support retention. METHODS: We conducted a mixed-methods study assessing implementation of an mHealth cash transfer study. This was part of a larger, hybrid implementation-effectiveness randomized controlled trial evaluating cash transfers conditional on visit attendance for viral suppression among Tanzanian PLHIV initiating ART. An mHealth system using fingerprint identification and mobile payments was used to automatically disburse mobile money to eligible PLHIV. We used Proctor's framework, assessing implementation of the mHealth system from the perspectives of PLHIV and clinicians. We analyzed mHealth system data and conducted surveys (n = 530) and in-depth interviews (n = 25) with PLHIV, clinic and pharmacy staff (n = 10), and structured clinic observations (n = 2293 visits). RESULTS: One thousand six hundred fifty-one cash transfers were delivered to 346 PLHIV in the cash arms, 78% through mobile money. Among those in the cash arms, 81% registered their mobile money account with the mHealth system by study end, signaling high adoption. While acceptability for fingerprinting and mobile payments was high among PLHIV, interviews revealed mixed views: some had privacy concerns while others felt the system was secure and accurate, and provided some legitimacy to the clinical visits. Pharmacists praised system efficiency, but concerns about duplicative recordkeeping and added work arose. Clinic staff voiced excitement for the system's potential to bring the cash program to all patients and simplify workflows; yet concerns about multiple systems, staffing, and intermittent connectivity tempered enthusiasm, highlighting structural issues beyond program scope. Structured observations revealed a steep learning curve; repeat fingerprint scans and manual entry declined as the system improved. CONCLUSIONS: Biometric identification and mobile payments were acceptable to most patients and staff. Fingerprinting encountered some feasibility limitations in the first months of testing; however, mobile payments were highly successful. Biometric identification and mobile payments may provide a scalable mechanism to improve patient tracking and efficiently implement financial incentives in low-resource settings. TRIAL REGISTRATION: Name of the registry: clinicaltrials.gov Trial registration number: NCT03351556 Date of registration: 11/24/2017 Checklists: StaRI (included with submission). Note CONSORT for cluster-randomized trials was used for the main trial but is not directly applicable to this manuscript.