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.

Accelerating COVID-19 Vaccination Among People Living With HIV and Health Care Workers in Tanzania: A Case Study.

BACKGROUND: There is limited evidence on COVID-19 vaccination uptake among people living with HIV (PLHIV) and health care workers (HCWs), with the current evidence concentrated in high-income countries. There is also limited documentation in the published literature regarding the feasibility and lessons from implementing targeted vaccination strategies to reach PLHIV and HCWs in low- and middle-income countries. PROGRAM DEVELOPMENT, PILOTING, AND IMPLEMENTATION: We designed and implemented multifaceted strategies to scale up targeted COVID-19 vaccination among PLHIV and HCWs in 11 administrative regions on the mainland of Tanzania plus Zanzibar. An initial 6-week intensification strategy was implemented using a diverse partnership model comprising key stakeholders at the national- and subnational levels. A layered package of strategies included expanding the number of certified vaccinators, creating vaccination points within HIV clinics, engaging HCWs to address their concerns, and building the capacity of HCWs as "champions" to promote and facilitate vaccination. We then closely monitored COVID-19 vaccination uptake in 562 high-volume HIV clinics. Between September 2021 and September 2022, the proportion of fully vaccinated adult PLHIV increased from <1% to 97% and fully vaccinated HCWs increased from 23% to 80%. LESSONS AND IMPLICATIONS: Our intra-action review highlighted the importance of leveraging a strong foundation of existing partnerships and platforms, integrating COVID-19 vaccination points within HIV clinics, and refining strategies to increase vaccination demand while ensuring continuity of vaccine supply to meet the increased demand. Lessons from Tanzania can inform targeted vaccination of vulnerable groups in future health emergencies.

The Impact of Financial Incentives on Mental Health among Adults in HIV Care in Lake Zone, Tanzania: A Two-Arm Randomized Controlled Trial.

OBJECTIVE: Depression and anxiety are prevalent among people living with HIV (PLHIV), hindering retention in care. Though economic interventions can improve care engagement and mental health in the general population, this remains understudied among PLHIV. This study assessed whether financial incentives improve mental health among adult antiretroviral therapy (ART) initiates in Lake Zone, Tanzania. DESIGN: Two-arm randomized controlled trial. METHODS: From 2021-2023, 32 clinics were randomized to offer patients monthly financial incentives (22,500 TSH/$10 USD) for ≤6 months (conditional on visit attendance) or standard-of-care (SoC) services. We assessed changes in depression (PHQ-2 scores) and anxiety (GAD-2 scores) symptoms at baseline, 6, and 12 months. Difference-in-differences effects were used to estimate changes over time by arm using inverse probability of censoring sample weights (IPCW). RESULTS: Participants (n = 1990) were 57.3% female; median age was 35.0. Baseline prevalences of depression and anxiety symptoms were 66.2% and 60.4%, respectively, and endline prevalences were 7.8% and 7.6%, respectively, with no differences by arm. Using IPCW, the differences in the prevalence of depression and anxiety symptoms between arms were 2.5 percentage points (95% CI: -3.0, 8.0) and 2.3 percentage points (95% CI: -3.2, 7.9) respectively after 6 months, and 5.5 percentage points (95% CI: -0.20, 10.8) and 3.8 percentage points (95% CI: -1.5, 9.2) respectively after 12 months. CONCLUSION: Both study arms experienced substantial reductions in poor mental health, primarily within the first 6 months of care. Financial incentives provided in this study did not significantly augment these downward trends but may improve engagement in care, indirectly improving mental health.

Social network strategy (SNS) for HIV testing: a new approach for identifying individuals with undiagnosed HIV infection in Tanzania.

Social network strategy (SNS) testing uses network connections to refer individuals at high risk to HIV testing services (HTS). In Tanzania, SNS testing is offered in communities and health facilities. In communities, SNS testing targets key and vulnerable populations (KVP), while in health facilities it complements index testing by reaching unelicited index contacts. Routine data were used to assess performance and trends over time in PEPFAR-supported sites between October 2021 and March 2023. Key indicators included SNS social contacts tested, and new HIV-positives individuals identified. Descriptive and statistical analysis were conducted. Univariable and multivariable analysis were applied, and variables with P-values <0.2 at univariable analysis were considered for multivariable analysis. Overall, 121,739 SNS contacts were tested, and 7731 (6.4%) previously undiagnosed individuals living with HIV were identified. Tested contacts and identified HIV-positives were mostly aged ≥15 years (>99.7%) and females (80.6% of tests, 79.4% of HIV-positives). Most SNS contacts were tested (78,363; 64.7%) and diagnosed (6376; 82.5%) in communities. SNS tests and HIV-positives grew 11.5 and 6.1-fold respectively, from October-December 2021 to January-March 2023, with majority of clients reached in communities vs. facilities (78,763 vs. 42,976). These results indicate that SNS testing is a promising HIV case-finding approach in Tanzania.

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.

The impact of cash incentives on mental health among adults initiating antiretroviral therapy in Tanzania.

Mental illness is prevalent among people living with HIV (PLHIV) and hinders engagement in HIV care. While financial incentives are effective at improving mental health and retention in care, the specific effect of such incentives on the mental health of PLHIV lacks quantifiable evidence. We evaluated the impact of a three-arm randomized controlled trial of a financial incentive program on the mental health of adult antiretroviral therapy (ART) initiates in Tanzania. Participants were randomized 1:1:1 into one of two cash incentive (combined; provided monthly conditional on clinic attendance) or the control arm. We measured the prevalence of emotional distress, depression, and anxiety via a difference-in-differences model which quantifies changes in the outcomes by arm over time. Baseline prevalence of emotional distress, depression, and anxiety among the 530 participants (346 intervention, 184 control) was 23.8%, 26.6%, and 19.8%, respectively. The prevalence of these outcomes decreased substantially over the study period; additional benefit of the cash incentives was not detected. In conclusion, poor mental health was common although the prevalence declined rapidly during the first six months on ART. The cash incentives did not increase these improvements, however they may have indirect benefit by motivating early linkage to and retention in care.Clinical Trial Number: NCT03341556.

Risk Factors for Recent HIV Infections among Adults in 14 Countries in Africa Identified by Population-Based HIV Impact Assessment Surveys, 2015-2019.

Identifying persons who have newly acquired HIV infections is critical for characterizing the HIV epidemic direction. We analyzed pooled data from nationally representative Population-Based HIV Impact Assessment surveys conducted across 14 countries in Africa for recent infection risk factors. We included adults 15-49 years of age who had sex during the previous year and used a recent infection testing algorithm to distinguish recent from long-term infections. We collected risk factor information via participant interviews and assessed correlates of recent infection using multinomial logistic regression, incorporating each survey's complex sampling design. Compared with HIV-negative persons, persons with higher odds of recent HIV infection were women, were divorced/separated/widowed, had multiple recent sex partners, had a recent HIV-positive sex partner or one with unknown status, and lived in communities with higher HIV viremia prevalence. Prevention programs focusing on persons at higher risk for HIV and their sexual partners will contribute to reducing HIV incidence.

Risk and protective factors for mental health and wellbeing among adolescent orphans.

Background: Research has demonstrated the importance of understanding risk factors for mental health and wellbeing. Less research has focused on protective factors that protect mental health and promote wellbeing in diverse contexts. Estimating structural paths from risk protective factors to psychopathology and wellbeing can inform prioritization of targeted investment in adolescent health programs that seek to modify factors that are most closely associated with mental wellbeing. Study objective: The purpose of this study was to examine risk factors (e.g. emotional neglect, emotional abuse, physical neglect, stigma) and protective factors (e.g. community relationships, self-esteem, and autonomy) among adolescent orphans, protective associations with depression, anxiety and externalizing behaviors and promotive associations with hope, happiness, and health. Methods: The analytic sample was collected between January and March of 2019 and included 350 adolescent orphans ages 10-15 from three districts in Tanzania. Participants completed survey interviews, 75-90 min in length, that measured risk and protective factors, psychological symptoms, and mental wellbeing measures. Results: Results of the fitted structural equation model indicated that structural paths from protective factors to psychopathology (ß = -0.53, p = 0.015) and mental wellbeing (ß = 0.72, p = 0.014) outcomes were significant. Structural paths from risk factors to psychopathology (ß = -0.34, p = 0.108) and mental wellbeing (ß = -0.24, p = 0.405) were not significant. Conclusion: In a sample of vulnerable youth, protective factors (e.g. community relationships, self-esteem, and autonomy) were significantly associated with reduced depression, anxiety and externalizing behaviors and increased hope, happiness, and health in a structural equation model that included risk factors (emotional neglect, emotional abuse, physical neglect). Results suggest that strong community relationships, self-esteem and autonomy may be important modifiable factors to target in intervention programs aimed at supporting adolescent mental wellbeing.

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.

Growth mindset, persistence, and self-efficacy in early adolescents: Associations with depression, anxiety, and externalising behaviours.

ABSTRACTGrowth mindset, persistence, and self-efficacy are important protective factors in understanding adolescent psychopathology, including depression, anxiety, and externalising behaviours. Previous studies have shown that dimensions of self-efficacy (academic, social, and emotional) have differential protective effects with mental health outcomes and these differences vary by sex. This study examines the dimensional mediation of self-efficacy from motivational mindsets on anxiety, depression, and externalising behaviours in a sample of early adolescents ages 10-11. Surveys were administered to participants to measure growth mindset and persistence on internalising and externalising symptoms. The Self-Efficacy Questionnaire for Children (SEQ-C) was used to measure domains of self-efficacy for mediation analysis. Multi-group structural equation modelling by sex indicated that structural paths were not invariant by sex. Significant direct effects were identified from persistence to externalising behaviours in boys, and significant direct effects were identified from growth mindset to depression in girls. In a sample of Tanzanian early adolescents, self-efficacy mediates the protective association between motivational mindsets on psychopathology. Higher academic self-efficacy was associated with reduced externalising problems in both boys and girls. Implications for adolescent programmes and future research are discussed.

Psychometric validation of the collective asset Utu: associations with coping strategies and resilience during adolescence.

BACKGROUND: Utu is a Kiswahili term with a long history of cultural significance in Tanzania. It conveys a value system of shared, collective humanity. While variants of Utu have been studied in other contexts, a measure of Utu that captures this important collective asset has not been developed in Tanzania. The aims of this study were to (1) examine dimensional constructs that represent Utu, (2) validate a measurement scale of Utu for use with adolescents, (3) examine differences between orphan and non-orphan adolescents in self-reported Utu and, (4) examine structural paths between adverse life experiences, coping strategies, Utu, and resilience.  METHODS: This study collected survey data from adolescents from three districts in peri-urban Tanzania in two samples: 189 orphan adolescents ages 10-17 in May 2020 and 333 non-orphan adolescents ages 10-14 in August 2020. Confirmatory factor analysis was used to validate the hypothesized factor structure of the developed Utu measure. Structural equation models were used to examine path associations with adverse life experiences, coping and resilience. RESULTS: The five dimensional constructs comprising the Utu measure included Resource Sharing, Group Solidarity, Respect and Dignity, Collectivity, and Compassion. Confirmatory factor analysis of the Utu measure demonstrated excellent fit (CFI = 0.98; TLI = 0.97; SRMR = 0.024; RMSEA = 0.046) and internal consistency (α = 0.94) among adolescents in this study. Positive, significant associations were found between Utu and coping (ß = 0.29, p < 0.001) and Utu and intra/interpersonal and collective resilience (ß = 0.13, p < 0.014). Utu was not significantly associated with adverse life experiences, age or gender. CONCLUSIONS: A five-dimensional measurement scale for Utu was validated in a sample of orphan and non-orphan adolescents in Tanzania. Utu is a collective asset associated with higher levels of reported resilience in both orphan and non-orphan adolescent populations in Tanzania. Promoting Utu may be an effective universal public health prevention approach. Implications for adolescent programming are discussed.

HIV virologic response, patterns of drug resistance mutations and correlates among adolescents and young adults: A cross-sectional study in Tanzania.

BACKGROUND: The emergence of HIV drug resistance mutations (DRMs) is of significant threat to achieving viral suppression (VS) in the quest to achieve global elimination targets. We hereby report virologic outcomes and patterns of acquired DRMs and its associated factors among adolescents and young adults (AYA) from a broader HIV drug resistance surveillance conducted in Tanzania. METHODS: Data of AYA was extracted from a cross-sectional study conducted in 36 selected facilities using a two-stage cluster sampling design. Dried blood spot (DBS) samples were collected and samples with a viral load (VL) ≥1000 copies/mL underwent genotyping for the HIV-1 pol gene. Stanford HIV database algorithm predicted acquired DRMs, Fisher's exact test and multivariable logistic regression assessed factors associated with DRMs and VS, respectively. FINDINGS: We analyzed data of 578 AYA on antiretroviral therapy (ART) for 9-15 and ≥ 36 months; among them, 91.5% and 88.2% had VS (VL<1000copies/mL) at early and late time points, respectively. Genotyping of 64 participants (11.2%) who had VL ≥1000 copies/ml detected 71.9% of any DRM. Clinically relevant DRMs were K103N, M184V, M41L, T215Y/F, L210W/L, K70R, D67N, L89V/T, G118R, E138K, T66A, T97A and unexpectedly absent K65R. Participants on a protease inhibitor (PI) based regimen were twice as likely to not achieve VS compared to those on integrase strand transfer inhibitors (INSTI). The initial VL done 6 months after ART initiation of ≥1000copies/mL was the primary factor associated with detecting DRMs (p = .019). CONCLUSIONS: VS amongst AYA is lower than the third UNAIDs target. Additionally, a high prevalence of ADR and high levels of circulating clinically relevant DRMs may compromise the long-term VS in AYA. Furthermore, the first VL result of ≥1000copies/ml after ART initiation is a significant risk factor for developing DRMs. Thus, strict VL monitoring for early identification of treatment failure and genotypic testing during any ART switch is recommended to improve treatment outcomes for AYA.

Designing for two: How enhancing human-centered design with behavioral nudges unlocked breakthroughs to promote young women's psychological safety and access to reproductive care in Tanzania.

Adolescent girls and young women (AGYW; ages 15-24) in sub-Saharan Africa face many barriers to accessing preventive sexual and reproductive health (SRH) services. We drew upon the strengths of two complementary approaches, human-centered design and behavioral economics, to craft a holistic, highly-tailored, and empathetic intervention to motivate AGYW to seek contraception and HIV self-test kits at community drug shops. To encourage engagement, we embedded "nudge" strategies at different opportunity points (uncovered during our design research) along the care-seeking and service delivery journey. Our Malkia Klabu intervention is a loyalty program designed to enhance drug shops' role as SRH providers through which AGYW earned punches for shop purchases redeemable for small prizes; free SRH products could be requested at any time. From our 4-month pilot in Shinyanga, Tanzania, we assess the extent to which different behavioral nudge strategies motivated behaviors as predicted by synthesizing findings from (1) in-depth interviews with AGYW and shopkeepers, (2) shop program records, (3) shop observations, and (4) customer exit surveys. Overall, we find that AGYW and shopkeepers were motivated by many intervention features as intended and consistent with hypothesized mechanisms. We found strong evidence of social norms for helping to spread awareness of Malkia Klabu among peers, prize incentives for drawing AGYW back to shops, and the opt-out default membership gift of an HIV self-test kit for encouraging testing uptake and exploration of contraceptives. Shopkeepers in both arms noted increased community status from distributing HIV self-testing kits (ego). Malkia Klabu shopkeepers experienced increased customer traffic and business revenues (incentives), which reduced shopkeepers' gatekeeping tendencies and earned them additional recognition as champions of AGYW well-being. Integrating human-centered design and behavioral economics was effective for developing an innovative and effective intervention that simultaneously met the different needs of economic actors in support of public health priorities.

Risks of Intimate Partner Violence for Women Living with HIV Receiving Cash Transfers: A Qualitative Study in Shinyanga, Tanzania.

Cash transfers are increasingly used to motivate adherence to HIV care. However, evidence on cash transfers and intimate partner violence (IPV) is mixed and little is known about their safety for women living with HIV. We conducted in-depth interviews with women living with HIV who participated in a randomized trial providing 6 months of cash transfers (~$4.5 or $11 USD) conditional on HIV clinic attendance in Shinyanga, Tanzania to assess how receiving cash affects IPV and relationship dynamics. Eligible participants were 18-49 years, received cash transfers, and in a partnership at baseline. Data were analyzed in Dedoose using a combined inductive-deductive coding approach. 25 interviews were conducted between November 2019-February 2020. Women's employment was found to be a source of household tension and violence. None of the participants reported physical or sexual IPV in relation to cash transfers, however, some women experienced controlling behaviors or emotional violence including accusations and withholding of money, particularly those who were unemployed. Cash transfers were predominantly used for small household expenses and were not viewed as being substantial enough to shift the financial dynamic or balance of power within relationships. Our findings suggest that small, short-term cash transfers do not increase physical or sexual IPV for women living with HIV however can exacerbate controlling behaviors or emotional violence. Modest incentives used as a behavioral nudge to improve health outcomes may affect women differently than employment or larger cash transfers. Nonetheless, consultations with beneficiaries should be prioritized to protect women from potential IPV risks.

Emerging integrase strand transfer inhibitor drug resistance mutations among children and adults on ART in Tanzania: findings from a national representative HIV drug resistance survey.

BACKGROUND: Despite the scale-up of ART and the rollout in Tanzania of dolutegravir, an integrase strand transfer inhibitor (INSTI), treatment success has not been fully realized. HIV drug resistance (HIVDR), including dolutegravir resistance, could be implicated in the notable suboptimal viral load (VL) suppression among HIV patients. OBJECTIVES: To determine the prevalence and patterns of acquired drug resistance mutations (DRMs) among children and adults in Tanzania. METHODS: A national cross-sectional HIVDR survey was conducted among 866 children and 1173 adults. Genotyping was done on dried blood spot and/or plasma of participants with high HIV VL (≥1000 copies/mL). HIV genes (reverse transcriptase, protease and integrase) were amplified by PCR and directly sequenced. The Stanford HIVDR Database was used for HIVDR interpretation. RESULTS: HIVDR genotyping was performed on blood samples from 137 participants (92 children and 45 adults) with VL ≥ 1000 copies/mL. The overall prevalence of HIV DRMs was 71.5%, with DRMs present in 78.3% of children and 57.8% of adults. Importantly, 5.8% of participants had INSTI DRMs including major DRMs: Q148K, E138K, G118R, G140A, T66A and R263K. NNRTI, NRTI and PI DRMs were also detected in 62.8%, 44.5% and 8% of participants, respectively. All the participants with major INSTI DRMs harboured DRMs targeting NRTI backbone drugs. CONCLUSIONS: More than 7 in 10 patients with high HIV viraemia in Tanzania have DRMs. The early emergence of dolutegravir resistance is of concern for the efficacy of the Tanzanian ART programme.

Financial incentives to improve re-engagement in HIV care: results from a randomized pilot study.

OBJECTIVE: Determine the feasibility, acceptability, and preliminary effectiveness of financial incentives to motivate re-engagement in HIV care in Shinyanga, Tanzania. METHODS: Out-of-care people living with HIV (PLHIV) were identified from medical records in four clinics and home-based care providers (HBCs) from April 13, 2018 to March 3, 2020. Shinyanga Region residents, ≥18 years, who were disengaged from care were randomized 1:1 to a financial incentive (∼$10 USD) or the standard of care (SOC), stratified by site, and followed for 180 days. Primary outcomes were feasibility (located PLHIV who agreed to discuss the study), acceptability (enrollment among eligibles), and re-engagement in care (clinic visit within 90 days). RESULTS: HBCs located 469/1,309 (35.8%) out-of-care PLHIV. Of these, 215 (45.8%) were preliminarily determined to be disengaged from care, 201 (93.5%) agreed to discuss the study, and 157 eligible (100%) enrolled. Within 90 days, 71 (85.5%) PLHIV in the incentive arm re-engaged in care vs. 58 (78.4%) in the SOC (Adjusted Risk Difference [ARD] = 0.08, 95% CI: -0.03, 0.19, p = 0.09). A higher proportion of incentivized PLHIV completed an additional (unincentivized) visit between 90-180 days (79.5% vs. 71.6%, ARD = 0.10, 95% CI: -0.03, 0.24, p = 0.13) and remained in care at 180 days (57.8% vs. 51.4%, ARD = 0.07, 95% CI: -0.09, 0.22, p = 0.40). CONCLUSIONS: Short-term financial incentives are feasible, acceptable, and have the potential to encourage re-engagement in care, warranting further study of this approach.

Reaching Adolescent Girls and Young Women With HIV Self-Testing and Contraception at Girl-Friendly Drug Shops: A Randomized Trial in Tanzania.

PURPOSE: We hypothesized that an intervention designed to create girl-friendly drug shops would increase access to sexual and reproductive health products and services among adolescent girls and young women (AGYW) (ages 15-24 years) in Tanzania. METHODS: We conducted a four-month randomized trial at 20 drug shops in Shinyanga, Tanzania from August-December 2019 to determine if the Malkia Klabu ("Queen Club") intervention increased AGYW patronage and the provision of HIV self-testing (HIVST), contraception, and health facility referrals to AGYW (primary outcomes). Drug shops were randomized 1:1 to the intervention or comparison arm. All shops were provided with OraQuick HIVST kits to give to AGYW for free. Intervention shops implemented Malkia Klabu, a loyalty program for AGYW created using human-centered design through which AGYW could also access free contraception. We compared outcomes in intention-to-treat analyses using shop observations and shopkeeper records. RESULTS: By endline, shops implementing Malkia Klabu had higher AGYW patronage than comparison shops (rate ratio: 4.4; 95% confidence interval: 2.0, 9.8). Intervention shops distributed more HIVST kits (median per shop: 130.5 vs. 58.5, P = .02) and contraceptives (325.5 vs. 7.0, P < .01) to AGYW and provided more referrals for HIV, family planning, or pregnancy services combined (3.5 vs. 0.5, P = .02) than comparison shops. DISCUSSION: The Malkia Klabu intervention increased AGYW patronage and the provision of HIVST kits, contraception, and referrals to AGYW at drug shops, despite HIVST kits being freely available at all participating shops. Enhancing drug shops with girl-friendly services may be an effective strategy to reach AGYW with sexual and reproductive health services.

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.

Correcting for selection bias in HIV prevalence estimates: an application of sample selection models using data from population-based HIV surveys in seven sub-Saharan African countries.

INTRODUCTION: Population-based biomarker surveys are the gold standard for estimating HIV prevalence but are susceptible to substantial non-participation (up to 30%). Analytical missing data methods, including inverse-probability weighting (IPW) and multiple imputation (MI), are biased when data are missing-not-at-random, for example when people living with HIV more frequently decline participation. Heckman-type selection models can, under certain assumptions, recover unbiased prevalence estimates in such scenarios. METHODS: We pooled data from 142,706 participants aged 15-49 years from nationally representative cross-sectional Population-based HIV Impact Assessments in seven countries in sub-Saharan Africa, conducted between 2015 and 2018 in Tanzania, Uganda, Malawi, Zambia, Zimbabwe, Lesotho and Eswatini. We compared sex-stratified HIV prevalence estimates from unadjusted, IPW, MI and selection models, controlling for household and individual-level predictors of non-participation, and assessed the sensitivity of selection models to the copula function specifying the correlation between study participation and HIV status. RESULTS: In total, 84.1% of participants provided a blood sample to determine HIV serostatus (range: 76% in Malawi to 95% in Uganda). HIV prevalence estimates from selection models diverged from IPW and MI models by up to 5% in Lesotho, without substantial precision loss. In Tanzania, the IPW model yielded lower HIV prevalence estimates among males than the best-fitting copula selection model (3.8% vs. 7.9%). CONCLUSIONS: We demonstrate how HIV prevalence estimates from selection models can differ from those obtained under missing-at-random assumptions. Further benefits include exploration of plausible relationships between participation and outcome. While selection models require additional assumptions and careful specification, they are an important tool for triangulating prevalence estimates in surveys with substantial missing data due to non-participation.

Predictors of loss to follow up from antiretroviral therapy among adolescents with HIV/AIDS in Tanzania.

Access to Antiretroviral Therapy (ART) is threatened by the increased rate of loss to follow-up (LTFU) among adolescents on ART care. We investigated the rate of LTFU from HIV care and associated predictors among adolescents living with HIV/AIDS in Tanzania. A retrospective cohort analysis of adolescents on ART from January 2014 to December 2016 was performed. Kaplan-Meier method was used to determine failure probabilities and the Cox proportion hazard regression model was used to determine predictors of loss to follow up. A total of 25,484 adolescents were on ART between 2014 and 2016, of whom 78.4% were female and 42% of adolescents were lost to follow-up. Predictors associated with LTFU included; adolescents aged 15-19 years (adjusted hazard ratio (aHR): 1.57; 95% Confidence Interval (CI); 1.47-1.69), having HIV/TB co-infection (aHR: 1.58; 95% CI, 1.32-1.89), attending care at dispensaries (aHR: 1.12; 95% CI, 1.07-1.18) or health center (aHR: 1.10; 95% CI, 1.04-1.15), and being malnourished (aHR: 2.27; 95% CI,1.56-3.23). Moreover, residing in the Lake Zone and having advanced HIV disease were associated with LTFU. These findings highlight the high rate of LTFU and the need for intervention targeting older adolescents with advanced diseases and strengthening primary public facilities to achieve the 2030 goal of ending HIV as a public health threat.