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Achieving the 95-95-95 UNAIDS targets requires meeting the needs of adolescents, however we lack evidenced-based approaches to improving adolescent adherence to antiretroviral therapy (ART), increasing viral suppression, and supporting general wellbeing. We developed Family Connections as a group intervention for adolescents and their adult caregivers and conducted a randomized controlled trial in Ndola, Zambia to test feasibility and acceptability. Fifty pairs (n = 100) of adolescents (15–19 years and on ART ≥ 6 months) and their caregivers were randomly assigned either to the intervention consisting of 10 group sessions over 6 months, or to a comparison group, which received the usual care. Each pair completed baseline and endline surveys, with adolescents also undergoing viral load testing. Of the 24-intervention adolescent/caregiver pairs, 88% attended at least eight group sessions. Most adolescents (96%) and all caregivers would recommend Family Connections to peers. Adolescent viral failure decreased but did not significantly differ by study group. Adolescents in the intervention group showed a greater reduction in HIV-related feelings of worthlessness and shame than the comparison group. The feasibility, acceptability, and the positive trend toward significantly reducing internalized stigma, generated by this Family Connections pilot study, contributes valuable data to support adolescent/caregiver approaches that use peer groups. [ABSTRACT FROM AUTHOR]

Background: Youth-led strategies remain untested in clinic-based programs to improve viral suppression (VS) and reduce stigma among HIV-positive adolescents and young adults (AYA) in sub-Saharan Africa. In response, Project YES! placed paid HIV-positive youth peer mentors (YPM) in four HIV clinics in Ndola, Zambia including a Children's Hospital (pediatric setting), an adult Hospital and two primary care facilities (adult settings). Methods: A randomized controlled trial was conducted from December 2017 to February 2019. Consecutively recruited 15 to 24-year-olds were randomly assigned to an intervention arm with monthly YPM one-on-one and group sessions and optional caregiver support groups, or a usual care comparison arm. Survey data and blood samples were collected at baseline and at the six-month midline. Generalized estimating equation models evaluated the effect of study arm over time on VS, antiretroviral treatment (ART) adherence gap, and internalized stigma. Results: Out of 276 randomized youth, 273 were included in the analysis (Intervention n = 137, Comparison n = 136). VS significantly improved in both arms (I:63.5% to 73.0%; C:63.7% to 71.3.0%) [OR:1.49, 95% CI:1.08, 2.07]. In a stratified analysis intervention (I:37.5% to 70.5%) versus the comparison (C:60.3% to 59.4%) participants from the pediatric clinic experienced a relative increase in the odds of VS by a factor of 4.7 [interaction term OR:4.66, 95% CI:1.84, 11.78]. There was no evidence of a study arm difference in VS among AYA in adult clinics, or in ART adherence gaps across clinics. Internalized stigma significantly reduced by a factor of 0.39 [interaction term OR:0.39, 95% CI:0.21,0.73] in the intervention (50.4% to 25.4%) relative to the comparison arm (45.2% to 39.7%) Conclusions: Project YES! engaged AYA, improving VS in the pediatric clinic and internalized stigma in the pediatric and adult clinics. Further research is needed to understand the intersection of VS and internalized stigma among AYA attending adult HIV clinics. Trial registration: ClinicalTrials.gov NCT04115813. [ABSTRACT FROM AUTHOR]

The article explores adolescents and young adults (AYAs) and how they are being impacted by the COVID-19 pandemic of 2020. The author describes how AYAs serve as the backbone of several social networks in contemporary society: connecting homes, schools and workplaces in their communities. AYAs also need support as they are going through a specific developmental period characterized by biological, cognitive and social change. Two potential public health approaches are offered: disaggregate and collect data and/or take a harm reduction approach.

Research suggests a syndemic of substance use, mental illness, and familial conflict is associated with poor HIV medical outcomes among African American persons living with HIV (PLHIV). Social support may facilitate positive health outcomes. This study explores psychosocial correlates of HIV medical outcomes, defined as undetectable viral load (UVL) and acute care minimization. Data were from baseline of the BEACON study (N = 351). UVL was ≤40 copies/mL. Acute care minimization was defined as no ER visits and/or hospitalizations in 6 months. Descriptive statistics and Poisson regression were implemented (N = 351). Moderate syndemic burden was associated with viral suppression. Individuals with main partner caregivers had 35% higher likelihood of viral suppression than individuals whose main supporters were neither kin nor main partners (adjusted point-prevalence rate ratio [APR] = 1.35; 95% CI [1.05, 1.74]). Surprisingly, individuals with more health-related support were more likely to use acute care than individuals with less health-related support (p<.05). Interaction analyses showed that physical function modified the relationship between main supporter type and acute care minimization. Results suggest that social support receipt was not consistently associated with HIV medical outcomes. Conversely, higher syndemic burden may have facilitated positive outcomes through necessitating increased rates of health care engagement. Health care professionals should elicit discussion of social support to strengthen PLHIVs’ and their supporters’ relationships to improve their health. Results highlight the need for culturally tailored interventions to improve HIV medical outcomes among African American PLHIV substance users. [ABSTRACT FROM AUTHOR]

Background: Organization of HIV care and treatment services, including clinic staffing and services, may shape clinical and financial outcomes, yet there has been little attempt to describe different models of HIV care in sub-Saharan Africa (SSA). Information about the relative benefits and drawbacks of different models could inform the scale-up of antiretroviral therapy (ART) and associated services in resource-limited settings (RLS), especially in light of expanded client populations with country adoption of WHO's test and treat recommendation.Methods: We characterized task-shifting/task-sharing practices in 19 diverse ART clinics in Tanzania, Uganda, and Zambia and used cluster analysis to identify unique models of service provision. We ran descriptive statistics to explore how the clusters varied by environmental factors and programmatic characteristics. Finally, we employed the Delphi Method to make systematic use of expert opinions to ensure that the cluster variables were meaningful in the context of actual task-shifting of ART services in SSA.Results: The cluster analysis identified three task-shifting/task-sharing models. The main differences across models were the availability of medical doctors, the scope of clinical responsibility assigned to nurses, and the use of lay health care workers. Patterns of healthcare staffing in HIV service delivery were associated with different environmental factors (e.g., health facility levels, urban vs. rural settings) and programme characteristics (e.g., community ART distribution or integrated tuberculosis treatment on-site).Conclusions: Understanding the relative advantages and disadvantages of different models of care can help national programmes adapt to increased client load, select optimal adherence strategies within decentralized models of care, and identify differentiated models of care for clients to meet the growing needs of long-term ART patients who require more complicated treatment management. [ABSTRACT FROM AUTHOR]

Objectives: To identify the reasons patients miss taking their antiretroviral therapy (ART) and the proportion who miss their ART because of symptoms; and to explore the association between symptoms and incomplete adherence. Methods: Secondary analysis of data collected during a cross-sectional study that examined ART adherence among adults from 18 purposefully selected sites in Tanzania, Uganda, and Zambia. We interviewed 250 systematically selected patients per facility (≥18 years) on reasons for missing ART and symptoms they had experienced (using the HIV Symptom Index). We abstracted clinical data from the patients’ medical, pharmacy, and laboratory records. Incomplete adherence was defined as having missed ART for at least 48 consecutive hours during the past 3 months. Results: Twenty-nine percent of participants reported at least one reason for having ever missed ART (1278/4425). The most frequent reason was simply forgetting (681/1278 or 53%), followed by ART-related hunger or not having enough food (30%), and symptoms (12%). The median number of symptoms reported by participants was 4 (IQR: 2–7). Every additional symptom increased the odds of incomplete adherence by 12% (OR: 1.1, 95% CI: 1.1–1.2). Female participants and participants initiated on a regimen containing stavudine were more likely to report greater numbers of symptoms. Conclusions: Symptoms were a common reason for missing ART, together with simply forgetting and food insecurity. A combination of ART regimens with fewer side effects, use of mobile phone text message reminders, and integration of food supplementation and livelihood programmes into HIV programmes, have the potential to decrease missed ART and hence to improve adherence and the outcomes of ART programmes. [ABSTRACT FROM AUTHOR]

Introduction: Worldwide, HIV-related mortality among adolescents living with HIV (ALHIV) increased by 50% from 2005 to 2012 and is attributed in part to a lack of support for adolescent retention to care and adherence to antiretroviral therapy (ART). This vulnerability reinforces the need to better understand incomplete ART adherence among ALHIV, particularly in sub-Saharan Africa, where the majority of the world's 2.1 million ALHIV reside. Methods: From December 2011 to February 2012, we conducted in-depth interviews with 32 ALHIV (aged 15 to 18) and 23 of their adult caregivers in the Copperbelt Province of Zambia. Interviews were transcribed and translated. An iterative qualitative process was used to code and analyze the data and main themes were summarized regarding the barriers to and facilitators of ART adherence. Results: More than a quarter of ALHIV reported missing a day or more of ART (ranging from one day to six months). Barriers to ART adherence included fear of disclosure and anticipated stigma. Few youth were willing to take their drugs outside of the home, which led to missed doses of ART. Similarly, families tended to manage HIV within the home only. As a result, although caregivers and families were often the greatest source of emotional and instrumental support, they coped with HIV in isolation of other potential support from their communities, schools or churches. Factors that supported ART adherence included attending clinicsponsored youth groups, wanting to maintain one's health and using phone and clock alarms. Involvement of adult caregivers in HIV management varied greatly and was often based on the age and health status of the youth. Some caregivers struggled with letting the adolescents assume responsibility for their medication, and ALHIV had few self-management skills and tools to help them regularly take ART. Conclusions: These data highlight the importance of families and home environments in supporting adherence to ART among ALHIV. Skill-building and family-based interventions to prepare ALHIV and their adult caregivers for HIV self-management and HIV status disclosure by youth are of paramount importance. Future research and programmes also need to address the fears adolescents and families have regarding HIV-related stigma that shape young peoples' adherence behaviours. [ABSTRACT FROM AUTHOR]

Background: Despite efforts to promote HIV counseling and testing (HCT) among couples, few couples know their own or their partners’ HIV status. We assessed trends in HCT uptake among married individuals in Rakai district, southwestern Uganda. Methods: We analysed data for 21,798 married individuals aged 15-49 years who were enrolled into the Rakai Community Cohort Study (RCCS) between 2003 and 2009. Married individuals were interviewed separately but were retrospectively linked to their partners at analysis. All participants had serologic samples obtained for HIV testing, and had the option of receiving HCT together (couples’ HCT) or separately (individual HCT). Individuals were categorized as concordant HIV-positive if both partners had HIV; concordant HIV-negative if both did not have HIV; or HIV-discordant if only one of the partners had HIV. We used χ2 tests to assess linear trends in individual and couples’ HCT uptake in the entire sample and conducted multinomial logistic regression on a sub-sample of 10,712 individuals to assess relative risk ratios (RRR) and 95% Confidence Intervals (95% CI) associated with individual and couples’ HCT uptake. Analysis was done using STATA version 11.0. Results: Uptake of couples’ HCT was 27.2% in 2003/04, 25.1% in 2005/06, 28.5% in 2006/08 and 27.8% in 2008/09 (χ2 for trend = 2.38; P = 0.12). Uptake of individual HCT was 57.9% in 2003/04, 60.2% in 2005/06, 54.0% in 2006/08 and 54.4% in 2008/09 (χ2 for trend = 8.72; P = 0.003). The proportion of couples who had never tested increased from 14.9% in 2003/04 to 17.8% in 2008/09 (χ2 for trend = 18.16; P < 0.0001). Uptake of couples’ HCT was significantly associated with prior HCT (Adjusted [Adj.] RRR = 6.80; 95% CI: 5.44, 8.51) and being 25-34 years of age (Adj. RRR = 1.81; 95% CI: 1.32, 2.50). Uptake of individual HCT was significantly associated with prior HCT (Adj. RRR = 6.26; 95% CI: 4.24, 9.24) and the female partner being HIV-positive (Adj. RRR = 2.46; 95% CI: 1.26, 4.80). Conclusion: Uptake of couples’ HCT remained consistently low (below 30%) over the years, while uptake of individual HCT declined over time. These findings call for innovative strategies to increase demand for couples’ HCT, particularly among younger couples and those with no prior HCT. [ABSTRACT FROM AUTHOR]

Objective To examine the relationship between condom social marketing programmes and condom use. Methods Standard systematic review and meta-analysis methods were followed. The review included studies of interventions in which condoms were sold, in which a local brand name(s) was developed for condoms, and in which condoms were marketed through a promotional campaign to increase sales. A definition of intervention was developed and standard inclusion criteria were followed in selecting studies. Data were extracted from each eligible study, and a meta-analysis of the results was carried out. Findings Six studies with a combined sample size of 23 048 met the inclusion criteria. One was conducted in India and five in sub-Saharan Africa. All studies were cross-sectional or serial cross-sectional. Three studies had a comparison group, although all lacked equivalence in sociodemographic characteristics across study arms. All studies randomly selected participants for assessments, although none randomly assigned participants to intervention arms. The random-effects pooled odds ratio for condom use was 2.01 (95% confidence interval, CI: 1.42-2.84) for the most recent sexual encounter and 2.10 (95% CI: 1.51-2.91) for a composite of all condom use outcomes. Tests for heterogeneity yielded significant results for both meta-analyses. Conclusion The evidence base for the effect of condom social marketing on condom use is small because few rigorous studies have been conducted. Meta-analyses showed a positive and statistically significant effect on increasing condom use, and all individual studies showed positive trends. The cumulative effect of condom social marketing over multiple years could be substantial. We strongly encourage more evaluations of these programmes with study designs of high rigour. [ABSTRACT FROM AUTHOR]

The article presents a study that examined the link between individual, relational and environmental factors and adolescent demand for HIV voluntary counseling and testing (VCT). The study involved 439 respondents aged 16 to 19 years old in Ndola, Zambia including those who planned to test for HIV and those who did not. Results have shown that 28% of respondents have planned to take an HIV test because they have had sex and they want to free their mind and know their status. On the other hand, over 31% of the 341 youth have no plans to take an HIV test for having no risk factor for HIV.

To examine the application of the transtheoretical model (TM) to women's experiences of ending intimate partner violence (IPV). Methods: Qualitative interviews were conducted with 23 abused women. Results: Women use 7 traditional processes of change. Women in early stages of change use cognitive processes. Women in later stages use behavioral processes. Consciousness-raising and social liberation appear in both early and later stages. Help-ing relationships are critical throughout. Decisional balance and self-efficacy are also related. Conclusions: Women ending IPV do use the TM processes and constructs of change. These findings support the development and evaluation of a TM stage-based IPV intervention. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic and subsequent mitigation measures led to social disruption and negative economic shocks for a large proportion of Uganda's population. The social and economic consequences of COVID-19 on Ugandan men's sexual behaviours, including transactional sex relationships, are unclear. We conducted in-depth interviews between November 2021–February 2022 with 26 men in a high HIV prevalence region of Uganda. Data were analysed thematically to understand how sexual relationships, including transactional sex, were impacted by COVID-19. We found that COVID-19 mitigation measures had far-reaching social and economic impacts on most respondents, particularly those employed in the informal economy. Men described experiencing job loss, food insecurity and restricted mobility, which limited opportunities to provide for and meet with transactional sex partners. Inability to provide financial resources meant that men could not form new transactional sex relationships and men who could no longer provide for their existing transactional sex partners consistently reported relationship dissolution. Men who reported stable employment during the pandemic described few changes in transactional sex relationships. Similarly, men in non-transactional relationships did not report relationship dissolution despite decreased financial provision. Further research should assess the potential short- and long-term impacts of COVID-19 mitigation measures on transactional sex relationships. [ABSTRACT FROM AUTHOR]

The Evidence Project conducts systematic reviews and meta-analyses of HIV behavioral interventions, behavioral aspects of biomedical interventions, combination prevention strategies, modes of service delivery, and integrated programs in low- and middle-income countries. Here, we present the overall protocol for our reviews. For each topic, we conduct a comprehensive search of five online databases, complemented by secondary reference searching. Articles are included if they are published in peer-reviewed journals and present pre/post or multi-arm data on outcomes of interest. Data are extracted from each included article by two trained coders working independently using standardized coding forms, with differences resolved by consensus. Risk of bias is assessed with the Evidence Project tool. Data are synthesized descriptively, and meta-analysis is conducted when there are similarly measured outcomes across studies. For over 20 years, this approach has allowed us to synthesize literature on the effectiveness of interventions and contribute to the global HIV response. [ABSTRACT FROM AUTHOR]

The Project YES! clinic-based peer mentoring program was a randomized controlled trial (RCT) conducted among 276 youth from four HIV clinics to test the impact of the program on promoting HIV self-management and reducing internalized stigma among youth living with HIV (ages 15–24 years) in Ndola, Zambia. We conducted a qualitative sub-study involving in-depth interviews with 40 intervention youth participants (21 female, 19 male) to explore their experiences with Project YES! which included: an orientation meeting led by a healthcare provider, monthly individual and group counseling sessions over six months, and three optional caregiver group sessions. Using baseline RCT data, we used maximum variation sampling to purposively select youth by sex, age, change in virologic results between baseline and midline, and study clinic. A four-person team conducted thematic coding. Youth described their increased motivation to take their HIV care seriously due to Project YES!, citing examples of improvements in ART adherence and for some, virologic results. Many cited changes in behavior in the context of greater feelings of self-worth and acceptance of their HIV status, resulting in less shame and fear associated with living with HIV. Youth also attributed Project YES! with reducing their sense of isolation and described Project YES! youth peer mentors and peers as their community and "family." Findings highlight that self-worth and personal connections play a critical role in improving youths' HIV outcomes. Peer-led programs can help foster these gains through a combination of individual and group counseling sessions. Greater attention to the context in which youth manage their HIV, beyond medication intake, is needed to reach global HIV targets. [ABSTRACT FROM AUTHOR]

Background: Despite efforts to promote HIV counseling and testing (HCT) among couples, few couples know their own or their partners' HIV status. We assessed trends in HCT uptake among married individuals in Rakai district, southwestern Uganda.Methods: We analysed data for 11,268 married individuals aged 15-49 years who were enrolled into the Rakai Community Cohort Study (RCCS) between 2003 and 2009. Married individuals were interviewed separately but were retrospectively linked to their partners at analysis. All participants had serologic samples obtained for HIV testing, and had the option of receiving HCT together (couples' HCT) or separately (individual HCT). Individuals were categorized as concordant HIV-positive if both partners had HIV; concordant HIV-negative if both did not have HIV; or HIV-discordant if only one of the partners had HIV. We used χ2 tests to assess linear trends in individual and couples' HCT uptake in the entire sample and conducted multinomial logistic regression on a sub-sample of 10,712 individuals to assess relative risk ratios (RRR) and 95% Confidence Intervals (95% CI) associated with individual and couples' HCT uptake. Analysis was done using STATA version 11.0.Results: Uptake of couples' HCT was 27.2% in 2003/04, 25.1% in 2005/06, 28.5% in 2006/08 and 27.8% in 2008/09 (χ2 for trend = 2.38; P = 0.12). Uptake of individual HCT was 57.9% in 2003/04, 60.2% in 2005/06, 54.0% in 2006/08 and 54.4% in 2008/09 (χ2 for trend = 8.72; P = 0.003). The proportion of couples who had never tested increased from 14.9% in 2003/04 to 17.8% in 2008/09 (χ2 for trend = 18.16; P < 0.0001). Uptake of couples' HCT was significantly associated with prior HCT (Adjusted [Adj.] RRR = 6.80; 95% CI: 5.44, 8.51) and being 25-34 years of age (Adj. RRR = 1.81; 95% CI: 1.32, 2.50). Uptake of individual HCT was significantly associated with prior HCT (Adj. RRR = 6.26; 95% CI: 4.24, 9.24) and the female partner being HIV-positive (Adj. RRR = 2.46; 95% CI: 1.26, 4.80).Conclusion: Uptake of couples' HCT remained consistently low (below 30%) over the years, while uptake of individual HCT declined over time. These findings call for innovative strategies to increase demand for couples' HCT, particularly among younger couples and those with no prior HCT. [ABSTRACT FROM AUTHOR]

The recognition and fulfilment of the sexual and reproductive health and rights (SRHR) of all individuals and couples affected by HIV, including HIV-serodiscordant couples, requires intervention strategies aimed at achieving safe and healthy pregnancies and preventing undesired pregnancies. Reducing risk of horizontal and vertical transmission and addressing HIV-related infertility are key components of such interventions. In this commentary, we present challenges and opportunities for achieving safe pregnancies for serodiscordant couples through a social ecological lens. At the individual level, knowledge (e.g. of HIV status, assisted reproductive technologies) and skills (e.g. adhering to antiretroviral therapy or pre-exposure prophylaxis) are important. At the couple level, communication between partners around HIV status disclosure, fertility desires and safer pregnancy is required. Within the structural domain, social norms, stigma and discrimination from families, community and social networks influence individual and couple experiences. The availability and quality of safer conception and fertility support services within the healthcare system remains essential, including training for healthcare providers and strengthening integration of SRHR and HIV services. Policies, legislation and funding can improve access to SRHR services. A social ecological framework allows us to examine interactions between levels and how interventions at multiple levels can better support HIV-serodiscordant couples to achieve safe pregnancies. Strategies to achieve safer pregnancies should consider interrelated challenges at different levels of a social ecological framework. Interventions across multiple levels, implemented concurrently, have the potential to maximize impact and ensure the full SRHR of HIV-serodiscordant couples. [ABSTRACT FROM AUTHOR]

The recognition and fulfilment of the sexual and reproductive health and rights (SRHR) of all individuals and couples affected by HIV, including HIV-serodiscordant couples, requires intervention strategies aimed at achieving safe and healthy pregnancies and preventing undesired pregnancies. Reducing risk of horizontal and vertical transmission and addressing HIV-related infertility are key components of such interventions. In this commentary, we present challenges and opportunities for achieving safe pregnancies for serodiscordant couples through a social ecological lens. At the individual level, knowledge (e.g. of HIV status, assisted reproductive technologies) and skills (e.g. adhering to antiretroviral therapy or pre-exposure prophylaxis) are important. At the couple level, communication between partners around HIV status disclosure, fertility desires and safer pregnancy is required. Within the structural domain, social norms, stigma and discrimination from families, community and social networks influence individual and couple experiences. The availability and quality of safer conception and fertility support services within the healthcare system remains essential, including training for healthcare providers and strengthening integration of SRHR and HIV services. Policies, legislation and funding can improve access to SRHR services. A social ecological framework allows us to examine interactions between levels and how interventions at multiple levels can better support HIV-serodiscordant couples to achieve safe pregnancies. Strategies to achieve safer pregnancies should consider interrelated challenges at different levels of a social ecological framework. Interventions across multiple levels, implemented concurrently, have the potential to maximize impact and ensure the full SRHR of HIV-serodiscordant couples. [ABSTRACT FROM AUTHOR]

Introduction: While disengagement from HIV care threatens the health of persons living with HIV (PLWH) and incidence‐reduction targets, re‐engagement is a critical step towards positive outcomes. Studies that establish a deeper understanding of successful return to clinical care among previously disengaged PLWH and the factors supporting re‐engagement are essential to facilitate long‐term care continuity. Methods: We conducted narrative, patient‐centred, in‐depth interviews between January and June 2019 with 20 PLWH in Lusaka, Zambia, who had disengaged and then re‐engaged in HIV care, identified through electronic medical records (EMRs). We applied narrative analysis techniques, and deductive and inductive thematic analysis to identify engagement patterns and enablers of return. Results: We inductively identified five trajectories of care engagement, suggesting patterns in patient characteristics, experienced barriers and return facilitators that may aid intervention targeting including: (1) intermittent engagement;(2) mostly engaged; (3) delayed linkage after testing; (4) needs time to initiate antiretroviral therapy (ART); and (5) re‐engagement with ART initiation. Patient‐identified periods of disengagement from care did not always align with care gaps indicated in the EMR. Key, interactive re‐engagement facilitators experienced by participants, with varied importance across trajectories, included a desire for physical wellness and social support manifested through verbal encouragement, facility outreach or personal facility connections and family instrumental support. The mechanisms through which facilitators led to return were: (1) the promising of living out one's life priorities; (2) feeling valued; (3) fostering interpersonal accountability; (4) re‐entry navigation support; (5) facilitated care and treatment access; and (6) management of significant barriers, such as depression. Conclusions: While preliminary, the identified trajectories may guide interventions to support re‐engagement, such as offering flexible ART access to patients with intermittent engagement patterns instead of stable patients only. Further, for re‐engagement interventions to achieve impact, they must activate mechanisms underlying re‐engagement behaviours. For example, facility outreach that reminds a patient to return to care but does not affirm a patient's value or navigate re‐entry is unlikely to be effective. The demonstrated importance of positive health facility connections reinforces a growing call for patient‐centred care. Additionally, interventions should consider the important role communities play in fostering treatment motivation and overcoming practical barriers. [ABSTRACT FROM AUTHOR]

Adolescents and young adults (AYA) 13–24 years old make up a disproportionate 21% of new HIV diagnoses. Unfortunately, they are less likely to treat HIV effectively, with only 30% achieving viral suppression, limiting efforts to interrupt HIV transmission. Previous work with mindfulness-based stress reduction (MBSR) has shown promise for improving treatment in AYA living with HIV (AYALH). This randomized controlled trial compared MBSR with general health education (HT). Seventy-four 13–24-year-old AYALH conducted baseline data collection and were randomized to nine sessions of MBSR or HT. Data were collected at baseline, post-program (3 months), 6 and 12 months on mindfulness and HIV management [medication adherence (MA), HIV viral load (HIV VL), and CD4]. Longitudinal analyses were conducted. The MBSR arm reported higher mindfulness at baseline. Participants were average 20.5 years old, 92% non-Hispanic Black, 51% male, 46% female, and 3% transgender. Post-program, MBSR participants had greater increases than HT in MA (p = 0.001) and decreased HIV VL (p = 0.052). MBSR participants showed decreased mindfulness at follow-up. Given the significant challenges related to HIV treatment in AYALH, these findings suggest that MBSR may play a role in improving HIV MA and decreasing HIV VL. Additional research is merited to investigate MBSR further for this important population. [ABSTRACT FROM AUTHOR]

Emerging data show associations between violence victimisation and negative HIV outcomes among youth in sub-Saharan Africa. We conducted in-depth interviews with adolescents and young adults living with HIV (aged 15–24 years) in Ndola, Zambia, to better understand this relationship. We purposively selected 41 youth (24 females, 17 males) with varied experiences of violence and virologic results. Analysis used thematic coding. Two-thirds of participants said violence affected their medication adherence, clinic attendance, and/or virologic results. They focused on the negative effects of psychological abuse from family members in homes and peers at schools, which were the most salient forms of violence raised, and sexual violence against females. In contrast, they typically depicted physical violence from caregivers and teachers as a standard discipline practice, with few impacts. Youth wanted HIV clinic settings to address verbal abuse and emotional maltreatment, alongside physical and sexual violence, including through peer mentoring. Violence – especially verbal and emotional forms – must be recognised as a potential barrier to HIV self-management among youth living with HIV in the region. Further testing of clinic, home, and school-based interventions may be critical to reducing levels of violence and improving HIV outcomes in this vulnerable but resilient population. Trial registration: ClinicalTrials.gov identifier: NCT04115813. [ABSTRACT FROM AUTHOR]

Background: Little is known about youth-led approaches to addressing HIV-related outcomes among adolescents and young adults (AYA) living with HIV. In response, Project YES! hired and trained youth living with HIV as peer mentors (YPMs) in four HIV clinics in Ndola, Zambia to hold meetings with 276 15-24-year-olds living with HIV. Within this randomized controlled trial, a qualitative sub-study was conducted to explore YPMs' implementing experiences. Methods: In-depth interviews were conducted with the eight YPMs (50% female) ages 21–26 years. YPMs were asked about their experiences working with clients, their feedback on program components, and what the experience meant to them personally and professionally. Interviews were audio-recorded, transcribed verbatim, and thematic analysis was performed. Results: YPMs connected with AYA clients by discussing shared struggles, modeling positive health behaviors, and establishing judgement-free environments. YPMs experienced powerful personal transformations in HIV-related health behaviors, conceptions of self, and plans for the future. Many expressed now seeing themselves as community leaders–"ambassadors", "game changers"–and "not just alone in this world." They described newfound commitments to reaching personal and professional goals. YPMs were adamant that Project YES! should expand so other HIV-positive AYA might benefit. Conclusion: Well-trained and compensated YPMs who are integrated into HIV clinics can support AYA in unique and important ways due to their shared experiences. The transformational experience of becoming YPMs empowers youth to see themselves as role models and leaders. Future programs should engage youth living with HIV as partners in efforts to end the HIV epidemic. [ABSTRACT FROM AUTHOR]

Introduction: Tracing patients lost to follow‐up (LTFU) from HIV care is widely practiced, yet we have little knowledge of its causal effect on care engagement. In a prospective, Zambian cohort, we examined the effect of tracing on return to care within 2 years of LTFU. Methods: We traced a stratified, random sample of LTFU patients who had received HIV care between August 2013 and July 2015. LTFU was defined as a gap of >90 days from last scheduled appointment in the routine electronic medical record. Extracting 2 years of follow‐up visit data through 2017, we identified patients who returned. Using random selection for tracing as an instrumental variable (IV), we used conditional two‐stage least squares regression to estimate the local average treatment effect of tracer contact on return. We examined the observational association between tracer contact and return among patient sub‐groups self‐confirmed as disengaged from care. Results: Of the 24,164 LTFU patients enumerated, 4380 were randomly selected for tracing and 1158 were contacted by a tracer within a median of 14.8 months post‐loss. IV analysis found that patients contacted by a tracer because they were randomized to tracing were no more likely to return than those not contacted (adjusted risk difference [aRD]: 3%, 95% CI: –2%, 8%, p = 0.23). Observational data showed that among contacted, disengaged patients, the rate of return was higher in the week following tracer contact (IR 5.74, 95% CI: 3.78–8.71) than in the 2 weeks to 1‐month post‐contact (IR 2.28, 95% CI: 1.40–3.72). There was a greater effect of tracing among patients lost for >6 months compared to those contacted within 3 months of loss. Conclusions: Overall, tracer contact did not causally increase LTFU patient return to HIV care, demonstrating the limited impact of tracing in this program, where contact occurred months after patients were LTFU. However, observational data suggest that tracing may speed return among some LTFU patients genuinely out‐of‐care. Further studies may improve tracing effectiveness by examining the mechanisms underlying the impact of tracing on return to care, the effect of tracing at different times‐since‐loss and using more accurate identification of patients who are truly disengaged to target tracing. [ABSTRACT FROM AUTHOR]

Objective: How clinics structure the delivery of antiretroviral therapy (ART) services may influence patient adherence. We assessed the relationship between models of HIV care delivery and adherence as measured by medication possession ratio (MPR) among treatment‐experienced adults in Tanzania, Uganda and Zambia. Methods: Eighteen clinics were grouped into three models of HIV care. Model 1‐Traditional and Model 2‐Mixed represented task‐sharing of clinical services between physicians and clinical officers, distinguished by whether nurses played a role in clinical care; in Model 3‐Task‐Shifted, clinical officers and nurses shared clinical responsibilities without physicians. We assessed MPR among 3,419 patients and calculated clinic‐level MPR summaries. We then calculated the mean differences of percentages and adjusted residual ratio (aRR) of the association between models of care and incomplete adherence, defined as a MPR <90%, adjusting for individual‐level characteristics. Results: In the adjusted analysis, patients in Model 1‐Traditional were more likely than patients in Model 2‐Mixed to have MPR <90% (aRR = 1.60, 95% CI 1–2.48). Patients in Model 1‐Traditional were no more likely than patients in Model 3‐Task‐Shifted to have a MPR <90% (aRR = 1.58, 95% 0.88–2.85). There was no evidence of differences in MPR <90% between Model 2‐Mixed and Model 3‐Task‐Shifted (aRR = 0.99, 95% CI 0.59–1.66). Conclusion: Non‐physician‐led ART programmes were associated with adherence levels as good as or better than physician‐led ART programmes. Additional research is needed to optimise models of care to support patients on lifelong treatment. [ABSTRACT FROM AUTHOR]

Introduction: Adolescents and young adults (AYAs) living with HIV face unique challenges and have poorer health outcomes than adults with HIV. Project YES! was a youth-led initiative to promote HIV self-management and reduce stigma among AYAs in four Ndola, Zambia clinics. Clinic health care providers (HCPs) were involved in multiple intervention aspects, including serving as expert resources during AYA and caregiver group meetings, facilitating resistance test-based AYA antiretroviral drug changes, meeting with participants referred through a safety protocol, and guiding a subset of participants' physical transition from pediatric to adult clinic settings. This study aimed to understand HCP insights on facilitators and barriers to implementing Project YES! and scaling up a clinic-based, youth-focused program. Methods: A trained interviewer conducted ten in-depth interviews with participating HCPs from November–December 2018 and analyzed data, identifying key themes. These themes were examined in terms of two implementation science outcomes–acceptability and feasibility–to inform scalability. Results: HCPs found peer mentoring valuable for AYAs with HIV and the bimonthly caregiver meetings beneficial to AYA caregivers. HCPs voiced a desire for more involvement in specific processes related to patient clinical care, such as drug changes. HCPs' experiences with the study safety protocol, including referrals for youth experiences of violence, shifted their views of AYAs and informed their understanding of key issues youth face. Considering this, many HCPs requested more resources to support AYAs' varied needs. HCPs noted limited time and clinic space as implementation barriers but felt the program was valuable overall. Conclusions: HCPs concluded youth peer mentoring was highly acceptable and feasible, supporting scale-up of youth-led interventions addressing the multi-faceted needs of AYAs living with HIV. Continued provider involvement in resistance test-based antiretroviral drug changes, considered in the context of health system and clinic policy, would enhance long-term success of the program at scale. [ABSTRACT FROM AUTHOR]

Background: Dynamic movement of patients in and out of HIV care is prevalent, but there is limited information on patterns of patient re-engagement or predictors of return to guide HIV programs to better support patient engagement. Methods: From a probability-based sample of lost to follow-up, adult patients traced by peer educators from 31 Zambian health facilities, we prospectively followed disengaged HIV patients for return clinic visits. We estimated the cumulative incidence of return and the time to return using Kaplan-Meier methods. We used univariate and multivariable Cox proportional hazards regression to conduct a risk factor analysis identifying predictors of incident return across a social ecological framework. Results: Of the 556 disengaged patients, 73.0% [95% confidence interval (CI): 61.0 to 83.8] returned to HIV care. The median follow-up time from disengagement was 32.3 months (interquartile range: 23.6-38.9). The rate of return decreased with time postdisengagement. Independent predictors of incident return included a previous gap in care [adjusted Hazard Ratio (aHR): 1.95, 95% CI: 1.23 to 3.09] and confronting a stigmatizer once in the past year (aHR: 2.14, 95% CI: 1.25 to 3.65). Compared with a rural facility, patients were less likely to return if they sought care from an urban facility (aHR: 0.68, 95% CI: 0.48 to 0.96) or hospital (aHR: 0.52, 95% CI: 0.33 to 0.82). Conclusions: Interventions are needed to hasten re-engagement in HIV care. Early and differential interventions by time since disengagement may improve intervention effectiveness. Patients in urban and tertiary care settings may need additional support. Improving patient resilience, outreach after a care gap, and community stigma reduction may facilitate return. Future re-engagement research should include causal evaluation of identified factors. [ABSTRACT FROM AUTHOR]

Infants born to HIV-infected mothers are more likely to be low birthweight (LBW) than other infants, a condition that is stigmatized in many settings worldwide, including sub-Saharan Africa. Few studies have characterized the social-cultural context and response to LBW stigma among mothers in sub-Saharan Africa or explored the views of women living with HIV (WLHIV) on the causes of LBW. We purposively sampled thirty postpartum WLHIV, who had given birth to either LBW or normal birthweight infants, from two tertiary hospitals in Accra, Ghana. Using semi-structured interviews, we explored women's understanding of the etiology of LBW, and their experiences of caring for a LBW infant. Interviews were analyzed using interpretive phenomenology. Mothers assessed their babies' smallness based on the baby's size, not hospital-recorded birthweight. Several participants explained that severe depression and a loss of appetite, linked to stigma following an HIV diagnosis during pregnancy, contributed to infants being born LBW. Women with small babies also experienced stigma due to the newborns' "undesirable" physical features and other people's unfamiliarity with their size. Consequently, mothers experienced blame, reluctance showing the baby to others, and social gossip. As a result of this stigma, women reported self-isolation and depressive symptoms. These experiences were layered on the burden of healthcare and infant feeding costs for LBW infants. LBW stigma appeared to attenuate with increased infant weight gain. A few of the women also did not breastfeed because they thought their baby's small size indicated pediatric HIV infection. Among WLHIV in urban areas in Ghana, mother and LBW infants may experience LBW-related stigma. A multi-component intervention that includes reducing LBW incidence, treating antenatal depression, providing psychosocial support after a LBW birth, and increasing LBW infants' weight gain are critically needed. [ABSTRACT FROM AUTHOR]

Background: HIV drug resistance (HIVDR) poses a threat to the HIV epidemic control in Zambia especially in sub-populations such as the 15–24 years where there is poor virological suppression. Understanding the prevalence and patterns of HIVDR in this population (15–24 years) will contribute to defining effective antiretroviral therapy (ART) regimens, improving clinical decision making, and supporting behavioral change interventions needed to achieve HIV epidemic control. Methods: A cross-sectional analysis of study enrollment data from the Project YES! Youth Engaging for Success randomized controlled trial was conducted. Participants were 15 to 24 years old, who knew their HIV status, and had been on ART for at least 6 months. All participants completed a survey and underwent viral load (VL) testing. Participants with viral failure (VL ≥1,000 copies/mL) underwent HIVDR testing which included analysis of mutations in the protease and reverse transcriptase genes. Results: A total of 99 out of 273 analyzed participants receiving ART had VL failure, of whom 77 had successful HIVDR amplification and analysis. Out of the 77, 75% (58) had at least one drug resistant mutation, among which 83% (48/58) required a drug change. Among the 58 with HIVDR mutations, the prevalence of at least one HIVDR mutation to nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs) were 81%, 65.5% and 1.7%. The mutation M184V which confers resistance to NRTI drugs of lamivudine (3TC) and emtricitabine (FTC) was the most common (81%) among NRTI associated mutations followed by K65R (34.5%) which is associated with both tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide fumarate (TAF) resistance. Thymidine analogue mutations (TAMs) which confer resistance primarily to zidovudine (AZT), stavudine (d4T) and other NRTIs were observed at 32.8%. Common TAMs were K70RTQNE (32.8%), K219QE (22.4%), D67N (17.2%) and T215IT (15.5%). The most common NNRTI associated mutation was the K103N (65.5%) which confers resistance to both efavirenz (EFV) and nevirapine (NVP). There was a relatively high occurrence of other NNRTI mutations V106A (36.2%), as well as Y188C (36.2%) and Y181C (36.2%) which confer resistance to etravirine. Conclusions: There is a high prevalence of HIVDR including TAMs despite majority of these patients (90.48%) being on AZT or d4T sparing first line ART among the youth. Emergence of these mutations including the NNRTI associated mutations (Y181C and Y188C) may compromise future second- and third-line regimens in the absence of routine HIVDR testing. HIVDR monitoring at start of ART or at first-line failure can better inform clinical decision making and ART programing. [ABSTRACT FROM AUTHOR]

Background: Little is known about violence against HIV-positive adolescents and young adults (AYA) in sub-Saharan Africa. This analysis examines experiences of violence victimization, and the perpetrators of this violence, among AYA living with HIV, aged 15–24 years, in Zambia. Methods: We analyzed baseline data from 272 AYA (60.1% female, 71.0% perinatally infected) enrolled in Project YES! (Youth Engaging for Success), a randomized controlled trial conducted in four HIV clinics in Ndola, Zambia. Violence measures were adapted from the ICAST-C and the WHO Multi-Country Study on Women's Health and Domestic Violence. Youth could report up to 12 perpetrator types for past-year experiences of violence. We estimated lifetime and past-year prevalence of physical violence, psychological abuse, and forced sex, disaggregated by sex and age group. Estimates were weighted using sex and age data from the 2013–14 Zambian Demographic and Health Survey to be representative of HIV-positive AYA in Zambia. Results: Estimated lifetime prevalence of any violence victimization was 78.2%. Past-year prevalence was 72.0% among males and 74.5% among females. Almost half of AYA (46.1%) had ever experienced polyvictimization (2+ types of violence). Psychological abuse was most common (70.4% lifetime, 65.3% past-year), followed by physical violence (50.8% lifetime, 44.7% past-year) and forced sex (10.4% lifetime, 4.7% past-year). Among past-year victims, males experienced more violence than females from a friend/peer (74.3% vs. 45.1%, p<0.001); females experienced more violence than males from a romantic partner (33.3% vs. 5.0%, p<0.001), parent/caregiver (32.4% vs. 17.6%, p = 0.02), and stranger (19.7% vs. 5.2%, p<0.001). Conclusion: The widespread and overlapping prevalence of multiple types of violence highlights the critical need for prevention and response efforts that are tailored to youths' sex and the perpetrator type. Future research should explore violence victimization and HIV outcomes, and the measurement of psychological abuse and sexual violence, among HIV-positive AYA in the region. [ABSTRACT FROM AUTHOR]

Women in sub-Saharan Africa are disproportionately at risk for the dual epidemics of intimate partner violence (IPV) and HIV. Little is known about how specific violence profiles affect women's HIV risk, limiting effective intervention. We analysed couples' data from the Zambia Demographic and Health Survey 2013–2014 to evaluate relationships among IPV, male partner HIV status and women's HIV status. We considered the individual and combined effects of physical, sexual, emotional, and high controlling behaviour violence and accumulated violence exposure, respectively. Among partnered women, 48.9% (n = 2,812) experienced IPV victimisation, of whom 52.1% (n = 1,465) reported polyvictimisation (experiencing two or more violence types). Female HIV prevalence was 13.2%. Adjusted for demographics, HIV was significantly higher for women who experienced three (17.3%, aPR 1.33, 95%CI: 1.04–1.69, p = 0.02) or four (22.1%, aPR 1.66, 95%CI: 1.23–2.26, p ≤ 0.01) types versus no IPV. Violence including emotional and/or high controlling victimisation was associated with female HIV infection (aPR: 1.31, 95%CI: 1.09–1.57, p = 0.01). Physical and/or sexual violence victimisation in the absence of other victimisation was not associated with HIV (aPR: 0.92, 95%CI:0.73–1.15, p = 0.46). IPV and HIV interventions are incomplete without addressing emotional and controlling IPV and the role of coercive relationship dynamics in transmission risk. [ABSTRACT FROM AUTHOR]

Background: Understanding and meeting the reproductive health needs of adolescents living with HIV (ALHIV) is a growing concern since advances in antiretroviral therapy mean that many ALHIV are now living into adulthood and starting to have sex. Methods: We conducted a mixed-methods study in the Copperbelt Province of Zambia to advance our understanding of the reproductive health needs of ALHIV and to assess the extent to which these needs are being met. We conducted in-depth interviews (IDIs) with 32 ALHIV from two HIV clinics, 23 with their caregivers, and 10 with clinic staff. ALHIV were interviewed twice. We used the data from the qualitative interviews to create a cross-sectional survey that we conducted with 312 ALHIV in three HIV clinics. Findings: The vast majority of ALHIV reported they wanted to have children in the future but lacked knowledge about preventing mother-to-child transmission. Some sexually active adolescents used condoms, although they wanted more information about and access to non-condom methods. Many ALHIV reported that their first sexual encounters were forced. Religious beliefs prevented some caregivers from discussing premarital sex and contraception with ALHIV. Clinic staff and caregivers had mixed views about integrating contraceptive counseling and method provision into HIV care and treatment services. Few sexually active ALHIV reported that they disclosed their HIV status to their sexual partners and few reported that they knew their sexual partner’s status. Conclusions: ALHIV are in dire need of comprehensive sexual and reproductive health services and information including a range of contraceptive methods to prevent pregnancy, knowledge about preventing mother-to-child transmission and having a healthy pregnancy, skills related to HIV disclosure and condom negotiation to prevent horizontal transmission, and screening for sexual violence for both males and females if services are available. [ABSTRACT FROM AUTHOR]

OBJECTIVES We assessed retention and predictors of attrition (recorded death or loss to follow-up) in antiretroviral treatment (ART) clinics in Tanzania, Uganda and Zambia. METHODS We conducted a retrospective cohort study among adults (=18 years) starting ART during 2003-2010. We purposefully selected six health facilities per country and randomly selected 250 patients from each facility. Patients who visited clinics at least once during the 90 days before data abstraction were defined as retained. Data on individual and programme level risk factors for attrition were obtained through chart review and clinic manager interviews. Kaplan-Meier curves for retention across sites were created. Predictors of attrition were assessed using a multivariable Coxproportional hazards model, adjusted for site-level clustering. RESULTS From 17 facilities, 4147 patients were included. Retention ranged from 52.0% to 96.2% at 1 year to 25.8%-90.4% at 4 years. Multivariable analysis of ART initiation characteristics found the following independent risk factors for attrition: younger age [adjusted hazard ratio (aHR) and 95% confidence interval (95%CI) = 1.30 (1.14-1.47)], WHO stage 4 ([aHR (95% CI): 1.56 (1.29-1.88)], >10% bodyweight loss [aHR (95%CI) = 1.17 (1.00-1.38)], poor functional status [ambulatory aHR (95%CI) = 1.29 (1.09-1.54); bedridden aHR1.54 (1.15-2.07)], and increasing years of clinic operation prior to ART initiation in government facilities [aHR (95%CI) = 1.17 (1.10-1.23)]. Patients with higher CD4 cell count were less likely to experience attrition [aHR (95%CI) = 0.88 (0.78-1.00)] for every log (tenfold) increase. Sites offering community ART dispensing [aHR (95% CI) = 0.55 (0.30-1.01) for women; 0.40 (0.21-0.75) for men] had significantly less attrition. CONCLUSIONS Patient retention to an individual programme worsened over time especially among males, younger persons and those with poor clinical indicators. Community ART drug dispensing programmes could improve retention. [ABSTRACT FROM AUTHOR]

The article discusses research which examined age-related antiretroviral therapy (ART) retention challenges in African countries in 2004-2013. Topics covered include the association between age groups and rates of death and loss to follow-up (LTFU), the prevalence of pregnancy in various age groups and the difference in ART enrollment characteristics of adolescents and young adults and older adults.

Although scale-up of antiretroviral therapy (ART) since 2005 has contributed to declines of about 30% in the global annual number of human immunodeficiency (HIV)-related deaths and declines in global HIV incidence, estimated annual HIV-related deaths among adolescents have increased by about 50% and estimated adolescent HIV incidence has been relatively stable. In 2012, an estimated 2,500 (40%) of all 6,300 daily new HIV infections occurred among persons aged 15-24 years. Difficulty enrolling adolescents and young adults in ART and high rates of loss to follow-up (LTFU) after ART initiation might be contributing to mortality and HIV incidence in this age group, but data are limited. To evaluate age-related ART retention challenges, data from retrospective cohort studies conducted in seven African countries among 16,421 patients, aged ≥15 years at enrollment, who initiated ART during 2004-2012 were analyzed. ART enrollment and outcome data were compared among three groups defined by age at enrollment: adolescents and young adults (aged 15-24 years), middle-aged adults (aged 25-49 years), and older adults (aged ≥50 years). Enrollees aged 15-24 years were predominantly female (81%-92%), commonly pregnant (3%-32% of females), unmarried (54%-73%), and, in four countries with employment data, unemployed (53%-86%). In comparison, older adults were more likely to be male (p<0.001), employed (p<0.001), and married, (p<0.05 in five countries). Compared with older adults, adolescents and young adults had higher LTFU rates in all seven countries, reaching statistical significance in three countries in crude and multivariable analyses. Evidence-based interventions to reduce LTFU for adolescent and young adult ART enrollees could help reduce mortality and HIV incidence in this age group. [ABSTRACT FROM AUTHOR]

Background: Different tools exist for assessing risk of bias of intervention studies for systematic reviews. We present a tool for assessing risk of bias across both randomized and non-randomized study designs. The tool was developed by the Evidence Project, which conducts systematic reviews and meta-analyses of behavioral interventions for HIV in low- and middle-income countries. Methods: We present the eight items of the tool and describe considerations for each and for the tool as a whole. We then evaluate reliability of the tool by presenting inter-rater reliability for 125 selected studies from seven published reviews, calculating a kappa for each individual item and a weighted kappa for the total count of items. Results: The tool includes eight items, each of which is rated as being present (yes) or not present (no) and, for some items, not applicable or not reported. The items include (1) cohort, (2) control or comparison group, (3) pre-post intervention data, (4) random assignment of participants to the intervention, (5) random selection of participants for assessment, (6) follow-up rate of 80% or more, (7) comparison groups equivalent on sociodemographics, and (8) comparison groups equivalent at baseline on outcome measures. Together, items (1)–(3) summarize the study design, while the remaining items consider other common elements of study rigor. Inter-rater reliability was moderate to substantial for all items, ranging from 0.41 to 0.80 (median κ = 0.66). Agreement between raters on the total count of items endorsed was also substantial (κw = 0.66). Conclusions: Strengths of the tool include its applicability to a range of study designs, from randomized trials to various types of observational and quasi-experimental studies. It is relatively easy to use and interpret and can be applied to a range of review topics without adaptation, facilitating comparability across reviews. Limitations include the lack of potentially relevant items measured in other tools and potential threats to validity of some items. To date, the tool has been applied in over 30 reviews. We believe it is a practical option for assessing risk of bias in systematic reviews of interventions that include a range of study designs. [ABSTRACT FROM AUTHOR]