A hybrid digital parenting programme to prevent abuse of adolescents in Tanzania: statistical analysis plan for a pragmatic cluster randomised controlled trial.

BACKGROUND: Globally, violence against children poses substantial health and economic challenges, with estimated costs nearing USD 7 trillion. This prompts the urgent call for effective evidence-based interventions in preventing and mitigating violence against children. ParentApp is a mobile, open-source application designed to offer a remote version of the Parenting for Lifelong Health (PLH) programme. ParentApp is the first digital parenting intervention for caregivers of adolescents aged 10-17 years to be tested in low- and middle-income settings. METHODS: This study is a pragmatic, two-arm, cluster-randomised trial in Mwanza, Tanzania's urban and peri-urban areas. Assessments are set for baseline, 1 month post-intervention, and 12 months post-intervention. We randomised 80 clusters, each with about 30 caregiver-adolescent dyads, with a 1:1 ratio stratified by urban or peri-urban location. Both arms receive an entry-level smartphone preloaded with Kiswahili apps-ParentApp for intervention and WashApp control. The primary method of analysis will be generalised linear mixed-effects models with adjustment for person-level characteristics and multiple imputation. In three-level models, measurement waves are nested within a person, nested within a sub-ward. Regressions will constrain groups to be equal at baseline and include covariates for stratification, percentage of male caregivers, and individual-level characteristics. DISCUSSIONS: Preparations for the trial began in December 2022, including community mobilisation and sensitisation. Rolling recruitment, baseline data collection, and implementation onboarding took place between April and September 2023. One-month post-test data collection began in August 2023 and thus far achieved 97% and 94% retention rates for caregivers and adolescents respectively. Final post-test data collection will begin in September 2024, anticipated to run until April 2025. This SAP was submitted to the journal before the interim analysis to preserve scientific integrity under a superiority hypothesis testing framework. TRIAL REGISTRATION: The trial was registered on the Open Science Framework on 14 March 2023: https://doi.org/10.17605/OSF.IO/T9FXZ . The trial protocol was published in Trials 25, 119 (2024): Baerecke, L., Ornellas, A., Wamoyi, J. et al. A hybrid digital parenting programme to prevent abuse of adolescents in Tanzania: study protocol for a pragmatic cluster-randomised controlled trial. Trials 25, 119 (2024). https://doi.org/10.1186/s13063-023-07893-x .

A hybrid digital parenting programme to prevent abuse of adolescents in Tanzania: study protocol for a pragmatic cluster-randomised controlled trial.

BACKGROUND: Evidence-based parenting programmes have strong evidence in preventing and mitigating violence, but in-person programmes are challenging to deliver at scale. ParentApp is an open-source, offline-first app-based adaptation of the Parenting for Lifelong Health for Parents and Teens programme to promote playful and positive parenting, reduce risks for sexual violence victimisation, and prevent violence against adolescents. This study aims to evaluate the effectiveness and cost-effectiveness of ParentApp compared to an attention-control group. METHODS: This study is a two-arm pragmatic cluster-randomised controlled trial to test whether ParentApp reduces adolescent physical abuse, emotional abuse, and sexual violence risks and victimisation at 1 month and 12 months post-intervention. Caregivers of adolescents aged 10-17 years and their adolescent children (N = 2400 caregiver-adolescent dyads) will be recruited in urban and peri-urban communities in the Mwanza region of Tanzania. A total of 80 study clusters will be stratified and randomised (1:1) to the intervention group, who will receive ParentApp with support through a WhatsApp group, or to an attention-control group, who will receive a water, sanitation, and hygiene app. Quantitative data will be collected through outcomes questionnaires with caregivers and adolescents, administered at baseline, 4 months post-baseline, and 16 months post-baseline, as well as through routine implementation data and ParentApp engagement data. Qualitative data will be collected through individual interviews and focus groups with caregivers, adolescents, and implementing partner staff. DISCUSSION: App-based interventions have the potential to expand access to evidence-based parenting support, but currently lack rigorous evidence in low- and middle-income countries. This is the first known randomised control trial of a hybrid digital parenting programme to prevent the abuse of adolescents in low- and middle-income settings. TRIAL REGISTRATION: The trial was registered on the Open Science Framework on 14 March 2023, registration: OSF.IO/T9FXZ .

Optimising engagement in a digital parenting intervention to prevent violence against adolescents in Tanzania: protocol for a cluster randomised factorial trial.

BACKGROUND: Violence against adolescents is a universal reality, with severe individual and societal costs. There is a critical need for scalable and effective violence prevention strategies such as parenting programmes, particularly in low- and middle-income countries where rates of maltreatment are highest. Digital interventions may be a scalable and cost-effective alternative to in-person delivery, yet maximising caregiver engagement is a substantial challenge. This trial employs a cluster randomised factorial experiment and a novel mixed-methods analytic approach to assess the effectiveness, cost-effectiveness, and feasibility of intervention components designed to optimise engagement in an open-source parenting app, ParentApp for Teens. The app is based on the evidence-based Parenting for Lifelong Health for Teens programme, developed collaboratively by academic institutions in the Global South and North, the WHO, and UNICEF. METHODS/DESIGN: Sixteen neighbourhoods, i.e., clusters, will be randomised to one of eight experimental conditions which consist of any combination of three components (Support: self-guided/moderated WhatsApp groups; App Design: sequential workshops/non-sequential modules; Digital Literacy Training: on/off). The study will be conducted in low-income communities in Tanzania, targeting socioeconomically vulnerable caregivers of adolescents aged 10 to 17 years (16 clusters, 8 conditions, 640 caregivers, 80 per condition). The primary objective of this trial is to estimate the main effects of the three components on engagement. Secondary objectives are to explore the interactions between components, the effects of the components on caregiver behavioural outcomes, moderators and mediators of programme engagement and impact, and the cost-effectiveness of components. The study will also assess enablers and barriers to engagement qualitatively via interviews with a subset of low, medium, and high engaging participants. We will combine quantitative and qualitative data to develop an optimised ParentApp for Teens delivery package. DISCUSSION: This is the first known cluster randomised factorial trial for the optimisation of engagement in a digital parenting intervention in a low- and middle-income country. Findings will be used to inform the evaluation of the optimised app in a subsequent randomised controlled trial. TRIAL REGISTRATION: Pan African Clinical Trial Registry, PACTR202210657553944. Registered 11 October 2022, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=24051 .

Routine health check-ups for adolescents in Mwanza City, Tanzania: stakeholders' recommendations on its content, venue, and mode of delivery.

BACKGROUND: Routine adolescent health screening aiming at the detection of unnoticed medical problems may increase awareness among policy makers and contribute to improved health in this population. Research is needed to inform the World Health Organization (WHO) and national health programs to provide evidence-based guidance on whether public health systems should offer comprehensive adolescent health screening, what should be included in different contexts, and how it should be delivered. We conducted formative research to define the content and delivery strategies for health check-ups to be performed in young (10-14 years) and older (15-19 years) adolescents, and to assess whether such services are likely to be acceptable and feasible in Tanzania. METHODS: As part of a collaborative research program coordinated by WHO in Chitungwiza, Zimbabwe; Mwanza City, Tanzania; and Cape Coast, Ghana a series of key informant interviews were conducted from April to July 2020, using a semi-structured guide with purposively selected stakeholders from government departments, non-governmental and community-based organisations, schools and health facilities. Data transcripts were coded using NVivo 12 software and thematic analysis was performed. RESULTS: We report results from 31 key informant interviews to address four main domains: proposed health conditions for routine health check-ups, health interventions to be combined with such check-ups, preferable venues, and the mode for delivering such screening activities. Stakeholders were supportive of introducing routine health check-ups among adolescents. They recommended focusing on non-communicable diseases, physical disabilities, common mental health problems, reproductive health problems, specific communicable diseases, and hygiene-related problems. They also recommended combining counselling and family planning information with these check-ups. Three venues were proposed: schools, community settings (to reach out-of-school adolescents), and youth-friendly health facilities (for conditions requiring a high level of confidentiality). CONCLUSIONS: Stakeholders were supportive of the proposed routine health check-ups for adolescents, recommending specific health conditions to be screened for in both community and school settings. Based on the above, we plan to conduct implementation research to determine the number of new treatable conditions detected, and the costs of offering such services. In the longer term, evaluation of their health impact and cost-effectiveness will be required to guide policy.

Effectiveness of Cash Transfer Delivered Along With Combination HIV Prevention Interventions in Reducing the Risky Sexual Behavior of Adolescent Girls and Young Women in Tanzania: Cluster Randomized Controlled Trial.

BACKGROUND: Poverty and social inequality exacerbate HIV risk among adolescent girls and young women (AGYW) in sub-Saharan Africa. Cash transfers can influence the structural determinants of health, thereby reducing HIV risk. OBJECTIVE: This study assessed the effectiveness of cash transfer delivered along with combination HIV prevention (CHP) interventions in reducing the risky sexual behavior of AGYW in Tanzania. The incidence of herpes simplex virus type 2 (HSV-2) infection was used as a proxy for sexual risk behavior. METHODS: A cluster randomized controlled trial was conducted in 15 matched pairs of communities (1:1 intervention to control) across 3 strata (urban, rural high-risk, and rural low-risk populations) of the Shinyanga Region, Tanzania. The target population was out-of-school AGYW aged 15-23 years who had completed 10-hour sessions of social and behavior change communication. Eligible communities were randomly assigned to receive CHP along with cash transfer quarterly (intervention group) or solely CHP interventions (control group) with no masking. Study recruitment and baseline survey were conducted between October 30, 2017 and December 1, 2017. Participants completed an audio computer-assisted self-interview, HIV counselling and testing, and HSV-2 testing at baseline and during follow-up visits at 6, 12, and 18 months after the baseline survey. A Cox proportional hazards model with random effects specified at the level of clusters (shared frailty) adjusted for matching pairs and other baseline imbalances was fitted to assess the effects of cash transfer on the incidence of HSV-2 infection (primary outcome). Secondary outcomes included HIV prevalence at follow-up, self-reported intergenerational sex, and self-reported compensated sex. All secondary outcomes were measured at each study visit. RESULTS: Of the 3026 AGYW enrolled in the trial (1482 in the intervention and 1544 in the control), 2720 AGYW (1373 in the intervention and 1347 in the control) were included in the final analysis. Overall, HSV-2 incidence was not significantly different at all follow-up points between the study arms in the adjusted analysis (hazard ratio 0.96, 95% CI 0.67-1.38; P=.83). However, HSV-2 incidence was significantly lower in the rural low-risk populations who received the cash transfer intervention (hazard ratio 0.45, 95% CI 0.29-0.71; P=.001), adjusted for potential confounders. CONCLUSIONS: Although this trial showed no significant impact of the cash transfer intervention on HSV-2 incidence among AGYW overall, the intervention significantly reduced HSV-2 incidence among AGYW in rural low-risk communities. Factors such as lesser poverty and more asset ownership in urban and rural high-risk communities may have undermined the impact of cash transfer. TRIAL REGISTRATION: ClinicalTrials.gov NCT03597243; https://clinicaltrials.gov/show/NCT03597243.

A mixed methods evaluation of the large-scale implementation of a school- and community-based parenting program to reduce violence against children in Tanzania: a study protocol.

BACKGROUND: Despite the rapid dissemination of parenting programs aiming to reduce and prevent violence against children (VAC) worldwide, there is limited knowledge about and evidence of the implementation of these programs at scale. This study addresses this gap by assessing the quality of delivery and impact of an evidence-based parenting program for parents/caregivers and their adolescent girls aged 9 to 14-Parenting for Lifelong Health Teens (PLH-Teens), known locally as Furaha Teens-on reducing VAC at scale in Tanzania. The study will explore participating family and staff perspectives on program implementation and examine factors associated with implementation and how implementation quality is associated with intervention outcomes when the program is delivered to approximately 50,000 parent-child dyads (N = 100,000) in schools and community centers across eight districts of Tanzania. METHODS: This mixed-methods study will answer the following research questions: (1) what is the implementation quality and fidelity of PLH-Teens at scale in Tanzania; (2) what factors are associated with the quality of delivery and implementation fidelity of PLH-Teens; (3) how are implementation quality and fidelity associated with intervention outcomes; (4) what are participant and implementing staff perspectives on the acceptability, appropriateness, feasibility, benefits, and challenges of delivering PLH-Teens in their schools and communities; (5) what is the impact of PLH-Teens on VAC and participant well-being; and (6) how much does it cost to deliver PLH-Teens at scale? Qualitative and quantitative data will be collected directly from implementers, parents/caregivers, and adolescents using pre-post questionnaires, observational assessments, cost surveys, focus groups, and interviews. Qualitative data will be analyzed thematically with the aid of NVIVO software. Quantitative data will be cleaned and analyzed using methods such as correlation, regression, and structural equation models using Stata and R. COREQ and TREND guidelines will be used, where appropriate. DISCUSSION: Findings will provide vital insights into some of the factors related to quality implementation at scale. Lessons learned regarding the implementation of PLH-Teens at scale will be applied in Tanzania, and also in the delivery of PLH parenting programs globally.

Female sex workers perspectives and concerns regarding HIV self-testing: an exploratory study in Tanzania.

BACKGROUND: HIV testing is a gateway to HIV care and treatment for people diagnosed with HIV and can link those with negative results to HIV preventive services. Despite the importance of HIV testing services (HTS) in HIV control, uptake of HTS among female sex workers (FSWs) across sub-Saharan Africa (SSA) remains sub-optimal. Concerns about stigma associated with sex work and fear of loss of livelihood if HIV status becomes known, are some of the restrictions for FSWs to utilize HTS offered through health care facilities. Introduction of HIV self-testing (HIVST) may mitigate some of the barriers for the uptake of HTS. This study explored the acceptability of FSWs towards the introduction of HIVST in Tanzania. METHODS: We conducted an exploratory study employing in-depth interviews (IDI) and participatory group discussions (PGD) with FSWs in selected regions of Tanzania. Study participants were recruited through snowball sampling. Data were thematically analysed by two analysts using NVivo software. The analysis was informed by the social-ecological model and focused on factors associated with the acceptability of HIVST. RESULTS: We conducted 21 PGD sessions involving 227 FSWs. Twenty three IDIs were conducted to complement data collected through PGD. Our study has demonstrated that FSWs are enthusiastic toward HIVST. Convenience (time and cost saved), and belief that HIVST will increase privacy and confidentiality motivated participants' support for the self-testing approach. Participants did express concerns about their ability to interpret and trust the results of the test. Participants also expressed concern that HIVST could cause personal harm, including severe distress and self-harm for individuals with a reactive test. Very likely, concern about adverse effects of HIVST was linked to the study participants' lay perception that HIVST would be provided only through unassisted modality. CONCLUSIONS: FSWs demonstrated high enthusiasm to use the HIVST once it becomes available. Expectations for increased confidentiality, autonomy, and reduced opportunity costs were among the leading factors that attracted FSWs to HIVST. The major obstacles to the acceptability of HIVST included fear of HIV reactive test and not trusting self-diagnoses. Our findings underscore the importance of providing adequate access to counselling and referral services in conjunction with HIVST.

The psychometric properties of PHQ-4 anxiety and depression screening scale among out of school adolescent girls and young women in Tanzania: a cross-sectional study.

BACKGROUND: Literature suggests that most mental disorders have their onset in childhood and adolescence, but go undiagnosed until adulthood. Shorter versions of the screening tools such as the Patient Health Questionnaire with four items (PHQ-4) may help to improve screening coverage. This study assessed the psychometric properties of the PHQ-4 in screening for core symptoms of depression and anxiety among out of school adolescent girls and young women (AGYW). METHODS: This is a cross-sectional analysis of data from a cluster randomized controlled trial conducted among AGYW between June and July 2018 in North-West Tanzania. Two thousand four hundred twenty-six out-of-school AGYW aged 15 to 23 years were included. Data were collected on tablets using audio computer-assisted self-interviews (ACASI). Cronbach's α was used to measure the reliability of the PHQ-4 while confirmatory factor analysis (CFA) and principal components analysis (PCA) were used for construct validity assessment. In CFA, three criteria were used to assess how well the model fits the data: Standardized Root Mean Square Residual (SRMR), the Comparative Fit Index (CFI), the Root Mean Square Error of Approximation (RMSEA) and 90% confidence interval for RMSEA. RESULTS: Of the 2426 participants, 33.8 and 35.5% screened positive for core symptoms of anxiety (GAD-2 ≥ 3) and depression (PHQ-2 ≥ 3), respectively. Cronbach's α of the PHQ-4 was 0.81. Both items-correlation and corrected items-correlation of the PHQ-4 had total correlations above 0.5 (p < 0.01). CFA showed that all items loaded significantly onto the single factor, and loadings were strong, ranging from 0.67 to 0.77 (p < 0.01). CFA indicates that the PHQ-4 scale stand for a unidimensional construct with good model fit (CFI = 0.995, SRMR = 0.013, RMSEA = 0.054 and 90% CI for RMSEA (0.031-0.079)). PCA confirmed two distinct components; GAD-2 (anxiety) and PHQ-2 (depression). Those who reported having suicidal thoughts and social function problems had significantly higher scores on PHQ-2, GAD-2, and PHQ-4 screening items (p < 0.01). CONCLUSIONS: The findings suggest that the PHQ-4 scale can reliably and validly screen for core symptoms of depression and anxiety among out of school AGYW. This tool is short and easy to administer. Thus, the PHQ-4 scale can be very useful in screening for anxiety and depression symptoms in the community, primary health facilities, research and programmatic settings.

Programmatic mapping and size estimation of key populations to inform HIV programming in Tanzania.

INTRODUCTION: A programmatic mapping and size estimation study was conducted in 24 districts in 5 regions of Tanzania to estimate the size and locations of female sex workers (FSW) and men who have sex with men (MSM) to inform the HIV programming for Key Populations. METHODOLOGY: Data were collected at two levels: first, interviews were conducted with informants to identify venues where FSWs and MSM frequent. Secondly, the size of MSM and FSWs were estimated through interviews with FSWs, MSM and other informants at the venue. The venue estimates were aggregated to generate the ward level estimates. Correction factors were then applied to adjust for MSM/FSW counted twice or more, absent from the venues on the mapping day or remain online and hidden. The ward size estimates for mapped wards were extrapolated to non-mapped wards and aggregated to generate district and regional level estimates. RESULTS: A total of 4,557 level I interviews were conducted. Further, 3,098 FSWs and 1,074 other informants at the FSWs venues and 558 MSM and 210 other informants at the MSM venues were interviewed during level II. The mapping survey identified 6,658 FSW, 1,099 FSW and MSM and 50 MSM venues in 75 wards. A total of 118,057 (range: 108,269 to 127,845) FSWs and 23,771 (range: 22,087 to 25,454) MSM were estimated in the study regions after extrapolation and accounting for correction factors. It was estimated that 5.6% and 1.3% of the female and male population of reproductive age (15-49 years old) could be FSWs and MSM in the study regions, respectively. CONCLUSION: This study provides the baseline figures for planning, target setting and monitoring of the HIV intervention services in the study areas and geographic prioritisation of the response by allocating more resources to areas with a large number of FSWs and MSM.

Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behavior (CARE): Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: The HIV epidemic in Eastern and Southern Africa is characterized by a high incidence and prevalence of HIV infection among adolescent girls and young women (AGYW) aged 15-24 years. For instance, in some countries, HIV prevalence in AGYW aged 20-24 years exceeds that in AGYW aged 15-19 years by 2:1. Sauti (meaning voices), a project supported by the United States Agency for International Development, is providing HIV combination prevention interventions to AGYW in the Shinyanga region, Tanzania. OBJECTIVE: The aim of this study is to determine the impact of cash transfer on risky sexual behavior among AGYW receiving cash transfer and HIV combination prevention interventions. This paper describes the research methods and general protocol of the study. Risky sexual behavior will be assessed by herpes simplex virus type 2 (HSV-2) incidence, compensated sex (defined as sexual encounters motivated by exchange for money, material support, or other benefits), and intergenerational sex (defined as a sexual partnership between AGYW and a man 10 or more years older). Through a qualitative study, the study seeks to understand how the intervention affects the structural and behavioral drivers of the HIV epidemic. METHODS: The trial employs audio computer-assisted self-interviewing, participatory group discussions (PGDs), and case studies to collect data. A total of 30 matched villages (15 intervention and 15 control clusters) were randomized to either receive cash transfer delivered over 18 months in addition to other HIV interventions (intervention arm) or to receive other HIV interventions without cash transfer (control arm). Study participants are interviewed at baseline and 6, 12, and 18 months to collect data on demographics, factors related to HIV vulnerabilities, family planning, sexual risk behavior, gender-based violence, and HSV-2 and HIV infections. A total of 6 PGDs (3 intervention, 3 control) were conducted at baseline to describe perceptions and preferences of different intervention packages, whereas 20 case studies are used to monitor and unearth the dynamics involved in delivery and uptake of cash transfer. RESULTS: The study was funded in June 2017; enrollment took place in December 2017. A total of two rounds of the follow-up survey are complete, and one round has yet to be conducted. The results are expected in December 2019 and will be disseminated through conferences and peer-reviewed publications. CONCLUSIONS: This study will document the synergetic impact of cash transfer in the presence of HIV combination prevention interventions on risky sexual behavior among out-of-school AGYW. The results will strengthen the evidence of cash transfer in the reduction of risky sexual behavior and provide feasible HIV prevention strategies for AGYW. TRIAL REGISTRATION: Clinicaltrials.gov NCT03597243; https://clinicaltrials.gov/ct2/show/NCT03597243. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14696.

Facilitators and barriers to linkage to HIV care and treatment among female sex workers in a community-based HIV prevention intervention in Tanzania: A qualitative study.

BACKGROUND: HIV-infected female sex workers (FSWs) have poor linkage to HIV care in sub-Sahara Africa. METHODS: We conducted 21 participatory group discussions (PGDs) to explore factors influencing linkage to HIV care among FSWs tested for HIV through a comprehensive community-based HIV prevention project in Tanzania. RESULTS: Influences on linkage to care were present at the system, societal and individual levels. System-level factors included unfriendly service delivery environment, including lengthy pre-enrolment sessions, concerns about confidentiality, stigmatising attitudes of health providers. Societal-level factors included myths and misconceptions about ART and stigma. On the individual level, most notable was fear of not being able to continue to have a livelihood if one's status were to be known. Facilitators were noted, including the availability of transport to services, friendly health care providers and peer-support referral and networks. CONCLUSION: Findings of this study underscore the importance of peer-supported linkages to HIV care and the need for respectful, high-quality care.

Prevalence and correlates of partner violence among adolescent girls and young women: Evidence from baseline data of a cluster randomised trial in Tanzania.

BACKGROUND: Little has been documented about partner violence among adolescent girls and young women (AGYW) who are out of school, a factor associated with HIV acquisition. To understand areas for prioritising HIV prevention intervention efforts, we explored the prevalence and correlates of partner violence among out of school AGYW in Shinyanga, Tanzania. METHODS: A cross-sectional analysis of data from AGYW aged 15-23 years recruited in a cluster randomised trial conducted between October and December 2017 was used to examine correlates of partner violence. Data were collected through an Audio Computer-Assisted Self-interview. Multivariate logistic regression analysis was used to evaluate the association. RESULTS: 2276 (75.5%) AGYW were sexually active. Of these, 816 (35.9%) reported having experienced violence from partners in the last six months. After adjusting for other covariates, being formerly married (AOR = 1.55, 95% CI:1.02, 2.37), having children (AOR = 1.79, 95% CI:1.47, 2.16), anxiety and depression symptoms (AOR = 3.27, 95%CI: 2.15, 4.96), having engaged in sex work in the past six months (AOR = 1.92, 95% CI: 1.45, 2.53) and economic deprivation (AOR = 1.61, 95% CI: 1.34,1.92) were significantly associated with partner violence. CONCLUSIONS: Almost one in three sexually active AGYW had experienced partner violence in the 6 months preceding the survey. The findings underscore the need for future research to focus on understanding the reasons and dynamics underlying high level of partner violence among AGYW. Furthermore, there is a need for implementing intervention programs that aim to reduce economic deprivation among AGYWs and address social norms and structures perpetuating violence against AGYW. TRIAL REGISTRATION: ClinicalTrials.gov-ID NCT03597243.

Prevalence and correlates of depression and anxiety symptoms among out-of-school adolescent girls and young women in Tanzania: A cross-sectional study.

BACKGROUND: In sub-Saharan Africa, adolescent girls and young women (AGYW) who are out of school are at higher risk of depressive and anxiety disorders compared to their school attending peers. However, little is known about the prevalence and risk factors for these conditions among out-of-school AGYW. This study examines the prevalence of depression and anxiety and associated factors in a community sample of out-of-school AGYW in Tanzania. METHODS: A cross-sectional analysis of baseline data from an on-going cluster randomized controlled trial in North-West Tanzania was conducted. A total of 3013 out-of-school AGYW aged 15 to 23 years from 30 clusters were included. Anxiety and depression were assessed using the Patient Health Questionnaire (PHQ-4), a tool comprising of PHQ-2 and Generalized Anxiety Disorders (GAD-2) screeners. Data were collected using Audio Computer-Assisted Self-Interview (ACASI). A random-effects logistic regression was fitted for binary outcomes and an ordinal logistic regression model with robust variance was used to adjust for clustering at the village level. Logistic regression and ordinal logistic regression were used to explore the associations between mental disorders symptoms and other factors. RESULTS: The prevalence of depressive (PHQ-2 ≥ 3) and anxiety (GAD-2 ≥ 3) symptoms among out-of-school AGYW were 36% (95% CI 33.8%-37.3%) and 31% (95% CI 29.0%-32.3%) respectively. Further, using the PHQ-4 tool, 33% (95% CI 30.8%-34.2%) had mild, 20% (95% CI 18.3%-21.1%) moderate and 6% (95% CI 5.5%-7.2%) had severe symptoms of anxiety and depression. After adjusting for other covariates, two factors most strongly associated with having anxiety symptoms were violence experience from sexual partners (AOR = 1.63, 95% CI: 1.36-1.96) and HIV positive status (AOR = 1.54, 95% CI: 1.03-2.31). Likewise, living alone, with younger siblings or others (AOR = 2.51, 95% CI: 1.47-4.29) and violence experience from sexual partners (AOR = 1.90, 95% CI: 1.59-2.27) were strongly associated with depression symptoms. Having savings (AOR = 0.81, 95% CI: 0.70-0.95) and emotional support (AOR = 0.82, 95% CI: 0.67-0.99) were protective against depression and anxiety, respectively. CONCLUSION: Depressive and anxiety symptoms are prevalent among out-of-school AGYW in Tanzania. The findings emphasize the need to strengthen preventive interventions and scale-up mental health disorder screening, referral for diagnosis and management.

Use of Lotteries for the Promotion of Voluntary Medical Male Circumcision Service: A Discrete-Choice Experiment among Adult Men in Tanzania.

Voluntary medical male circumcision (VMMC) is effective in reducing the risk of human immunodeficiency virus (HIV). However, countries like Tanzania have high HIV prevalence but low uptake of VMMC. We conducted a discrete-choice experiment to evaluate the preferences for VMMC service attributes in a random sample of 325 men aged 18 years or older from the general population in 2 Tanzanian districts, Njombe and Tabora. We examined the preference for financial incentives in the form of a lottery ticket or receiving a guaranteed transport voucher for attendance at a VMMC service. We created a random-parameters logit model to account for individual preference heterogeneity and a latent class analysis model for identifying groups of men with similar preferences to test the hypothesis that men who reported sexually risky behaviors (i.e., multiple partners and any condomless sex in the past 12 months) may have a preference for participation in a lottery-based incentive. Most men preferred a transport voucher (84%) over a lottery ticket. We also found that offering a lottery-based financial incentive may not differentially attract those with greater sexual risk. Our study highlights the importance of gathering local data to understand preference heterogeneity, particularly regarding assumptions around risk behaviors.

Using discrete choice experiments to inform the design of complex interventions.

BACKGROUND: Complex health interventions must incorporate user preferences to maximize their potential effectiveness. Discrete choice experiments (DCEs) quantify the strength of user preferences and identify preference heterogeneity across users. We present the process of using a DCE to supplement conventional qualitative formative research in the design of a demand creation intervention for voluntary medical male circumcision (VMMC) to prevent HIV in Tanzania. METHODS: The VMMC intervention was designed within a 3-month formative phase. In-depth interviews (n = 30) and participatory group discussions (n = 20) sought to identify broad setting-specific barriers to and facilitators of VMMC among adult men. Qualitative results informed the DCE development, identifying the role of female partners, service providers' attitudes and social stigma. A DCE among 325 men in Njombe and Tabora, Tanzania, subsequently measured preferences for modifiable VMMC service characteristics. The final VMMC demand creation intervention design drew jointly on the qualitative and DCE findings. RESULTS: While the qualitative research informed the community mobilization intervention, the DCE guided the specific VMMC service configuration. The significant positive utilities (u) for availability of partner counselling (u = 0.43, p < 0.01) and age-separated waiting areas (u = 0.21, p < 0.05) led to the provision of community information booths for partners and provision of age-separated waiting areas. The strong disutility of female healthcare providers (u = - 0.24, p < 0.01) led to re-training all providers on client-friendliness. CONCLUSION: This is, to our knowledge, the first study documenting how user preferences from DCEs can directly inform the design of a complex intervention. The use of DCEs as formative research may help increase user uptake and adherence to complex interventions.

Determinants of access to HIV testing and counselling services among female sex workers in sub-Saharan Africa: a systematic review.

BACKGROUND: HIV testing and counselling (HTC) is an essential component for HIV prevention and a critical entry point into the HIV continuum of care and treatment. Despite the importance of HTC for HIV control, access to HTC services among female sex workers (FSWs) in sub-Saharan Africa (SSA) remains suboptimal and little is known about factors influencing FSWs' access to HTC. Guided by the client-centred conceptual framework, we conducted a systematic review to understand the facilitators and barriers influencing FSWs in SSA to access HTC services. METHODS: A systematic search was conducted in MEDLINE, POPLINE and Web of Science databases for literature published between January 2000 and July 2017. References of relevant articles were also searched. We included primary studies of any design, conducted in SSA and published in the English language. Studies conducted in multi-sites inclusive of SSA were included only if data from sites in SSA were separately analysed and reported. Similarly, studies that included other subpopulations were only eligible if a separate analysis was done for FSWs. This review excluded papers published as systematic reviews, editorial comments and mathematical modelling. The protocol for this review is registered in the Prospective Register of Systematic Reviews (PROSPERO), registration number CRD42017062203. RESULTS: This review shows that factors related to approachability, acceptability, availability, affordability and appropriateness of the services are crucial in influencing access to HTC services among FSWs in SSA. These factors were mediated by individual attributes such as HIV risk perceptions, awareness of the availability of HTC, and perceptions of the importance and quality of HTC services. The decision to utilise HTC was predominantly hampered by discriminatory social norms such as HIV stigma and criminalisation of sex work. CONCLUSIONS: FSWs' access to HTC is facilitated by multiple factors, including individual awareness of the availability of HTC services, and perceived quality of HTC especially with regard to assured confidentiality. Concerns about HIV stigma and fear about discrimination due to community intolerance of sex work acted as major barriers for FSWs to seek HTC services from the facilities offering health services to the general population.

Participants' accrual and delivery of HIV prevention interventions among men who have sex with men in sub-Saharan Africa: a systematic review.

BACKGROUND: Across sub-Saharan Africa (SSA), HIV disproportionately affects men-who-have-sex-with-men (MSM) compared with other men of the same age group in the general population. Access to HIV services remains low among this group although several effective interventions have been documented. It is therefore important to identify what has worked well to increase the reach of HIV services among MSM. METHODS: We searched MEDLINE, POPLINE and the Web of Science databases to collect published articles reporting HIV interventions among MSM across sub-Saharan Africa. Covidence was used to review the articles. The review protocol was registered in International Prospective Register of Systematic Reviews (PROSPERO) - CRD42017060808. RESULTS: The search identified 2627 citations, and following removal of duplicates and inclusion and exclusion criteria, only 15 papers were eligible for inclusion in the review. The articles reported various accrual strategies, namely: respondent driven sampling, known peers identified through hotspot or baseline surveys, engagement with existing community-based organizations, and through peer educators contacting MSM in virtual sites. Some programs, however, combined some of these accrual strategies. Peer-led outreach services were indicated to reach and deliver services to more MSM. A combination of peer outreach and mobile clinics increased uptake of health information and services. Health facilities, especially MSM-friendly facilities attract access and use of services by MSM and retention into care. CONCLUSIONS: There are various strategies for accrual and delivering services to MSM across SSA. However, each of these strategies have specific strengths and weaknesses necessitating combinations of interventions and integration of the specific context to inform implementation. If the best of intervention content and implementation are used to inform these services, sufficient coverage and impact of HIV prevention and treatment programs for MSM across SSA can be optimized.

Cost and Cost-Effectiveness of a Demand Creation Intervention to Increase Uptake of Voluntary Medical Male Circumcision in Tanzania: Spending More to Spend Less.

BACKGROUND: Although voluntary medical male circumcision (VMMC) reduces the risk of HIV acquisition, demand for services is lower among men in most at-risk age groups (ages 20-34 years). A randomized controlled trial was conducted to assess the effectiveness of locally-tailored demand creation activities (including mass media, community mobilization, and targeted service delivery) in increasing uptake of campaign-delivered VMMC among men aged 20-34 years. We conducted an economic evaluation to understand the intervention's cost and cost-effectiveness. SETTING: Tanzania (Njombe and Tabora regions). METHODS: Cost data were collected on surgery, demand creation activities, and monitoring and supervision related to VMMC implementation across clusters in both trial arms, as well as start-up activities for the intervention arms. The Decision Makers' Program Planning Tool was used to estimate the number of HIV infections averted and related cost savings, given the total VMMCs per cluster. Disability-adjusted life years were calculated and used to estimate incremental cost-effectiveness ratios. RESULTS: Client load was higher in the intervention arms than in the control arms: 4394 vs. 2901 in Tabora and 1797 vs. 1025 in Njombe, respectively. Despite additional costs of tailored demand creation, demand increased more than proportionally: mean costs per VMMC in the intervention arms were $62 in Tabora and $130 in Njombe, and in the control arms $70 and $191, respectively. More infections were averted in the intervention arm than in the control arm in Tabora (123 vs. 67, respectively) and in Njombe (164 vs. 102, respectively). The intervention dominated the control because it was both less costly and more effective. Cost savings were observed in both regions stemming from the antiretroviral treatment costs averted as a result of the VMMCs performed. CONCLUSIONS: Spending more to address local preferences as a way to increase uptake of VMMC can be cost-saving.

Increasing voluntary medical male circumcision uptake among adult men in Tanzania.

OBJECTIVE: We evaluated a demand-creation intervention to increase voluntary medical male circumcision (VMMC) uptake among men aged 20-34 years in Tanzania, to maximise short-term impact on HIV incidence. METHODS: A cluster randomized controlled trial stratified by region was conducted in 20 outreach sites in Njombe and Tabora regions. The sites were randomized 1 : 1 to receive either a demand-creation intervention package in addition to standard VMMC outreach, or standard VMMC outreach alone. The intervention package included enhanced public address messages, peer promotion by recently circumcised men, facility setup to increase privacy, and engagement of female partners in demand creation. The primary outcome was the proportion of VMMC clients aged 20-34 years. FINDINGS: Overall, 6251 and 3968 VMMC clients were enrolled in intervention and control clusters, respectively. The proportion of clients aged 20-34 years was slightly greater in the intervention than control arm [17.7 vs. 13.0%; prevalence ratio = 1.36; 95% confidence intervals (CI):0.9-2.0]. In Njombe region, the proportion of clients aged 20-34 years was similar between arms but a significant two-fold difference was seen in Tabora region (P value for effect modification = 0.006). The mean number of men aged 20-34 years (mean difference per cluster = 97; 95% CI:40-154), and of all ages (mean difference per cluster = 227, 95% CI:33-420) were greater in the intervention than control arm. CONCLUSION: The intervention was associated with a significant increase in the proportion of clients aged 20-34 years in Tabora but not in Njombe. The intervention may be sensitive to regional factors in VMMC programme scale-up, including saturation.

"If You Are Not Circumcised, I Cannot Say Yes": The Role of Women in Promoting the Uptake of Voluntary Medical Male Circumcision in Tanzania.

Voluntary Medical Male Circumcision (VMMC) for HIV prevention in Tanzania was introduced by the Ministry of Health and Social Welfare in 2010 as part of the national HIV prevention strategy. A qualitative study was conducted prior to a cluster randomized trial which tested effective strategies to increase VMMC up take among men aged ≥20 years. During the formative qualitative study, we conducted in-depth interviews with circumcised males (n = 14), uncircumcised males (n = 16), and participatory group discussions (n = 20) with men and women aged 20-49 years in Njombe and Tabora regions of Tanzania. Participants reported that mothers and female partners have an important influence on men's decisions to seek VMMC both directly by denying sex, and indirectly through discussion, advice and providing information on VMMC to uncircumcised partners and sons. Our findings suggest that in Tanzania and potentially other settings, an expanded role for women in VMMC communication strategies could increase adult male uptake of VMMC services.