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 .

Transactional sex and age-disparate sexual partnerships among adolescent girls and young women in Tanzania.

Introduction: Adolescent girls and young women (AGYW) continue to experience a high incidence of HIV in southern and eastern Africa, even in the context of large-scale HIV prevention interventions. In Tanzania, AGYW account for the largest proportion of new infections and have a higher risk of HIV acquisition than males of comparable age. Methods: We used routinely collected data from the PEPFAR/USAID-funded Sauti Project, a large combination HIV prevention program, to examine the relationship between transactional sex and sex with older partners among AGYW in Tanzania (2015-2020). Out-of-school AGYW 15-24 years completed a vulnerability index and were tested for HIV. We estimated weighted prevalence ratios (PR) and 95% confidence intervals (CI) for the associations of transactional sex (sex exchanged for money/services/gifts outside of sex work) and sex with older partners (≥5-years older, ≥10-years older) with prevalent HIV. Age cutoffs of 5 and 10 years were used to align partner age differences with age-disparate and intergenerational sex, respectively. We assessed potential synergism between exposures, and subgroup analyses explored associations among girls 15-19. Results: Sixty seven thousand three hundred fifty seven AGYW completed the vulnerability index and 14,873 had captured HIV testing records. Median age was 20 years (IQR 18-22). Transactional sex and age-disparate sex were common (35% and 28%, respectively); 13% of AGYW reported both behaviors. HIV prevalence was associated with both transactional sex (PR: 1.28; 95% CI 1.00-1.63) and age-disparate sex (PR:1.26, 95% CI 0.99-1.60). In common referent analysis, transactional sex remained strongly associated with HIV, even in the absence of age-disparate sex (PR 1.41; 95% CI 1.02-1.94). Discussion: Evidence of statistical synergism was not present, suggesting both transactional sex and age-disparate sex operate through similar pathways to increase HIV risk. Increased specificity within HIV prevention programs is needed to better meet the sexual and reproductive health needs of AGYW at high risk of HIV in Tanzania, including investment in tailored youth-friendly strategies for AGYW who have been marginalized from the current HIV response.

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 .

Pathways to transactional sex among peri-urban South African women: the role of relationship control, food insecurity and alcohol misuse.

Transactional sex increases sub-Saharan African women's risk of HIV acquisition. We quantitatively explored the pathways contributing towards women's future engagement in transactional sex with casual partners and khwapheni (secret concurrent sex partners). We conducted secondary data analysis from a cluster randomised controlled trial in urban informal settlements in eThekwini Municipality., South Africa. Data were collected at enrolment (t0) and 24 months' later (t2) using self-completed questionnaires. Structural equation modelling (SEM) assessed pathways leading to transactional sex over two years. 677 women 18-35 years were enrolled and 80.5% (n = 545) were followed up. At t2, 44.6% of respondents reported transactional sex with a casual partner or khwapheni. The SEM demonstrated a small effect (d = 0.23) between transactional sex at t0 and at t2. Controlling for past transactional sex, main partner relationship control had a large effect size on future transactional sex (d = 0.60). Hazardous drinking had a medium effect size (d = 0.45) and food insecurity a small effect (d = 0.24), (RMSEA 0.03, 90%CI 0.02-0.04; CFI 0.97; TLI 0.96). HIV prevention programming should highlight current transactional sex but also address structural issues predicting future transactional sex, including food insecurity and alcohol misuse. Gender transformative interventions to reduce controlling behaviours in main relationships are worth investigating.

Systematic review of cash plus or bundled interventions targeting adolescents in Africa to reduce HIV risk.

BACKGROUND: HIV remains a leading cause of death for adolescents and young people aged 10-24 years. HIV prevention requires multisectoral approaches that target adolescents and young people, addressing HIV risk pathways (e.g., transactional sex, gender-based violence, and school attendance) through bundled interventions that combine economic strengthening, health capabilities, and gender equality education. However, best practices are unknown because evidence on multisectoral programming targeted to adolescents and combining these components has not been systematically reviewed. METHODS: We conducted a systematic review to summarize the evidence on bundled interventions combining health and economic strengthening components for adolescents and young people and their effects on HIV/STI incidence and risk factors. We included studies from Africa published between 2005 and 2023, combining at least one economic strengthening and one health component, directed toward adolescents and young people aged 10-24 years. Included studies measured programmatic impacts on primary outcomes: HIV and STI incidence/prevalence; and mediators as secondary outcomes: sexual behaviours, sexual and reproductive health, school attendance, health-seeking behaviours, and violence. We conducted key word searches in PubMed, EMBASE, and Web of Science, imported titles/abstracts from the initial search, and reviewed them using the inclusion criteria. Full texts of selected articles were reviewed and information was extracted for analysis. Findings from the full texts identified were summarized. RESULTS: We reviewed 58 studies, including 43 quantitative studies and 15 qualitative studies, evaluating 26 unique interventions. A majority of studies reviewed were conducted in Eastern and Southern Africa. Interventions reviewed showed a greater number of significant results in improving economic outcomes; mental health and psychosocial outcomes; sexual and reproductive health knowledge and services utilization; and HIV prevention knowledge and testing. They showed fewer significant results in improving outcomes related to HIV incidence/prevalence; sexual risk behaviours; gender-based violence; gender attitudes; education; STI incidence, prevalence and testing; and sexual debut. CONCLUSIONS: Our review demonstrated the potential for bundled, multisectoral interventions for preventing HIV and facilitating safe transitions to adulthood. Findings have implications for designing HIV sensitive programmes on a larger scale, including how interventions may need to address multiple strata of the social ecological model to achieve success in the prevention of HIV and related pathways.

Partnerships with religious leaders to promote family planning in rural Tanzania: an open-label, cluster randomised trial.

BACKGROUND: Family planning benefits maternal-child health, education, and economic wellbeing. Despite global efforts, an unsatisfied demand for family planning persists in sub-Saharan Africa. Based on previous successful partnerships, the aim of this study was to determine whether an educational intervention for religious leaders would increase community knowledge, demand for, and ultimately uptake of family planning. METHODS: In this open-label, cluster randomised trial in Tanzania, 24 communities were randomised (1:1) to intervention or control arm. Communities, defined as the catchment area of a single public health facility, were eligible if they were at least 15 km from Mwanza City and had not previously participated in a health intervention for religious leaders. Random allocations were determined by coin toss and were not revealed to clinicians at health facilities in intervention and control communities, nor to the data entry team; however, due to the nature of the intervention, masking of religious leaders in the intervention communities was not possible. All Christian religious institutions were invited to send four leaders to an educational intervention that incorporated cultural, theological, and medical teaching about family planning. The primary outcome was contraceptive uptake at the community health facility during the year post intervention versus the year before the intervention. This trial was registered at clinicaltrials.gov, NCT03594305. FINDINGS: 75 communities in three districts were assessed for eligibility. 19 communities were excluded and 56 were eligible for study inclusion and were placed in random order to be invited to participate. The first 24 communities that were invited agreed to participate and were randomly assigned to receive the educational intervention either during the trial or after trial completion. Between July 10, 2018 and Dec 11, 2021, we provided the intervention in 12 communities and compared contraceptive uptake with 12 control communities. All were followed up for 12 months. In intervention communities, contraceptive uptake increased by a factor of 1·47 (95% CI 1·41-1·53) in the post-intervention (prospective) versus pre-intervention (historical) year (geometric mean of contraceptive uptake, 466 in the prospective year vs 312 in the historical year), versus 1·24 (95% CI 1·20-1·29) in control communities (geometric mean, 521 in the prospective year vs 429 in the historical year). The rate of change in contraceptive uptake was greater in intervention communities (between-group ratio of geometric mean ratios over time, 1·19 [95% CI 1·12-1·25]; p<0·0001). The COVID-19 pandemic was associated with decreased contraceptive uptake (geometric mean, 365 during the pandemic in communities that had the majority of their prospective 12-month data collection periods occur after March 16, 2020, vs 494 before the pandemic; geometric mean ratio, 0·72 [95% CI 0·57-0·90]; p=0·0040). INTERPRETATION: This intervention offers a scalable model, leveraging influence of trusted religious leaders to increase knowledge and uptake of family planning. New strategies such as this could help to overcome setbacks that occurred during the COVID-19 pandemic. FUNDING: John Templeton Foundation and Weill Cornell Medicine Dean's Diversity and Healthcare Disparity Award. TRANSLATION: For the Kiswahili translation of the abstract see Supplementary Materials section.

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 .

Shifting social norms to prevent age-disparate transactional sex in Tanzania: what we can learn from intervention development research.

This paper reflects on the development process (2015-2020) of the Learning Initiative for Norms, Exploitation, and Abuse (LINEA) Intervention. The LINEA Intervention is a multi-component social norms intervention to prevent age-disparate transactional sex in Tanzania. This paper aims to: (1) critically reflect on the LINEA Intervention development process by retrospectively comparing it with a pragmatic, phased framework for intervention development in public health, the Six Essential Steps for Quality Intervention Development (6SQuID); and (2) discuss the usefulness and applicability of this framework to guide intervention development for gender-based violence prevention. This paper contributes to a growing field of intervention development research to improve the designs of interventions to prevent gender-based violence. Findings showed that the LINEA Intervention development approach mostly aligned with the steps in 6SQuID framework. However, the LINEA Intervention development process placed particular emphasis on two phases of the 6SQuID framework. First, the LINEA Intervention development process included significant investment in formative research, feasibility testing, and refinement; and second, the LINEA Intervention was informed by a clearly articulated behavior change theory-social norms theory. Beyond the 6SQuID framework the LINEA Intervention development process: (i) followed a non-linear, iterative process; (ii) applied ongoing feasibility testing to refine the intervention, and (iii) relied on co-development with local implementers and participants. This paper suggests future components for a robust intervention development process, highlighting beneficial additions to the 6SQuID approach, a well-recognized intervention development sequence. Particularly useful additions include incorporating sufficient time, flexibility, and resources to foster meaningful collaborations and iteration on the intervention design.

"It Gives You a Feeling of Pride when You Touch Her": The Role of Masculinity in Sexual Harassment of Adolescent Schoolgirls in Tanzania.

Sexual harassment or the unwanted offensive behaviours that women and girls experience is a pervasive global challenge. Yet, there is limited evidence on the lived experiences of sexual harassment from school-based settings in sub-Saharan Africa. We explore students' perceived experiences, perpetration, and drivers of sexual harassment in schools in Mwanza, Tanzania. This study employed a qualitative research design involving 30 in-depth interviews and seven focus group discussions with 30 male and 40 female secondary school pupils aged 13-19 years. Data was analysed using a thematic approach. The findings show that experiences of sexual harassment among schoolgirls were widespread. Common forms of harassment were verbal and non-verbal gestures of a sexual nature. The desire to prove one's masculinity and peer pressure were key drivers of perpetration among schoolboys. Teachers took advantage of their positions of authority to sexually harass female pupils and employed corporal punishment to those who resisted their advances. Sexual harassment had multiple negative outcomes, including schoolgirls dropping out of school and mental health issues, such as anxiety, stress and poor academic performance. Girls rarely reported sexual harassment for fear of further victimisation and stigma from others. Sexual harassment of girls is common in secondary schools in Mwanza and is mainly driven by peer pressure and the desire to prove one's masculinity. Given its harmful effects, there is a need to implement clear policies to protect girls, support confidential disclosure and reporting and to address toxic masculinity norms among young men.

Sexual Harassment in Low- and Middle-Income Countries: A Qualitative Systematic Review.

Sexual harassment is a pervasive form of gender-based violence that has negative social and health impacts, yet there is only limited research available on sexual harassment in low- and middle-income countries (LMICs). The aim of this qualitative systematic review was to better understand how participants across a variety of countries and settings conceptualized sexual harassment and to investigate its causal factors, consequences, coping strategies, and recommendations for prevention and interventions. We searched eight databases and included English language qualitative studies published from 1990 until June 2021 if they mentioned sexual harassment in LMICs and included female or male participants aged 12 and older. This resulted in 34 included studies. Overall, this review established that sexual harassment was salient in participants' lives, yet their conceptualizations of sexual harassment varied widely and were strongly influenced by contextual and sociocultural factors. Overall, our review has highlighted (1) the conflation of sexual harassment and sexual violence, (2) the intersections of gendered power with other hierarchies of authority, age, and socio-economic status and how the role of power is different in street versus educational and workplace settings, (3) the patriarchal norms, gender inequalities, and normalization of gender-based violence that enable sexual harassment and silence those affected by it, (4) the varied expectations of how women should cope with sexual harassment in order for their experiences to be validated, and (5) the need for gender norms change and fair and effective policies in order to not only prevent sexual harassment but also address the underlying causes.