Understanding the determinants and consequences of HIV status disclosure in Manicaland, Zimbabwe: cross-sectional and prospective analyses.

Few longitudinal studies have measured trends and effects of disclosure over ART scale-up in general-population samples. We investigated levels, determinants and outcomes of disclosure to relatives and partners in a large general-population cohort in Zimbabwe. Trends in disclosure levels from 2003 to 2013 were analysed, and multivariable logistic regression was used to identify determinants. Longitudinal analyses were conducted testing associations between disclosure and prevention/treatment-related outcomes. Disclosure to anyone increased from 79% to 100% in men and from 63% to 98% in women from 2003 to 2008; but declined to 89% in both sexes in 2012-2013. More women than men disclosed to relatives (67.8% versus 44.4%; p < 0.001) but fewer women disclosed to partners (85.3% versus 95.0%; p < 0.001). In 2012-2013,secondary/higher education, being single, and experience of stigma were associated with disclosure to relatives in both sexes. Partner characteristics and HIV-group attendance were associated with disclosure to partners for women. Reactions to disclosure were generally supportive but less so for females than males disclosing to partners (92.0% versus 97.4%). Partner disclosure was weakly associated (p < 0.08) with having had a CD4 count or taken ART at follow-up in females. To conclude, this study shows disclosure is vital to HIV prevention and treatment, and programmes to facilitate disclosure should be re-invigorated.

The validity of dementia diagnoses in routinely collected electronic health records in the United Kingdom: A systematic review.

PURPOSE: The purpose of the study is to assess the validity of codes or algorithms used to identify dementia in UK electronic health record (EHR) primary care and hospitalisation databases. METHODS: Relevant studies were identified by searching the MEDLINE/EMBASE databases from inception to June 2018, hand-searching reference lists, and consulting experts. The search strategy included synonyms for "Dementia", "Europe", and "EHR". Studies were included if they validated dementia diagnoses in UK primary care or hospitalisation databases, irrespective of validation method used. The Quality Assessment for Diagnostic Accuracy Studies-2 (QUADAS-2) tool was used to assess risk of bias. RESULTS: From 1469 unique records, 14 relevant studies were included. Thirteen validated individual diagnoses against a reference standard, reporting high estimates of validity. Most reported only the positive predictive value (PPV), with estimates ranging between 0.09 and 1.0 and 0.62 and 0.85 in primary care and hospitalisation databases, respectively. One study performed a rate comparison, indicating good generalisability of dementia diagnoses in The Health Improvement Network (THIN) database to the UK population. Studies were of low methodological quality. As studies were not comparable, no summary validity estimates were produced. CONCLUSION: While heterogenous across studies, reported validity estimates were generally high. However, the credibility of these estimates is limited by the methodological quality of studies, primarily resulting from insufficient blinding of researchers interpreting the reference test. Inadequate reporting, particularly of the specific codes validated, hindered comparison of estimates across studies. Future validation studies should make use of more robust reference tests, follow established reporting guidelines, and calculate all measures of validity.

Do risk, time and prosocial preferences predict risky sexual behaviour of youths in a low-income, high-risk setting?

Young people in sub-Saharan Africa are particularly at high risk of sexually transmitted infections. Little is known about their preferences and even less about their association with risky sexual behaviour. We conducted incentivized economic experiments to measure risk, time and prosocial preferences in Zimbabwe. Preferences measured at baseline predict biomarker and self-reported measures of risky sexual behaviour gathered 12 months later. We find robust evidence that individuals more altruistic at baseline are more likely to be Herpes Simplex Virus Type-2 (HSV-2) positive 12 months later. Analysis by sex shows this association is driven by our sample of women. Having more sexual partners is associated with greater risk tolerance amongst men and greater impatience amongst women. Results highlight heterogeneity in the association between preferences and risky sexual behaviour.

The impact of COVID-19 on sexual risk behaviour for HIV acquisition in east Zimbabwe: An observational study.

The Covid-19 pandemic and associated restrictions have the potential to alter sexual risk behaviours for HIV acquisition with important implications for HIV prevention programmes in sub-Saharan Africa. To date, no large-scale data have been published to substantiate hypothesised changes in sexual risk behaviours. We used longitudinal survey data to assess the impact of Covid-19 on sexual risk behaviours in east Zimbabwe. Data on sexual behaviours in HIV-negative adults aged 15-54 years were collected in two rounds of a general population open-cohort survey conducted in Manicaland, Zimbabwe shortly before (July 2018 to December 2019; N = 7316) and several months into the Covid-19 epidemic (February to July 2021; N = 6356). Descriptive statistics and logistic regression models of serial cross-sectional and prospective cohort data were used to assess changes in sexual risk behaviours. The proportion of females aged 15-19 years reporting sexual debut declined from 29.7% before Covid-19 to 20.3% during Covid-19 (adjusted odds ratio (AOR) = 0.49, 95% confidence interval (95% CI), 0.38-0.63). Fewer sexually-active females reported multiple sexual partners during Covid-19 (3.35% versus 6.07%; AOR = 0.55, 95% CI, 0.43-0.72). No population-level changes in male behaviour between survey rounds were recorded but the cohort analysis revealed a complex pattern of behaviour change with HIV risk behaviours increasing for some individuals and decreasing for others. Overall HIV risk behaviours remained high in a sub-Saharan African population with a generalised HIV epidemic over a period of Covid-19 lockdowns when movements and social contacts were restricted.

Temporal changes in cause of death among adolescents and adults in six countries in eastern and southern Africa in 1995-2019: a multi-country surveillance study of verbal autopsy data.

BACKGROUND: The absence of high-quality comprehensive civil registration and vital statistics systems across many settings in Africa has led to little empirical data on causes of death in the region. We aimed to use verbal autopsy data to provide comparative, population-based estimates of cause-specific mortality among adolescents and adults in eastern and southern Africa. METHODS: In this surveillance study, we harmonised verbal autopsy and residency data from nine health and demographic surveillance system (HDSS) sites in Kenya, Malawi, Tanzania, South Africa, Uganda, and Zimbabwe, each with variable coverage from Jan 1, 1995, to Dec 31, 2019. We included all deaths to adolescents and adults aged 12 or over that were residents of the study sites and had a verbal autopsy conducted. InSilicoVA, a probabilistic model, was used to assign cause of death on the basis of the signs and symptoms reported in the verbal autopsy. Levels and trends in all-cause and cause-specific mortality rates and cause-specific mortality fractions were calculated, stratified by HDSS site, sex, age, and calendar periods. FINDINGS: 52 484 deaths and 5 157 802 person-years were reported among 1 071 913 individuals across the nine sites during the study period. 47 961 (91·4%) deaths had a verbal autopsy, of which 46 570 (97·1%) were assigned a cause of death. All-cause mortality generally decreased across the HDSS sites during this period, particularly for adults aged 20-59 years. In many of the HDSS sites, these decreases were driven by reductions in HIV and tuberculosis-related deaths. In 2010-14, the top causes of death were: road traffic accidents, HIV or tuberculosis, and meningitis or sepsis in adolescents (12-19 years); HIV or tuberculosis in adults aged 20-59 years; and neoplasms and cardiovascular disease in adults aged 60 years and older. There was greater between-HDSS and between-sex variation in causes of death for adolescents compared with adults. INTERPRETATION: This study shows progress in reducing mortality across eastern and southern Africa but also highlights age, sex, within-HDSS, and between-HDSS differences in causes of adolescent and adult deaths. These findings highlight the importance of detailed local data to inform health needs to ensure continued improvements in survival. FUNDING: National Institute of Child Health and Human Development of the US National Institutes of Health.

Risk of early horizontal transmission of hepatitis B virus in children of uninfected mothers in sub-Saharan Africa: a systematic review and meta-analysis.

BACKGROUND: Sub-Saharan Africa is highly endemic for hepatitis B virus (HBV); historically, most people were exposed during childhood through vertical or horizontal transmission. Although all African countries now provide a three-dose infant hepatitis B vaccination starting at age 6-8 weeks, only a third of African countries have introduced birth dose (HepB-BD) vaccine. Adding HepB-BD is fundamental to prevent vertical transmission, but its effectiveness in preventing horizontal transmission, compared with the three-dose infant vaccination alone, is unknown. We aimed to estimate the risk of early horizontal transmission in children of hepatitis B surface antigen (HBsAg)-negative mothers in sub-Saharan Africa stratified according to the vaccination schedule. METHODS: In this systematic review and meta-analysis we searched MEDLINE, Global Health, Embase, African Index Medicus and African Journals Online from their inception to Oct 24, 2022, for studies reporting HBsAg or HBV DNA, or both, in children (aged 0-5 years) of HBsAg-negative mothers. We excluded studies if children were only tested at birth. Two reviewers independently screened the titles and abstracts of all articles and data were extracted using a standardised pre-piloted data extraction sheet, and authors were contacted if any important information was missing. The primary outcome was the risk of HBV infection in children of HBsAg-negative mothers, stratified by vaccination schedule (no vaccination, first dose at 6-8 weeks, or first dose at birth). We pooled the child risks of HBsAg or HBV DNA-positivity from the age of 0 years to 5 years via a random-effect meta-analysis using a generalised linear mixed model. The study was registered on PROSPERO, CRD42021236203. FINDINGS: Of 8856 articles identified, 27 studies evaluating 10 003 children of HBsAg-negative mothers were included. The pooled risks of infection were 6·16% (95% CI 3·05-12·04; 155/1407) in the no vaccination group, 0·21% (0·04-1·15; 10/3425) in children who received their first dose at 6-8 weeks, and 0·05% (0·00-1·32; 3/2902) in children who received their first dose at birth. The difference was not statistically significant in children who received their first dose at 6-8 weeks and children who received their first dose at birth after adjusting for the study period, region, and maternal HIV status (test of moderators p=0·37). INTERPRETATION: In children of HBsAg-negative mothers, the risk of infection might be minimal even with the vaccination starting at 6-8 weeks, without clear additional benefit from HepB-BD. When births take place at home and timely administration of HepB-BD is challenging, antenatal HBsAg screening and selective HepB-BD might allow efficient allocation of resources to mother and child pairs at high risk compared with universal HepB-BD. FUNDING: None. TRANSLATION: For the French translation of the abstract see Supplementary Materials section.

Associations between HIV status and self-reported hypertension in a high HIV prevalence sub-Saharan African population: a cross-sectional study.

OBJECTIVES: This study examined whether HIV status and antiretroviral therapy (ART) exposure were associated with self-reported hypertension in Zimbabwe. DESIGN: Study data were taken from a cross-sectional, general population survey, which included HIV testing (July 2018-December 2019). SETTING: The data were collected in Manicaland Province, Zimbabwe. PARTICIPANTS: 9780 people aged 15 years and above were included. OUTCOME MEASURE: Self-reported hypertension was the outcome measure. This was defined as reporting a previous diagnosis of hypertension by a doctor or nurse. After weighting of survey responses by age and sex using household census data, χ2 tests and logistic regression were used to explore whether HIV status and ART exposure were associated with self-reported hypertension. RESULTS: The weighted prevalence of self-reported hypertension was 13.6% (95% CI 12.9% to 14.2%) and the weighted prevalence of HIV was 11.1% (10.4% to 11.7%). In univariable analyses, there was no evidence of a difference in the weighted prevalence of self-reported hypertension between people living with HIV (PLHIV) and HIV-negative people (14.1%, 11.9% to 16.3% vs 13.3%, 12.6% to 14.0%; p=0.503) or between ART-exposed and ART-naive PLHIV (14.8%, 12.0% to 17.7% vs 12.8%, 9.1% to 16.4%,p=0.388). Adjusting for socio-demographic variables in logistic regression did not alter this finding (ORs:HIV status:0.88, 0.70 to 1.10, p=0.261; ART exposure:0.83, 0.53 to 1.30, p=0.411). CONCLUSIONS: Approximately one in seven PLHIV self-reported having hypertension, highlighting an important burden of disease. However, no associations were found between HIV status or ART exposure and self-reported hypertension, suggesting that it will be valuable to focus on managing other risk factors for hypertension in this population. These findings should be fully accounted for as Zimbabwe reorients its health system towards non-communicable disease control and management.

Relationship between psychological distress, health behaviours and future reports of hypertension among adults in East Zimbabwe: a cohort study.

INTRODUCTION: Extensive cross-sectional evidence has demonstrated an association between psychological distress (PD) and hypertension. However, evidence on the temporal relationship is limited, especially in low-income and middle-income countries. The role of health risk behaviours including smoking and alcohol consumption in this relationship is also largely unknown. The aim of this study was to investigate the association between PD and later development of hypertension, and how this association may have been influenced by health risk behaviours, among adults in east Zimbabwe. METHODS: The analysis included 742 adults (aged 15-54 years) recruited by the Manicaland general population cohort study, who did not have hypertension at baseline in 2012-2013, and who were followed until 2018-2019. In 2012-2013, PD was measured using the Shona Symptom Questionnaire, a screening tool validated for use in Shona-speaking countries including Zimbabwe (cut-off point: 7). Smoking, alcohol consumption and use of drugs (health risk behaviours) were also self-reported. In 2018-2019, participants reported if they had diagnosed with hypertension by a doctor or nurse. Logistic regression was used to assess the association between PD and hypertension. RESULTS: In 2012, 10.4% of the participants had PD. The odds of new reports of hypertension were 2.04 times greater (95% CI 1.16 to 3.59) among those with PD at baseline, after adjusting for sociodemographic and health risk behaviour variables. Female gender (adjusted odds ratio, AOR 6.89, 95% CI 2.71 to 17.53), older age (AOR 2.67, 95% CI 1.63 to 4.42), and greater wealth (AOR 2.10, 95% CI 1.04 to 4.24 more wealthy, 2.88, 95% CI 1.24 to 6.67 most wealthy) were significant risk factors for hypertension. The AOR for the relationship between PD and hypertension did not differ substantially between models with and without health risk behaviours. CONCLUSION: PD was associated with an increased risk of later reports of hypertension in the Manicaland cohort. Integrating mental health and hypertension services within primary healthcare may reduce the dual burden of these non-communicable diseases.

Strengthening the HIV prevention cascade to maximise epidemiological impact in eastern Zimbabwe: a modelling study.

BACKGROUND: HIV prevention cascades provide a systematic understanding of barriers to prevention. In this study we used mathematical modelling to understand the consequences of these barriers and how the cascade could be strengthened to maximise epidemiological impact, providing potentially important insights for programmes. METHODS: We used an individual-based model of HIV transmission (PopART-IBM), calibrated to data from the Manicaland cohort from eastern Zimbabwe. HIV prevention cascade estimates from this cohort were used as probabilities for indicators in the model representing an individual's motivation, access, and capacity to effectively use pre-exposure prophylaxis, voluntary male medical circumcision, and condoms. We examined how current barriers affect the number and distribution of HIV infections compared with a no-barrier scenario. Using assumptions about how interventions could strengthen the HIV prevention cascade, we estimated the reduction in HIV infections over a 10-year period through addressing different elements of the cascade. FINDINGS: 21 200 new potentially avertable HIV infections will occur over the next 10 years due to existing HIV prevention cascade barriers, 74·2% of the 28 500 new infections that would occur with existing barriers in a population of approximately 1·2 million adults. Removing these barriers would reduce HIV incidence below the benchmarks for epidemic elimination. Addressing all cascade steps in one priority population is substantially more effective than addressing one step across all populations. INTERPRETATION: Interventions exist in eastern Zimbabwe to reduce HIV towards elimination, but barriers of motivation, access, and effective use prevent their full effect being realised. Interventions need to be multilayered and address all steps along the HIV prevention cascade. Models incorporating the HIV prevention cascade can help to identify the main barriers to greater effectiveness. FUNDING: National Institutes of Mental Health, Bill & Melinda Gates Foundation, and Medical Research Council Centre for Global Infectious Disease Analysis funding from the UK Medical Research Council and UK Foreign, Commonwealth & Development Office (FCDO).

Status of the HIV epidemic in Manicaland, east Zimbabwe prior to the outbreak of the COVID-19 pandemic.

BACKGROUND: Manicaland province in eastern Zimbabwe has a high incidence of HIV. Completion of the seventh round of the Manicaland Survey in 2018-2019 provided the opportunity to assess the state of the epidemic prior to the start of the COVID-19 pandemic. The study aims were to: a) estimate HIV seroprevalence and assess whether prevalence has declined since the last round of the survey (2012-2013), b) describe and analyse the socio-demographic and behavioural risk factors for HIV infection and c) describe the HIV treatment cascade. METHODS: Participants were administered individual questionnaires collecting data on socio-demographic characteristics, sexual relationships, HIV prevention methods and treatment access, and were tested for HIV. Descriptive analyses were followed by univariate and multivariate analyses of risk factors for HIV seropositvity using logistic regression modelling based on the proximate-determinants framework. RESULTS: HIV prevalence was 11.3% [95% CI; 10.6-12.0] and was higher in females than males up to 45-49 years. Since 2012-2013 HIV prevalence has significantly declined in 30-44 year-olds in males, and 20-44 year-olds in females. The HIV epidemic has aged since 2012-2013, with an increase in the mean age of HIV positive persons from 38 to 41 years. Socio-demographic determinants of HIV prevalence were church denomination in males, site-type, wealth-status, employment sector and alcohol use in females, and age and marital status in both sexes. Behavioural determinants associated with increased odds of HIV were a higher number of regular sexual partners (lifetime), non-regular sexual partners (lifetime) and condom use in both sexes, and early sexual debut and concomitant STIs in females; medical circumcision was protective in males. HIV status awareness among participants testing positive in our study was low at 66.2%. ART coverage amongst all participants testing positive for HIV in our study was 65.0% and was lower in urban areas than rural areas, particularly in males. CONCLUSIONS: Prevalence has declined, and ART coverage increased, since 2012-2013. Majority of the associations with prevalence hypothesised by the theoretical framework were not observed in our data, likely due to underreporting of sexual risk behaviours or the treatment-as-prevention effect of ART curtailing the probability of transmission despite high levels of sexual risk behaviour. Further reductions in HIV incidence require strengthened primary prevention, HIV testing and linkage to risk behaviour counselling services. Our results serve as a valuable baseline against which to measure the impact of the COVID-19 pandemic on HIV prevalence and its determinants in Manicaland, Zimbabwe, and target interventions appropriately.

The determinants and impacts of age-disparate relationships on women in Zimbabwe: A life course perspective.

Age-disparate relationships (ADR) with older men have been studied mostly in the context of HIV and found to be associated with increased HIV prevalence among young women in sub-Saharan Africa. Less is known about the impact of ADR on the broader life course of women. The objectives of this study are to identify the factors associated with being in ADR and estimate the association between ADR and a set of life outcomes in Manicaland, Zimbabwe. We used data from a general population open-cohort survey from 1998 to 2013 in Manicaland. We applied binary logistic regression models to estimate the odds ratios for association between socio-demographic determinants and ADR and multinomial logistic regression models to estimate the association between ADR and women's life outcomes. We found that women with less education, younger age at first sex and first marriage were more likely to be in ADR, and women in ADR have male partners with less education and less skilled employment. In terms of life and relationship outcomes, women in ADR had mostly negative life outcomes compared to women not in ADR. Future policies and research on ADR in women should reflect these complexities and study a wider range of life outcomes, beyond the commonly studied narrower topics such as HIV.

Comprehensive investigation of sources of misclassification errors in routine HIV testing in Zimbabwe.

INTRODUCTION: Misclassification errors have been reported in rapid diagnostic HIV tests (RDTs) in sub-Saharan African countries. These errors can lead to missed opportunities for prevention-of-mother-to-child-transmission (PMTCT), early infant diagnosis and adult HIV-prevention, unnecessary lifelong antiretroviral treatment (ART) and wasted resources. Few national estimates or systematic quantifications of sources of errors have been produced. We conducted a comprehensive assessment of possible sources of misclassification errors in routine HIV testing in Zimbabwe. METHODS: RDT-based HIV test results were extracted from routine PMTCT programme records at 62 sites during national antenatal HIV surveillance in 2017. Positive- (PPA) and negative-percent agreement (NPA) for HIV RDT results and the false-HIV-positivity rate for people with previous HIV-positive results ("known-positives") were calculated using results from external quality assurance testing done for HIV surveillance purposes. Data on indicators of quality management systems, RDT kit performance under local climatic conditions and user/clerical errors were collected using HIV surveillance forms, data-loggers and a Smartphone camera application (7 sites). Proportions of cases with errors were compared for tests done in the presence/absence of potential sources of errors. RESULTS: NPA was 99.9% for both pregnant women (N = 17224) and male partners (N = 2173). PPA was 90.0% (N = 1187) and 93.4% (N = 136) for women and men respectively. 3.5% (N = 1921) of known-positive individuals on ART were HIV negative. Humidity and temperature exceeding manufacturers' recommendations, particularly in storerooms (88.6% and 97.3% respectively), and premature readings of RDT output (56.0%) were common. False-HIV-negative cases, including interpretation errors, occurred despite staff training and good algorithm compliance, and were not reduced by existing external or internal quality assurance procedures. PPA was lower when testing room humidity exceeded 60% (88.0% vs. 93.3%; p = 0.007). CONCLUSIONS: False-HIV-negative results were still common in Zimbabwe in 2017 and could be reduced with HIV testing algorithms that use RDTs with higher sensitivity under real-world conditions and greater practicality under busy clinic conditions, and by strengthening proficiency testing procedures in external quality assurance systems. New false-HIV-positive RDT results were infrequent but earlier errors in testing may have resulted in large numbers of uninfected individuals being on ART.

Age patterns of HIV incidence in eastern and southern Africa: a modelling analysis of observational population-based cohort studies.

BACKGROUND: As the HIV epidemic in sub-Saharan Africa matures, evidence about the age distribution of new HIV infections and how this distribution has changed over the epidemic is needed to guide HIV prevention. We aimed to assess trends in age-specific HIV incidence in six population-based cohort studies in eastern and southern Africa, reporting changes in mean age at infection, age distribution of new infections, and birth cohort cumulative incidence. METHODS: We used a Bayesian model to reconstruct age-specific HIV incidence from repeated observations of individuals' HIV serostatus and survival collected among population HIV cohorts in rural Malawi, South Africa, Tanzania, Uganda, and Zimbabwe, in a collaborative analysis of the ALPHA network. We modelled HIV incidence rates by age, time, and sex using smoothing splines functions. We estimated incidence trends separately by sex and study. We used estimated incidence and prevalence results for 2000-17, standardised to study population distribution, to estimate mean age at infection and proportion of new infections by age. We also estimated cumulative incidence (lifetime risk of infection) by birth cohort. FINDINGS: Age-specific incidence declined at all ages, although the timing and pattern of decline varied by study. The mean age at infection was higher in men (cohort mean 27·8-34·6 years) than in women (24·8-29·6 years). Between 2000 and 2017, the mean age at infection per cohort increased slightly: 0·5 to 2·8 years among men and -0·2 to 2·5 years among women. Across studies, between 38% and 63% (cohort medians) of the infections in women were among those aged 15-24 years and between 30% and 63% of infections in men were in those aged 20-29 years. Lifetime risk of HIV declined for successive birth cohorts. INTERPRETATION: HIV incidence declined in all age groups and shifted slightly to older ages. Disproportionate new HIV infections occur among women aged 15-24 years and men aged 20-29 years, supporting focused prevention in these groups. However, 40-60% of infections were outside these ages, emphasising the importance of providing appropriate HIV prevention to adults of all ages. FUNDING: Bill & Melinda Gates Foundation.

Improving risk perception and uptake of voluntary medical male circumcision with peer-education sessions and incentives, in Manicaland, East Zimbabwe: study protocol for a pilot randomised trial.

BACKGROUND: Voluntary medical male circumcision (VMMC) is a key component of combination HIV-prevention programmes. Several high-HIV-prevalence countries in sub-Saharan Africa, including Zimbabwe, are looking to scale up VMMC activities. There is limited evidence on how a combination of social learning from peer education by a role model with different behavioural incentives influences demand for VMMC in such settings. METHODS/DESIGN: This matched-cluster randomised controlled trial with 1740 participants will compare two behavioural incentives against a control with no intervention. In the intervention clusters, participants will participate in an education session delivered by a circumcised young male ("role model") on the risks of HIV infection and the benefits from medical male circumcision. All participants will receive contributions towards transport costs to access medical male circumcision at participating clinics. Via blocked randomisation, in the intervention clusters participants will be randomly assigned to receive one of two types of incentives - fixed cash payment or lottery payment - both conditional on undergoing surgical VMMC. In two sites, a community-led intervention will also be implemented to address social obstacles and to increase support from peers, families and social structures. Baseline measures of endpoints will be gathered in surveys. Follow-up assessment at 6 months will include self-reported uptake of VMMC triangulated with clinic data. DISCUSSION: This is the first trial to pilot-test social learning to improve risk perception and self-efficacy and to address the fear of pain associated with VMMC and possible present-biased preferences with front-loaded compensations as well as fixed or lottery-based cash payments. This study will generate important knowledge to inform HIV-prevention policies about the effectiveness of behavioural interventions and incentives, which could be easily scaled-up. TRIAL REGISTRATION: This trial has been registered on ClinicalTrials.gov (identifier: NCT03565588). Registered on 21 June 2018.

Application of the HIV prevention cascade to identify, develop and evaluate interventions to improve use of prevention methods: examples from a study in east Zimbabwe.

INTRODUCTION: The HIV prevention cascade could be used in developing interventions to strengthen implementation of efficacious HIV prevention methods, but its practical utility needs to be demonstrated. We propose a standardized approach to using the cascade to guide identification and evaluation of interventions and demonstrate its feasibility for this purpose through a project to develop interventions to improve HIV prevention methods use by adolescent girls and young women (AGYW) and potential male partners in east Zimbabwe. DISCUSSION: We propose a six-step approach to using a published generic HIV prevention cascade formulation to develop interventions to increase motivation to use, access to and effective use of an HIV prevention method. These steps are as follows: (1) measure the HIV prevention cascade for the chosen population and method; (2) identify gaps in the cascade; (3) identify explanatory factors (barriers) contributing to observed gaps; (4) review literature to identify relevant theoretical frameworks and interventions; (5) tailor interventions to the local context; and (6) implement and evaluate the interventions using the cascade steps and explanatory factors as outcome indicators in the evaluation design. In the Zimbabwe example, steps 1-5 aided development of four interventions to overcome barriers to effective use of pre-exposure prophylaxis (PrEP) in AGYW (15-24 years) and voluntary medical male circumcision in male partners (15-29). For young men, prevention cascade analyses identified gaps in motivation and access as barriers to voluntary medical male circumcision uptake, so an intervention was designed including financial incentives and an education session. For AGYW, gaps in motivation (particularly lack of risk perception) and access were identified as barriers to PrEP uptake: an interactive counselling game was developed addressing these barriers. A text messaging intervention was developed to improve PrEP adherence among AGYW, addressing reasons underlying lack of effective PrEP use through improving the capacity ("skills") to take PrEP effectively. A community-led intervention (community conversations) was developed addressing community-level factors underlying gaps in motivation, access and effective use. These interventions are being evaluated currently using outcomes from the HIV prevention cascade (step 6). CONCLUSIONS: The prevention cascade can guide development and evaluation of interventions to strengthen implementation of HIV prevention methods by following the proposed process.

Improving risk perception and uptake of pre-exposure prophylaxis (PrEP) through interactive feedback-based counselling with and without community engagement in young women in Manicaland, East Zimbabwe: study protocol for a pilot randomized trial.

BACKGROUND: HIV incidence in adolescent girls and young women remains high in sub-Saharan Africa. Progress towards uptake of HIV prevention methods remains low. Studies of oral pre-exposure prophylaxis (PrEP) have shown that uptake and adherence may be low due to low-risk perception and ambivalence around using antiretrovirals for prevention. No evidence exists on whether an interactive intervention aimed at adjusting risk perception and addressing the uncertainty around PrEP will improve uptake. This pilot research trial aims to provide an initial evaluation of the impact of an interactive digital tablet-based counselling session, correcting risk perception, and addressing ambiguity around availability, usability, and effectiveness of PrEP. METHODS/DESIGN: This is a matched-cluster randomized controlled trial which will compare an interactive tablet-based education intervention against a control with no intervention. The study will be implemented in eight sites. In each site, two matched clusters of villages will be created. One cluster will be randomly allocated to intervention. In two sites, a community engagement intervention will also be implemented to address social obstacles and to increase support from peers, families, and social structures. A total of 1200 HIV-negative young women aged 18-24 years, not on PrEP at baseline, will be eligible. Baseline measures of endpoints will be gathered in surveys. Follow-up assessment at six months will include biomarkers of PrEP uptake and surveys. DISCUSSION: This will be the first randomized controlled trial to determine whether interactive feedback counselling leads to uptake of HIV prevention methods such as PrEP and reduces risky sexual behavior. If successful, policymakers could consider such an intervention in school-based education campaigns or as post-HIV-testing counselling for young people. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03565575. Registered on 21 June 2018.