Differentiated prevention and care to reduce the risk of HIV acquisition and transmission among female sex workers in Zimbabwe: study protocol for the 'AMETHIST' cluster randomised trial

BACKGROUND: Female sex workers (FSW) in sub-Saharan Africa are disproportionately affected by HIV and are critical to engage in HIV prevention, testing and care services. We describe the design of our evaluation of the 'AMETHIST' intervention, nested within a nationally-scaled programme for FSW in Zimbabwe. We hypothesise that the implementation of this intervention will result in a reduction in the risk of HIV transmission within sex work. METHODS: The AMETHIST intervention (Adapted Microplanning to Eliminate Transmission of HIV in Sex Transactions) is a risk-differentiated intervention for FSW, centred around the implementation of microplanning and self-help groups. It is designed to support uptake of, and adherence to, HIV prevention, testing and treatment behaviours among FSW. Twenty-two towns in Zimbabwe were randomised to receive either the Sisters programme (usual care) or the Sisters programme plus AMETHIST. The composite primary outcome is defined as the proportion of all FSW who are at risk of either HIV acquisition (HIV-negative and not fully protected by prevention interventions) or of HIV transmission (HIV-positive, not virally suppressed and not practicing consistent condom use). The outcome will be assessed after 2 years of intervention delivery in a respondent-driven sampling survey (total n = 4400; n = 200 FSW recruited at each site). Primary analysis will use the 'RDS-II' method to estimate cluster summaries and will adapt Hayes and Moulton's '2-step' method produce adjusted effect estimates. An in-depth process evaluation guided by our project trajectory will be undertaken. DISCUSSION: Innovative pragmatic trials are needed to generate evidence on effectiveness of combination interventions in HIV prevention and treatment in different contexts. We describe the design and analysis of such a study. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR202007818077777 . Registered on 2 July 2020

Differentiated prevention and care to reduce the risk of HIV acquisition and transmission among female sex workers in Zimbabwe:study protocol for the ‘AMETHIST’ cluster randomised trial

Background: Female sex workers (FSW) in sub-Saharan Africa are disproportionately affected by HIV and are critical to engage in HIV prevention, testing and care services. We describe the design of our evaluation of the ‘AMETHIST’ intervention, nested within a nationally-scaled programme for FSW in Zimbabwe. We hypothesise that the implementation of this intervention will result in a reduction in the risk of HIV transmission within sex work. Methods: The AMETHIST intervention (Adapted Microplanning to Eliminate Transmission of HIV in Sex Transactions) is a risk-differentiated intervention for FSW, centred around the implementation of microplanning and self-help groups. It is designed to support uptake of, and adherence to, HIV prevention, testing and treatment behaviours among FSW. Twenty-two towns in Zimbabwe were randomised to receive either the Sisters programme (usual care) or the Sisters programme plus AMETHIST. The composite primary outcome is defined as the proportion of all FSW who are at risk of either HIV acquisition (HIV-negative and not fully protected by prevention interventions) or of HIV transmission (HIV-positive, not virally suppressed and not practicing consistent condom use). The outcome will be assessed after 2 years of intervention delivery in a respondent-driven sampling survey (total n = 4400; n = 200 FSW recruited at each site). Primary analysis will use the ‘RDS-II’ method to estimate cluster summaries and will adapt Hayes and Moulton’s ‘2-step’ method produce adjusted effect estimates. An in-depth process evaluation guided by our project trajectory will be undertaken. Discussion: Innovative pragmatic trials are needed to generate evidence on effectiveness of combination interventions in HIV prevention and treatment in different contexts. We describe the design and analysis of such a study. Trial registration: Pan African Clinical Trials Registry PACTR202007818077777. Registered on 2 July 2020.</p

Differentiated prevention and care to reduce the risk of HIV acquisition and transmission among female sex workers in Zimbabwe:study protocol for the ‘AMETHIST’ cluster randomised trial

Background: Female sex workers (FSW) in sub-Saharan Africa are disproportionately affected by HIV and are critical to engage in HIV prevention, testing and care services. We describe the design of our evaluation of the ‘AMETHIST’ intervention, nested within a nationally-scaled programme for FSW in Zimbabwe. We hypothesise that the implementation of this intervention will result in a reduction in the risk of HIV transmission within sex work. Methods: The AMETHIST intervention (Adapted Microplanning to Eliminate Transmission of HIV in Sex Transactions) is a risk-differentiated intervention for FSW, centred around the implementation of microplanning and self-help groups. It is designed to support uptake of, and adherence to, HIV prevention, testing and treatment behaviours among FSW. Twenty-two towns in Zimbabwe were randomised to receive either the Sisters programme (usual care) or the Sisters programme plus AMETHIST. The composite primary outcome is defined as the proportion of all FSW who are at risk of either HIV acquisition (HIV-negative and not fully protected by prevention interventions) or of HIV transmission (HIV-positive, not virally suppressed and not practicing consistent condom use). The outcome will be assessed after 2 years of intervention delivery in a respondent-driven sampling survey (total n = 4400; n = 200 FSW recruited at each site). Primary analysis will use the ‘RDS-II’ method to estimate cluster summaries and will adapt Hayes and Moulton’s ‘2-step’ method produce adjusted effect estimates. An in-depth process evaluation guided by our project trajectory will be undertaken. Discussion: Innovative pragmatic trials are needed to generate evidence on effectiveness of combination interventions in HIV prevention and treatment in different contexts. We describe the design and analysis of such a study. Trial registration: Pan African Clinical Trials Registry PACTR202007818077777. Registered on 2 July 2020.</p

Potential reduction in female sex workers' risk of contracting HIV during coronavirus disease 2019.

Female sex workers' livelihoods in Zimbabwe have been severely impacted by the coronavirus disease 2019 pandemic due to closure of entertainment venues. Competition over fewer clients has reduced ability to negotiate condom use. At the same time as partner numbers have decreased, frequency of reported condomless sex has not increased, suggesting potential reduction in overall HIV and sexually transmitted infection risk and an opportunity for programmes to reach sex workers with holistic social and economic support and prevention services

90‐90‐90 by 2020? Estimation and projection of the adult HIV epidemic and ART programme in Zimbabwe – 2017 to 2020

INTRODUCTION: The 90-90-90 targets set by the United Nations aspire to 73% of people living with HIV (PLHIV) being virally suppressed by 2020. Using the HIV Synthesis Model, we aim to mimic the epidemic in Zimbabwe and make projections to assess whether Zimbabwe is on track to meet the 90-90-90 targets and assess whether recently proposed UNAIDS HIV transition metrics are likely to be met. METHODS: We used an approximate Bayesian computation approach to identify model parameter values which result in model outputs consistent with observed data, evaluated using a calibration score. These parameter values were then used to make projections to 2020 to compare with the 90-90-90 targets and other key indicators. We also calculated HIV transition metrics proposed by UNAIDS (percentage reduction in new HIV infections and AIDS-related mortality from 2010 to 2020, absolute rate of new infections and AIDS-related mortality, incidence-mortality ratio and incidence-prevalence ratios). RESULTS: After calibration, there was general agreement between modelled and observed data. The median predicted outcomes in 2020 were: proportion of PLHIV (aged 15 to 65) diagnosed 0.91 (90% uncertainty range 0.87, 0.94) (0.84 men, 0.95 women); of those diagnosed, proportion on treatment 0.92 (0.90, 0.93); of those receiving treatment, proportion with viral suppression 0.86 (0.81, 0.91). This results in 72% of PLHIV having viral suppression in 2020. We estimated a percentage reduction of 36.5% (13.7% increase to 67.4% reduction) in new infections from 2010 to 2020, and of 30.4% (9.7% increase to 56.6% reduction) in AIDS-related mortality (UNAIDS target 75%). The modelled absolute rates of HIV incidence and AIDS-related mortality in 2020 were 5.48 (2.26, 9.24) and 1.93 (1.31, 2.71) per 1000 person-years respectively. The modelled incidence-mortality ratio and incidence-prevalence ratios in 2020 were 1.05 (0.46, 1.66) and 0.009 (0.004, 0.013) respectively. CONCLUSIONS: Our model was able to produce outputs that are simultaneously consistent with an array of observed data and predicted that while the 90-90-90 targets are within reach in Zimbabwe, increased efforts are required in diagnosing men in particular. Calculation of the HIV transition metrics suggest increased efforts are needed to bring the HIV epidemic under control

Using a Programme Science approach to substantially reduce the risk of HIV transmission and acquisition in sex transactions among female sex workers in Zimbabwe

Introduction: We used a Programme Science platform, to generate evidence to support the implementation of programmes for sex workers in Africa. Female sex workers are estimated to make up 1.6% (1.3%–1.8%) of the population of women aged 15−49 years in Zimbabwe. We highlight how programme science can be used to help distinguish between when, where and with whom programmes need to be implemented and discuss two case studies that exemplify implementing better (Case study 1 (1 June 2019−30 June 2021) Optimizing implementation of a risk differentiated microplanning intervention) and implementing differently (Case study 2 (1 October 2016−30 September 2022) Reorientating implementation of DREAMS for young women selling sex). Methods: Zimbabwe's nationally scaled programme for sex workers was established in 2009 in partnership with sex workers to provide comprehensive services for sex workers and generate evidence for programme design, implementation and scale up. Since inception, comprehensive data have been collected from all sex workers seeking services. As the scope of service provision has expanded so has the scope of data collection and analysis. At enrolment, sex workers are assigned an alphanumeric unique identifier which links consultations within and across programme sites. We conduct descriptive analyses of the Key Population (KP) programme data to guide programme implementation and redesign, embedding programmatic qualitative enquiry as required. Results: Two case studies describing different approaches to programme optimization are presented. In the first, an optimization exercise was used to strengthen programme implementation ensuring that the KP programme got back on track after SARS‐COV‐2. In the second, an in‐depth review of research and programme data led to a re‐orientation of the DREAMS programme to ensure that young women at the highest risk of HIV acquisition were enrolled and had access to DREAMS social support interventions in turn strengthening their uptake of HIV prevention. Conclusions: Optimizing and sustaining HIV care and treatment programmes requires effective delivery with sufficient scale and intensity for population impact. Our programme science approach guided the scale up of the KP programme in Zimbabwe, providing evidence to support strategy, implementation and ongoing management, and importantly helping us distinguish between when we needed to just implement, implement better or implement differently

Strengthening the scale-up and uptake of effective interventions for sex workers for population impact in Zimbabwe.

INTRODUCTION: UNAIDS' goal of ending AIDS by 2030 is unreachable without better targeting of testing, prevention and care. Female sex workers (FSW) in Zimbabwe are at high risk of HIV acquisition and transmission. Here, we report on collated programme and research data from Zimbabwe's national sex work programme. We also assess the potential for wider population impact of FSW programmes by modelling the impact on HIV incidence of eliminating transmission through FSW (i.e. calculate the population attributable fraction of incidence attributable to sex work). METHODS: Descriptive analyses of individual-level programme data collected from FSW between 2009 and June 2018 are triangulated with data collected through 37 respondent driven sampling surveys from 19 sites in Zimbabwe 2011 to 2017. We describe programme coverage, uptake, retention and patterns of sex work behaviour and gaps in service provision. An individual-level stochastic simulation model is used to reconstruct the epidemic and then the incidence compared with the counter-factual trend in incidence from 2010 had transmission through sex work been eliminated from that date. RESULTS: Sisters has reached >67,000 FSW since 2009, increasing attendance as number of sites, programme staff and peer educators were increased. Over 57% of all FSW estimated to be working in Zimbabwe in 2017 (n = 40,000) attended the programme at least once. The proportion of young FSW reached has increased with introduction of the "Young Sisters programme." There are no clear differences in pattern of sex work across settings. Almost all women report condom use with clients at last sex (95%); however, consistent condom use with clients in the last month varies from 52% to 95% by site. Knowledge of HIV-positive status has increased from 48 to 78% between 2011 and 2016, as has prevalence of ART use among diagnosed women (29 to 67%). Although subject to uncertainty, modelling suggests that 70% (90% range: 32%, 93%) of all new infections in Zimbabwe from 2010 are directly or indirectly attributable to transmission via sex work. CONCLUSIONS: It is feasible to increase coverage and impact of sex work programming through community-led scale-up of evidence-based interventions. Eliminating transmission through commercial sex would likely have a substantial impact on new infections occurring more widely across Zimbabwe

Differentiated prevention and care to reduce the risk of HIV acquisition and transmission among female sex workers in Zimbabwe : study protocol for the ‘AMETHIST’ cluster randomised trial

Background: Female sex workers (FSW) in sub-Saharan Africa are disproportionately affected by HIV and are critical to engage in HIV prevention, testing and care services. We describe the design of our evaluation of the ‘AMETHIST’ intervention, nested within a nationally-scaled programme for FSW in Zimbabwe. We hypothesise that the implementation of this intervention will result in a reduction in the risk of HIV transmission within sex work. Methods: The AMETHIST intervention (Adapted Microplanning to Eliminate Transmission of HIV in Sex Transactions) is a risk-differentiated intervention for FSW, centred around the implementation of microplanning and self-help groups. It is designed to support uptake of, and adherence to, HIV prevention, testing and treatment behaviours among FSW. Twenty-two towns in Zimbabwe were randomised to receive either the Sisters programme (usual care) or the Sisters programme plus AMETHIST. The composite primary outcome is defined as the proportion of all FSW who are at risk of either HIV acquisition (HIV-negative and not fully protected by prevention interventions) or of HIV transmission (HIV-positive, not virally suppressed and not practicing consistent condom use). The outcome will be assessed after 2 years of intervention delivery in a respondent-driven sampling survey (total n = 4400; n = 200 FSW recruited at each site). Primary analysis will use the ‘RDS-II’ method to estimate cluster summaries and will adapt Hayes and Moulton’s ‘2-step’ method produce adjusted effect estimates. An in-depth process evaluation guided by our project trajectory will be undertaken. Discussion: Innovative pragmatic trials are needed to generate evidence on effectiveness of combination interventions in HIV prevention and treatment in different contexts. We describe the design and analysis of such a study. Trial registration: Pan African Clinical Trials Registry PACTR202007818077777. Registered on 2 July 2020

The effect on HIV transmission and cost-effectiveness of programmes for female sex workers in East, Central, and Southern Africa:a modelling study

BACKGROUND: HIV prevalence and incidence has declined in East, Central, and Southern Africa (ECSA), but remains high among female sex workers (FSWs). Sex worker programmes have the potential to considerably increase access to HIV testing, prevention, and treatment. We aimed to quantify these improvements by modelling the potential effect of sex worker programmes at two different intensities on HIV incidence and key health outcomes, and assessed the programmes' potential cost-effectiveness in order to help inform HIV policy decisions. METHODS: Using a model previously used to review policy decisions in ECSA, we assumed a low-intensity sex worker programme had run from 2010 until 2023; this resulted in care disadvantages among FSWs being reduced, and also increased testing, condom use, and willingness to take pre-exposure prophylaxis (PrEP). After 2023, three policy options were considered: discontinuation, continuation, and a scale-up of the programme to high-intensity, which would have a broader reach, and higher influences on condom use, antiretroviral therapy (ART) adherence, testing, and PrEP use. Outputs of the key outcomes (the percentage of FSWs who were diagnosed with HIV, on ART, and virally suppressed; the percentage of FSWs with zero condomless partners, and HIV incidence) were compared in 2030. The maximum cost for a sex worker programme to be cost-effective was calculated over a 50-year time period and in the context of 10 million adults. The cost-effectiveness analysis was conducted from a health-care perspective; costs and disability-adjusted life-years were both discounted to present US$values at 3$500 per disability-adjusted life-year averted, $34 million per year can be spent for a high-intensity programme to be cost-effective. INTERPRETATION: A sex worker programme, even with low-level interventions, has a positive effect on key outputs for FSWs. A high-intensity programme has a considerably higher effect; HIV incidence among FSW and in the general population can be substantially reduced, and should be considered for implementation by policy makers. FUNDING: Wellcome Trust

Track E Implementation Science, Health Systems and Economics

Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/138412/1/jia218443.pd