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

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Abstract

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.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-022-06119-w.

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Most cited references 35

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Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

T C Hoffmann, P P Glasziou, I Boutron … (2015)

Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.

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Implementation strategies: recommendations for specifying and reporting

Enola K. Proctor, Byron J. Powell, J. McMillen (2013)

Implementation strategies have unparalleled importance in implementation science, as they constitute the ‘how to’ component of changing healthcare practice. Yet, implementation researchers and other stakeholders are not able to fully utilize the findings of studies focusing on implementation strategies because they are often inconsistently labelled and poorly described, are rarely justified theoretically, lack operational definitions or manuals to guide their use, and are part of ‘packaged’ approaches whose specific elements are poorly understood. We address the challenges of specifying and reporting implementation strategies encountered by researchers who design, conduct, and report research on implementation strategies. Specifically, we propose guidelines for naming, defining, and operationalizing implementation strategies in terms of seven dimensions: actor, the action, action targets, temporality, dose, implementation outcomes addressed, and theoretical justification. Ultimately, implementation strategies cannot be used in practice or tested in research without a full description of their components and how they should be used. As with all intervention research, their descriptions must be precise enough to enable measurement and ‘reproducibility.’ We propose these recommendations to improve the reporting of implementation strategies in research studies and to stimulate further identification of elements pertinent to implementation strategies that should be included in reporting guidelines for implementation strategies.

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A community empowerment approach to the HIV response among sex workers: effectiveness, challenges, and considerations for implementation and scale-up.

Deanna Kerrigan, Caitlin Kennedy, Ruth Morgan-Thomas … (2015)

A community empowerment-based response to HIV is a process by which sex workers take collective ownership of programmes to achieve the most effective HIV outcomes and address social and structural barriers to their overall health and human rights. Community empowerment has increasingly gained recognition as a key approach for addressing HIV in sex workers, with its focus on addressing the broad context within which the heightened risk for infection takes places in these individuals. However, large-scale implementation of community empowerment-based approaches has been scarce. We undertook a comprehensive review of community empowerment approaches for addressing HIV in sex workers. Within this effort, we did a systematic review and meta-analysis of the effectiveness of community empowerment in sex workers in low-income and middle-income countries. We found that community empowerment-based approaches to addressing HIV among sex workers were significantly associated with reductions in HIV and other sexually transmitted infections, and with increases in consistent condom use with all clients. Despite the promise of a community-empowerment approach, we identified formidable structural barriers to implementation and scale-up at various levels. These barriers include regressive international discourses and funding constraints; national laws criminalising sex work; and intersecting social stigmas, discrimination, and violence. The evidence base for community empowerment in sex workers needs to be strengthened and diversified, including its role in aiding access to, and uptake of, combination interventions for HIV prevention. Furthermore, social and political change are needed regarding the recognition of sex work as work, both globally and locally, to encourage increased support for community empowerment responses to HIV.

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Author and article information

Contributors

Frances M. Cowan:

ORCID: http://orcid.org/0000-0003-3087-4422

frances.cowan@lstmed.ac.uk

Fortunate Machingura: fmachingura@ceshhar.co.zw

Sungai T. Chabata: sungai@ceshhar.co.zw

M. Sanni Ali: Sanni.ali@lshtm.ac.uk

Joanna Busza: Joanna.Busza@lshtm.ac.uk

Richard Steen: steenr7@gmail.com

Nicola Desmond: nicola.desmond@lstmed.ac.uk

Maryam Shahmanesh: m.shahmanesh@ucl.ac.uk

Paul Revill: paul.revill@york.ac.uk

Amon Mpofu: ampofu@nac.org.zw

Raymond Yekeye: ryekeye@nac.org.zw

Owen Mugurungi: atp.director@ymail.com

Andrew N. Phillips: andrew.phillips@ucl.ac.uk

James R. Hargreaves: James.Hargreaves@lshtm.ac.uk

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 12 March 2022

Publication date PMC-release: 12 March 2022

Publication date Collection: 2022

Volume: 23

Electronic Location Identifier: 209

Affiliations

[1 ]GRID grid.48004.38, ISNI 0000 0004 1936 9764, Department of International Public Health, , Liverpool School of Tropical Medicine, ; Pembroke Place, Liverpool, United Kingdom

[2 ]Centre for Sexual Health Zimbabwe, 4 Bath Road, Belgravia, Harare, Zimbabwe

[3 ]GRID grid.8991.9, ISNI 0000 0004 0425 469X, Public Health, Environments and Society, , London School of Hygiene and Tropical Medicine, ; Keppel Street, London, United Kingdom

[4 ]GRID grid.83440.3b, ISNI 0000000121901201, Institute for Global Health, , University College London, ; Gower Street, London, United Kingdom

[5 ]GRID grid.5685.e, ISNI 0000 0004 1936 9668, Centre for Health Economics, , University of York, ; York, United Kingdom

[6 ]GRID grid.463487.a, National AIDS Council Zimbabwe, ; Harare, Zimbabwe

[7 ]GRID grid.415818.1, Ministry of Health and Child Care Zimbabwe, ; Harare, Zimbabwe

Author information

Frances M. Cowan http://orcid.org/0000-0003-3087-4422

Article

Publisher ID: 6119

DOI: 10.1186/s13063-022-06119-w

PMC ID: 8917622

PubMed ID: 35279215

SO-VID: a950831f-d7e5-4b59-85b5-569fa3df5e1c

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 28 April 2021

Date accepted : 16 February 2022

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100004440, Wellcome Trust;

Award ID: 214280/Z/18/Z

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: effectiveness,hidden population,pragmatic trials,randomised control trial,respondent driven sampling,sex workers

Data availability:

ScienceOpen disciplines: Medicine

Keywords: effectiveness, hidden population, pragmatic trials, randomised control trial, respondent driven sampling, sex workers

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

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Abstract

Background

Methods

Discussion

Trial registration

Supplementary Information

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UCL: UN SDG 03 Good Health and Well-Being

Most cited references 35

Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

Implementation strategies: recommendations for specifying and reporting

A community empowerment approach to the HIV response among sex workers: effectiveness, challenges, and considerations for implementation and scale-up.

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