Reducing Vulnerability in the Intimate Partnerships of Female Sex Workers Sex Workers
NCT ID: NCT02807259
Last Updated: 2020-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
809 participants
INTERVENTIONAL
2015-01-31
2017-10-31
Brief Summary
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The intervention consists of: (i) couples counselling sessions between FSWs and their intimate partners; (ii) separate group work among FSWs and intimate partners to increase self-esteem and encourage reflection about violence; (iii) strengthening supportive crisis management systems that address domestic and sex worker violence; (iv) training male 'champions' to encourage action against violence; and (v) training media to promote informed discussions about violence and HIV risk.The program involves changing perceptions on acceptability of physical violence as a form of discipline, challenging assumptions that give men authority over women, and working with men and women to encourage new relationship models based on equality and respect. The intervention will reach 800 FSWs and their intimate partners living in 47 villages in north Karnataka, India. The evaluation uses a cluster-randomized control trial design that introduces the intervention into half of villages for the first 24 months and the remaining half receive the intervention thereafter. The primary outcomes of the trial are: the proportion of FSWs who report: i) consistent condom use in their intimate relationship; and ii) experiencing partner violence within the past 6 months.
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Detailed Description
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Samvedana Plus is a multi-level intervention programme that works with FSWs, their IPs, the sex worker community, and the general population, and aims to reduce violence and increase consistent condom use within these 'intimate' relationships. The programme involves shifting norms around the acceptability of beating as a form of discipline, challenging gender roles that give men authority over women, and working with men and women to encourage new relationship models based on gender equity and respect. The programme will aim to cover 800 FSWs and their IPs living in 47 villages in Bagalkot district, northern Karnataka. The study is designed to assess three primary outcomes: the proportion of FSWs who report: (i) any physical or sexual partner violence; (ii) severe/moderate physical or sexual partner violence in the last 6 months; and iii) consistent condom use in their intimate relationship. The evaluation will employ a cluster-randomised controlled trial design, with 50% of the village clusters (n=24) randomly selected to receive the intervention for the first 24 months and the remaining 50% (n=23) receiving the intervention thereafter. Statisticians will be blinded to treatment arm allocation. The evaluation will use an adjusted, individual-level intention to treat analysis, comparing outcomes in intervention and control villages at endline (24 months) using a mixed effects logistic model. We will adjust for confounders in two ways: i) outcome variables are adjusted for at a cluster level using the mean baseline summaries; ii) other variables will be adjusted for an at an individual level using endline data. We will include all women survey at endline. We will also report cluster-level summaries by trial arm for each primary and secondary outcome to double check our analyses. The evaluation design will involve quantitative and qualitative assessments with (i) all FSWs who report an IP (ii) IPs; and process/ implementation monitoring.
This is an innovative intervention programme that aims to address violence by IPs as part of HIV prevention programming with FSWs. Reducing violence is expected to reduce vulnerability to HIV acquisition, and help women to work and live without fear of violence.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Multi-level intervention
This is a cluster-randomised controlled trial design. The unit of randomisation is village.
Multi-level intervention
At the individual level, the intervention will focus on: (i) structured reflection groups for FSWs to enhance self-esteem, encourage critical reflection around gender norms and violence, and build individual and collective efficacy; (ii) separate sessions for intimate partners to discuss issues around violence and condom use as well as gender, equity, respect and responsibility; (iii) skills building around female condoms (iv) access to individual and couples-based counselling. At the community level, the intervention will focus on: (i) strengthening the supportive crisis management systems so that they are able to address 'domestic' as well as 'work-place' violence among FSWs and (ii) building an environment that encourages action against violence from intimate partners by training male champions and developing folk media troops to generate discussion around gender, masculinity, violence and HIV risk behaviours.
Control
The intervention will rolled out to all participating villages after 24 months.
Multi-level intervention
At the individual level, the intervention will focus on: (i) structured reflection groups for FSWs to enhance self-esteem, encourage critical reflection around gender norms and violence, and build individual and collective efficacy; (ii) separate sessions for intimate partners to discuss issues around violence and condom use as well as gender, equity, respect and responsibility; (iii) skills building around female condoms (iv) access to individual and couples-based counselling. At the community level, the intervention will focus on: (i) strengthening the supportive crisis management systems so that they are able to address 'domestic' as well as 'work-place' violence among FSWs and (ii) building an environment that encourages action against violence from intimate partners by training male champions and developing folk media troops to generate discussion around gender, masculinity, violence and HIV risk behaviours.
Interventions
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Multi-level intervention
At the individual level, the intervention will focus on: (i) structured reflection groups for FSWs to enhance self-esteem, encourage critical reflection around gender norms and violence, and build individual and collective efficacy; (ii) separate sessions for intimate partners to discuss issues around violence and condom use as well as gender, equity, respect and responsibility; (iii) skills building around female condoms (iv) access to individual and couples-based counselling. At the community level, the intervention will focus on: (i) strengthening the supportive crisis management systems so that they are able to address 'domestic' as well as 'work-place' violence among FSWs and (ii) building an environment that encourages action against violence from intimate partners by training male champions and developing folk media troops to generate discussion around gender, masculinity, violence and HIV risk behaviours.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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London School of Hygiene and Tropical Medicine
OTHER
University of Manitoba
OTHER
Karnataka Health Promotion Trust
OTHER
Responsible Party
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Principal Investigators
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Lori Heise
Role: PRINCIPAL_INVESTIGATOR
London School of Hygiene and Tropical Medicine
Locations
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Karnataka Health Promotion Trust
Bengaluru, Karnataka, India
Countries
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References
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Javalkar P, Platt L, Prakash R, Beattie TS, Collumbien M, Gafos M, Ramanaik S, Davey C, Jewkes R, Watts C, Bhattacharjee P, Thalinja R, Dl K, Isac S, Heise L. Effectiveness of a multilevel intervention to reduce violence and increase condom use in intimate partnerships among female sex workers: cluster randomised controlled trial in Karnataka, India. BMJ Glob Health. 2019 Nov 6;4(6):e001546. doi: 10.1136/bmjgh-2019-001546. eCollection 2019.
Javalkar P, Platt L, Prakash R, Beattie T, Bhattacharjee P, Thalinja R, L KD, Sangha CATM, Ramanaik S, Collumbien M, Davey C, Moses S, Jewkes R, Isac S, Heise L. What determines violence among female sex workers in an intimate partner relationship? Findings from North Karnataka, south India. BMC Public Health. 2019 Mar 29;19(1):350. doi: 10.1186/s12889-019-6673-9.
Beattie TS, Isac S, Bhattacharjee P, Javalkar P, Davey C, Raghavendra T, Nair S, Ramanaik S, Kavitha DL, Blanchard JF, Watts C, Collumbien M, Moses S, Heise L. Reducing violence and increasing condom use in the intimate partnerships of female sex workers: study protocol for Samvedana Plus, a cluster randomised controlled trial in Karnataka state, south India. BMC Public Health. 2016 Jul 29;16:660. doi: 10.1186/s12889-016-3356-7.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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SamPlus01
Identifier Type: -
Identifier Source: org_study_id
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