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Trial record 1 of 1 for:    NCT02807259
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Reducing Vulnerability in the Intimate Partnerships of Female Sex Workers Sex Workers (SamPlus)

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ClinicalTrials.gov Identifier: NCT02807259
Recruitment Status : Completed
First Posted : June 21, 2016
Last Update Posted : November 24, 2017
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
University of Manitoba
Information provided by (Responsible Party):
Karnataka Health Promotion Trust

Brief Summary:

Female sex workers (FSWs) frequently experience violence from their intimate partners (non-paying lovers), which compromises their health and increases their the risk of infection with HIV or other sexually transmitted infections. Samdevena Plus is a complex multi-level intervention that works with FSWs, their intimate partners, the sex worker community and the general population. The intervention aims to reduce partner violence and increase consistent condom use within these relationships.

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.


Condition or disease Intervention/treatment Phase
Violence Sexual Behaviour HIV Behavioral: Multi-level intervention Not Applicable

Detailed Description:

Female sex workers (FSWs) are at increased risk of HIV and sexually transmitted infections (STI) compared to women in the general population, and frequently experience violence in their working and domestic lives from a variety of perpetrators, which can enhance this risk. While progress has been made in addressing violence by police and clients, little work has been done to understand and prevent violence by intimate partners (IPs) among FSW populations.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 547 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Samvedana Plus: An Intervention With Female Sex Workers (FSWs) and Their Intimate Partners to Reduce Partner Violence and Increase Consistent Condom Use Within Intimate Relationships
Study Start Date : January 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Multi-level intervention
This is a cluster-randomised controlled trial design. The unit of randomisation is village.
Behavioral: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Condom use [ Time Frame: 30 days ]
    Proportion of sex workers who report consistent condom use in their intimate relationship

  2. Intimate partner violence [ Time Frame: 6 months ]
    Proportion of FSWs who report experiencing intimate partner violence

  3. Severe intimate partner violence [ Time Frame: 6 months ]
    Proportion of sex workers experienced severe physical and/or sexual violence from intimate partners


Secondary Outcome Measures :
  1. Self-efficacy [ Time Frame: 6 months ]
    Proportion of FSWs who report ability to negotiate condom use and HIV/STI testing by their IP

  2. Reduced acceptance of violence [ Time Frame: 6 months ]
    Proportion of FSWs who report acceptance of violence by the intimate partners

  3. Increased disclosure of violence from intimate partners [ Time Frame: 6 months ]
    Proportion of FSWs who are willing to disclose incidences of violence by their intimate partner

  4. Increased solidarity among FSWs around violence [ Time Frame: 6 months ]
    Proportion of FSWs who support their peers to reduce incidences of violence among FSWs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female Sex Workers who engage in commercial sex and who currently have an intimate partner or have had an intimate partner in the last 6 months, living in any of the 47 villages.

Exclusion Criteria:

  • Female sex workers aged younger than 18 years, who do not have an intimate partner or have not had one in the last 6 months, or who live outside of the villages.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807259


Locations
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India
Karnataka Health Promotion Trust
Bengaluru, Karnataka, India
Sponsors and Collaborators
Karnataka Health Promotion Trust
London School of Hygiene and Tropical Medicine
University of Manitoba
Investigators
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Principal Investigator: Lori Heise London School of Hygiene and Tropical Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Karnataka Health Promotion Trust
ClinicalTrials.gov Identifier: NCT02807259     History of Changes
Other Study ID Numbers: SamPlus01
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be anonymised and made available for secondary analyses on request, following publication of trial findings.