Reducing Vulnerability in the Intimate Partnerships of Female Sex Workers Sex Workers

HIV Clinical Trial

— SamPlus  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02807259
• Other study ID #: SamPlus01
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: October 2017

Study information

• Verified date: March 2020
• Source: Karnataka Health Promotion Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 809
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• Sexual Behaviour
• Violence

Intervention

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.

Locations

Country	Name	City	State
India	Karnataka Health Promotion Trust	Bengaluru	Karnataka

Sponsors (3)

Lead Sponsor	Collaborator
Karnataka Health Promotion Trust	London School of Hygiene and Tropical Medicine, University of Manitoba

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intimate Partner Violence	Proportion of FSWs who report experiencing any intimate partner violence in the last 6 months	27 months after implementing the intervention
Primary	Severe Intimate Partner Violence	Proportion of sex workers experienced severe physical and/or sexual violence from intimate partners in the past 6 months	27 months after implementing the intervention
Primary	Condom Use	Proportion of sex workers who report consistent condom use in their intimate relationship in the last 30 days	27 months after implementing the intervention
Secondary	Changes in Acceptance of Violence	Change in the proportion of FSWs who report violent actions from intimate partners to be unacceptable	27 months after implementing the intervention
Secondary	Change in Disclosure of Violence From Intimate Partners	Change in proportion of FSWs who are willing to disclose incidences of violence by their intimate partner	27 months after implementing the intervention
Secondary	Changes in Self-efficacy	Proportion of FSWs who report ability to negotiate condom use and HIV/STI testing by their IP	27 months after implementing the intervention
Secondary	Changes in Solidarity Among FSWs Around Violence	Change in proportion of FSWs who support their peers to reduce incidences of violence among FSWs	27 months after implementing the intervention